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其他類,äººé«”ç ”ç©¶å€«ç†å¯©æŸ¥å§”員會組織åŠé‹ä½œç®¡ç†è¾¦æ³•æ³•è¦å‘½ä»¤äººé«”ç ”ç©¶å€«ç†å¯©æŸ¥å§”員會組織åŠé‹ä½œç®¡ç†è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾äººé«”ç ”ç©¶æ³•ï¼ˆä»¥ä¸‹ç°¡ç¨±æœ¬æ³•ï¼‰ç¬¬ä¸ƒæ¢ç¬¬ä¸‰é …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法第三æ¢ç¬¬äºŒé …æ‰€å®šç ”ç©¶æ©Ÿæ§‹ï¼Œå¾—è¨ä¸€å€‹ä»¥ä¸Šå€«ç†å¯©æŸ¥å§”員會（以下簡稱審查會）。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …ç ”ç©¶æ©Ÿæ§‹ï¼ŒåŒ…æ‹¬å¸æ ¡ã€é†«é™¢ã€å…¬å‹™æ©Ÿé—œï¼ˆæ§‹ï¼‰ã€æ³•äººã€åœ˜é«”。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç ”ç©¶æ©Ÿæ§‹æ‡‰è¨‚å®šå¯©æŸ¥æœƒå§”å“¡é´è˜æ¢ä»¶ã€ç¨‹åºã€ä»»æœŸã€ä»»å‹™ã€é–‹æœƒç¨‹åºã€è°æ±ºæ–¹å¼ã€é‹ä½œåŠå…¶ä»–ç›¸é—œäº‹é …ç‰è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">審查會委員之姓åã€è·æ¥åŠèˆ‡ç ”究機構之關係，應予公開。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¯©æŸ¥æœƒå¯©æŸ¥ç ”ç©¶è¨ˆç•«ï¼Œæ‡‰å…ˆç¶œåˆè©•ä¼°ç ”究目的ã€ç ”究性質ã€è’集資料ã€è³‡è¨Šæˆ–檢體之é©ç•¶æ€§åŠä¾µå®³ç¨‹åº¦ç‰äº‹é …，判斷其為本法第五æ¢ç¬¬ä¸€é …所定得å…審查ã€æœ¬æ³•ç¬¬å…«æ¢æ‰€å®šç°¡æ˜“程åºå¯©æŸ¥æˆ–一般程åºå¯©æŸ¥æ¡ˆä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¯©æŸ¥æœƒæ‡‰è¨‚å®šä¸¦å…¬é–‹å¯©æŸ¥ç ”ç©¶è¨ˆç•«æ™‚ä¹‹å„é …æ¨™æº–ä½œæ¥ç¨‹åºï¼ŒåŒ…括接觸或擷å–使用å„種文件ã€æª”案與資料庫之權é™åŠç¨‹åºï¼Œä¸¦å®šæœŸæŸ¥æ ¸ã€æª¢è¨Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查會å¬é–‹ä¸€èˆ¬ç¨‹åºå¯©æŸ¥æœƒè°æ™‚，其出å¸å§”員應包括機構外之éžå…·ç”Ÿç‰©é†«å¸ç§‘å¸èƒŒæ™¯å§”員一人以上。</span> </p><p><span style="font-family: 新細明體,serif;">五人以上，ä¸è¶³ä¸ƒäººä¹‹å¯©æŸ¥æœƒï¼Œæ‡‰æœ‰ä¸‰åˆ†ä¹‹äºŒä»¥ä¸Šä¹‹å§”員出å¸ï¼›ä¸ƒäººä»¥ä¸Šä¹‹å¯©æŸ¥æœƒï¼Œæ‡‰æœ‰åŠæ•¸ä»¥ä¸Šä¹‹å§”員出å¸ï¼Œå§‹å¾—開會。</span> </p><p><span style="font-family: 新細明體,serif;">出å¸å§”å“¡å‡ç‚ºå–®ä¸€æ€§åˆ¥æ™‚，ä¸å¾—進行會è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查會應符åˆä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å¯©æŸ¥å§”å“¡åŠè¡Œæ”¿äº‹å‹™äººå“¡ï¼Œæ‡‰ç°½ç½²ä¿å¯†å”定。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¯©æŸ¥å§”å“¡åŠè¡Œæ”¿äº‹å‹™äººå“¡ï¼Œæ‡‰å®šæœŸæŽ¥å—教育訓練課程。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…·æœ‰é©ç•¶ä¹‹è¡Œæ”¿äº‹å‹™äººå“¡ï¼Œä¸¦å®šæ˜Žå…¶å·¥ä½œè·æŽŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å…·å‚™è™•ç†è¡Œæ”¿äº‹å‹™ä¹‹è™•æ‰€åŠé©ç•¶ä¹‹æª”案儲å˜ç©ºé–“。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第二款教育訓練課程è‰æ˜Žæ–‡ä»¶ï¼Œæ‡‰ç¶“審查會審查，並妥善ä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查委員é‡æœ‰ä¸‹åˆ—情形之一者，應å³è¿´é¿ï¼Œä¸å¾—åƒåŠ 審查：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç‚ºå—å¯©ç ”ç©¶è¨ˆç•«æˆ–å…¶å計畫之主æŒäººã€å”åŒä¸»æŒäººæˆ–委託人。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€èˆ‡å—å¯©ç ”ç©¶è¨ˆç•«ä¸»æŒäººæœ‰é…å¶ã€å››è¦ªç‰å…§ä¹‹è¡€è¦ªæˆ–三親ç‰å…§ä¹‹å§»è¦ªæˆ–曾有æ¤é—œä¿‚。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€èˆ‡å—å¯©ç ”ç©¶è¨ˆç•«å§”è¨—å» å•†å…·æœ‰è˜åƒ±é—œä¿‚。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æœ‰å…·é«”事實，足èªæœ‰åé —ä¹‹è™žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å…¶ä»–經審查會決è°æ‡‰äºˆè¿´é¿è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç ”ç©¶è¨ˆç•«ä¹‹å¯©æŸ¥ï¼Œæ‡‰è‡³å°‘åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä¸»æŒäººè³‡æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç ”究å°è±¡ä¹‹æ¢ä»¶åŠå¬å‹Ÿæ–¹å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¨ˆç•«ä¹‹å…§å®¹åŠå…¶åŸ·è¡Œæ–¹å¼èˆ‡å ´æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æœ¬æ³•ç¬¬åå››æ¢æ‰€å®šå‘ŠçŸ¥åŒæ„äº‹é …ã€å‘ŠçŸ¥å°è±¡ã€åŒæ„æ–¹å¼åŠç¨‹åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç ”究å°è±¡ä¹‹ä¿è·ï¼ŒåŒ…括諮詢åŠæŠ•è¨´ç®¡é“ç‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰æ¢å¯©æŸ¥æœƒæœƒè°ä¹‹è°æ±ºæ–¹å¼ï¼Œä»¥å¤šæ•¸æ±ºç‚ºåŽŸå‰‡ï¼›ä»¥æŠ•ç¥¨æ–¹å¼è¡¨æ±ºæ™‚，應記錄其æ£ã€åç‰è¡¨æ±ºæƒ…形。未出å¸æœƒè°ä¹‹å§”員，ä¸å¾—åƒèˆ‡è¡¨æ±ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法第八æ¢æ‰€å®šç°¡æ˜“程åºå¯©æŸ¥ï¼Œæ‡‰ç”±å§”員一人以上為之。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …簡易程åºå¯©æŸ¥æ¡ˆä»¶ï¼Œå§”å“¡å¾—ä»£è¡¨å¯©æŸ¥æœƒè¡Œä½¿æ ¸å‡†ä¹‹æ±ºå®šï¼Œä¸¦å°‡çµæžœæå¯©æŸ¥æœƒå ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …å¯©æŸ¥æ¡ˆä»¶ï¼Œå§”å“¡æœªç‚ºæ ¸å‡†ä¹‹æ±ºå®šæ™‚ï¼Œæ‡‰ç¶“ä¸€èˆ¬ç¨‹åºå¯©æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查會之會è°ç´€éŒ„，應予公開。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …公開之內容，應至少包括會è°æ—¥æœŸã€å‡ºå¸èˆ‡ç¼ºå¸å§”員姓åã€ç ”究計畫å稱ã€è¨Žè«–內容摘è¦åŠæ±ºè°äº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查會應ä¾æœ¬æ³•ç¬¬å七æ¢ç¬¬ä¸€é …è¦å®šï¼Œæ¯å¹´è‡³å°‘ä¸€æ¬¡å®šæœŸæŸ¥æ ¸ç ”ç©¶è¨ˆç•«ä¹‹åŸ·è¡Œæƒ…å½¢ï¼›ç ”ç©¶è¨ˆç•«æœ‰ä¸‹åˆ—æƒ…å½¢ä¹‹ä¸€è€…ï¼Œå¯©æŸ¥æœƒæ‡‰å³æŸ¥æ ¸ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¶³ä»¥å½±éŸ¿ç ”究å°è±¡æ¬Šç›Šã€å®‰å…¨æˆ–褔祉之情事。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç ”究å°è±¡ç™¼ç”Ÿåš´é‡ä¸è‰¯äº‹ä»¶æˆ–å應。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å‡ºç¾å½±éŸ¿è¨ˆç•«é¢¨éšªåˆ©ç›Šè©•ä¼°ä¹‹é‡è¦äº‹ä»¶æˆ–資訊。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …æŸ¥æ ¸ï¼Œå¾—ä»¥æ›¸é¢æˆ–實地查è‰æ–¹å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查會ä¾å‰æ¢è¦å®šæŸ¥æ ¸çµæžœï¼Œæ‡‰ä»¥æ›¸é¢é€šçŸ¥è¨ˆç•«ä¸»æŒäººï¼›å…¶æœ‰è®Šæ›´åŽŸå¯©æŸ¥æ±ºå®šè€…，並應載明。</span> </p><p><span style="font-family: 新細明體,serif;">å¯©æŸ¥æœƒæŸ¥æ ¸çµæžœæœ‰æœ¬æ³•ç¬¬å七æ¢ç¬¬äºŒé …ã€ç¬¬ä¸‰é …æ‰€å®šæ‡‰é€šå ±æƒ…å½¢è€…ï¼Œæ‡‰æ–¼ä½œæˆæ±ºå®šå¾Œåå››æ—¥å…§ï¼Œé€šå ±ç ”ç©¶æ©Ÿæ§‹åŠä¸å¤®ç›®çš„事æ¥ä¸»ç®¡æ©Ÿé—œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查會應è¦æ±‚計畫主æŒäººæ–¼è¨ˆç•«å®Œæˆå¾Œï¼Œæå ±åŸ·è¡Œæƒ…å½¢åŠçµæžœã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查會應ä¿å˜è¨ˆç•«å¯©æŸ¥ã€æŸ¥æ ¸ã€æœŸä¸åŠæœŸæœ«å ±å‘Šç‰ç›¸é—œè³‡æ–™è‡³è¨ˆç•«çµæŸå¾Œä¸‰å¹´ï¼Œä¸¦ä¾›ä¸å¤®ç›®çš„事æ¥ä¸»ç®¡æ©Ÿé—œéš¨æ™‚調閱。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6049&type=0
藥政管ç†é¡ž,藥物樣å“è´ˆå“管ç†è¾¦æ³•æ³•è¦å‘½ä»¤è—¥ç‰©æ¨£å“è´ˆå“管ç†è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾è—¥äº‹æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第五å五æ¢ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物符åˆä¸‹åˆ—å„款è¦å®šä¹‹ä¸€è€…，得申請為藥物樣å“：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å•†ç”³è«‹ä¾›æŸ¥é©—ç™»è¨˜æˆ–æ”¹é€²è£½é€ æŠ€è¡“ä¹‹ç”¨è€…ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å•†ã€å¸è¡“ç ”ç©¶æˆ–è©¦é©—æ©Ÿæ§‹ã€è©¦é©—委託機構ã€é†«è—¥å¸è¡“團體或教å¸é†«é™¢ï¼Œå› æ¥å‹™éœ€è¦ï¼Œç”³è«‹å°ˆä¾›ç ”究ã€è©¦é©—之用者。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€å°ˆç§‘æ•™å¸é†«é™¢æˆ–å€åŸŸç´šä»¥ä¸Šæ•™å¸é†«é™¢ç”³è«‹ä¾›è¨ºæ²»å±æ€¥æˆ–é‡å¤§ç—…患之用者。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€ç—…患經醫療機構出具è‰æ˜Žç”³è«‹ä¾›è‡ªç”¨è€…。但應由醫師或專æ¥äººå“¡æ“作之醫療器æ除外。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">五ã€é†«ç™‚器æ藥商申請供特定展覽或示範之醫療器æ。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å…ã€è—¥å•†ç”³è«‹ä¾æœ¬æ³•è¦å®šå·²æ ¸ç™¼è¨±å¯è‰ä¹‹è—¥ç‰©ä¾›æ•™è‚²å®£å°Žä¹‹ç”¨è€…。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">七ã€ç”³è«‹ä¾›å…¬å…±å®‰å…¨æˆ–公共衛生或é‡å¤§ç½å®³ä¹‹ç”¨è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱藥物贈å“，係指ä¾æœ¬æ³•è¦å®šå·²æ ¸ç™¼è¨±å¯è‰ä¹‹è—¥ç‰©ï¼Œç”³è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è´ˆèˆ‡å„級衛生醫療機構ã€é†«é™¢è¨ºæ‰€æˆ–救濟機構作為慈善事æ¥ä½¿ç”¨è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物樣å“或贈å“應由申請者填具申請書，詳列å“åã€è£½é€ å» åã€ç”¢åœ°ã€è¦æ ¼æˆ–包è£å½¢æ…‹åŠæ•¸é‡ï¼Œæ•˜æ˜Žç”³è«‹ç†ç”±èˆ‡ç”¨é€”ï¼Œä¸¦æª¢é™„ç”³è«‹è€…è³‡æ ¼è‰æ˜Žæ–‡ä»¶å½±æœ¬åŠç¬¬ä¸ƒæ¢è‡³ç¬¬å五æ¢è¦å®šè³‡æ–™ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæå‡ºç”³è«‹ï¼Œç¶“æ ¸å‡†å¾Œå§‹å¯è£½é€ ã€è¼¸å…¥æˆ–æå–。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å‰é …ç”³è«‹è€…è³‡æ ¼è‰æ˜Žæ–‡ä»¶ï¼ŒæŒ‡ç—…患身分è‰æˆ–è·ç…§ã€è—¥å•†è¨±å¯åŸ·ç…§æˆ–機構ã€åœ˜é«”登記è‰ç…§ç‰ã€‚但機關或醫院以蓋å°ä¿¡å…¬æ–‡æ出申請者å…附。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請供é‡å¤§ç½å®³ä½¿ç”¨ä¹‹è—¥ç‰©æ¨£å“，ä¸é©ç”¨å‰æ¢ä¹‹è¦å®šï¼Œä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—視情æ³èªå®šæ ¸å‡†ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物樣å“申請數é‡ï¼Œä»¥å¯¦éš›éœ€è¦é‡ç‚ºé™ã€‚但申請供改進技術ã€ç‰¹å®šå±•è¦½æˆ–示範之醫療器æ樣å“，除特殊情形外，åŒä¸€åž‹è™Ÿä»¥ä¸€éƒ¨</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">個</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為é™ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬å››æ¬¾è¦å®šç”³è«‹è€…，除準用å‰é …è¦å®šå¤–，並應符åˆä¸‹åˆ—å„款è¦å®šï¼š</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€è™•æ–¹è—¥å“ä¸å¾—超éŽè™•æ–¹ç®‹ä¹‹åˆç†ç”¨é‡ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€éžè™•æ–¹è—¥å“æ–¼å…個月內ä¸å¾—é‡è¤‡ç”³è«‹ã€‚除特殊需è¦ï¼Œæ‡‰ç”³è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å¤–，æ¯æ¬¡æ•¸é‡ä¸å¾—超éŽå二瓶或軟管類å二支或總é‡ä¸€åƒäºŒç™¾é¡†ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€é†«ç™‚器æ儀器åŒä¸€åž‹è™Ÿä»¥ä¸€éƒ¨ç‚ºé™ï¼Œå±¬è€—æ或衛生æ料類者，ä¸å¾—超éŽå…個月用é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬ä¸€æ¬¾è¦å®šç”³è«‹ä¾›æ”¹é€²è£½é€ 技術用之藥å“或醫療器æ樣å“，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€åŸ·è¡Œæ”¹é€²è£½é€ 技術之å¸è¡“ç ”ç©¶å–®ä½è‰æ˜Žæˆ–è—¥å“è£½é€ æ¥ã€é†«ç™‚器æè£½é€ æ¥è—¥å•†è¨±å¯åŸ·ç…§å½±æœ¬ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€è¼‰æ˜Žç¶“æ ¸å‡†ä¹‹è—¥å“或醫療器æ樣å“絕ä¸è½‰å”®ã€è½‰ä¾›ä»–用åŠä¾›è‡¨åºŠä½¿ç”¨ä¹‹åˆ‡çµæ›¸ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€æ”¹é€²æŠ€è¡“相關資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬äºŒæ¬¾è¦å®šç”³è«‹ä¾›éžè‡¨åºŠç ”ç©¶æˆ–é«”å¤–è©¦é©—ç ”ç©¶ç”¨ä¹‹è—¥ç‰©æ¨£å“，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€ç ”究試驗計畫書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€è—¥ç‰©ç›¸é—œè³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬äºŒæ¬¾è¦å®šç”³è«‹åŽŸç”¢åœ‹æœªæ ¸å‡†ä¸Šå¸‚之試驗用藥å“，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€åŸ·è¡Œè©¦é©—之準醫å¸ä¸å¿ƒä»¥ä¸Šæ•™å¸é†«é™¢äººé«”試驗委員會åŒæ„書，或執行特殊用藥試驗之專科教å¸é†«é™¢äººé«”試驗委員會åŒæ„書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€ç¬¦åˆé†«ç™‚法施行細則第五åæ¢è¦å®šä¹‹äººé«”試驗計畫書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€å—試者åŒæ„書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å‰é …è—¥å“屬生物藥å“者，並應檢附å‰æ¬¡ç”³è«‹æ¨£å“之æµå‘資料。但首次申請者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬äºŒæ¬¾è¦å®šç”³è«‹åŽŸç”¢åœ‹å·²æ ¸å‡†ä¸Šå¸‚之試驗用藥å“，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€åŸ·è¡Œè©¦é©—之å€åŸŸç´šä»¥ä¸Šæ•™å¸é†«é™¢äººé«”試驗委員會åŒæ„書，或執行特殊用藥試驗之專科教å¸é†«é™¢äººé«”試驗委員會åŒæ„書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€ç¬¦åˆé†«ç™‚法施行細則第五åæ¢è¦å®šä¹‹äººé«”試驗計畫書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€å—試者åŒæ„書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥å“原產國上市è‰æ˜Žã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å‰é …è—¥å“屬生物藥å“者，準用第ä¹æ¢ç¬¬äºŒé …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬äºŒæ¬¾è¦å®šç”³è«‹åŽŸç”¢åœ‹æœªæ ¸å‡†ä¸Šå¸‚之試驗醫療器æ，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€åŸ·è¡Œè©¦é©—之準醫å¸ä¸å¿ƒä»¥ä¸Šæ•™å¸é†«é™¢äººé«”試驗委員會åŒæ„書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€è©¦é©—醫療器æ之çµæ§‹ã€è¦æ ¼ã€æ€§èƒ½ã€ç”¨é€”åŠåœ–樣ç‰æŠ€è¡“資料。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€è©¦é©—醫療器æ之安全性åŠåŠŸæ•ˆæ€§ç›¸é—œè©¦é©—資料。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€ç¬¦åˆé†«ç™‚法施行細則第五åæ¢è¦å®šä¹‹äººé«”試驗計畫書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">五ã€å—試者åŒæ„書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬äºŒæ¬¾è¦å®šç”³è«‹åŽŸç”¢åœ‹å·²æ ¸å‡†ä¸Šå¸‚之醫療器æ，供臨床試驗之用者，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€åŸ·è¡Œè©¦é©—之å€åŸŸç´šä»¥ä¸Šæ•™å¸é†«é™¢äººé«”試驗委員會åŒæ„書。ã€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€é†«ç™‚器æ原產國上市è‰æ˜Žã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€ç¬¦åˆé†«ç™‚法施行細則第五åæ¢è¦å®šä¹‹äººé«”試驗計畫書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€å—試者åŒæ„書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬ä¸‰æ¬¾è¦å®šç”³è«‹è—¥ç‰©æ¨£å“，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€ç”³è«‹é†«é™¢äººé«”試驗委員會åŒæ„書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€å®Œæ•´ä¹‹æ²»ç™‚æ–¹å¼ã€ç™‚程åŠç›¸é—œæ–‡ç»ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€ç—…æ‚£åŒæ„書。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€è—¥ç‰©åŽŸç”¢åœ‹ä¸Šå¸‚è‰æ˜Žã€ä»¿å–®æˆ–å„國醫藥å“集收載影本。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥物樣å“之é©æ‡‰ç—‡ã€ç”¨æ³•ç”¨é‡èˆ‡åŽŸæ ¸å®šä¸ç¬¦è€…，除å‰é …å„款</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¦å®šè³‡æ–™å¤–，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—令申請者檢附相關臨床文ç»ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …æ¨£å“屬生物藥å“者，準用第ä¹æ¢ç¬¬äºŒé …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬å››æ¬¾è¦å®šç”³è«‹è—¥ç‰©æ¨£å“自用者，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€æ”¶ä»¶äººç‚ºç—…患姓åä¹‹åœ‹éš›åŒ…è£¹æ‹›é ˜å–®æˆ–æµ·é—œæ單。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€è—¥ç‰©å¤–ç›’ã€èªªæ˜Žæ›¸ã€ä»¿å–®æˆ–目錄。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€è¼‰æ˜Žã€Œç¶“æ ¸å‡†ä¹‹è—¥ç‰©æ¨£å“絕ä¸å‡ºå”®ã€è½‰è®“與轉供治療其他病</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">患之用ã€ä¹‹åˆ‡çµæ›¸ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請樣å“屬處方藥å“或醫療器æ者，並應檢附國內醫療院所出具</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之診斷è‰æ˜ŽåŠé†«å¸«è™•æ–¹ï¼Œæˆ–ç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šä¹‹åœ‹å¤–原就</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">診之醫療院所出具之診斷è‰æ˜ŽåŠé†«å¸«è™•æ–¹ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">除å‰äºŒé …è¦å®šè³‡æ–™å¤–，必è¦æ™‚，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—令申請者檢</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">附藥物原產國上市è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾ç¬¬äºŒæ¢ç¬¬äº”款è¦å®šç”³è«‹é†«ç™‚器æ樣å“供特定展覽或示範之用</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">者，應檢附下列資料：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€é†«ç™‚器æ仿單ã€èªªæ˜Žæ›¸æˆ–目錄åŠå…¶ä¸è¯æœ¬ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€é†«å¸æœƒã€å¸è¡“機構或醫療院所åŒæ„展示函。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€è¼‰æ˜Žç¶“æ ¸å‡†ä¹‹é†«ç™‚å™¨æ樣å“，絕ä¸å‡ºå”®ã€è®“與ã€è½‰ä¾›ä»–用與</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">用於臨床治療åŠä¾ç¬¬å七æ¢è¦å®šæŒ‰æ™‚退é‹ä¹‹åˆ‡çµæ›¸ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">具輻射之醫療器æ，並應檢附行政院原å能委員會åŒæ„書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">符åˆç¬¬äºŒæ¢ç¬¬äº”款è¦å®šä¸¦ç¶“æ ¸å‡†ä¹‹é†«ç™‚å™¨æ樣å“，其展覽或示範</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">期間ä¸å¾—超éŽå…個月。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請者應將下列醫療器æ於展覽ã€ç¤ºç¯„期間çµæŸæˆ–治療ã€è‡¨åºŠè©¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">驗計畫完æˆå¾Œä¸€å€‹æœˆå…§é€€é‹åŽŸå» ，並將海關退é‹å‡ºå£è‰æ˜Žæ–‡ä»¶é€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸è¾¦ï¼š</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€ç¬¦åˆç¬¬äºŒæ¢ç¬¬äº”款è¦å®šä¸¦ç¶“æ ¸å‡†ä¹‹é†«ç™‚å™¨æ樣å“。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€ç¬¦åˆç¬¬äºŒæ¢ç¬¬äºŒæˆ–第三款è¦å®šä¸¦ç¶“æ ¸å‡†ä¹‹é†«ç™‚å™¨æ儀器樣</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†ä¹‹è—¥ç‰©æ¨£å“或贈å“，ä¸å¾—出售ã€è®“與或轉供他用；供改進</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">技術用之藥物樣å“，並ä¸å¾—為臨床使用。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†ä¹‹è—¥ç‰©è´ˆå“åŠä¾›æ•™è‚²å®£å°Žä¹‹è—¥ç‰©æ¨£å“，其仿單ã€æ¨™ç±¤åŠåŒ…</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£å¼æ¨£ï¼Œæ‡‰èˆ‡åŽŸæ ¸ç™¼è¨±å¯è‰ç™»è¨˜äº‹é …相符。供教育宣導之藥物樣</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“包è£å®¹é‡ï¼Œä¸¦ä¸å¾—多於其原登記之最å°åŒ…è£é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†ä¹‹è—¥ç‰©æ¨£å“或贈å“包è£ï¼Œæ‡‰æ–¼å°é¢ä¸Šæ¨™ç¤ºæ˜Žé¡¯ä¹‹ã€Œæ¨£å“ã€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">或「贈å“ã€å—樣。其供臨床試驗用者，並應標示「臨床試驗用ã€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—樣。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05
臨床試驗類,è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則法è¦å‘½ä»¤è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則<p><span style="font-size: 20pt; font-family: 標楷體;">è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則</span> </p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">ç¬¬ä¸€ç« ã€€ç¸½å‰‡ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第　一　æ¢ã€€ã€€æœ¬æº–則ä¾è—¥äº‹æ³•ç¬¬å››å二æ¢ç¬¬äºŒé …è¦å®šè¨‚定之。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　二　æ¢ã€€ã€€è—¥å“生體å¯ç”¨çŽ‡èˆ‡ç”Ÿé«”相ç‰æ€§åŠæœ‰é—œè©¦é©—之執行，應符 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">åˆæœ¬æº–則之è¦å®šï¼›æœ¬æº–則未è¦å®šè€…，ä¾è—¥å“優良臨床試驗準 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">則ã€è—¥å“查驗登記審查準則åŠå…¶ä»–有關法令之è¦å®šã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　三　æ¢ã€€ã€€æœ¬æº–則用詞定義如下： </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€ç”Ÿé«”å¯ç”¨çŽ‡ï¼ˆBioavailability）：指藥å“有效æˆåˆ†ç”±è£½åŠ‘ä¸å¸æ”¶é€²å…¥å…¨èº«è¡€æ¶²å¾ªç’°æˆ–作用部ä½ä¹‹é€ŸçŽ‡ï¼ˆrate）與程度（extent）之指標。如係ä¸å…·å…¨èº«æ€§å¸æ”¶ä¹‹è—¥å“，則指以有效æˆåˆ†åˆ°é”作用部ä½ä¹‹é€ŸçŽ‡èˆ‡ç¨‹åº¦ä½œè©•ä¼°ä¹‹æŒ‡æ¨™ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€è—¥åŠ‘相ç‰å“（Pharmaceutical Equivalents）：指具有相åŒæœ‰æ•ˆæˆåˆ†åŠç›¸ç‰å«é‡ä¹‹ç›¸åŒåŠ‘型之藥å“，其æˆå“檢驗è¦æ ¼ç¬¦åˆç›¸åŒä¹‹è—¥å…¸æˆ–其他經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹å“質è¦å®šè€…。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€è—¥åŠ‘替代å“（Pharmaceutical Alternatives）：指具有相åŒæœ‰æ•ˆæˆåˆ†æˆ–å…¶å‰é©…藥物（precursor），惟劑型ã€å«é‡ã€é¹½åŸºæˆ–酯類未必相åŒä¹‹è—¥å“，其æˆå“檢驗è¦æ ¼ç¬¦åˆç›¸åŒä¹‹è—¥å…¸æˆ–其他經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹å“質è¦å®šè€…。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">å››ã€ç”Ÿé«”相ç‰æ€§ï¼ˆBioequivalence）：指二個藥劑相ç‰å“或藥劑替代å“，於é©ç•¶ç ”究è¨è¨ˆä¸‹ï¼Œä»¥ç›¸åŒæ¢ä»¶ã€ç›¸åŒèŽ«è€³åŠ‘é‡ï¼ˆmolar dose）給與人體時，具有相åŒä¹‹ç”Ÿé«”å¯ç”¨çŽ‡ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　四　æ¢ã€€ã€€åŸ·è¡Œç”Ÿé«”å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—之å‰</span><span style="font-size: 14pt; font-family: 標楷體;">，藥商應å‘ä¸å¤® </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹æ ¸å®šè¨ˆç•«ï¼Œå…¶è©¦é©—è¨ˆç•«æ›¸ä¹‹å…§å®¹ï¼Œæ‡‰ç¬¦åˆ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">è—¥å“優良臨床試驗準則之è¦å®šã€‚但å¸å藥之生體å¯ç”¨çŽ‡åŠç”Ÿ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">體相ç‰æ€§è©¦é©—計畫書，得å…事先申請。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　五　æ¢ã€€ã€€ä¾æœ¬æº–å‰‡ç”³è«‹æ ¸å®šå„種</span><span style="font-size: 14pt; font-family: 標楷體;">è©¦é©—ä¹‹è¨ˆç•«èˆ‡å ±å‘Šï¼Œæ‡‰ç¹³ç´è²»ç”¨ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">，並填具ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€å®šä¹‹ç”³è«‹æ›¸è¡¨ï¼Œä¾æ›¸è¡¨æ‰€è¼‰äº‹é …備齊相關資料，é€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æ ¸ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">　　å‰é …所稱之申請書表</span><span style="font-size: 14pt; font-family: 標楷體;">，包括藥å“生體å¯ç”¨çŽ‡è©¦é©—計畫書申請表</span><span style="font-size: 14pt; font-family: 標楷體;">ã€è—¥å“</span><span style="font-size: 14pt; font-family: 標楷體;">生體相ç‰æ€§è©¦é©—計畫書申請表</span><span style="font-size: 14pt; font-family: 標楷體;">ã€</span><span style="font-size: 14pt; font-family: 標楷體;">è—¥å“生體å¯ç”¨çŽ‡è©¦é©—å ±å‘Šæ›¸ç”³è«‹è¡¨</span><span style="font-size: 14pt; font-family: 標楷體;">ã€è—¥å“</span><span style="font-size: 14pt; font-family: 標楷體;">生體相ç‰æ€§è©¦é©—å ±å‘Šæ›¸ç”³è«‹è¡¨</span><span style="font-size: 14pt; font-family: 標楷體;">ã€æº¶é›¢çŽ‡æ›²ç·šæ¯”å°å ±å‘Šç”³è«‹è¡¨åŠå…¶ä»–與申請程åºæœ‰é—œä¹‹æ›¸è¡¨æ ¼å¼ã€‚　　　 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　å…　æ¢ã€€ã€€</span><span style="font-size: 14pt; font-family: 標楷體;">è©¦é©—å ±å‘Šï¼Œæ‡‰ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¦å®šä¹‹æ–¹å¼æ’°å¯«ï¼Œä¸¦æª¢é™„有關試驗之完整內容åŠè©¦é©—資料æäº¤å¯©æ ¸ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">申請人應以書é¢è²æ˜Žä¸¦ç¢ºèªåŸ·è¡Œè©¦é©—之藥å“å³ç‚ºæŸ¥é©—ç™» </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">記之藥å“。試驗數據之å“è³ªèˆ‡å®Œæ•´æ€§ä¹‹æœ€çµ‚è²¬ä»»ï¼Œæ‡‰ç”±ç”³è«‹äººè² è²¬ã€‚</span> </p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　七　æ¢ã€€ã€€éžç¶“血管內給藥且能發生全身性作用（systemic action）之å„種製劑，如有下列情形之一者，應執行生體å¯ç”¨çŽ‡æˆ–生體相ç‰æ€§è©¦é©—： </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€æ–°è—¥åŠè—¥å“查驗登記審查準則è¦å®šæ‡‰åŸ·è¡Œè€…。但申請人如有æ出資料經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥èªå¯è€… </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">，得å…執行生體å¯ç”¨çŽ‡æˆ–生體相ç‰æ€§è©¦é©—。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€éžç›£è¦–è—¥å“經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šæ‡‰åŸ·è¡Œç”Ÿé«”å¯ç”¨çŽ‡æˆ–生體相ç‰æ€§è©¦é©—者。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">　　　　　　　申請查驗登記之å¸å藥，如å«æœ‰åˆ—入新藥監視之æˆåˆ†è€…（å«ç›£è¦–ä¸åŠç›£è¦–期滿æˆåˆ†ï¼‰ï¼Œæ‡‰æª¢é™„生體相ç‰æ€§è©¦é©—資料。但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹å“é …ï¼Œå¾—å…檢附。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第　八　æ¢ã€€ã€€ç¬¦åˆä¸‹åˆ—情形之一者</span><span style="font-size: 14pt; font-family: 標楷體;">，得å…除生體相ç‰æ€§è©¦é©—： </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€è¡€ç®¡å…§çµ¦è—¥æ³¨å°„劑。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€å¸åè—¥å£æœæº¶æ¶²åŠ‘，如其賦形劑ä¸å½±éŸ¿ä¸»æˆåˆ†å¸æ”¶è€…。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€è¡€ç®¡å¤–給藥注射劑，如å¸åè—¥æ³¨å°„æº¶æ¶²åŠ‘èˆ‡åŽŸé–‹ç™¼å» ç”¢å“或藥典收載è¦æ ¼ä¹‹é…¸é¹¼å€¼ï¼ˆpH值）相åŒï¼Œä¸”除防è…劑ã€ç·©è¡åŠ‘外之é…æ–¹å‡ç›¸åŒè€…。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 112: ;"><span style="font-size: 14pt; font-family: 標楷體;">å››ã€ä¾›å¸å…¥ä¹‹æ°£é«”或蒸氣。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">五ã€çš®è†šå¤–用製劑之å¸å藥。但ä¸å«éœ€çš®ä¸‹åŠçš®å…§å¸æ”¶ä¹‹è£½åŠ‘。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">å…ã€çœ¼ç”¨ã€è€³ç”¨è£½åŠ‘之å¸å藥。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">七ã€åŒä¸€å£æœå›ºé«”製劑之高ã€ä½ŽåŠ‘é‡ç”¢å“查驗登記ã€æˆ–已執行生體相ç‰æ€§è©¦é©—ä¸”ç¶“æ ¸å‡†ä¸Šå¸‚å¾Œä¹‹è®Šæ›´ç™»è¨˜ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯å¾—以溶離曲線比å°è©¦é©—替代生體相ç‰æ€§è©¦é©—者。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">å…«ã€å…¶ä»–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾ç”³è«‹äººæª¢é™„ä¹‹è³‡æ–™æ ¸å®šå¾—å…除者。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">ç¬¬äºŒç« ã€€ç”Ÿé«”å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©— 　　　　　　　　　　　　　　　　　　　　　　　　　　 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　ä¹ã€€æ¢ã€€ã€€åŸ·</span><span style="font-size: 14pt; font-family: 標楷體;">行生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—å‰ï¼Œå®œå…ˆé€²è¡Œé 試驗 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">，以確定所使用之劑é‡ã€æŠ½è¡€æˆ–å–尿之é‡ã€èˆ‡å–樣時間間隔是å¦æ°ç•¶ã€åˆ†æžæ–¹æ³•æ˜¯å¦å¯è¡Œï¼Œä¸¦å°‡æ‰€å¾—之數據處ç†å®Œç•¢å¾Œï¼Œå§‹é€²å…¥ä¸»è©¦é©—。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">執行試驗之藥å“（å«å—試藥å“åŠå°ç…§è—¥å“），應先完æˆä¸€èˆ¬æˆå“檢驗，並宜執行溶離曲線比å°è©¦é©—。å—試藥å“與å°ç…§è—¥å“之å«é‡å·®ç•°ï¼Œä¸å®œè¶…éŽç™¾åˆ†ä¹‹äº”。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">供試驗之藥å“生產批é‡ï¼Œä»¥æœ€ä½Žä¸å¾—少於一è¬å€‹åŠ‘åž‹å–®ä½ï¼ˆdosage units）為原則，如有特殊情æ³ï¼Œä¸åœ¨æ¤é™ã€‚但ä»ä¸å¾—低於生產批é‡ä¹‹å分之一。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">執行試驗，應è˜æœ‰è—¥å‹•å¸å°ˆæ¥äººå“¡ã€é©ç•¶ä¹‹åˆ†æžäººå“¡åŠé†«å¸«ï¼ˆæˆ–與教å¸é†«é™¢åˆä½œï¼‰ï¼Œä¸¦å…·å‚™ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šä¹‹é©ç•¶è‡¨åºŠè©¦é©—åŠåˆ†æžè™•æ‰€ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …藥動å¸å°ˆæ¥äººå“¡ï¼Œæ‡‰å…·æœ‰è—¥å¸ç›¸é—œç¢©å£«å¸ä½ä»¥ä¸Šï¼Œä¸¦æœ‰è—¥å‹•å¸ä¹‹ç ”究或發表者。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第　å　æ¢ã€€ã€€åŸ·</span><span style="font-size: 14pt; font-family: 標楷體;">行生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—，</span><span style="font-size: 14pt; font-family: 標楷體;">å…¶</span><span style="font-size: 14pt; font-family: 標楷體;">å—試者之é¸æ“‡ï¼Œæ‡‰ç¬¦åˆäººé«”試驗倫ç†è¦ç¯„，除有特殊情æ³å¤–，原則上以自願å¥åº·æˆå¹´äººç‚ºå°è±¡ï¼Œä¸¦è€ƒæ…®å…¶æ€§åˆ¥ã€å¹´ç´€èˆ‡æ—群ç‰å› ç´ ï¼Œæ–¼è¨ˆç•«æ›¸ä¸æ‡‰è©³è¿°ç´å…¥åŠæŽ’除æ¢ä»¶ï¼Œä¸¦ä»¥ä¸€èˆ¬å¯¦é©—室檢查（standard laboratory tests）ã€ç–¾ç—…å²ï¼ˆmedical history）åŠç†å¸æª¢æŸ¥ï¼ˆphysical examination）ç‰é …目篩é¸ï¼Œä¸”應就個別藥å“之特性作個別醫å¸æª¢æŸ¥é …目之è¦æ±‚（如心電圖ç‰ï¼‰ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">å—試者之人數，至少應有å二å，且應用é©ç•¶ä¹‹æª¢å®šåŠ›è¨ˆç®—（appropriate power calculations）以評估å—試者之人數。試驗進行å‰ï¼Œæ‡‰ç¶“人體試驗委員會之åŒæ„，並å–å¾—å—試者åŒæ„書。å—試者åŒæ„書之內容，應ä¾è—¥å“優良臨床試驗準則之è¦å®šï¼Œä¸”宜投ä¿ã€‚å—試者之臨床試驗間隔，應符åˆæ血者å¥åº·æ¨™æº–之è¦å®šï¼Œä»¥ä¿éšœå—試者之權益。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第 å一 æ¢ã€€ã€€é¸æ“‡åŸ·</span><span style="font-size: 14pt; font-family: 標楷體;">行生體相ç‰æ€§è©¦é©—之å°ç…§è—¥å“，è¦å®šå¦‚下： </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一</span><span style="font-size: 14pt; font-family: 標楷體;">ã€</span><span style="font-size: 14pt; font-family: 標楷體;">監視新藥æˆåˆ†ä¹‹å°ç…§è—¥å“，應é¸ç”¨æœ‰è³‡æ–™è‰æ˜Žä¿‚åŽŸé–‹ç™¼å» ä¹‹ç”¢å“或ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ä¸Šå¸‚之第一家產å“。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 123: ;"><span style="font-size: 14pt; font-family: 標楷體;">二</span><span style="font-size: 14pt; font-family: 標楷體;">ã€</span><span style="font-size: 14pt; font-family: 標楷體;">éžç›£è¦–æ–°è—¥æˆåˆ†ä¹‹å°ç…§è—¥å“，應é¸ç”¨æœ‰è³‡æ–™è‰æ˜Žä¿‚符åˆä¸‹åˆ—情形之一者： </span></p><p style="layout-grid-mode: char; line-height: 23pt; 151: ;"><span style="font-size: 14pt; font-family: 標楷體;">ï¼ˆä¸€ï¼‰åŽŸé–‹ç™¼å» ä¹‹ç”¢å“。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 151: ;"><span style="font-size: 14pt; font-family: 標楷體;">（二）已知生體å¯ç”¨çŽ‡ä¹‹åœ‹å…§å¸‚å”®å“。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 151: ;"><span style="font-size: 14pt; font-family: 標楷體;">ï¼ˆä¸‰ï¼‰èˆ‡åŽŸé–‹ç™¼å» ä¹‹ç”¢å“具生體相ç‰æ€§æˆ–è‰æ˜Žè‡¨åºŠæœ‰ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 151: ;"><span style="font-size: 14pt; font-family: 標楷體;">效性之產å“。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 121: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€é™¤å‰äºŒæ¬¾è¦å®šä¹‹æƒ…形外，其他經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹å°ç…§è—¥å“。</span> </p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 å二 æ¢ã€€ã€€é¸æ“‡åŸ·</span><span style="font-size: 14pt; font-family: 標楷體;">行生體å¯ç”¨çŽ‡è©¦é©—之å°ç…§è—¥å“，其主æˆåˆ†æˆ–具療效æˆåˆ†ï¼ˆtherapeutic moiety）應符åˆä¸‹åˆ—情形之一： </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€éœè„ˆæ³¨å°„劑。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 112: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€å£æœæº¶æ¶²åŠ‘（solution）或懸液劑（suspension）。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 112: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€åŽŸé–‹ç™¼å» 之產å“或已知生體å¯ç”¨çŽ‡ä¹‹åœ‹å…§å¸‚å”®å“。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">å››ã€é™¤å‰ä¸‰æ¬¾ä¹‹æƒ…形外，具有確實之科å¸æ ¹æ“šä¸”經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯è€…。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 å三 æ¢ã€€ã€€åŸ·</span><span style="font-size: 14pt; font-family: 標楷體;">行生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—</span><span style="font-size: 14pt; font-family: 標楷體;">之</span><span style="font-size: 14pt; font-family: 標楷體;">評估標的，得以血 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">ã€å°¿ä¸ä¹‹è—¥å“或其代è¬ç‰©æ¿ƒåº¦ï¼ˆä»¥ä¸‹ç°¡ç¨±è¡€ä¸æ¿ƒåº¦ã€å°¿ä¸æ¿ƒåº¦ï¼‰ã€æˆ–以é©ç•¶ä¹‹è—¥ç†å應åŠè‡¨åºŠæ•ˆæ‡‰ç‚ºå°è±¡ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 åå›› æ¢ã€€ã€€</span><span style="font-size: 14pt; font-family: 標楷體;">生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—之è¨è¨ˆï¼Œæ‡‰ä¾å—試藥å“åŠå°ç…§è—¥å“採用隨機之雙å‘或多å‘交å‰è¨è¨ˆï¼ˆrandomized two or more way crossover designs）或拉ä¸æ–¹æ ¼è¨è¨ˆï¼ˆLatin Square Designsï¼‰ï¼Œä»¥æ¸›ä½Žå› å—è©¦è€…é–“æ‰€é€ æˆä¹‹å·®ç•°ã€‚如無法執行交å‰è¨è¨ˆä¹‹è©¦é©—時，得採用平行è¨è¨ˆï¼ˆParallel Designs）。但平行è¨è¨ˆä¹‹è©¦é©—，其å„組å—試人數應é©ç•¶è¨å®šã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">å¥åº·å—試者於åƒåŠ 試驗å‰ï¼Œæ‡‰ç¦æœä»»ä½•è—¥å“二週以上。æœè—¥å‰ï¼Œæ‡‰ç¦é£Ÿåå°æ™‚以上；如係執行食物影響試驗（ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">Food Effect Study</span><span style="font-size: 14pt; font-family: 標楷體;">）者，在指給與食物å‰ï¼Œæ‡‰ç¦é£Ÿåå°æ™‚以上。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">æœè—¥å¾Œï¼Œæ‡‰å†ç¹¼çºŒç¦é£Ÿå››å°æ™‚。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 å五 æ¢ã€€ã€€åŸ·è¡Œ</span><span style="font-size: 14pt; font-family: 標楷體;">生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§</span><span style="font-size: 14pt; font-family: 標楷體;">試驗之</span><span style="font-size: 14pt; font-family: 標楷體;">採樣與時間，è¦å®šå¦‚下： </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€æŠ½è¡€æ™‚間至少應æŒçºŒè‡³åˆ°é”最高血ä¸æ¿ƒåº¦ï¼ˆCmax）後三å€ä»¥ä¸Šä¹‹è—¥å“排除åŠè¡°æœŸï¼›å–尿時間應為排除åŠè¡°æœŸä¹‹ä¸ƒå€ä»¥ä¸Šã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€æŽ¡æ¨£æ¬¡æ•¸ï¼Œæ‡‰ä»¥è¶³å¯èªªæ˜Žè—¥å“於體內之å¸æ”¶ã€åˆ†å¸ƒåŠæŽ’除為標準。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€æ–¼äº¤å‰è©¦é©—ä¸ï¼Œå…¶äºŒæ¬¡è™•ç†æœŸé–“（treatment period）之藥å“洗除期間（washout period），原則上至少應為該藥å“排除åŠè¡°æœŸä¹‹äº”å€ã€‚但æœè—¥å‰ä¹‹è¡€ä¸æ¿ƒåº¦ä¸å¾—超éŽæœ€é«˜è¡€ä¸æ¿ƒåº¦ï¼ˆCmax）之百分之五。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …第三款所稱二次處ç†æœŸé–“（treatment period）之藥å“洗除期間（washout period），係指完æˆç¬¬ä¸€æ¬¡ä½¿ç”¨è—¥å“之最後一次採樣後，迄第二次使用藥å“時æ¢ä¹‹é–“隔時間。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">多劑é‡è©¦é©—之採樣與時間，得ä¸å—å‰äºŒé …è¦å®šä¹‹é™åˆ¶ã€‚但其採樣時間，應é”到足以測定其穩定狀態（steady state）之血ä¸æ¿ƒåº¦ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 åå… æ¢ã€€ã€€</span><span style="font-size: 14pt; font-family: 標楷體;">生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—之檢體分æžï¼Œæ‡‰ä¾å¾ªéžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„，並符åˆä¸‹åˆ—è¦å®šï¼š </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€ä½¿ç”¨ä¹‹åˆ†æžæ–¹æ³•ï¼Œæ‡‰èƒ½æ¸¬å¾—原始試驗藥å“或其代è¬ç‰©ï¼Œä¸¦æœ‰é©ç•¶ä¹‹æœ€ä½Žå¯æ¸¬å¾—濃度。如以其代è¬ç‰©ç‚ºåˆ†æžæ¨™çš„者，應事先經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 127: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€ç”Ÿé«”å«é‡åˆ†æžæ–¹æ³•ç¢ºæ•ˆï¼ˆBioanalytical Method Validation），應涵蓋精密度（Precision）ã€æº–確度（Accuracy）ã€é¸æ“‡æ€§ï¼ˆSelectivity）ã€åŸºè³ªæ•ˆæ‡‰ï¼ˆMartrix Effect）ã€æª¢é«”之安定性（Stability）åŠæœ€ä½Žå®šé‡æ¿ƒåº¦ï¼ˆLower Limit of Quantification）ç‰è³‡æ–™ï¼Œä¸¦æ‡‰æ³¨æ„系統é©ç”¨æ€§ï¼ˆSystem Suitability）。檢體之安定性，應包括冷å‡èˆ‡è§£å‡å®‰å®šæ€§ï¼ˆFreeze and Thaw Stability）ã€çŸæœŸå®¤æº«å®‰å®šæ€§ï¼ˆShort Term Temperature Stability）ã€é•·æœŸå®‰å®šæ€§ï¼ˆLong Term Stability）ã€è²¯æ¶²å®‰å®šæ€§ï¼ˆStock Solution Stability）ã€åˆ†æžæœŸé–“安定性（Post Preparative Stabilityï¼‰ã€‚ä½†å¦‚æœ‰ç‰¹æ®ŠåŽŸå› ï¼Œç”³è«‹äººèªªæ˜Žç†ç”±ä¸¦æª¢é™„相關文ç»åŠè‰æ˜Žè³‡æ–™ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯è€…，ä¸åœ¨æ¤é™ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€æº–確度之測定，其å„濃度平å‡å€¼æ‡‰åœ¨ç†è«–值之百分之å五範åœå…§ï¼Œä¸”最低定é‡æ¿ƒåº¦æ‡‰åœ¨ç†è«–值之百分之二å範åœå…§ã€‚精密度之測定，其æ¯å€‹æ¿ƒåº¦ä¹‹è®Šç•°ä¿‚數（Coefficient of Variation）ä¸å¾—超éŽç™¾åˆ†ä¹‹å五，且最低定é‡æ¿ƒåº¦ä¹‹è®Šç•°ä¿‚數ä¸å¾—超éŽç™¾åˆ†ä¹‹äºŒå。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 å七 æ¢ã€€ã€€åŸ·è¡Œ</span><span style="font-size: 14pt; font-family: 標楷體;">生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§</span><span style="font-size: 14pt; font-family: 標楷體;">試驗之</span><span style="font-size: 14pt; font-family: 標楷體;">數據，應包括å„å—試者之原始資料åŠå¾—自ä¸åŒè©•ä¼°æ¨™çš„所å–得之é‡è¦ç”Ÿé«”å¯ç”¨çŽ‡åƒæ•¸ï¼Œä¸¦ç¬¦åˆä¸‹åˆ—è¦å®šï¼š </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€å¦‚以血ä¸è—¥ä¹‹æ¿ƒåº¦ç‚ºè©•ä¼°æ¨™çš„者，應比較下列å„åƒæ•¸ï¼Œå¿…è¦æ™‚，得ä¾è—¥å‹•å¸åŽŸç†æ¯”較其他有關åƒæ•¸ï¼š </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 154: ;"><span style="font-size: 14pt; font-family: 標楷體;">（一）</span><span style="font-size: 14pt; font-family: 新細明體,serif;">Â</span><span style="font-size: 14pt; font-family: 標楷體;">速放劑型（Immediate Release Dosage Forms）之單劑é‡è©¦é©—：最高血ä¸æ¿ƒåº¦ï¼ˆCmax）ã€æ›²ç·šä¸‹ç¸½é¢ç©ã€‚å°åŠè¡°æœŸé•·ä¸”分布åŠæ¸…除率呈ç¾å€‹é«”內變異性低之藥å“，必è¦æ™‚，事先æå‡ºç”³è«‹ç¶“æ ¸å®šè€…ï¼Œå¾—ä½¿ç”¨æˆªå¹³æ›²ç·šä¸‹ç¸½é¢ç©ã€€ã€€ï¼ˆTruncated AUC）。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 154: ;"><span style="font-size: 14pt; font-family: 標楷體;">（二）速放劑型之多劑é‡è©¦é©—：穩定狀態之最高血ä¸æ¿ƒåº¦ï¼ˆCmax,ss）åŠç©©å®šç‹€æ…‹ä¹‹ä¸€å€‹æœè—¥é–“隔曲線下總é¢ç©ï¼ˆAUC<sub><span style="color: #000000;">0-</span></sub><sub><span style="color: #000000;">τ,ss</span></sub><span style="color: #000000;">，τ：一個給藥間隔時間）。 </span></span></p><p style="layout-grid-mode: char; line-height: 23pt; 154: ;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">（三）控釋劑型之多劑é‡è©¦é©—：穩定狀態之最高血ä¸æ¿ƒåº¦ï¼ˆCmax,ss）åŠç©©å®šç‹€æ…‹ä¹‹ä¸€å€‹æœè—¥é–“隔曲線下總é¢ç©ï¼ˆAUC<sub>0-</sub><sub>τ,ss</sub>，τ：一個給藥間隔時間）。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 154: ;"><span style="font-size: 14pt; font-family: 標楷體;">（四）控釋劑型之單劑é‡è©¦é©—（應併執行高脂高å¡è·¯é‡Œä¹‹é£Ÿç‰©å½±éŸ¿è©¦é©—）：最高血ä¸æ¿ƒåº¦ï¼ˆCmax）ã€æ›²ç·šä¸‹ç¸½é¢ç©ã€‚å°åŠè¡°æœŸé•·ä¸”分布åŠæ¸…除率呈ç¾å€‹é«”內變異性低之藥å“，必è¦æ™‚，事先æå‡ºç”³è«‹ç¶“æ ¸å®šè€…ï¼Œå¾—ä½¿ç”¨æˆªå¹³æ›²ç·šä¸‹ç¸½é¢ç©ï¼ˆTruncated AUC）。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€å¦‚以尿液為評估標的者，應比較藥在尿ä¸å„時段所測得之排出é‡åŠç”±èµ·å§‹æ™‚間至試驗終æ¢æ™‚é–“å°¿ä¸æŽ’出藥之累ç©é‡ä¹‹å€¼ã€‚å¿…è¦æ™‚，得ä¾è—¥å‹•å¸åŽŸç†æ¯”較其他有關åƒæ•¸ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€å¦‚試驗係屬觀察藥ç†æ•ˆæ‡‰ï¼Œå…¶è—¥ç†åæ‡‰é ˆåœ¨èˆ‡åŠ‘é‡æˆæ£æ¯”之範åœå…§ï¼Œä¸¦æ‡‰æ¯”較藥ç†æ•ˆæ‡‰å¼·åº¦èˆ‡ç™¼ç”Ÿæ™‚間之關係，包括其起點ã€çµ‚點åŠä¹…æš«ç‰ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 98: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …第一款第一目åŠç¬¬å››ç›®ä¹‹æ›²ç·šä¸‹ç¸½é¢ç©ï¼Œæ‡‰åŒ…括採 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">時間零至無é™å¤§ä¹‹æ›²ç·šä¸‹ç¸½é¢ç©ï¼ˆAUC<sub>0-</sub><sub>∞</sub>）åŠæ™‚間零至最終採血點時間之曲線下總é¢ç©ï¼ˆAUC<sub>0-t</sub>，t：最終採血點時間），且時間零至最終採血點時間之曲線下總é¢ç©ï¼ˆAUC<sub>0-t</sub>）除以時間零至無é™å¤§ä¹‹æ›²ç·šä¸‹ç¸½é¢ç©ï¼ˆAUC<sub>0-</sub><sub>∞</sub>）之比值ä¸å¾—å°æ–¼é›¶é»žå…«ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 56: ;"><span style="font-size: 14pt; font-family: 標楷體;">å„有關數據之統計比較çµæžœï¼Œæ‡‰åˆ—圖表說明。</span><span style="font-size: 14pt; font-family: 標楷體;">　　 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 åå…« æ¢ã€€ã€€</span><span style="font-size: 14pt; font-family: 標楷體;">åƒèˆ‡çµ±è¨ˆåˆ†æžä¹‹ç”Ÿé«”å¯ç”¨çŽ‡åƒæ•¸ï¼Œæ‡‰å–å°æ•¸å€¼å…ˆé€²è¡Œè®Šç•°æ•¸åˆ†æžï¼ˆANOVA），其α值è¨å®šç‚ºé›¶é»žé›¶äº”，å†è¨ˆç®—è—¥å“效應（Treatment Effect）之百分之ä¹åä¿¡è³´å€é–“（90% Confidence Interval）。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">åƒèˆ‡çµ±è¨ˆåˆ†æžä¹‹ç”Ÿé«”å¯ç”¨çŽ‡åƒæ•¸ï¼Œå…¨éƒ¨ä»¥å°æ•¸å€¼è¨ˆç®—百分之ä¹åä¿¡è³´å€é–“，其å–åå°æ•¸å€¼ä¹‹ç™¾åˆ†ä¹‹ä¹åä¿¡è³´å€é–“ï¼ŒåŽŸå‰‡ä¸Šæ‡‰æ–¼é›¶é»žå…«è‡³ä¸€é»žäºŒäº”ä¹‹é–“ã€‚ä½†ç¶“äº‹å…ˆç”³è«‹æ ¸å®šï¼Œä¸”æ–¼èªå¯å®‰å…¨æ€§åŠæœ‰æ•ˆæ€§ä¸‹ä¸¦ç¬¦åˆåœ‹éš›è¦å®šæ™‚，最高血ä¸æ¿ƒåº¦ï¼ˆCmax）得放寬至零點七五至一點三三之間。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 åä¹ æ¢ã€€ã€€</span><span style="font-size: 14pt; font-family: 標楷體;">特殊劑型（如微脂粒ã€ç¶“çš®å¸æ”¶ã€å¸å…¥æ€§ç‰è£½åŠ‘）之生體相ç‰æ€§è©¦é©—åŠç”Ÿé«”å¯ç”¨çŽ‡è©¦é©—å ±å‘Šï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¦–å…¶å“質ã€è¦æ ¼ï¼Œä¾å€‹æ¡ˆæƒ…å½¢å¯©æ ¸ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第 二å æ¢ã€€ã€€äºŒ</span><span style="font-size: 14pt; font-family: 標楷體;">種藥å“之生體相ç‰æ€§æ¯”較，得以生體å¯ç”¨çŽ‡è©¦é©—連åŒè‡¨åºŠè©¦é©—替代。但原則上以生體相ç‰æ€§è©¦é©—為優先。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 113: ;"><span style="font-size: 14pt; font-family: 標楷體;">如以生體å¯ç”¨çŽ‡è©¦é©—連åŒè‡¨åºŠè©¦é©—替代者，所執行之臨 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">床試驗，應具有統計顯著（Statistical Significance）之æ„義。</span> </p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">ç¬¬ä¸‰ç« ã€€æº¶é›¢æ›²ç·šæ¯”å°è©¦é©— 　　　　　　　　　　　　　　　　　　　　　　　　　　 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第二å一æ¢ã€€ã€€åŸ·è¡Œæº¶é›¢æ›²ç·šæ¯”å°</span><span style="font-size: 14pt; font-family: 標楷體;">試驗，應符åˆä¸‹åˆ—è¦å®šï¼š </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€ä¾åŸ·è¡Œè©¦é©—之目的，é¸æ“‡é©ç•¶ä¹‹å°ç…§è—¥å“。執行試驗之藥å“，應有é…æ–¹ã€è£½é€ åŠå“管資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€å—試藥å“與å°ç…§è—¥å“之溶離曲線比å°ï¼Œæ‡‰æ–¼åŒä¸€è©¦é©—æ¢ä»¶ä¸‹é€²è¡Œï¼Œä¸¦æ‡‰å…·å‚™é©ç•¶ä¹‹è©¦é©—æ¢ä»¶ï¼Œå¦‚使用網籃è£ç½®ï¼ˆBasket Method）五å至一百轉速或攪拌槳è£ç½®ï¼ˆPaddle Method）五å至七å五轉速，並於模擬胃腸é“酸鹼值（pH值）或至少三個足以模擬胃腸é“（pH值之範åœæ‡‰æ–¼ä¸€é»žäºŒè‡³å…點八之間）之溶媒，於æ”æ°ä¸‰å七度進行試驗。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 126: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€å¦‚æœ‰ç‰¹æ®ŠåŽŸå› ï¼Œé ˆæ–¼å…¶ä»–è©¦é©—æ¢ä»¶ä¸‹é€²è¡Œè€…，應檢附科å¸è³‡æ–™ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©å®šã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第二å二æ¢ã€€ã€€åŸ·è¡Œæº¶é›¢æ›²ç·šæ¯”å°</span><span style="font-size: 14pt; font-family: 標楷體;">試驗所用之è¨å‚™åŠåˆ†æžæ–¹æ³•ï¼Œæ‡‰æª¢å…·æ‰€ç”¨æº¶é›¢è£ç½®ä¹‹ç³»çµ±é©ç”¨æ€§ï¼ˆSystem Suitability）åŠå®šé‡åˆ†æžæ–¹æ³•ç¢ºæ•ˆï¼ˆAnalytical Methods Validation）之資料。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第二å三æ¢ã€€ã€€ä»¥æº¶é›¢æ›²ç·šæ¯”å°è©¦é©—替代生體相ç‰æ€§è©¦é©—時</span><span style="font-size: 14pt; font-family: 標楷體;">，</span><span style="font-size: 14pt; font-family: 標楷體;">執行溶離曲線比å°</span><span style="font-size: 14pt; font-family: 標楷體;">試驗所比å°ä¹‹å—試藥å“與å°ç…§è—¥å“數é‡ï¼Œæ‡‰å„有至少å二個劑型單ä½ï¼ˆdosage unitsï¼‰ï¼Œä¸”è©¦é©—æ‡‰æœ‰è¶³å¤ ä¹‹æŽ¡æ¨£é»žï¼Œä¸¦æœ‰æº¶é›¢ç›¸ä¼¼æ€§ï¼ˆf<sub>2</sub>值）或其他é©ç•¶ä¹‹çµ±è¨ˆçµæžœã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;"> </span><span style="font-size: 14pt; font-family: 標楷體;">å‰é …採樣第一時間點å—試藥å“與å°ç…§è—¥å“之變異係數ä¸å¾—超éŽç™¾åˆ†ä¹‹äºŒå，其他時間點之變異係數ä¸å¾—超éŽç™¾åˆ†ä¹‹å。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">ç¬¬ä¸€é …å—試藥å“與å°ç…§è—¥å“溶出百分之八å五以後，僅得å–一點計算溶離相似性（f<sub>2</sub>值）；å五分é˜å…§æº¶å‡ºç™¾åˆ†ä¹‹å…«å五以上藥物者，å…計算溶離相似性（f<sub>2</sub>值）。 </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70: ;"><span style="font-size: 14pt; font-family: 標楷體;">溶離相似性（f<sub>2</sub>值）之計算方å¼åŠçµæžœèªå®šï¼Œè¦å®šå¦‚附件。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">ç¬¬å››ç« ã€€é™„å‰‡ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第二åå››æ¢ã€€ã€€</span><span style="font-size: 14pt; font-family: 標楷體;">申請人應自行或委由試驗執行機構ä¿å˜åŸ·è¡Œç”Ÿé«”å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—之藥å“（å«å—試藥å“åŠå°ç…§è—¥å“ï¼‰ï¼Œä¸”è¶³å¤ ç•™æ¨£è‡³å ±å‘Šæ ¸å‡†å¾Œè‡³å°‘äº”å¹´ï¼Œä¸¦é…åˆè¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¦†é©—ã€æŸ¥æ ¸ã€‚è©¦é©—å ±å‘Šæœªç²æ ¸å‡†è€…，亦åŒã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt; 70pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第二å五æ¢ã€€ã€€ç¶“æ ¸å‡†</span><span style="font-size: 14pt; font-family: 標楷體;">之å„ç¨®è©¦é©—è¨ˆç•«èˆ‡å ±å‘Šï¼Œéžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œåŒæ„，ä¸å¾—變更。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第二åå…æ¢ã€€ã€€æœ¬æº–則自發布日施行。 </span></p><span style="font-size: 14pt; font-family: 標楷體;"><br clear="all" style="page-break-before: always;" /></span><p style="layout-grid-mode: char; line-height: 23pt;"> </p><p style="layout-grid-mode: char; line-height: 23pt; 42pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">附件：溶離相似性</span><span style="font-size: 14pt; font-family: 標楷體;">（f<sub>2</sub>值）之計算方å¼åŠçµæžœèªå®š</span><span style="font-size: 14pt; font-family: 標楷體;">（藥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則第二å三æ¢ç¬¬å››é …附件）。</span> </p><p><span style="position: relative; top: 49pt;"></span></p><p><span style="font-family: 標楷體;"><br /><img alt="" src="../Files/NewsUpload/2.png" /><br /><br /><br /><br />上列公å¼f <sub>2</sub>溶離相似值，n為溶出之採樣點數， ä¿‚å°ç…§è—¥å“æ–¼t時間點之平å‡æº¶å‡ºç™¾åˆ†æ¯”， ä¿‚å—試藥å“æ–¼t時間點之平å‡æº¶å‡ºç™¾åˆ†æ¯”。 </span></p><p><span>In this equation <i>f</i> <sub>2</sub><i> </i>is the similarity factor, n is the number of time points, is the mean percent drug dissolved of e.g. a reference product, and is the mean percent drug dissolved of e.g. a test product.</span></p><p><i></i></p><p><span style="font-family: 標楷體;">f <sub>2</sub></span><span style="font-family: 標楷體;">值≧50，為èªå®šå—試藥å“åŠå°ç…§è—¥å“溶離曲線比å°ç›¸ä¼¼ä¹‹å¿…è¦æ¢ä»¶ã€‚</span> </p><p style="layout-grid-mode: char; line-height: 23pt;"> </p>2013-12-05
其他類,æ血者å¥åº·æ¨™æº–行政解釋附表æ血者å¥åº·ç¯©æª¢é …ç›®<p style="margin: auto 0cm;" class="null"><b><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">附表　</span></b><b><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">æ血者å¥åº·ç¯©æª¢é …ç›®</span></b> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 450.9pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">一ã€é«”é‡ï¼šå¥³æ€§æ‡‰</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">45</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公斤以上，男性應</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">50</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公斤以上。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">二ã€é«”溫：å£æº«ä¸è¶…éŽæ”æ°</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">37.5</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">度。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">三ã€è¡€å£“：收縮壓</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">90</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">～</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">160</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">毫米汞柱，舒張壓</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">50~95</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">毫米汞柱，如兩者之è·é›¢ä½Žæ–¼</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">30</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">或高於</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">90</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">æ¯«ç±³æ±žæŸ±ï¼Œé ˆç¶“é†«å¸«è¨±å¯ã€‚</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">å››ã€è¡€æ¶²æª¢æŸ¥</span> </p> <p class="044-1"><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">　 (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">一</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">) </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">è¡€ç´…ç´ ï¼šç”·æ€§</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">13</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公克</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">%</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上（使用硫酸銅法時血液比é‡</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">1.054</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;"><br /> </span><span style="font-family: arial unicode ms; color: #333333; font-size: 9pt;"> </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">女性</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">12</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">公克</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">%</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上（使用硫酸銅法時血液比é‡</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">1.052</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p class="044-1"><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">　 (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">二</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">) </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">è¡€å°æ¿ï¼šæè¡€å°æ¿è€…，其血å°æ¿æ•¸ç›®æ‡‰åœ¨</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">15</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">×</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">10,000/mm3</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上。</span> </p> <p class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">　</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;"> (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">三</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">) </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">白血çƒï¼šæ白血çƒè€…，其絕å°é¡†ç²’çƒæ•¸ç›®æ‡‰åœ¨</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">3,000/mm3</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上。</span> </p> <p class="044-1"><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;"> (</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">å››</span><span style="font-family: times new roman,serif; color: #333333; font-size: 10pt;">) </span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血漿總蛋白：æ血漿者，應於首次æ血暨æ¯éš”åŠå¹´åŠ 驗血漿總蛋白é‡ï¼Œå…¶è¡€æ¼¿ç¸½è›‹ç™½æ‡‰åœ¨</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">6g/d1</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">以上。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">五ã€</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">ABO</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血型檢驗。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">å…ã€</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Rh</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">血型檢驗。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">七ã€ç´…è¡€çƒç•°é«”抗體篩檢。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">å…«ã€è¡€æ¸…轉胺酶檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">ALT</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">ä¹ã€æ¢…毒血清檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">STS</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 24.5pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">åã€</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">B</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">åž‹è‚炎病毒表é¢æŠ—原檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">HBsAg</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 30.1pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">å一ã€äººé¡žå…疫缺ä¹ç—…毒第一型ã€ç¬¬äºŒåž‹æŠ—體檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Anti- HIV-1/2</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 30.1pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">å二ã€</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">C</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">åž‹è‚炎病毒抗體檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Anti-HCV</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> <p style="margin: 0cm 2.4pt 0pt 30.1pt;" class="044-1"><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">å三ã€äººé¡žå—œ</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">T</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">æ·‹å·´çƒç—…毒抗體檢驗（</span><span style="font-family: arial unicode ms; color: #333333; font-size: 10pt;">Anti-HTLV-I/II</span><span style="font-family: 新細明體,serif; color: #333333; font-size: 10pt;">）。</span> </p> </td> </tr> </tbody></table></div>2013-12-04
臨床試驗類,è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則行政解釋公告生體相ç‰æ€§è©¦é©—之å—è¨—ç ”ç©¶æ©Ÿæ§‹ç®¡ç†è¦ç¯„åŠæŸ¥æ ¸è¡¨è‰æ¡ˆ<div class="WordSection1" style="layout-grid: 18pt none;"><p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 20pt;">生體相ç‰æ€§è©¦é©—之å—è¨—ç ”ç©¶æ©Ÿæ§‹ç®¡ç†è¦ç¯„è‰æ¡ˆ</span></b><b> </b></p><p><b><span style="font-family: 標楷體; font-size: 16pt;">壹ã€ç¸½å‰‡</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">為èªå®šå—è¨—ç ”ç©¶æ©Ÿæ§‹åŸ·è¡Œç”Ÿé«”ç›¸ç‰æ€§è©¦é©—之æ“作åŠåˆ†æžæ¨™æº–，å¥å…¨å—è¨—ç ”ç©¶æ©Ÿæ§‹ä¹‹ç®¡ç†ï¼Œä¾è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則第ä¹æ¢ç¬¬å››é …之è¦å®šï¼Œè¨‚定本è¦ç¯„。</span> </p><p><span style="font-family: times new roman, serif;">二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">本è¦ç¯„用詞，定義如下：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ä¸è‰¯äº‹ä»¶</span><span style="font-family: times new roman, serif;">(adverse event)</span><span style="font-family: 標楷體;">：å—試者åƒåŠ 試驗後所發生之任何ä¸è‰¯æƒ…æ³</span><span style="font-family: 標楷體;">。</span><span style="font-family: 標楷體;">æ¤é …ä¸è‰¯æƒ…æ³èˆ‡è©¦é©—è—¥å“é–“ä¸ä»¥å…·æœ‰å› 果關係為必è¦ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—ç¨½æ ¸</span><span style="font-family: times new roman, serif;">(audit of a trial)</span><span style="font-family: 標楷體;">：指由ä¸ç›´æŽ¥æ¶‰åŠè©¦é©—之人員進行系統性檢查，以評估試驗的實施是å¦èˆ‡æ³•è¦</span><span style="font-family: 標楷體;">ã€</span><span style="font-family: 標楷體;">標準作æ¥ç¨‹åºåŠè©¦é©—è¨ˆç•«æ›¸ç›¸ç¬¦ï¼Œè³‡æ–™å ±å‘Šæ˜¯å¦èˆ‡ç¾å ´è¨˜éŒ„ä¸€è‡´ï¼Œå¦‚ï¼šå€‹æ¡ˆå ±å‘Šè¡¨ä¸çš„è³‡æ–™å ±å‘Šå’Œè¨˜éŒ„æ˜¯å¦èˆ‡é†«é™¢ç—…æ·æˆ–原始記錄相符åˆã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相ç‰æ€§</span><span style="font-family: 標楷體;">（</span><span style="font-family: times new roman, serif;">Bioequivalence</span><span style="font-family: 標楷體;">）</span><span style="font-family: 標楷體;">：指二個藥劑相ç‰å“或藥劑替代å“，於é©ç•¶ç ”究è¨è¨ˆä¸‹ï¼Œä»¥ç›¸åŒæ¢ä»¶ã€ç›¸åŒèŽ«è€³åŠ‘é‡ï¼ˆmolar dose）給與人體時，具有相åŒä¹‹ç”Ÿé«”å¯ç”¨çŽ‡ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å€‹æ¡ˆå ±å‘Šè¡¨</span><span style="font-family: times new roman, serif;">(case report form)</span><span style="font-family: 標楷體;">：指按試驗計畫書è¨è¨ˆçš„å ±å‘Šè¡¨æ ¼ï¼Œç”¨ä»¥è¨˜éŒ„å—試者在試驗éŽç¨‹ä¸çš„資料。資料收集éŽç¨‹å¿…需確ä¿è³‡è¨Šå¾—以良好ä¿å˜ã€ç¶è·ä¸¦ä¸”å¯å†å–得，且方便驗è‰ã€ç¨½æ ¸èˆ‡æŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å°ç…§å“</span><span style="font-family: times new roman, serif;">(comparator product)</span><span style="font-family: 標楷體;">：指臨床試驗ä¸åšç‚ºåƒè€ƒå“之一種製劑或是其他產å“（å¯ä»¥æ˜¯å®‰æ…°åŠ‘）。</span> </p><p><span style="font-family: times new roman, serif;">(å…) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">委託</span><span style="font-family: times new roman, serif;">(contract)</span><span style="font-family: 標楷體;">ï¼šæŒ‡ä¸€å€‹ç”±ç ”ç©¶è€…ã€ç ”究機構和臨床試驗委託者å°è²¡å‹™å•é¡Œèˆ‡è²¬ä»»çš„授權與分é…é”æˆä¸€è‡´åŒæ„並共åŒç°½ç« 並註明日期之文件。包å«ä»¥ä¸Šè³‡è¨Šä¹‹è©¦é©—計畫並由責任人簽å—，則å¯è¦–為委託。</span> </p><p><span style="font-family: 標楷體;">(七) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹</span><span style="font-family: times new roman, serif;">(contract research organization)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">å’Œè©¦é©—å§”è¨—è€…ç· ç´„ä»¥æ‰¿æ“”è‡¨åºŠè©¦é©—ä¸€éƒ¨æˆ–å…¨éƒ¨å·¥ä½œä¹‹å€‹äººæˆ–æ©Ÿæ§‹ã€‚</span><span style="font-family: 標楷體;">æ¤ç¨®å§”è¨—å¿…é ˆæœ‰æ›¸é¢ç´„定。 </span></p><p><span><span style="font-family: calibri;">(å…«) </span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">人體試驗委員會</span><span style="font-family: times new roman, serif;">(ethics committee or institutional review board)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">由具醫å¸èƒŒæ™¯ä¹‹å°ˆæ¥äººå“¡èˆ‡éžé†«å¸èƒŒæ™¯ä¹‹ç¤¾æœƒå…¬æ£äººå£«æ‰€å…±åŒçµ„æˆä¹‹å§”員會，其責任在ä¿è·å—試者之權利ã€å®‰å…¨èˆ‡ç¦ç¥‰</span><span style="font-family: 標楷體;">。</span> </p><p><span style="font-family: times new roman, serif;">(ä¹) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æœ€çµ‚å ±å‘Š</span><span style="font-family: times new roman, serif;">(final report)</span><span style="font-family: 標楷體;">：指臨床試驗完æˆå¾Œå°è©¦é©—所åšçš„綜åˆæ述。包括試驗方法和分æžæ–¹æ³•çš„æ述，試驗用的æ料，試驗çµæžœçš„æ述與分æžï¼Œçµ±è¨ˆåˆ†æžï¼Œé‚„有一個嚴謹的åˆä¹Žå€«ç†èˆ‡çµ±è¨ˆçš„臨床評估。</span> </p><p><span style="font-family: times new roman, serif;">(å) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è—¥å“優良臨床試驗準則</span><span style="font-family: times new roman, serif;">(good clinical practice)</span><span style="font-family: 標楷體;">：一套有關臨床試驗的è¨è¨ˆã€åŸ·è¡Œã€ç›£æ¸¬ã€çµ‚æ¢ã€ç¨½æ ¸ã€åˆ†æžã€å ±å‘Šå’Œè¨˜éŒ„的標準，該標準乃為確ä¿è‡¨åºŠè©¦é©—具科å¸æ€§ä¸”符åˆå€«ç†ï¼›ä¸¦ä¿è‰å…¶è‡¨åºŠç‰¹æ€§æ£ç¢ºè¨˜éŒ„，所得數據æ£ç¢ºå¯ä¿¡ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥物éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„</span><span style="font-family: times new roman, serif;">(good laboratory practice)</span><span style="font-family: 標楷體;">：一套關於éžè‡¨åºŠå¯¦é©—室å°æ–¼å¥åº·èˆ‡ç’°å¢ƒå®‰å…¨ç ”究之計畫ã€åŸ·è¡Œã€ç›£æ¸¬ã€è¨˜éŒ„ã€å ±å‘Šå’Œæª”案的組織架構和æ¢ä»¶çš„å“質系統。</span> </p><p><span style="font-family: times new roman, serif;">(å二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者åŒæ„書</span><span style="font-family: times new roman, serif;">(informed consent)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">å—試者於å—告知並了解將åƒèˆ‡ä¹‹è‡¨åºŠè©¦é©—之相關訊æ¯ï¼Œä¸”åƒé…Œæ˜¯å¦åƒèˆ‡è©¦é©—ä¹‹æ‰€æœ‰å› ç´ å¾Œï¼Œè‡ªé¡˜ç°½ç½²é¡˜æ„åƒåŠ 試驗之文件</span><span style="font-family: 標楷體;">。</span> </p><p><span style="font-family: 標楷體;">(å三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æŸ¥æ ¸(inspection)：指藥å“主管機關å°ä¸€é …臨床試驗進行的官方檢查，（檢閱包括å“質管制ã€äººå“¡åƒèˆ‡ã€æŽˆæ¬Šèˆ‡ç¨½æŸ¥ç‰è³‡æ–™ï¼‰ï¼ŒæŸ¥æ ¸ä½œæ¥å¯ä»¥åœ¨è©¦é©—å–®ä½ã€è‡¨åºŠè©¦é©—委託者或å—è¨—ç ”ç©¶æ©Ÿæ§‹ä¹‹è™•æ‰€é€²è¡Œï¼Œä»¥è‰æ˜Ž</span><span style="font-family: 標楷體;">符åˆè—¥å“優良臨床試驗準則</span><span style="font-family: 標楷體;">與</span><span style="font-family: 標楷體;">éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„</span><span style="font-family: 標楷體;">之è¦å®š</span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: times new roman, serif;">(åå››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗用藥å“的標籤</span><span style="font-family: times new roman, serif;">(investigational labelling)</span><span style="font-family: 標楷體;">：臨床試驗ä¸è©¦é©—è—¥å“的專用標籤。</span> </p><p><span style="font-family: times new roman, serif;">(å五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥å“</span><span style="font-family: times new roman, serif;">(investigational product or study product)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">臨床試驗ä¸ç”¨ä¾†è©¦é©—之藥å“，或當作åƒè€ƒä¹‹æ´»æ€§æˆåˆ†è£½åŠ‘或安慰劑。</span><span style="font-family: times new roman, serif;"> </span></p><p><span style="font-family: times new roman, serif;">(åå…) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäºº</span><span style="font-family: times new roman, serif;">(investigator)</span><span style="font-family: 標楷體;">ï¼šè©¦é©—æ©Ÿæ§‹åŸ·è¡Œè‡¨åºŠè©¦é©—ä¹‹è² è²¬äººã€‚æŒ‡å¯¦æ–½è‡¨åºŠè©¦é©—ä¸¦å°å—試者權益ã€å¥åº·åŠç¦åˆ©è² 責的人。試驗主æŒäººå¿…é ˆç¬¦åˆé†«ç™‚法與藥事法相關è¦å®šè¦æ±‚ä¹‹è³‡æ ¼èˆ‡èƒ½åŠ›ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å七) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">監測員</span><span style="font-family: times new roman, serif;">(monitor)</span><span style="font-family: 標楷體;">：由臨床試驗委託者任命並å°è‡¨åºŠè©¦é©—委託者或</span><span style="font-family: times new roman, serif;">CRO</span><span style="font-family: 標楷體;">è² è²¬ä¹‹å…·å‚™ç›¸é—œçŸ¥è˜äººå“¡ï¼Œå…¶ä»»å‹™æ˜¯ç›£æ¸¬åŠå ±å‘Šè©¦é©—的進行情æ³å’Œæ ¸å¯¦è³‡æ–™ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(åå…«) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è—¥å“</span><span style="font-family: times new roman, serif;">(pharmaceutical product)</span><span style="font-family: 標楷體;">：指使用於診斷</span><span style="font-family: 標楷體;">ã€</span><span style="font-family: 標楷體;">治療，減輕或é 防人類疾病之原料藥或製劑。</span> </p><p><span style="font-family: times new roman, serif;">(åä¹) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">總試驗主æŒäºº</span><span style="font-family: times new roman, serif;">(principal investigator)</span><span style="font-family: 標楷體;">ï¼šæŒ‡è² è²¬å”調數個臨床試驗（如多ä¸å¿ƒè‡¨åºŠè©¦é©—）的試驗主æŒäººã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二å) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書</span><span style="font-family: times new roman, serif;">(protocol)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">記載臨床試驗之目的ã€è¨è¨ˆã€æ–¹æ³•ã€çµ±è¨ˆè€ƒé‡èˆ‡ç·¨åˆ¶ç‰äº‹é …之文件，並得載明試驗之相關背景åŠç†è«–。</span> </p><p><span style="font-family: times new roman, serif;">(二å一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗的å“質ä¿è‰</span><span style="font-family: times new roman, serif;">(quality assurance relating to clinical trials)</span><span style="font-family: 標楷體;">：為了確ä¿è‡¨åºŠè©¦é©—之æ“作與資料之產出符åˆè—¥å“優良臨床試驗準則與藥物éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„所建立的系統與å“質管制程åºã€‚包括確ä¿ç¬¦åˆå€«ç†å’Œå°ˆæ¥çš„臨床æ“作ã€æ¨™æº–作æ¥ç¨‹åºã€å ±å‘ŠåŠäººå“¡çš„å°ˆæ¥è³‡æ ¼å’ŒæŠ€èƒ½ç‰ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二å二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">原始資料</span><span style="font-family: times new roman, serif;">(raw data)</span><span style="font-family: 標楷體;">：指在臨床試驗當ä¸ç”¨ä¾†é‡å»ºæˆ–評估試驗的所有最åˆçš„觀察資料，臨床發ç¾æˆ–臨床試驗ä¸çš„å…¶ä»–æ´»å‹•çš„è¨˜éŒ„æˆ–ç°½ç« çš„å½±æœ¬ã€‚é€™äº›è³‡æ–™åŒ…æ‹¬ï¼šå¯¦é©—å®¤ç†è¨˜ï¼Œå‚™å¿˜éŒ„，計算çµæžœèˆ‡æ–‡æª”，還包括那些自動儀器的資料記錄與æŸäº›ç²¾ç¢ºè€Œç°½ç« éŽçš„影本（比如：影å°æˆ–ç¸®å½±è† ç‰‡å½¢å¼çš„æª”ï¼‰ã€‚åŽŸå§‹è³‡æ–™ä¹ŸåŒ…æ‹¬ç›¸ç‰‡åº•ç‰‡ï¼Œç¸®å½±è† ç‰‡ï¼Œç£ä»‹è³ªï¼ˆå¦‚電腦ç£ç‰‡ï¼‰å’Œå…‰å¸ä»‹è³ªï¼ˆå¦‚</span><span style="font-family: times new roman, serif;">CD-ROMs</span><span style="font-family: 標楷體;">）。</span> </p><p><span style="font-family: times new roman, serif;">(二å三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">åš´é‡ä¸è‰¯äº‹ä»¶</span><span style="font-family: times new roman, serif;">(serious adverse event)</span><span style="font-family: 標楷體;">：指臨床試驗éŽç¨‹ä¸ç™¼ç”ŸåŒ…括æ»äº¡ã€å±åŠç”Ÿå‘½</span><span style="font-family: 標楷體;">ã€</span><span style="font-family: 標楷體;">導致病人ä½é™¢æˆ–延長病人ä½é™¢æ™‚é–“ã€é€ æˆæ°¸ä¹…性殘疾ã€å…ˆå¤©æ€§ç•¸å½¢åŠå…¶ä»–需作處置以防永久性傷害的ä¸è‰¯äº‹ä»¶ã€‚</span><span style="font-family: times new roman, serif;"> </span></p><p><span style="font-family: times new roman, serif;">(二åå››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗委託者</span><span style="font-family: times new roman, serif;">(sponsor)</span><span style="font-family: 標楷體;">：臨床試驗之發起åŠç®¡ç†è€…。</span> </p><p><span style="font-family: times new roman, serif;">(二å五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">標準作æ¥ç¨‹åº</span><span style="font-family: times new roman, serif;">(standard operating procedures</span><span style="font-family: 標楷體;">ï¼›</span><span style="font-family: times new roman, serif;">SOP)</span><span style="font-family: 標楷體;">：為有效地實施和完æˆæŸä¸€ç‰¹å®šçš„臨床試驗ä¸æ¯é …工作所擬定的標準和詳細的書é¢è¦ç¨‹ã€‚</span> </p><p><span style="font-family: 標楷體;">(二åå…) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ç ”ç©¶ä¸»æŒäºº</span><span style="font-family: times new roman, serif;">(study director)</span><span style="font-family: 標楷體;">：</span><span style="font-family: 標楷體;">在生體相ç‰æ€§è©¦é©—ï¼Œç ”ç©¶ä¸»æŒäººè² 責主導試驗ä¸ç”Ÿç‰©æª¢é«”分æžä¹‹å·¥ä½œã€‚ </span></p><p><span style="font-family: times new roman, serif;">(二å七) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者</span><span style="font-family: times new roman, serif;">(trial subject)</span><span style="font-family: 標楷體;">：指åƒåŠ 臨床試驗而接å—試驗藥å“或å°ç…§è—¥å“之個人。這個人å¯ä»¥æ˜¯ï¼š</span> </p><p><span><span style="font-family: calibri;">1</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">願æ„åƒåŠ 試驗的å¥åº·å—試者。</span> </p><p><span><span style="font-family: calibri;">2</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">個體情æ³èˆ‡ä½¿ç”¨è©¦é©—è—¥å“無關的人。</span> </p><p><span><span style="font-family: calibri;">3</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">個體情æ³èˆ‡ä½¿ç”¨è©¦é©—è—¥å“有關的人（通常是病人）。</span> </p><p><span style="font-family: times new roman, serif;">(二åå…«) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確效作æ¥</span><span style="font-family: times new roman, serif;">(validation)</span><span style="font-family: 標楷體;">：確效作æ¥ç³»æŒ‡æœ‰æ–‡ä»¶è‰æ˜Žçš„作æ¥ç¨‹åºï¼Œä¾æ“šè—¥å“優良臨床試驗準則與藥物éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„，è‰å¯¦ä»»ä½•æ¥é©Ÿã€è™•ç†ã€è¨å‚™ï¼ˆåŒ…括使用的軟ã€ç¡¬é«”）ã€ç‰©æ–™ã€é€²è¡Œä¹‹æ´»å‹•å’Œç³»çµ±ç¢ºå¯¦ä¸€è‡´ä¸”å¯è‡´é 期之çµæžœã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二åä¹) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料驗è‰</span><span style="font-family: times new roman, serif;">(verification of data)</span><span style="font-family: 標楷體;">：指為確ä¿æœ€çµ‚å ±å‘Šä¸çš„資料與最åˆçš„觀察資料一致而採å–çš„æ¥é©Ÿã€‚該æ¥é©Ÿäº¦å¯æ˜¯é›»è…¦ç¨‹å¼ï¼Œé©ç”¨æ–¼åŽŸå§‹è³‡æ–™ï¼Œå€‹æ¡ˆå ±å‘Šè¡¨ä¸çš„資料（文書版或電å版），電腦列å°è¼¸å‡ºï¼Œè³‡æ–™åˆ†æžå’Œè¡¨æ ¼ã€‚</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">è²³ã€çµ„織與管ç†</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹ï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰ç¬¦åˆç›¸é—œæ³•è¦ä¹‹è¦ç¯„。藥å“è£½é€ å» ä¹‹ç ”ç™¼å–®ä½ï¼Œäº¦åŒã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰æœ‰çµ„ç¹”æž¶æ§‹åœ–ï¼Œè¼‰æ˜Žä¸»è¦è² 責人姓å與è·å‹™ï¼Œä¸¦ç¶“è² è²¬äººç°½å授權åŠåŠ 註日期。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">所有工作人員應有工作æ¥å‹™ä¹‹èªªæ˜Žæ–‡ä»¶ï¼ŒåŒ…括主è¦è² 責人之責任範åœã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">人員之簽å樣å¼æ‡‰ä½œæˆåˆ—表。</span> </p><p><span style="font-family: times new roman, serif;">å››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦åŠç¡¬é«”è¨å‚™ï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦數é‡æ‡‰è¶³ä¾›äººå“¡é€²è¡Œè³‡æ–™ç™»éŒ„ã€è³‡æ–™ç®¡ç†ã€è¨ˆç®—èˆ‡ç·¨å¯«å ±å‘Šã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦應有充足之空間與記憶體。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">輸入åŠå„²å˜æ–¼é›»è…¦ä¹‹è©¦é©—相關資料應有明確方法進行控管。å°æ–¼æœ‰æ¬ŠæŽ§ç®¡è³‡æ–™åº«ä¹‹äººå“¡æ‡‰ä½œæˆåˆ—表ä¿å˜ã€‚</span> </p><p><span style="font-family: times new roman, serif;">五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦軟體，應符åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">電腦軟體之é¸ç”¨æ‡‰ç¬¦åˆå¯¦éš›éœ€è¦ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">é¸ç”¨è»Ÿé«”程å¼ã€ç—…毒掃æé »æ¬¡ã€è³‡æ–™å„²å˜ï¼ŒåŠå‚™ä»½æª”之製作ã€å˜æª”ã€ä¿å˜ç‰äº‹ä»¶ï¼Œæ‡‰æœ‰æ–‡ä»¶æ˜Žç¢ºèªªæ˜Žã€‚</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">é¸ç”¨è»Ÿé«”應能é”到å“質åŠè³‡è¨Šç®¡ç†ä¹‹éœ€æ±‚，並應ä¿è‰å…¶å¯ä¿¡åº¦èˆ‡æº–確性。資料處ç†è»Ÿé«”應至少包å«æ–‡æ›¸è™•ç†ã€è³‡æ–™ç™»éŒ„ã€è³‡æ–™åº«ã€åœ–表製作ã€è—¥å‹•å¸èˆ‡çµ±è¨ˆå¸è»Ÿé«”。使用者自行è¨è¨ˆä¹‹è»Ÿé«”，亦åŒã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入，指將原始資料ã€å€‹æ¡ˆå ±å‘Šè¡¨ã€åˆ†æžæ€§è³‡æ–™å‚³è¼¸è‡³é›»è…¦ç³»çµ±ï¼Œä½œç‚ºè—¥å‹•å¸é‹ç®—或統計å¸åˆ†æžåŠå ±å‘Šä¹‹ç”¨ã€‚</span> </p><p><span style="font-family: times new roman, serif;">七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入，應符åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入程åºå®œå…·é˜²æ¢éŒ¯èª¤ç™¼ç”Ÿä¹‹è¨è¨ˆï¼Œä¸¦æœ‰æ¨™æº–作æ¥æµç¨‹è©³ç´°èªªæ˜Žã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">資料輸入宜採複å¼è¼¸å…¥æ³•ã€‚è³‡æ–™æ ¡å°ã€è¤‡å¼è¼¸å…¥ã€é›»åé‚輯控制ç‰è³‡æ–™ç¢ºæ•ˆä¹‹æ–¹æ³•å¸ï¼Œæ‡‰æ出詳細說明。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">更改資料庫之資料應由專人或其授權之人為之，並詳細記錄。</span> </p><p><span style="font-family: times new roman, serif;">å…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰è¦åŠƒé©ç•¶ä¹‹ç©ºé–“，並能防ç«ï¼Œä»¥ä¾›å„²å˜è‡¨åºŠè©¦é©—資料檔案與試驗藥å“ç‰ã€‚</span> </p><p><span style="font-family: times new roman, serif;">ä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">儲å˜æª”案，應符åˆä»¥ä¸‹è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">儲å˜æª”案應有標準作æ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檔案室出入應進行管制，éžç¶“授權之人ä¸å¾—出入。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">標準作æ¥æµç¨‹å°è©¦é©—åŽŸå§‹è³‡æ–™èˆ‡ç ”ç©¶ç´€éŒ„ä¹‹å„²å˜æœŸé™æ‡‰è©³ç‚ºè¦å®šã€‚</span> </p><p><span style="font-family: times new roman, serif;">å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢å“ä¿å˜æœŸé–“應ä¾ç›¸é—œæ³•è¦ä¹‹è¦å®šï¼Œä¸¦æ–¼æ¨™æº–作æ¥æµç¨‹ä¸è©³ç´°èªªæ˜Žã€‚</span> </p><p><span style="font-family: times new roman, serif;">å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗應在ä¿è‰å—試者安全之æ¢ä»¶ä¸‹é€²è¡Œï¼Œå…¶å–®ä½å ´æ‰€ä¹‹é¸æ“‡æ‡‰è€ƒé‡ç”¢å“ç ”ç™¼éšŽæ®µåŠæ½›åœ¨å±éšªæ€§ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰è¦åŠƒå……足空間，供相關試驗人員ä½å®¿ã€æ´»å‹•æˆ–進行試驗之用。</span> </p><p><span style="font-family: times new roman, serif;">å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è‡¨åºŠè©¦é©—å ´æ‰€æ‡‰æœ‰å¯¦é©—å®¤åŠå…¶ä»–è¶³å¤ è¨æ–½ï¼Œä¸¦æ‡‰å¦¥ç‚ºè¦åŠƒè¨ç½®ï¼Œä»¥åˆ©è©¦é©—æ´»å‹•é †åˆ©é€²è¡Œã€‚è©¦é©—å ´æ‰€ä¹‹å‡ºå…¥æ‡‰é€²è¡Œç®¡åˆ¶ã€‚</span> </p><p><span style="font-family: times new roman, serif;">åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室之è¨ç½®ï¼Œæ‡‰ä»¥é©æ–¼äººå“¡ä¹‹å¯¦é©—æ“作為原則，並應有充足空間，以防æ¢è—¥å“æ··æ·†ã€æ±™æŸ“或交å‰æ±™æŸ“，åŠä¾›å„²è—檢å“ã€æ¨™æº–å“ã€å„€å™¨ã€è¨å‚™ã€æº¶åŠ‘ã€è©¦åŠ‘和紀錄。儲è—室ç‰é‡è¦å€åŸŸä¹‹æº«åº¦æŽ§åˆ¶æ‡‰è¨é è¦ç³»çµ±ï¼Œå®šæœŸé€²è¡Œæ¸¬è©¦ï¼Œä»¥ç¢ºä¿å…¶æ£å¸¸é‹è¡Œã€‚æ¯æ—¥ä¹‹æº«åº¦è¨˜éŒ„應ä¿å˜ï¼Œå¦‚有檢測é è¦ç³»çµ±ï¼Œäº¦æ‡‰è¨˜éŒ„之。</span> </p><p><span style="font-family: times new roman, serif;">å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ´æ‰€æ‡‰æœ‰é›»è©±ã€å‚³çœŸåŠç™¼é€é›»å郵件之è¨å‚™ï¼Œä»¥ç¢ºä¿èˆ‡å¤–界之æ£å¸¸è¯ç¹«ã€‚æ¤å¤–，å—è¨—ç ”ç©¶æ©Ÿæ§‹äº¦æ‡‰é…ç½®å°è¡¨æ©Ÿæˆ–å½±å°æ©Ÿç‰å¿…è¦ä¹‹è¾¦å…¬è¨å‚™ï¼Œä»¥å®Œæˆå…¶å·¥ä½œã€‚</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">åƒã€è‡¨åºŠæœŸä¹‹ç®¡ç†</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相ç‰æ€§è©¦é©—為人體試驗，應符åˆé†«ç™‚法åŠå…¶æŽˆæ¬Šç›¸é—œæ³•ä»¤ã€è—¥äº‹æ³•åŠå…¶æŽˆæ¬Šç›¸é—œæ³•ä»¤ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: times new roman, serif;">å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗應於符åˆæ³•è¦è¦å®šä¹‹é†«ç™‚機構內進行，並應確ä¿å—試者之安全。</span> </p><p><span style="font-family: times new roman, serif;">åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">進行試驗之醫療機構，應符åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æ‡‰æœ‰è¶³å¤ ç©ºé–“ï¼Œä»¥å®¹ç´å—試者。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">夜間工作之辦公è¨æ–½åŠåºŠä½ï¼Œå¾—ä¾è©¦é©—é¡žåž‹åŠè©¦é©—è—¥å“之需è¦ï¼Œåœ¨é©ç•¶æ¢ä»¶ä¸‹æä¾›é…置，並應於試驗計畫書ä¸è¼‰æ˜Žã€‚</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æ›´æ›ã€å˜æ”¾ã€æ¸…洗衣物或供盥洗之處所，應è¨æ–¼ç ”究人員易於所åŠä¹‹è™•ï¼Œå…¶æ•¸é‡ä¸¦æ‡‰ç¬¦åˆäººæ•¸ä¹‹éœ€è¦ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ´æ‰€æ‡‰é…置下列è¨æ–½ï¼Œå¿…è¦æ™‚並應有é©ç•¶ä¹‹å€éš”：</span> </p><p><span><span style="font-family: calibri;">1</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者登記和檢查之處所。</span> </p><p><span><span style="font-family: calibri;">2</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ä¾›å—試者休閒之處所。</span> </p><p><span><span style="font-family: calibri;">3</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">其他附屬於å—è©¦è€…ä¹‹å ´æ‰€ã€‚</span> </p><p><span><span style="font-family: calibri;">4</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">供儲è—ã€é‡æ–°åŒ…è£ã€èª¿åŠ‘ã€è¨˜éŒ„ç‰è—¥äº‹ä½œæ¥ç”¨ä¹‹ç®¡åˆ¶é€²å‡ºå ´æ‰€ã€‚</span> </p><p><span><span style="font-family: calibri;">5</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">供藥å“之定é‡ã€çµ¦è—¥ï¼ŒåŠæª¢é«”收集之處所。</span> </p><p><span><span style="font-family: calibri;">6</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">血漿分離ã€å†·è—室ç‰æª¢å“處ç†æˆ–儲è—之處所。</span> </p><p><span><span style="font-family: calibri;">7</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">儲å˜è©¦é©—器æã€è—¥å“ã€æ–‡ä»¶æª”æ¡ˆèˆ‡å€‹æ¡ˆå ±å‘Šè¡¨ä¹‹ç›£æŽ§å ´æ‰€ã€‚</span> </p><p><span><span style="font-family: calibri;">8</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">準備標準é¤é£ŸåŠç”¨é¤ä¹‹è™•æ‰€ã€‚</span> </p><p><span><span style="font-family: calibri;">9</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">緊急情æ³ä¸‹å¯ç”¨çš„資æºã€æ¶æ•‘è¨å‚™ï¼ŒåŠç·Šæ€¥äº‹ä»¶ä¸å¿…備之急救藥å“。</span> </p><p><span><span style="font-family: calibri;">10</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">緊急救è·æˆ–其他醫療救è·æ™‚，足供妥善照顧å—試者之è¨æ–½ã€‚</span> </p><p><span><span style="font-family: calibri;">11</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å˜æª”è¨æ–½ã€‚</span> </p><p><span style="font-family: times new roman, serif;">åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢體分æžæ‡‰æ–¼åˆé©ä¸”符åˆæ¨™æº–之分æžå¯¦é©—室進行。</span> </p><p><span style="font-family: times new roman, serif;">二å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">血液檢查ã€å°¿æ¶²æª¢æŸ¥æˆ–其他檢驗，應於試驗計畫書所定之試驗期間進行。</span> </p><p><span style="font-family: times new roman, serif;">二å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰æœ‰å¯¦é©—å®¤åˆ†æžæ–¹æ³•ã€å¿…è¦æ™‚é ˆæ供載明日期之實驗室分æžæ¨™æº–範åœï¼ŒåŠå¯¦é©—室èªè‰è‰æ›¸ç‰å…·é«”資料。</span> </p><p><span style="font-family: times new roman, serif;">二å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室的資料檔ä¸ï¼Œæ‡‰æœ‰è² 責分æžäººå“¡ç°½ç½²ä¹‹æœ€æ–°å€‹äººç°¡æ·ã€‚</span> </p><p><span style="font-family: times new roman, serif;">二å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室應替æ¯ä¸€ä½å—試者建立單ç¨ä¹‹å ±å‘Šæª”æ¡ˆï¼Œä½œç‚ºå€‹æ¡ˆå ±å‘Šè¡¨ä¹‹ä¸€éƒ¨åˆ†ï¼Œä¸¦æ‡‰æœ‰æ‰€æœ‰è©¦é©—æ¸¬è©¦çš„åŽŸå§‹è³‡æ–™å˜æª”。</span> </p><p><span style="font-family: times new roman, serif;">二åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰æœ‰å……è¶³çš„å·¥ä½œäººå“¡å¾žäº‹è‡¨åºŠè©¦é©—ï¼Œç›¸é—œäººå“¡æ‡‰å…·å‚™ç‰¹å®šè³‡æ ¼ä¸¦ç¶“å°ˆé–€åŸ¹è¨“ã€‚å“¡å·¥äººæ•¸æ‡‰è¦–å—è¨—ç ”ç©¶æ©Ÿæ§‹å¾žäº‹è‡¨åºŠè©¦é©—ä¹‹å¤šå¯¡åŠé›£åº¦ä»¥æ±ºå®šã€‚</span> </p><p><span style="font-family: times new roman, serif;">二å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">為ä¿è‰å—試者之權利ã€å®‰å…¨åŠå¥åº·ï¼ŒåŒ…括夜晚在內之試驗期間內，應ç¶æŒè¶³å¤ 之åˆæ ¼ä¸”經專門培訓之員工人數，並應在çªç™¼äº‹ä»¶ä¸å¦¥å–„照顧å—試者。</span> </p><p><span style="font-family: times new roman, serif;">二åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相ç‰æ€§è©¦é©—之é‹ä½œåŠåˆ†æžï¼Œæ‡‰ç”±ä¸‹åˆ—é—œéµäººå“¡è² 責執行：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">醫å¸æˆ–科技指導員。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">主è¦è©¦é©—主æŒäººæˆ–試驗主æŒäººï¼Œèˆ‡å”åŒä¸»æŒäººã€‚</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ç ”ç©¶ä¸»æŒäººã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å“質ä¿è‰ç¶“ç†ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">技術經ç†ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å…) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å“質管制經ç†ã€‚</span> </p><p><span style="font-family: times new roman, serif;">二å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">é™¤è² è²¬å“質ä¿è‰ä¹‹äººå“¡æ‡‰ç‚ºç¨ä»»å¤–，åŒä¸€äººå“¡å¾—兼任其他è·å‹™ã€‚å“質ä¿è‰äººå“¡ä¸¦æ‡‰å°‡ç¨½æ ¸çµæžœå‘機構之最高管ç†éšŽå±¤å½™å ±ã€‚</span> </p><p><span style="font-family: times new roman, serif;">二åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹å¾—é›‡å‚å…¼è·äººå“¡å¾žäº‹ä¸€å®šå·¥ä½œï¼ŒæƒŸå…¶ç°¡æ·èˆ‡åŸ¹è¨“記錄皆應比照全è·äººå“¡è¨˜éŒ„在案。</span> </p><p><span style="font-family: times new roman, serif;">二åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è² è²¬è¨ˆç•«åŠå¯¦æ–½ç ”究的管ç†äººå“¡æ‡‰æœ‰é©ç•¶ä¹‹è³‡æ ¼ï¼Œä¸¦å…·å‚™ç›¸é—œé ˜åŸŸä¹‹å°ˆæ¥çŸ¥è˜èˆ‡ç¶“驗。</span> </p><p><span style="font-family: times new roman, serif;">三å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">藥物éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„與藥å“優良臨床試驗準則之培訓åŠè€ƒæ ¸ï¼Œæ‡‰ä½œæˆç´€éŒ„並ä¿å˜ã€‚</span> </p><p><span style="font-family: times new roman, serif;">三å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å“質ä¿è‰ï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—之è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰æœ‰ç›¸æ‡‰ä¹‹å“質ä¿è‰ç³»çµ±ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å“質ä¿è‰äººå“¡åŠå…¶è² 責人，應ç¨ç«‹æ–¼è©¦é©—執行或監測員之外。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å“質ä¿è‰å–®ä½ä¹‹ä¸»è¦è·è²¬å¦‚下：</span> </p><p><span><span style="font-family: calibri;">1</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ç¨½æ ¸è©¦é©—éŽç¨‹ä¸æ‰€é€²è¡Œä¹‹ä»»ä½•æ´»å‹•ã€‚</span> </p><p><span><span style="font-family: calibri;">2</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確ä¿å“質ä¿è‰ç³»çµ±èˆ‡å—è¨—ç ”ç©¶æ©Ÿæ§‹çš„æ¨™æº–ä½œæ¥ç¨‹åºä¹‹é †åˆ©é‹ä½œã€è¤‡æ ¸åŠæ›´æ–°ã€‚</span> </p><p><span><span style="font-family: calibri;">3</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確ä¿æ‰€æœ‰è³‡æ–™ä¹‹å¯ä¿¡åº¦èˆ‡å¯è¿½æº¯æ€§ã€‚</span> </p><p><span><span style="font-family: calibri;">4</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ä¾ç…§æ¨™æº–作æ¥ç¨‹åºï¼Œæ–¼å›ºå®šä¸”ç‰¹å®šä¹‹æ™‚é–“å…§ï¼Œè¨ˆç•«åŸ·è¡Œå…§éƒ¨ç¨½æ ¸å·¥ä½œï¼Œå¿…è¦æ™‚並追蹤矯æ£æŽªæ–½ä¹‹é€²åº¦ã€‚</span> </p><p><span><span style="font-family: calibri;">5</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確ä¿åˆ†æžå¯¦é©—室åŠå…¶ä»–委託單ä½ä¾è—¥ç‰©éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„é€²è¡Œï¼ŒåŒ…æ‹¬ç¨½æ ¸å¯¦é©—å®¤è¨æ–½ï¼Œå¿…è¦æ™‚並追蹤矯æ£æŽªæ–½ä¹‹é€²åº¦ã€‚</span> </p><p><span><span style="font-family: calibri;">6</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å¯©æ ¸è‡¨åºŠå ±å‘Šï¼Œä¸¦ç¢ºä¿è‡¨åºŠå ±å‘Šèƒ½æº–確且完整åæ˜ ç ”ç©¶çµæžœè³‡æ–™ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗委託人如欲å°è©¦é©—進行監測，或å°è‡¨åºŠè©¦é©—ã€åˆ†æžèˆ‡å¯¦é©—å ´æ‰€é€²è¡Œç¨½æ ¸ï¼Œå—è¨—ç ”ç©¶æ©Ÿæ§‹ä¸å¾—拒絕。</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">分æžå¯¦é©—室應è¨ç«‹ç¨ç«‹ä¹‹å“質ä¿è‰å–®ä½ã€‚å“質ä¿è‰å–®ä½æ‡‰èˆ‡è² 責分æžå·¥ä½œä¹‹äººå“¡åˆ†åˆ¥ç¨ç«‹ï¼Œä»¥ç¢ºä¿è©¦é©—採用最新之分æžæ–¹æ³•ä¸¦é€šéŽç¢ºæ•ˆä½œæ¥ã€‚</span> </p><p><span style="font-family: times new roman, serif;">三å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應於臨床試驗執行å‰ä¾æ³•ç¶“ç¨ç«‹ä¹‹äººé«”è©¦é©—å§”å“¡æœƒæ ¸å‡†ã€‚äººé«”è©¦é©—å§”å“¡æœƒæœƒæœŸå…§ä¹‹è¨Žè«–ã€å»ºè°ã€çµè«–，應詳實記錄；人體試驗委員會應有充足之時間，å°è‡¨åºŠè©¦é©—計畫書ã€å—試者åŒæ„書åŠç›¸é—œæ–‡ä»¶é€²è¡Œè©•å¯©ã€‚</span> </p><p><span style="font-family: times new roman, serif;">三å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者åŒæ„，應符åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者åŒæ„，應使用å—試者或其法定代ç†äººå¯ç†è§£ä¹‹èªžè¨€æ–‡å—，以å£é åŠæ›¸é¢ä¹‹å½¢å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者åŒæ„應ä¾è—¥å“優良臨床試驗準則之è¦å®šï¼Œæ–¼è‡¨åºŠè©¦é©—å„é …æ¥é©Ÿé€²è¡Œå‰å®Œæˆï¼Œä¸¦è¨˜éŒ„å˜æª”。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者得ä¸é™„任何ç†ç”±ï¼Œéš¨æ™‚退出試驗。有附ç†ç”±è€…，應記錄之。</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者應å—明確告知有關ä¿éšªåŠå› åƒèˆ‡è©¦é©—而致傷殘所å—之補償和治療ç‰è³‡è¨Šã€‚</span> </p><p><span style="font-family: times new roman, serif;">三åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗之監測，應符åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ç›£æ¸¬å“¡æ‡‰å…·å‚™ä¸€å®šè³‡æ ¼ï¼Œè² è²¬ç¢ºä¿è©¦é©—éŽç¨‹ä¾æ“šè¨ˆç•«æ›¸ã€è—¥å“éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„ã€è—¥å“優良臨床試驗準則ã€è©¦é©—倫ç†åŠç›¸é—œæ³•è¦é€²è¡Œï¼ŒåŒ…æ‹¬æŒ‡å¼•å€‹æ¡ˆå ±å‘Šè¡¨åŠè©¦é©—資料ä¾æ£ç¢ºç¨‹åºé€²è¡Œã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">委託人得將監ç£ç®¡ç†ä¹‹å·¥ä½œå§”託予å—è¨—ç ”ç©¶æ©Ÿæ§‹ï¼Œä½†ä»¥ç‰¹æ®Šæƒ…å½¢ï¼Œä¸”è©²å—è¨—ç ”ç©¶æ©Ÿæ§‹å·²ä¾æ³•è¦è¦æ±‚安排臨床試驗監測工作者為é™ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">ç›£æ¸¬èª¿æŸ¥ä¹‹é »æ¬¡ç”±å§”è¨—äººèˆ‡å—è¨—ç ”ç©¶æ©Ÿæ§‹å”商定之，惟臨床試驗執行å‰ã€åŸ·è¡Œä¸èˆ‡å®Œæˆå¾Œï¼Œå‡æ‡‰è‡³å°‘執行一次監測。監測員並應於å„次監測調查後作æˆæ›¸é¢å ±å‘Šã€‚</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰è£½ä½œé—œæ–¼ç›£æ¸¬èª¿æŸ¥ã€åŽŸå§‹è³‡æ–™å¯©æ ¸ç¯„åœã€è—¥å“管ç†è²¬ä»»å’Œå±¥è¡Œè©¦é©—計畫相關之書é¢æ¨™æº–作æ¥æµç¨‹ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">監測員於期å‰èª¿æŸ¥ã€æœŸä¸å¸¸è¦èª¿æŸ¥ã€æœŸæœ«èª¿æŸ¥ï¼Œæ‡‰å„有一份書é¢æ¨™æº–作æ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: times new roman, serif;">三å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäººï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—之è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäººæ‡‰å°è‡¨åºŠè©¦é©—ä¹‹åŸ·è¡Œè² å®Œå…¨è²¬ä»»ï¼ŒåŒ…æ‹¬è©¦é©—è¨è¨ˆã€è©¦é©—用藥之管ç†ã€èˆ‡ä¸»ç®¡æ©Ÿé—œæˆ–人體試驗委員會之è¯ç¹«ã€è¨ˆç•«æ›¸åŠè©¦é©—å ±å‘Šä¹‹ç°½ç½²ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäººï¼Œå…¶è³‡æ ¼æ‡‰ç¬¦åˆäººé«”試驗管ç†è¾¦æ³•ä¹‹è¦å®š</span><span style="font-family: 標楷體;">。</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å…·é†«å¸«è³‡æ ¼ä¹‹è©¦é©—ä¸»æŒäººæ‡‰è² 責å—試者在臨床試驗期間之安全ã€å¥åº·èˆ‡ç¦åˆ©ï¼Œä¸¦å…·å¯¦è¨˜éŒ„試驗相關之臨床數據。</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäººç”±å—è¨—ç ”ç©¶æ©Ÿæ§‹é¸ä»»ä¹‹ï¼Œå¦‚試驗主æŒäººéžå—è¨—ç ”ç©¶æ©Ÿæ§‹é•·æœŸè˜é›‡è€…，並應與å—è¨—ç ”ç©¶æ©Ÿæ§‹ç°½è¨‚æ›¸é¢å¥‘約，並經é©ç•¶åŸ¹è¨“。</span> </p><p><span style="font-family: times new roman, serif;">三åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰è©³å¯¦è¨˜éŒ„ã€å„²å˜è‡¨åºŠè©¦é©—å„階段之試驗藥å“與å°ç…§è—¥å“之接收ã€å„²å˜ã€è™•ç†ã€è²¬ä»»ç®¡ç†ç‰ä¸€åˆ‡è³‡è¨Šï¼Œä¸¦æ‡‰åšå¥½å‰©é¤˜è©¦é©—è—¥å“之出貨ã€éžé€ã€æŽ¥æ”¶ã€å„²å˜ã€èª¿åŠ‘ã€çµ¦è—¥ã€è¤‡æ ¸ï¼Œä»¥åŠå‰©é¤˜è—¥å“退回與銷毀之紀錄。</span> </p><p><span style="font-family: times new roman, serif;">三å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥å“之資訊內容，應包括藥å“劑型ã€åŠ‘é‡ã€æ‰¹è™Ÿã€æœ‰æ•ˆæœŸé™ï¼Œä»¥åŠå…¶ä»–å¯è³‡é‘‘別藥å“特殊性質之代碼。</span> </p><p><span style="font-family: times new roman, serif;">三åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥å“應é 留原包è£è—¥å“ï¼Œä»¥å‚™æœªä¾†å¿…é ˆç¢ºèªä¹‹ç”¨ã€‚</span> </p><p><span style="font-family: times new roman, serif;">三åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰å…·é©ç•¶ä¹‹ç©ºé–“，並與社å€è—¥å±€æˆ–醫院藥局共åŒæ‰¿ç•¶è©¦é©—è—¥å“與å°ç…§è—¥å“之儲å˜ã€éžé€ã€é€€å›žå’Œè¨˜éŒ„。</span> </p><p><span style="font-family: times new roman, serif;">å››å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥å“應在é©ç•¶æ¢ä»¶ä¸‹ä¿å˜ï¼Œå…¶ä¿å˜æ¢ä»¶æ‡‰é”委託人æ供之藥典或藥å“資訊所載之標準。</span> </p><p><span style="font-family: times new roman, serif;">å››å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥å“應å˜æ”¾æ–¼ç‰¹å®šå€åŸŸä¸¦ä¸ŠéŽ–，éžç¶“授權之人ä¸å¾—進入。</span> </p><p><span style="font-family: times new roman, serif;">å››å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗藥å“之隨機å–樣與調劑，包括貼標作æ¥ï¼Œæ‡‰ä¾è—¥å“å„ªè‰¯è£½é€ è¦ç¯„ã€è—¥å“優良調劑作æ¥æº–則åŠæ¨™æº–作æ¥ç¨‹åºæ“作，並應ä¿ç•™ç›¸é—œä¹‹ç´€éŒ„。</span> </p><p><span style="font-family: times new roman, serif;">å››å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">åŸ·è¡Œä¸‹åˆ—é …ç›®æ‡‰è¨˜éŒ„å˜æª”，並得åƒé…Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è¦å®šï¼š</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">確ä¿éš¨æ©Ÿå–樣å¯æ“作性所採行之措施。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å…除å¯èƒ½éŒ¯èª¤æ‰€æŽ¡è¡Œä¹‹æŽªæ–½ï¼ŒåŒ…括清ç†ç·šè·¯ã€åˆ†é–‹æ“作試驗藥å“åŠå°ç…§å“ã€ç”±ä»–人å°æ“作進行監ç£ç‰ã€‚</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">執行完畢之調整。</span> </p><p><span style="font-family: times new roman, serif;">å››åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è—¥å“èª¿åŠ‘ï¼Œæ‡‰ç”±ç›£æ¸¬å“¡æˆ–å…¶ä»–äººå“¡é€²è¡Œè¤‡æ ¸ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å››å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäººæ‡‰ç…§è©¦é©—計畫書之è¦æ±‚執行臨床試驗åŠéš¨æ©Ÿå–樣，必è¦æ™‚得使用盲性è¨è¨ˆã€‚</span> </p><p><span style="font-family: times new roman, serif;">å››åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäººæ‡‰ç¢ºèªè—¥å“劑é‡ä¹‹æº–確，並確ä¿è©¦é©—è—¥å“之紀錄檔案ã€æŠ•èˆ‡å—試者之藥å“å稱ã€æˆåˆ†ã€åŠ‘é‡ç‰è¨˜éŒ„之真確。</span> </p><p><span style="font-family: times new roman, serif;">å››å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å€‹æ¡ˆå ±å‘Šè¡¨æ‡‰è¨˜éŒ„è‡¨åºŠè©¦é©—éŽç¨‹ä¸æ¯ä¸€ä½å—è©¦è€…ä¹‹ç ”ç©¶è³‡æ–™ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å››åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å¿…è¦æ™‚，委託人得è¦æ±‚å—è¨—ç ”ç©¶æ©Ÿæ§‹æå‡ºå€‹æ¡ˆå ±å‘Šè¡¨è¨è¨ˆæ¥é©Ÿï¼Œæˆ–æŽ¡ç”¨æ¨™æº–æ ¼å¼ã€‚è¡¨æ ¼ä¹‹è¨è¨ˆä»¥ç¬¦åˆå€‹åˆ¥ç ”究之需è¦ç‚ºè€ƒé‡ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å››åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應詳細載明自æ¯ä¸€ä½å—試者身上欲è’é›†ä¹‹è³‡æ–™ï¼Œä¸¦æ‡‰é™„ç©ºç™½å€‹æ¡ˆå ±å‘Šè¡¨æ¨£å¼ä¹™ä»½ã€‚</span> </p><p><span style="font-family: times new roman, serif;">五å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å€‹æ¡ˆå ±å‘Šè¡¨ä¸æ‡‰ç²å–ã€ä¿æŒèˆ‡ç•™å˜å—試者資訊，並應åæ˜ ç ”ç©¶ä¸æ‰€ç²ä¹‹çœŸå¯¦è³‡æ–™ï¼Œä¸”易於å°è³‡æ–™é€²è¡Œå¯©æ ¸ã€ç¨½æ ¸èˆ‡æŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: 標楷體;">五å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗主æŒäººæ‡‰ç¢ºèªå€‹æ¡ˆå ±å‘Šè¡¨ä¹‹æ£ç¢ºæ€§ï¼Œä¸”應有標準程åºåŠç´€éŒ„ã€‚å€‹æ¡ˆå ±å‘Šè¡¨ä¸Šå¦‚æœ‰éŒ¯èª¤ã€å…¶å¢žåˆªæˆ–修改應載明緣由，刪改之日期åŠåˆªæ”¹äººç°½åç‰è³‡æ–™ã€‚ </span></p><p><span style="font-family: times new roman, serif;">五å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æ¯ä¸€ä½å—試者應ä¿å˜ä¸€æª”案，以記錄其åƒèˆ‡å„階段臨床試驗之éŽç¨‹ï¼Œä¸¦è¨˜éŒ„å°æ–¼å¾ŒçºŒç ”究有用之資訊。</span> </p><p><span style="font-family: times new roman, serif;">五å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生體相ç‰æ€§è©¦é©—之å—è¨—ç ”ç©¶æ©Ÿæ§‹ï¼Œæ‡‰é å‚™è¶³å¤ ä¹‹å¥åº·å—試者，並已事先經醫師檢查åŠç¯©é¸ã€‚</span> </p><p><span style="font-family: times new roman, serif;">五åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">篩é¸ç¬¦åˆè©¦é©—所需之å—試者å‰ï¼Œæ‡‰å…ˆå–å¾—å…¶å—試者åŒæ„æ›¸ã€‚æ–¼ç ”ç©¶ä¸æ‰€é€²è¡Œä¹‹ä»»ä½•ç¯©é¸ï¼Œäº¦åŒã€‚</span> </p><p><span style="font-family: times new roman, serif;">五å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書ä¸æ‡‰è¼‰æ˜Žå—試者招募之程åºåŠç¯©é¸åˆæ ¼ä¹‹æ¨™æº–。</span> </p><p><span style="font-family: times new roman, serif;">五åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—æœŸé–“æ‡‰åš´æ ¼æŽ§åˆ¶å—試者空腹與進食，以é¿å…食物æ”å–é‡æ˜Žé¡¯å½±éŸ¿è—¥å“之å¸æ”¶ã€‚é¤é»žã€é£²æ–™æ‡‰ä¾è‡¨åºŠè©¦é©—計畫書æ供予å—試者。</span> </p><p><span style="font-family: times new roman, serif;">五å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">進食之時間ã€æœŸé–“åŠé£Ÿç‰©èˆ‡æ¶²é«”之æ”å–é‡æ‡‰è¨˜éŒ„並ä¿å˜ã€‚</span> </p><p><span style="font-family: times new roman, serif;">五åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">åˆç†çš„試驗計畫應充分評估å—試者å¯èƒ½ç™¼ç”Ÿä¹‹ä»»ä½•å±éšªã€‚試驗éŽç¨‹æ‡‰æœ‰è¨ˆåŠƒã€æœ‰çµ„織的執行與管ç†ï¼Œä¸¦æ‡‰å¾—所有å—試者åŠç›¸é—œäººå“¡èªå¯ã€‚</span> </p><p><span style="font-family: times new roman, serif;">五åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è‡¨åºŠè©¦é©—å ´æ‰€æ‡‰å‚™æœ‰æ€¥æ•‘è¨å‚™èˆ‡è—¥å“，並有充足è¨æ–½ä»¥æ‡‰å—試者æ¶æ•‘或其他醫療è·ç†ä¹‹éœ€ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">發生ä¸è‰¯å應時，試驗主æŒäººæ‡‰å°å…¶é†«ç™‚åˆ¤æ–·è² è²¬ï¼Œä¸¦ç«‹å³é€šå ±ç›¸é—œé†«ç™‚機構ã€è©¦é©—委託人，必è¦æ™‚應通知人體試驗委員會，ä¸å¾—é²èª¤ã€‚如發生嚴é‡ä¸è‰¯äº‹ä»¶ï¼Œæ‡‰ä¾æœ‰é—œæ³•ä»¤ä¹‹è¦å®šï¼Œæ–¼é™æœŸå…§é€šå ±ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—è¨—ç ”ç©¶æ©Ÿæ§‹æ‡‰æ供試驗主æŒäººæœ‰é—œç™»è¨˜ã€é€šå ±ä¸è‰¯å應之é©ç•¶è¡¨æ ¼ï¼Œä¸¦ä½œç‚ºå€‹æ¡ˆå ±å‘Šè¡¨ä¹‹ä¸€éƒ¨åˆ†ã€‚å¿…è¦æ™‚，亦得採用其他委託人所æä¾›ä¹‹è¡¨æ ¼ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體è¦æ ¼ã€å–樣方法ã€å®¹ç©åŠæ•¸é‡æ‡‰æ–¼è©¦é©—計畫書ä¸è¦å®šï¼Œä¸¦æ供資訊予å—試者。血漿檢體ä¸æŠ—å‡è¡€åŠ‘的使用，亦åŒã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體之採集ã€æº–å‚™ã€é‹è¼¸åŠè²¯å˜ï¼Œæ‡‰å®Œæ•´è¨˜éŒ„å…¶éŽç¨‹ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢體之實際採集次數ã€æ™‚間與原訂計畫有出入時，應記錄之。</span> </p><p><span style="font-family: times new roman, serif;">å…å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">採集生物檢體之標籤應清晰，以確ä¿èƒ½çœŸç¢ºé‘‘別åŠè¿½æº¯ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體貯å˜æ¢ä»¶æ‡‰æ ¹æ“šç ”究藥å“之特性為之。所有貯å˜æ¢ä»¶æ‡‰æ–¼è©¦é©—計畫書ä¸èªªæ˜Žã€‚貯å˜æœŸé–“與é‹è¼¸é€”ä¸ä¹‹è²¯å˜æ¢ä»¶äº¦æ‡‰å—控制ã€ç›£æ¸¬ä¸¦è¨˜éŒ„，且宜ä¿è‰ç³»çµ±ç™¼ç”ŸéŒ¯èª¤æ™‚，ä»èƒ½ç¢ºä¿ç”Ÿç‰©æª¢é«”之完整性。</span> </p><p><span style="font-family: times new roman, serif;">å…å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體之貯å˜åŠå›žæ”¶ç´€éŒ„應ä¿å˜ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體宜雙套ä¿å˜æˆ–備份，並分開貯å˜ã€é‹è¼¸ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體åŠå…¶ç›¸é—œè€—æ之處ç†ã€éŠ·æ¯€æˆ–回收應符åˆç›¸é—œæ³•ä»¤ä¹‹è¦å®šã€‚</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">肆ã€ç”Ÿç‰©æª¢é«”分æžæœŸä¹‹ç®¡ç†</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">七å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è—¥å“濃度分æžå¾—由執行臨床試驗之åŒä¸€å—è¨—ç ”ç©¶æ©Ÿæ§‹é€²è¡Œï¼Œäº¦å¾—å§”è¨—å…¶ä»–ç¬¦åˆè³‡æ ¼å—è¨—ç ”ç©¶æ©Ÿæ§‹ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: times new roman, serif;">七å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">臨床試驗之生物檢體分æžï¼Œæ‡‰ç¬¦åˆè—¥ç‰©éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„，並應在已建立å“質ä¿è‰ä¹‹å¯¦é©—室ä¸é€²è¡Œã€‚</span> </p><p><span style="font-family: times new roman, serif;">七å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">生物檢體分æžä¹‹å ´åœ°èˆ‡è¨å‚™ï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-family: times new roman, serif;">(一) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室分æžæ‡‰æœ‰è¶³å¤ 空間與基本è¨å‚™ï¼Œå„別æµç¨‹æ‡‰æœ‰ç›¸äº’隔離之æ“作å€åŸŸï¼Œä¸¦ç•™æ„檢å“在製備åŠåˆ†æžæµç¨‹ä¸ä¹‹äº¤äº’混雜或汙染。</span> </p><p><span style="font-family: times new roman, serif;">(二) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æ°´ã€æ°£ã€æ²¹ã€é›»ç‰è³‡æºä¹‹ä¾›æ‡‰æ‡‰å……足ã€ç©©å®šåŠé€£çºŒã€‚</span> </p><p><span style="font-family: times new roman, serif;">(三) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">分æžè¨å‚™åŠå„€å™¨æ‡‰ç²¾ç¢ºæ ¡æ£ã€ç¶è·ä»¥ç¬¦åˆæ¨™æº–。分æžä¹‹æ–¹æ³•æ‡‰è¨˜éŒ„並執行確效。</span> </p><p><span style="font-family: times new roman, serif;">(å››) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è¨å‚™ä¹‹æ“作ã€ä½¿ç”¨ã€æ ¡æ£åŠé 防性ç¶è·ï¼Œå‡æ‡‰æœ‰æ¨™æº–作æ¥ç¨‹åºï¼Œä¸¦æ‡‰ä¿ç•™ç´€éŒ„。</span> </p><p><span style="font-family: times new roman, serif;">(五) <span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗ä¸ä½¿ç”¨ä¹‹è¨å‚™å‡æ‡‰é€²è¡Œé‘‘定ã€æ ¡æ£ä¸¦ç¢ºèªå…¶ç¬¦åˆæ¨™æº–，以確ä¿å…¶å¯è¿½æº¯æ€§ã€‚</span> </p><p><span style="font-family: times new roman, serif;">七å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應詳細說明分æžæ–¹æ³•ä¹‹ç¢ºæ•ˆä½œæ¥ç¨‹åºã€‚ä¸åŒåˆ†æžæ–¹æ³•äº¦æ‡‰æœ‰å…¶å„別之標準作æ¥è¦æ±‚。</span> </p><p><span style="font-family: times new roman, serif;">七åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šæ›¸ä¸æ‡‰æ出資料，說明檢體ä¿å˜æ–¼ç‰¹å®šç’°å¢ƒä¸‹ä¹‹å®‰å®šæ€§ã€‚</span> </p><p><span style="font-family: times new roman, serif;">七å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">化å¸è—¥å“ã€è©¦åŠ‘ã€æº¶åŠ‘與溶液應標示其æˆåˆ†ã€æœ‰æ•ˆæœŸé™åŠç‰¹æ®Šè²¯å˜æ¢ä»¶ï¼Œä¸¦å®œæ¨™ç¤ºå…¶é‘‘別ã€ç´”度或雜質濃度ã€ä¾†æºã€è£½å‚™æ—¥æœŸåŠå®‰å®šæ€§è³‡æ–™ã€‚</span> </p><p><span style="font-family: times new roman, serif;">七åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å„次分æžä½œæ¥å‡æ‡‰åŒ…å«æ ¡æ£åŠå“管用檢å“之分æžè³‡æ–™ï¼Œå…¶åˆ†æžæ¨™æº–並應於標準作æ¥ç¨‹åºä¸èªªæ˜Žã€‚</span> </p><p><span style="font-family: times new roman, serif;">七å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用層æžæ³•åˆ†æžï¼Œæ‡‰æ–¼æ¨™æº–作æ¥æµç¨‹ä¸æ•˜æ˜Žå±¤æžæ³•ä¹‹é©—è‰åŠå±¤æžåœ–èœæ¨™æº–ç©åˆ†ã€‚å„批次之å—試者檢å“ã€æ ¡æ£æª¢å“åŠå“管用檢å“應一併處ç†ã€‚層æžåœ–èœä¹‹å†è™•ç†æ‡‰äº¤ç”±ç¶“é©ç•¶è¨“練之人員執行，並應ä¿å˜å…¶ç´™æœ¬è¨˜éŒ„或電åç¨½æ ¸æª”æ¡ˆã€‚</span> </p><p><span style="font-family: times new roman, serif;">七åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">標準作æ¥ç¨‹åºä¸æ‡‰è©³ç´°è¼‰æ˜Žæª¢é«”å†åˆ†æžçµæžœå ±å‘Šä¹‹æ¨™æº–ã€‚è©¦é©—å ±å‘Šä¸¦æ‡‰åˆ—å‡ºå†åˆ†æžæª¢é«”之清單ã€å†åˆ†æžä¹‹åŽŸå› ã€å†åˆ†æžçµæžœæ•¸æ“šåŠè©¦é©—å ±å‘Šæ›¸ä¸æ‰€å‘ˆç¾ä¹‹æ•¸æ“šã€‚</span> </p><p><span style="font-family: times new roman, serif;">七åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗期間內所有å“管檢體之分æžçµæžœï¼Œå‡æ‡‰æ–¼è©¦é©—å ±å‘Šä¸æ•˜æ˜Žä¸¦ç´å…¥çµ±è¨ˆåˆ†æžï¼Œéžå› 特別分æžå•é¡Œä¸å¾—ä»»æ„æ¨æ£„。æ¨æ£„ä¹‹åŽŸå› æ‡‰è©³ç‚ºæ•˜æ˜Žã€‚è©¦é©—å‰ä¹‹åˆ†æžæ–¹æ³•ç¢ºæ•ˆï¼Œäº¦åŒã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…«å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">所有原始分æžè³‡æ–™æ‡‰ä½œæˆç´€éŒ„，並應確ä¿æ—¥å¾Œèƒ½è¿½æº¯æª¢é«”數é‡ã€æ‰€ç”¨è¨å‚™ã€åˆ†æžæ—¥æœŸèˆ‡æ™‚間，åŠæ“作人員姓å。層æžæ³•åˆ†æžä¹‹åŽŸå§‹åœ–èœï¼Œæ‡‰ä»¥é©ç•¶æ¯”例呈ç¾ï¼Œå…¶å³°å½¢èˆ‡å³°å€¼æ‡‰æ¸…æ™°å¯è¦‹ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…«å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æ¯ä¸€æ•¸æ“šé»žæ‡‰è¶³ä»¥è¿½æº¯å°æ‡‰ç‰¹å®šä¹‹æª¢é«”，其所æ供之資料應包括檢體數é‡ã€æŽ¡æ¨£æ™‚é–“åŠåˆ†æžæ™‚間，並得æ供離心éŽæ¿¾æ™‚間或冷å‡æ™‚é–“ç‰è³‡æ–™ï¼Œä½¿ç ”究主æŒäººå¾—以判斷å¯èƒ½ä¹‹ç•°å¸¸çµæžœèˆ‡æª¢é«”錯誤是å¦ç›¸é—œã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…«å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">實驗室應具備編碼技術，必è¦æ™‚應有方法以進行盲性分æžã€‚</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">ä¼ã€è—¥å‹•å¸èˆ‡çµ±è¨ˆ</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">å…«å三<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗çµæžœä¹‹è¨ˆç®—應由符åˆè³‡æ ¼ä¹‹äººå“¡é€²è¡Œã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…«åå››<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗計畫書應詳細載明計算方å¼ã€‚資料之分æžäº¦æ‡‰æ»¿è¶³è¨ˆç•«æ›¸ä¹‹éœ€æ±‚。</span> </p><p><b><span style="font-family: 標楷體; font-size: 16pt;">陸ã€è©¦é©—å ±å‘Š</span></b><b> </b></p><p><span style="font-family: times new roman, serif;">å…«å五<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šæ‡‰æº–ç¢ºå‘ˆç¾æ‰€æœ‰è©¦é©—éŽç¨‹åŠçµæžœã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…«åå…<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šä¹‹æ›¸å¯«æ‡‰å®Œæ•´ç°¡æ˜Žï¼Œè©¦é©—éŽç¨‹ä¸ä»»ä½•èˆ‡è©¦é©—計畫相異之處，å‡æ‡‰æ–¼è©¦é©—å ±å‘Šæ›¸ä¸èªªæ˜Žã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…«å七<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šä¹‹çµæžœè³‡æ–™æ‡‰èˆ‡åŽŸå§‹ç´€éŒ„無差異。</span> </p><p><span style="font-family: times new roman, serif;">å…«åå…«<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šä¹‹æ’°å¯«æ‡‰ä¾ç›¸é—œæ³•è¦ä¹‹è¦å®šï¼ŒæŒ‰æ¨™æº–æ ¼å¼æ’°å¯«ã€‚</span> </p><p><span style="font-family: times new roman, serif;">å…«åä¹<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šæ‡‰æœ‰ç”Ÿç‰©æª¢é«”åˆ†æžå ±å‘Šï¼ŒåŒ…括生物檢體分æžä¹‹æ–¹æ³•èªªæ˜Žï¼ŒåŠåˆ†æžæ–¹æ³•ç¢ºæ•ˆä½œæ¥å ±å‘Šã€‚</span> </p><p><span style="font-family: times new roman, serif;">ä¹å<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šæ‡‰è©³ç´°èªªæ˜Žè©¦é©—ä¸»æŒäººèˆ‡å§”託人å°è©¦é©—å ±å‘Šä¹‹è¨±å¯ç¨‹åºï¼Œä¸”宜有詳細且明確的標準程åºã€‚</span> </p><p><span style="font-family: times new roman, serif;">ä¹å一<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">è©¦é©—å ±å‘Šæ‡‰æœ‰ç›¸é—œè² è²¬äººå“¡ä¹‹ç°½åï¼Œä¸¦åŠ è¨»æ—¥æœŸã€‚</span> </p><p><span style="font-family: times new roman, serif;">ä¹å二<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">æœ€çµ‚è©¦é©—å ±å‘Šå…¬é–‹å‰ï¼Œæ‡‰æœ‰å®Œæ•´ç›£æ¸¬å ±å‘ŠåŠç¨½æ ¸å ±å‘Šã€‚</span> </p><span style="font-family: times new roman, serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 20pt;">生體相ç‰æ€§è©¦é©—è‡¨åºŠè©¦é©—å ´æ‰€æŸ¥æ ¸è¡¨</span> </p><p style="text-align: center; layout-grid-mode: char;"> </p><table width="100%" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="background-color: transparent;border: #f0f0f0;"> <div> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 20pt;">附件一</span> </p> </div> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: calibri; font-size: 14pt;"> </span></p><p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 14pt;">醫療機構å稱</span><span style="font-family: calibri; font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">地å€</span><span style="font-family: calibri; font-size: 14pt;">:</span></p><p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: calibri; font-size: 14pt;"> </span></p><div style="text-align: center;"><table width="695" style="width: 521.1pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 28.5pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; padding-right: 1.4pt; height: 28.5pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.55pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è¦</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">é …</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">ç›®</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.35pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è‡ªè¡ŒæŸ¥æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">æŸ¥æ ¸çµæžœ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 28.5pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 449.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">試</span><span> </span><span style="font-family: 標楷體;">é©—</span><span> </span><span style="font-family: 標楷體;">å ´</span><span> </span><span style="font-family: 標楷體;">所</span><span> </span><span style="font-family: 標楷體;">之</span><span> </span><span style="font-family: 標楷體;">è¨</span><span> </span><span style="font-family: 標楷體;">æ–½</span><span> </span><span style="font-family: 標楷體;">（一）</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.55pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;">1. </span><span style="font-family: 標楷體;">應æä¾›é©ç•¶ä¹‹æ€¥æ•‘è¨æ–½ï¼Œæ€¥æ•‘è¨å‚™è‡³å°‘應包å«ä¸‹åˆ—é …ç›®ï¼š</span> </p> <p><span style="font-family: calibri; text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">æ•‘</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">器</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">å…·</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">å</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">稱</span><span style="font-family: calibri; text-decoration: underline;"> </span></p> <p><span style="font-family: 標楷體;">急救車</span> </p> <p><span style="font-family: 標楷體;">心臟電擊器</span> </p> <p><span style="font-family: calibri;">EKG</span><span style="font-family: 標楷體;">監視器</span> </p> <p><span style="font-family: 標楷體;">å–‰é é¡</span> </p> <p><span style="font-family: 標楷體;">抽痰機</span> </p> <p><span style="font-family: 標楷體;">氧氣ç’</span> </p> <p><span style="font-family: 標楷體;">氧氣罩或攜帶å¼æ°§æ°£è£½é€ æ©Ÿ</span> </p> <p><span style="font-family: 標楷體;">血壓計</span> </p> <p><span style="font-family: 標楷體;">點滴架</span> </p> <p><span style="font-family: 標楷體;">點滴輸液套</span> </p> <p><span style="font-family: 標楷體;">éœè„ˆç•™ç½®é‡</span> </p> <p><span style="font-family: 標楷體;">氣管內管（å«</span><span style="font-family: calibri;">No.6.0/ 7.0 /7.5 /8.0</span><span style="font-family: 標楷體;">）</span> </p> <p><span style="font-family: 標楷體;">輪椅</span> </p> <p><span style="font-family: 標楷體;">氧氣推車</span> </p> <p><span style="font-family: 標楷體;">離心機</span> </p> <p><span style="font-family: 標楷體;">é‡é 銷毀機</span> </p> <p><span style="font-family: 標楷體;">電冰箱</span><span style="text-decoration: underline;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.35pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 85.4pt; padding-right: 1.4pt; height: 449.5pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> </tbody></table></div><p style="layout-grid-mode: char; 36: ;"><span style="font-family: 標楷體;">★ </span><span style="font-family: 標楷體;">å„é …è¨æ–½ä¹‹æ•¸é‡ä»¥ç¬¦åˆéœ€è¦ç‚ºè¦æ±‚</span> </p></div><span style="font-family: calibri, sans-serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><div class="WordSection2" style="layout-grid: 18pt none;"><div style="text-align: center;"><table width="690" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.3pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 26.9pt; padding-right: 1.4pt; height: 26.3pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è¦</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">é …</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">ç›®</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è‡ªè¡ŒæŸ¥æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">æŸ¥æ ¸çµæžœ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 323.2pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 26.9pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">試</span><span> </span><span style="font-family: 標楷體;">é©—</span><span> </span><span style="font-family: 標楷體;">å ´</span><span> </span><span style="font-family: 標楷體;">所</span><span> </span><span style="font-family: 標楷體;">之</span><span> </span><span style="font-family: 標楷體;">è¨</span><span> </span><span style="font-family: 標楷體;">æ–½</span><span> </span><span style="font-family: 標楷體;">（二）</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;">2. </span><span style="font-family: 標楷體;">應æä¾›é©ç•¶ä¹‹æ€¥æ•‘è¨æ–½ï¼Œæ€¥æ•‘è—¥å“至少應包å«ä¸‹åˆ—é …ç›®ï¼š</span> </p> <p><span style="font-family: calibri; text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">急</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">æ•‘</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">è—¥</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">å“</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">å</span><span style="text-decoration: underline;"> </span><span style="font-family: 標楷體; text-decoration: underline;">稱</span><span style="font-family: calibri; text-decoration: underline;"> </span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Aminophylline 250mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Atropine 1mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Diphehydramine 30mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Dopamine 200mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Epinephrine HCI 1mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Calcium Gluconate 10% /10ml</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">20% Glucose 4gm/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Hydrocortisone sodium succinate 100mg/ Vial</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Isoproterenol 0.2mg/ml/amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Norepinephrine Bitartrate</span><span style="font-family: 標楷體;">（</span><span style="font-family: calibri;">Levophed</span><span style="font-family: 標楷體;">）</span><span style="font-family: calibri;">4mg/4ml/amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">0.9% Normal Saline 500ml/bottle</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Sodium Bicarbonate 7% /20ml/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Verapamil 2.5mg/Amp</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: calibri;">Xylocaine 2% 100mg/Vial</span></p> <p style="line-height: 19pt; layout-grid-mode: char; 25: ;"><span style="font-family: 標楷體;">★å„é …æ€¥æ•‘è—¥å“之數é‡ä»¥ç¬¦åˆéœ€è¦ç‚ºè¦æ±‚。</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 323.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">3. </span><span style="font-family: 標楷體;">è©¦é©—å ´æ‰€ä¹‹ç©ºé–“æ˜¯å¦è¶³å¤ </span><span style="font-family: calibri;">? </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.2pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">4. </span><span style="font-family: 標楷體;">è©¦é©—å ´æ‰€ä¹‹åœ°é»žæ˜¯å¦é©ç•¶</span><span style="font-family: calibri;">?</span><span style="font-family: 標楷體;">應能迅速與醫療網è¯ç¹«ã€‚</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 17.2pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 16.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">5. </span><span style="font-family: 標楷體;">è©¦é©—å ´æ‰€æ˜¯å¦æœ‰è¶³å¤ 之逃生è¨å‚™åŠä¾¿æ·ä¹‹é€ƒç”Ÿç®¡é“</span><span style="font-family: calibri;">?</span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 16.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">6. </span><span style="font-family: 標楷體;">è©¦é©—å ´æ‰€æ‡‰è¶³ä»¥è™•ç†ç·Šæ€¥ç‹€æ³ä¹‹æ¬é‹ã€‚</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 236.7pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: calibri;">7. </span><span style="font-family: 標楷體;">試驗機構內應æä¾›é©ç•¶ä¼‘æ¯å ´æ‰€ã€‚</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.7pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 84.75pt; padding-right: 1.4pt; height: 25.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: calibri;"> </span></p> </td> </tr> </tbody></table></div></div><span style="font-family: calibri, sans-serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><div style="text-align: center;"><table width="690" style="margin: auto auto auto 28.25pt; width: 517.8pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.3pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 31.7pt; padding-right: 1.4pt; height: 26.3pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è¦</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">é …</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">ç›®</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è‡ªè¡ŒæŸ¥æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">æŸ¥æ ¸çµæžœ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.7pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 31.7pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">執行試驗之人員</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">執行</span><span style="font-family: calibri;">BA/BE</span><span style="font-family: 標楷體;">試驗時，是å¦æœ‰é†«å¸«åœ¨å ´ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.7pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">試驗主æŒäººæˆ–å”åŒé†«å¸«æ˜¯å¦æœ‰åƒèˆ‡å—試者之採血éŽç¨‹ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">åƒèˆ‡åŸ·è¡Œè©¦é©—之æ¯ä¸€ä½äººå“¡åŠè² 有監ç£è²¬ä»»è€…，是å¦æœ‰å…·å‚™ç›¸ç•¶ä¹‹å¸è˜ã€ç¶“驗並經訓練而能å‹ä»»å…¶è·å‹™ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">試驗機構是å¦æœ‰è¨å“質ä¿è‰äººå“¡æˆ–å–®ä½ï¼Œè² è²¬ç¨½æ ¸è©¦é©—ä¹‹å„é …å·¥ä½œï¼Œå¦‚è©¦é©—è—¥å“之å–樣ã€ä½¿ç”¨ç´€éŒ„ã€çµ¦è—¥ã€ç°½åˆ°ã€ç°½é€€ç‰ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 28.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">å—託執行單ä½æ˜¯å¦æœ‰åˆ°è—¥å» çžè§£æŠ½æ¨£</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 28.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 31.7pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">試驗執行之書é¢ä½œæ¥ç¨‹åº</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">應能迅速與醫療網è¯ç¹«ï¼Œå¦‚緊急狀æ³ä¹‹é‹é€ï¼Œæ˜¯å¦æœ‰åˆ¶å®šèˆ‡é†«é™¢ç·Šæ€¥è¯çµ¡ä¹‹æ›¸é¢ä½œæ¥ç¨‹åºã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">試驗éŽç¨‹ä¸å¯èƒ½ä¹‹ä¸è‰¯äº‹ä»¶ï¼Œæ˜¯å¦æœ‰åˆ¶å®šä¸¦å¼µè²¼æ€¥æ•‘或緊急處ç†ä¹‹ä½œæ¥ç¨‹åºä¸¦è©³ç´°ç´€éŒ„之。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.35pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是å¦æœ‰ä»¥æ›¸é¢åˆ¶å®šåƒèˆ‡åŸ·è¡Œè©¦é©—之æ¯ä¸€ä½äººå“¡ä¹‹å·¥ä½œè·è²¬ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 12.35pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是å¦æœ‰åˆ¶è¨‚新進åŠåœ¨è·äººå“¡æ‡‰æœ‰ä¹‹è¨“練程åºï¼Œä»¥ç¢ºä¿æ¯ä¸€ä½è©¦é©—æ“作人員å‡èƒ½å‹ä»»å…¶è·å‹™ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是å¦æœ‰åˆ¶å®šæ ¡æ£åŠç¶è·å„€å™¨ã€å™¨å…·ã€è£ç½®ã€å„€è¡¨åŠè¨˜éŒ„器ç‰ä¹‹æ¨™æº–作æ¥ç¨‹åºï¼Œæ˜Žç¢ºè¦å®šå…¶æ ¡æ£ã€ç¶è·ä¹‹æ–¹æ³•åŠé »çŽ‡ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 17.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">æ‰€æœ‰å„€å™¨æŸ¥æ ¸ã€ç¶è·åŠæ ¡æ£ç´€éŒ„是å¦æœ‰ä¿å˜ã€‚è‹¥å› å„€å™¨åŠŸèƒ½å¤±å¸¸æ‰€åŸ·è¡Œä¹‹éžä¾‹è¡Œç¶è·å·¥ä½œï¼Œå…¶ç´€éŒ„應記載該缺點發生的時間ã€åŽŸå› 以åŠæ‰€æŽ¡å–之補救措施。</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26.3pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">é‡è¦ä¹‹æ›¸é¢ä½œæ¥ç¨‹åºæ˜¯å¦æœ‰æ˜Žé¡¯å¼µè²¼ã€‚</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 81.05pt; padding-right: 1.4pt; height: 26pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> </tbody></table></div><span style="font-family: calibri, sans-serif; font-size: 12pt;"><br clear="all" style="page-break-before: always;" /></span><p><span style="font-family: calibri;"> </span></p><div style="text-align: center;"><table width="684" style="width: 512.65pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid; height: 26.4pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 29.15pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.4pt; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="12"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">å—試者資料 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è¦</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">定</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">é …</span><span style="font-family: calibri; font-size: 13pt;"> </span><span style="font-family: 標楷體; font-size: 13pt;">ç›®</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è‡ªè¡ŒæŸ¥æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">æŸ¥æ ¸çµæžœ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 26.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是å¦æœ‰å—試者抵é”åŠé›¢é–‹è©¦é©—å ´æ‰€ä¹‹æ™‚é–“ç´€éŒ„</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: calibri;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">å—試者於試驗å‰ä¹‹æ´»å‹•æ˜¯å¦éµå®ˆè¨ˆç•«æ›¸ä¹‹ç´å…¥/排除標準 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">å—試者給藥與採樣時間與原計畫是å¦ç›¸ç¬¦ </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">å—è©¦è€…çµ¦è—¥é †åºæ˜¯å¦éš¨æ©Ÿåˆ†é… </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是å¦æœ‰</span><span style="font-family: 標楷體;">å—試者出血時間紀錄 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">採血時間之紀錄是å¦å®Œæ•´ï¼Œä¸¦è¨»æ˜Žæ˜¯</span><span style="font-family: calibri;">starting time</span><span style="font-family: 標楷體;">ã€</span><span style="font-family: calibri;">medium time</span><span style="font-family: 標楷體;">或</span><span style="font-family: calibri;"> end time</span><span style="font-family: 標楷體;">ã€æˆ–其他檢å“之採集紀錄是å¦å®Œæ•´ </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是å¦æœ‰</span><span style="font-family: 標楷體;">å—試者給藥å‰åŠçµ¦è—¥å¾Œç”Ÿå‘½å¾µè±¡ä¹‹ç´€éŒ„ </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">是å¦æœ‰</span><span style="font-family: 標楷體;">å—試者總人數ã€ä¸é€”退出人數ã€å¯¦éš›è©•ä¼°äººæ•¸ã€ä¸è‰¯äº‹ä»¶åŠè™•ç†æ–¹å¼ç‰ä¹‹è¨˜è¼‰ </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體之採集次數ã€æ™‚間是å¦å離原計畫 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">10.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">試驗完æˆæ™‚，</span><span style="font-family: 標楷體;">是å¦æœ‰è¨˜éŒ„</span><span style="font-family: 標楷體;">å—試者之狀æ³ï¼›åŠå®Œæˆå¾Œå—試者狀æ³ä¹‹è¿½è¹¤ï¼ˆå¦‚有需è¦ï¼‰ </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">11.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å—試者之體檢與åƒèˆ‡è©¦é©—å稱ã€æ—¥æœŸæ˜¯å¦æœ‰è©³ç´°ç´€éŒ„並留å˜å‚™æŸ¥ã€‚</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 29.15pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="10"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">檢å“ä¹‹è™•ç† </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體之溶血紀錄 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體編碼方法ã€å˜æ”¾ç´€éŒ„(包括時間åŠç‹€æ³)åŠé‹é€æ™‚間紀錄 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體的é‹é€æ–¹å¼åŠä¿è·æ–¹æ³•(如以乾冰隔絕空氣之容器)</span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體之è’集ã€é»žæ”¶ã€é»žäº¤æ˜¯å¦å°ˆäººè² 責 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體é‹é€åŠè™•ç†éŽç¨‹ï¼Œæ˜¯å¦ç¶æŒé©ç•¶çš„溫度</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžå‰, 檢體是å¦å˜æ”¾æ–¼é©ç•¶çš„儲å˜è¨å‚™ </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">儲å˜è¨å‚™æ˜¯å¦æœ‰æº«åº¦ç´€éŒ„è£ç½® </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 24pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">緊急狀æ³ç™¼ç”Ÿæ™‚，儲å˜è¨å‚™</span><span style="font-family: 標楷體;">是å¦æœ‰</span><span style="font-family: 標楷體;">應變措施 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 24pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">檢體間是å¦æœ‰é©ç•¶ä¹‹å€éš”åŠæ¨™ç¤ºï¼Œä»¥é¿å…與其他試驗之檢體混淆 </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">10.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">檢體之標籤或辨è˜å¡æ˜¯å¦å®Œæ•´ï¼Œä¸¦è¶³ä»¥é 防攜出分æžæ™‚ç™¼ç”Ÿæ··æ·†ä¹‹ç‹€æ³ </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 12.45pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 29.15pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體;">其他 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.75pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 標楷體;">試驗藥å“之管ç†ï¼ˆé‹é€ã€å„²å˜ã€è©¦é©—çµæŸä¹‹è™•ç†ï¼‰ </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.9pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 79.95pt; padding-right: 1.4pt; height: 12.45pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"> </p> </td> </tr> </tbody></table></div><p style="text-align: center; line-height: 22pt; layout-grid-mode: char;"> </p><table width="100%" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="background-color: transparent;border: #f0f0f0;"> <div> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 20pt;">附件二</span> </p> </div> </td> </tr> </tbody></table><span style="font-family: 標楷體; font-size: 20pt;">生體相ç‰æ€§è©¦é©—分æžå ´æ‰€æŸ¥æ ¸è¡¨</span><p style="line-height: 22pt;"><span style="font-family: 標楷體; font-size: 14pt;">å…¬å¸å稱：</span><span style="font-family: calibri; font-size: 14pt;"> </span><span style="font-family: 標楷體; font-size: 14pt;">地å€ï¼š</span> </p><div style="text-align: center;"><table width="698" align="left" style="margin: auto 6.75pt; width: 523.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.25pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; padding-right: 1.4pt; height: 26.25pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">è¦ å®š é … ç›® </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">è‡ªè¡ŒæŸ¥æ ¸ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">æŸ¥æ ¸çµæžœ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-family: 標楷體; font-size: 13pt;">附註 </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">基本資料 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本å“åŠå°ç…§å“之å“管資料（å«é‡æ¸¬å®šã€å–®ä½åŠ‘é‡å‡ä¸€åº¦è©¦é©—ã€æº¶é›¢çŽ‡è©¦é©—資料）ã€å§”託執行書ã€IRBåŒæ„函åŠè©¦é©—主æŒäººã€å”åŒé†«å¸«ã€ç ”究主æŒäººåŒæ„書</span> </li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本å“åŠå°ç…§å“之外觀ã€åŠ‘åž‹ã€åŠ‘é‡ã€æ‰¹è™Ÿã€è£½é€ 日期ã€æœ‰æ•ˆæ—¥æœŸæ˜¯å¦åŒæ–¼é€å¯©å ±å‘Š</span> </li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">分æžä¹‹å„€å™¨è¨å‚™</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžå ´æ‰€æ‰€ç”¨ä¹‹ä¸»è¦å„€å™¨è¨å‚™ï¼Œå…¶é¡žåž‹ã€å“牌ã€åž‹è™Ÿæ˜¯å¦èˆ‡é€å¯©å ±å‘Šä¸€è‡´ï¼Œå¦‚æžœä¸åŒï¼Œè«‹èªªæ˜Žä¹‹ </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">評估主è¦å„€å™¨ç‹€æ³æœ‰ç„¡å—æ，å¯èƒ½è‡´çµæžœä¸å¯ä¿¡è³´ä¹‹æƒ…å½¢ </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">主è¦å„€å™¨æ˜¯å¦æœ‰æ›¸é¢æ“作方法，實驗室人員是å¦å¯å°±è¿‘å–得。 </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">所有分æžè¨å‚™æ˜¯å¦æœ‰å®šæœŸæ ¡æ£ã€ç¶ä¿®ã€ä¿é¤Šè¨˜éŒ„åŠæ˜¯å¦æœ‰ä¸æ–·é›»ç³»çµ± </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本試驗是å¦ç”¨åˆ°å…¶ä»–特殊è¨å‚™ </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">é›»å記錄 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">本試驗有哪些部分應用到電å資料系統（如未用電å資料系統，æ¤éƒ¨ä»½å¯ä¸å¡«ï¼‰ </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 32.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">輸入電腦之資料，其æ£ç¢ºæ€§ã€å®‰å…¨æ€§ã€åŠå¯è¿½æº¯æ€§å¦‚ä½•ç¢ºèª </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 32.9pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">è² è²¬è¼¸å…¥ã€è¤‡æ ¸ã€é€²å…¥ç³»çµ±ä¹‹äººå“¡åå–® </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 28.4pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">分æžæ–¹æ³•ç¢ºæ•ˆ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžå ´æ‰€æ˜¯å¦èƒ½æ具資料支æŒæ‰€æŽ¡ä¹‹åˆ†æžæ–¹æ³•å…·å°ˆä¸€æ€§ </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžå ´æ‰€æ˜¯å¦èƒ½æ具資料支æŒæ‰€æŽ¡ä¹‹åˆ†æžæ–¹æ³•å…·ç·šæ€§é—œä¿‚ </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžäººå“¡æ˜¯å¦èƒ½æ具資料<span style="color: black;">顯示</span>最低準確測é‡æ¿ƒåº¦(LLOQ )之å†ç¾æ€§ </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžäººå“¡æ˜¯å¦èƒ½æ具資料<span style="color: black;">顯示分æžæ–¹æ³•çš„精密度(precision)</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžå ´æ‰€æ˜¯å¦èƒ½æ具資料<span style="color: black;">顯示藥物回收率（ recovery）</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžå ´æ‰€æ˜¯å¦èƒ½æ具資料<span style="color: black;">顯示藥物在生物檢體ä¸çš„安定性</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 234pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">分æžå ´æ‰€æ˜¯å¦èƒ½æ具資料<span style="color: black;">顯示藥物貯å˜éŽç¨‹å¦‚冷è—，å°è—¥ç‰©ä¹‹å®‰å®šæ€§ç„¡ä¸è‰¯å½±éŸ¿</span> </span></li> </ol> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 87pt; padding-right: 1.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"> </p> </td> </tr> </tbody></table></div><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><div style="text-align: center;"><table width="697" style="width: 522.5pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.25pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; padding-right: 5.4pt; height: 26.25pt; padding-top: 0cm;border: windowtext 1pt solid;"> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è¦ å®š é … ç›® </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è‡ªè¡ŒæŸ¥æ ¸ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">æŸ¥æ ¸çµæžœ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註 </span></p> </td> </tr> <tr style="height: 26.25pt;"> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; layout-flow: vertical-ideographic; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="18"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">檢體分æž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">以隨機方å¼æˆ–ç‰¹å®šé †åºä¾†åˆ†æžæª¢é«”</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">åŒä¸€å—試者其本å“åŠå°ç…§å“之檢體是å¦åœ¨ç›¸åŒæ¨™æº–曲線ã€æŽ§åˆ¶çµ„ã€åŠç›¸åŒå„€å™¨ä¸‹é€²è¡Œåˆ†æž</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">本å“åŠå°ç…§å“之檢體是å¦åœ¨åŒä¸€æ™‚é–“åŠæ¢ä»¶ä¸‹é€²è¡Œåˆ†æž</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">æ¯ä¸€æ‰¹æœªçŸ¥æ¿ƒåº¦æª¢é«”進行分æž</span><span style="font-family: 標楷體;">時是å¦é…置有<span style="color: black;">標準線，如果ä¸æ˜¯ï¼Œæ¨™æº–ç·šä¹‹åŸ·è¡Œé »çŽ‡ï¼ŒåŠæ˜¯å¦æ‰€æœ‰çš„æ¨™æº–ç·šçš†é™„æ–¼å ±å‘Šå…§</span> </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">分æžçµæžœæ˜¯å¦åœ¨æ¨™æº–線的有效範åœå…§ï¼Œæœ‰ç„¡å離之數值</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">分æžå ´æ‰€æ˜¯å¦è¨‚有數據å¯æŽ¥å—或排除之標準作æ¥ç¨‹åº(SOP)，所é€å ±å‘Šæ˜¯å¦éµå®ˆæ¤ä¸€æ¨™æº–作æ¥ç¨‹åº</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">分æžéŽç¨‹æ˜¯å¦æœ‰ç›²æ€§æŽ§åˆ¶çµ„或éžç›²æ€§æŽ§åˆ¶çµ„</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">控制組檢體與未知濃度組檢體分æžéŽç¨‹æ˜¯å¦å®Œå…¨ç›¸åŒ</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">空白試驗之生物檢</span><span style="font-family: 標楷體;">體來<span style="color: black;">æº</span> </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">10.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">è—¥å“標準å“的來æºï¼Œå…¶å“質åŠç´”度如何確èª</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">11.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分æžéŽç¨‹å„€å™¨æ‰€ç™¼ç”Ÿ</span><span style="font-family: 標楷體;">之特殊狀æ³åŠç‰¹å®šæ¢ä»¶<span style="color: black;">是å¦è¨˜è¼‰æ–¼å¯¦é©—室日誌或紀錄本ä¸</span> </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">12.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分æžå„€å™¨ä¹‹æ ¡æ£æ˜¯å¦è¨‚有標準作æ¥è¦ç¯„åŠç´€éŒ„ </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">13.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分æžæ–¹æ³•æ˜¯å¦åŒæ–¼é€å¯©å ±å‘Šï¼Œæ˜¯å¦æ‰€æœ‰æ•¸å€¼çš†æœ‰ç´€éŒ„，如果是é‡æ–°åˆ†æžï¼Œå°ç…§çµ„是å¦åŒæ™‚進行</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif;">14.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">é€å¯©æŸ¥ä¹‹åœ–èœæ˜¯å¦è¶³ä»¥ä»£è¡¨æ•´å€‹è©¦é©—圖èœä¹‹å“質</span> </p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">15.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">檢體é‡æ–°åˆ†æžä¹‹æ•¸å€¼æ˜¯ç”±èˆŠçš„或新的標準曲線求得，是å¦æ‰€æœ‰é‡æ–°åˆ†æžä¹‹æ•¸å€¼çš†æª¢é™„æ–¼é€å¯©ä¹‹å ±å‘Š </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">16.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">檢體é‡æ–°åˆ†æžä¹‹æ¨™æº–，是å¦æ‰€æœ‰å ±å‘Šçš†éµå®ˆæ¤ä¸€åŽŸå‰‡ </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">17.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black;">分æžéŽç¨‹æ‰€ç”¨ä¹‹è©¦åŠ‘，其é…製方法是å¦æœ‰å®Œæ•´çš„紀錄（包括é…製日期ã€ä¿å˜æ¢ä»¶ç‰ï¼‰ </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 245.7pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 17pt: ;"><span style="font-family: times new roman, serif; color: black;">18.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">完整層æžåœ–èœï¼ˆæœªæœè—¥è¡€æ¸…層æžåœ–ã€åŠ 藥血清層æžåœ–ã€å…§éƒ¨æ¨™æº–層æžåœ–ã€æŽ§åˆ¶çµ„層æžåœ–ã€æ¯ä¸€å—試者層æžåœ–ç‰ï¼‰ </span></p> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.9pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 83.95pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> </tbody></table></div><span style="font-family: calibri, sans-serif; font-size: 14pt;"><br clear="all" style="page-break-before: always;" /></span><p><span style="font-family: calibri; font-size: 14pt;"> </span></p><div style="text-align: center;"><table width="691" style="width: 518.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 26.25pt;"> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; padding-right: 5.4pt; height: 26.25pt; padding-top: 0cm;border: windowtext 1pt solid;"> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è¦ å®š é … ç›® </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">è‡ªè¡ŒæŸ¥æ ¸ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">æŸ¥æ ¸çµæžœ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 13pt;">附註 </span></p> </td> </tr> <tr> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; layout-flow: vertical-ideographic; padding-right: 5.4pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">資料處ç†èˆ‡ä¿å˜</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">有關的試驗記錄åŠæ•¸æ“šæ‡‰ç•™å˜æ–¼</span><span style="font-family: 標楷體;">é©ç•¶åœ°é»ž</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">是å¦è¨æœ‰å¯¦é©—室日誌，</span><span style="font-family: 標楷體;">是å¦æŒ‰æ—¥æœŸé †åºå¡«å¯«<span style="color: black;">，試驗æ“作者是å¦åœ¨ç´€éŒ„上簽å，是å¦æœ‰å°ˆäººè¤‡æ ¸ç°½å</span></span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">原始資料</span><span style="font-family: 標楷體;">åŠå‰¯æœ¬<span style="color: black;">是å¦å®Œæ•´ä¿å˜</span></span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">原始資料上是å¦æœ‰äººç°½ååŠåŠ 註日期，</span><span style="font-family: 標楷體;">是å¦æœ‰ä¸»ç®¡è¤‡æ ¸ä¸¦ç°½å</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">æ¤é¡žè³‡æ–™ä¹‹ä¿å˜æœŸé™</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr style="height: 26.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">æ述實驗資料ä¿å˜çš„情形</span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; height: 26.25pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體; color: black;">資料ä¸å®Œæ•´ï¼ˆå¦‚</span><span style="font-family: 標楷體;">ä¿®<span style="color: black;">改或缺ä¹æ—¥æœŸè€…）的ç†ç”±</span></span> </li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 25.05pt; layout-flow: vertical-ideographic; padding-right: 5.4pt; border-top: #f0f0f0 solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體;">ç°½ç« </span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">æœ€å¾Œå ±å‘Šä»¥ä½•ç¨®æ–¹å¼çµ¦äºˆè©¦é©—委託者（書é¢ã€å‚³çœŸã€ç£ç‰‡ã€å…‰ç¢Ÿã€ç‡’錄片） </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 241.45pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <ol> <li><span style="font-family: 標楷體;">å¦‚æ–¼æœ€å¾Œå ±å‘Šç™¼ç¾éŒ¯èª¤ï¼Œåˆªé™¤æˆ–更改ç‰äº‹é …之處ç†æ–¹å¼ </span></li> </ol> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> <td valign="top" style="border-bottom: windowtext 1pt solid; border-left: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 82.4pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> </td> </tr> </tbody></table></div>2013-12-16
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,生物藥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•æ³•è¦å‘½ä»¤ã€ˆç”Ÿç‰©è—¥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•ã€‰é™„件一：生物藥å“檢驗å°ç·˜ç”³è«‹æ›¸<pre><span style="font-family: "times new roman","serif"; font-size: 14pt; mso-fareast-font-family: 標楷體; mso-font-kerning: 1.0pt; mso-bidi-font-family: 'courier new'; mso-bidi-font-size: 10.0pt;" lang="EN-US"><o:O:P><span style="font-family: 新細明體; font-size: 16px;"></span> <table style="border-collapse: collapse; mso-table-layout-alt: fixed; mso-border-alt: solid windowtext .5pt; mso-yfti-tbllook: 480; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt;" class="MsoTableGrid" border="1" cellspacing="0" cellpadding="0" width="622"><span style="font-family: 新細明體;"></span><tbody><tr style="mso-yfti-irow: 0; mso-yfti-firstrow: yes;"><span style="font-family: 新細明體;"></span><td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; padding-top: 0cm; mso-border-alt: solid windowtext .5pt;border: windowtext 1pt solid;" valign="top" colspan="7"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">附件一ã€ç”Ÿç‰©è—¥å“檢驗å°ç·˜ç”³è«‹æ›¸<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 33.4pt; mso-yfti-irow: 1;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top" rowspan="3"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="margin: 0cm 0cm 0pt;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">ç”³è«‹å» å•†<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">å稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">（蓋å°ï¼‰<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">è² è²¬äºº<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 33.4pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">ï¼ˆç°½ç« ï¼‰<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 18.75pt; mso-yfti-irow: 2;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">地å€<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">電話<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 18.75pt; mso-yfti-irow: 3;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px; text-decoration: underline;">申請<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 18.75pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px; text-decoration: underline;">å°ç·˜è‰æ˜Žæ›¸ï¼š<span style="mso-spacerun: yes;" lang="EN-US"> </span>份<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; text-decoration: underline;">放行è‰æ˜Žï¼ˆå¤–銷用）：<span style="mso-spacerun: yes;" lang="EN-US"> </span>份</span><span style="font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 4;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top" rowspan="7"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: 0.05pt; margin: 0cm 0cm 0pt -1.55pt; mso-para-margin-left: -.13gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">申請檢驗å°ç·˜è—¥å“<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">ä¸æ–‡å稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">è—¥å“許å¯è‰å—號<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 5;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">外文å稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">批號<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 6;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">æˆåˆ†åŠå–®ä½å«é‡<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">有效日期<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 7;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">包è£<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">貯å˜æ–¹æ³•<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 8;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 54pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" rowspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">åŽŸè£½é€ å» <span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">å稱<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="2"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">進å£æ—¥æœŸ<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">民國<span style="mso-spacerun: yes;" lang="EN-US"> </span>å¹´<span style="mso-spacerun: yes;" lang="EN-US"> </span>月<span style="mso-spacerun: yes;" lang="EN-US"> </span>æ—¥<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 9;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">地å€<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 352.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="4"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 10;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 54pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: rgb(0,0,0) 0px; padding-top: 0cm; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-bottom-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">進å£<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">è£½é€ <span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 36pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-top-alt: solid windowtext .5pt; mso-border-bottom-alt: solid windowtext .5pt; mso-border-right-alt: solid windowtext .5pt;"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">數é‡<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 126pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 60pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm; mso-border-left-alt: solid windowtext .5pt;border: rgb(0,0,0) 0px;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">å°ç·˜<span style="text-decoration: underline;"><span lang="EN-US">/</span>外銷<span lang="EN-US"><o:O:P></o:O:P></span></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-align: right; text-indent: -11pt; margin: 0cm 0cm 0pt 5pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; font-size: 11pt; text-decoration: underline;">藥物檢查è‰</span><span style="font-family: 標楷體; font-size: 11pt;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: rgb(0,0,0) 0px; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 30pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-right-alt: solid windowtext .5pt;"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體; font-size: 16px;">數é‡<span lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 136.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -12pt; margin: 0cm 0cm 0pt 6pt; mso-char-indent-count: -1.0; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr style="height: 1.8pt; mso-yfti-irow: 11; mso-yfti-lastrow: yes;"><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt;" valign="top"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-indent: -5.15pt; margin: 0cm 0cm 0pt -0.85pt; mso-char-indent-count: -.43; mso-para-margin-left: -.5gd;" class="MsoNormal"><span style="font-size: 16px;"><span style="font-family: 標楷體; mso-spacerun: yes;" lang="EN-US"> </span><span style="font-family: 標楷體;">應附資料文件<span lang="EN-US"><o:O:P></o:O:P></span></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="border-bottom: windowtext 1pt solid; border-left: rgb(0,0,0) 0px; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 442.8pt; padding-right: 5.4pt; height: 1.8pt; border-top: rgb(0,0,0) 0px; border-right: windowtext 1pt solid; padding-top: 0cm; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt;" valign="top" colspan="6"><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(1)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">輸入包è£æ¸…å–®</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">(Packing list)<span style="mso-spacerun: yes;"> </span>(</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">國產製å“å¾—å…附</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(2)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">生物藥å“原產國國家檢驗機關之檢定åˆæ ¼è‰æ˜Ž</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><span style="mso-spacerun: yes;"> </span>(</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">國產製å“å¾—å…附</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">。</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(3)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">è¡›ç”Ÿç½²æ ¸ç™¼è—¥å“許å¯è‰æˆ–æ ¸å¯æ–‡ä»¶ä¹‹å½±æœ¬ã€‚</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(4)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">生物藥å“之製程ã€æª¢é©—方法ã€è¦æ ¼åŠæœ‰é—œæ–‡ç»ã€‚</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">â–¡</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：å„é …åŽŸå» è‰æ˜Žè³‡æ–™èˆ‡æŸ¥é©—登記資料相符，請准å…é€ã€‚</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(5)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">動物原料來æºç®¡åˆ¶ä¹‹æ¨™æº–æ“作程åº</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">(SOP)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">åŠåŽŸæ–™ä¾†æºè‰æ˜Žã€‚</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">â–¡</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：å„é …åŽŸå» è‰æ˜Žè³‡æ–™èˆ‡å‰æ¬¡ç”³è«‹æª¢é©—å°ç·˜è³‡æ–™ç›¸ç¬¦ï¼Œè«‹å‡†å…é€ã€‚</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: -13.5pt; margin: 0cm 0cm 0pt 13.5pt; vertical-align: baseline; mso-layout-grid-align: none; mso-list: l0 level1 lfo1;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 'times new roman'; mso-list: ignore;" lang="EN-US">(6)</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">本批生物藥å“製程之分è£æ•¸é‡ç´€éŒ„與檢定紀錄åŠæˆå“之檢定紀錄與æˆç¸¾æ›¸ã€‚</span><span style="mso-fareast-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-size: 16px;"><span style="mso-fareast-font-family: 標楷體;" lang="EN-US">â–¡</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">：</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman'; mso-hansi-font-family: 'times new roman';">å› æ‡‰é˜²ç–«æˆ–å¤–éŠ·ç”¨ç”Ÿç‰©è—¥å“，</span><span style="font-family: 標楷體; mso-ascii-font-family: 'times new roman';">請准後補資料。（檢附åŒæ„函）</span><span style="mso-fareast-font-family: 標楷體; mso-hansi-font-family: 標楷體;" lang="EN-US"><o:O:P></o:O:P></span></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 18pt; text-indent: 15.7pt; margin: 0cm 0cm 0pt; vertical-align: baseline; mso-char-indent-count: 1.31; mso-layout-grid-align: none;" class="MsoNormal"><span style="font-family: 標楷體;" lang="EN-US"><o:O:P><span style="font-size: 16px;"> </span></o:O:P></span></p><span style="font-family: 新細明體; font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span><tr><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 31px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 72px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 48px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 168px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 80px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 40px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span><td style="background-color: transparent; width: 182px;border: rgb(0,0,0) 0px;"><span style="font-size: 16px;"></span></td><span style="font-family: 新細明體;"></span></tr><span style="font-family: 新細明體;"></span></tbody></table></o:O:P></span><span style="font-family: "times new roman","serif"; font-size: 14pt; mso-fareast-font-family: 標楷體; mso-font-kerning: 1.0pt; mso-bidi-font-family: 'courier new'; mso-bidi-font-size: 10.0pt;" lang="EN-US"><o:O:P></o:O:P></span></pre>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4487&type=0
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,生物藥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•æ³•è¦å‘½ä»¤ã€ˆç”Ÿç‰©è—¥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•ã€‰é™„件二：生物藥å“å°ç·˜è‰æ˜Žæ›¸<p style="margin: 0cm 0cm 0pt;" class="MsoNormal"><span lang="EN-US"><o:O:P><span style="font-family: arial unicode ms;"><table style="border-collapse: collapse;" border="1" cellspacing="0" cellpadding="0" width="622"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" colspan="2"> <p><span style="font-family: 標楷體; font-size: 18px;">附件二ã€ç”Ÿç‰©è—¥å“å°ç·˜è‰æ˜Žæ›¸ </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px;border: rgb(0,0,0) 0px;"> <p><span style="font-size: 18px;"> </span></p> </td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" rowspan="2" colspan="2"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"><span style="font-family: arial unicode ms; text-decoration: none;"> </span><span style="font-family: 標楷體; text-decoration: underline;">行政院衛生署食å“藥物管ç†å±€ </span> </span></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 18px;">生物藥å“å°ç·˜è‰æ˜Žæ›¸ </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"> <span style="font-family: 標楷體; text-decoration: underline;">FDA</span><span style="font-family: 標楷體; text-decoration: underline;">ç ”å—第OOOOOOOOOO號 </span></span></p> <span style="font-size: 18px;"></span> <p><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span> <p><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span> <div style="text-align: center;"><span style="font-size: 18px;"></span> <table style="border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <span style="font-size: 18px;"></span> <tbody> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">ç”³è«‹å» å•†</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p class="a"><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">製劑å稱</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">è£½é€ å» å</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">批號</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">有效日期</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">包è£</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">å°ç·˜æ•¸é‡</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 64.1pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: left;" class="a"><span style="font-size: 18px;"><span style="font-family: 標楷體; font-size: 12pt; text-decoration: underline;">å°ç·˜åŠ‘é‡</span><span style="font-size: 12pt; text-decoration: underline;">:</span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 282.05pt; padding-right: 5.4pt; padding-top: 0cm;border: rgb(0,0,0);" valign="top"><span style="font-size: 18px;"></span> <p><span style="font-size: 18px; text-decoration: underline;">OOO</span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> </tbody> </table> <span style="font-size: 18px;"></span></div> <span style="font-size: 18px;"></span> <p style="margin-left: 6pt;"><span style="font-size: 18px;"><span style="font-family: 標楷體; text-decoration: underline;">上述生物藥å“之å°ç·˜æª¢é©—案，符åˆç”Ÿç‰©è—¥å“檢驗å°ç·˜ä½œæ¥ä¹‹è¦å®šï¼Œäºˆä»¥å°ç·˜ï¼Œæ¤è‰ã€‚</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-size: 18px;"><span style="font-family: 標楷體; text-decoration: underline;">局長 </span><span style="font-family: 標楷體; text-decoration: underline;">â—‹â—‹â—‹</span><span style="text-decoration: underline;"> </span></span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px; text-decoration: none;"> </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> <tr style="height: 42pt;"> <span style="font-size: 18px;"></span> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 42pt; padding-top: 0cm;border: rgb(0,0,0) 0px;" valign="top" colspan="2"><span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;"> </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;"> </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 18px;">ä¸è¯æ°‘國 å¹´ 月 æ—¥ </span></p> <span style="font-size: 18px;"></span> <p style="text-align: center;"><span style="font-family: arial unicode ms; font-size: 18px;"> </span></p> <span style="font-size: 18px;"></span></td> <span style="font-size: 18px;"></span> <td style="background-color: transparent; width: 0px; height: 42pt;border: rgb(0,0,0) 0px;"></td> <span style="font-size: 18px;"></span> </tr> <span style="font-size: 18px;"></span> </tbody></table><p style="margin: 0cm 0cm 0pt;" class="MsoNormal"> </p></span><p style="margin: 0cm 0cm 0pt;" class="MsoNormal"> </p></o:O:P></span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4486&type=0
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,生物藥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•æ³•è¦å‘½ä»¤ã€ˆç”Ÿç‰©è—¥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•ã€‰é™„件三：外銷用生物藥å“批次放行è‰æ˜Žæ›¸<table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="622"> <tbody> <tr style="height: 31.25pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 31.25pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="12"> <p><span style="font-family: 標楷體;">附件三ã€å¤–銷用生物藥å“批次放行è‰æ˜Žæ›¸ </span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: left; line-height: 12pt; margin: 0cm 7.1pt 0pt 0cm;" class="a"><span style="font-size: 10pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 209.7pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: left; margin: 0cm 7.1pt 0pt 0cm;" class="a"><span style="color: #414141; font-size: 10pt; font-weight: normal;" class="panelti21">No.161-2, Kunyang St., Nangang District, <br /> Taipei 115-61, Taiwan (R.O.C)</span></p> <p><span style="color: #414141;"><span style="font-size: 10pt; font-weight: normal;" class="panelti21"> TEL</span><span style="font-family: 新細明體,serif; font-size: 10pt; font-weight: normal;" class="panelti21">：</span><span style="font-size: 10pt; font-weight: normal;" class="panelti21">886-2-27878000</span> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 233.1pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="8"> <p style="text-align: center;"><span style="font-size: 14pt; font-weight: normal;" class="panelti21"><img width="726" height="255" alt="" style="width: 256px; height: 77px;" src="../Files/NewsUpload/1.png" /></span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="12"> <p style="text-align: center;" class="a"><span style="font-family: harlow solid italic; color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Food and Drug Administration</span></p> <p style="text-align: center;" class="a"><span style="color: #414141;"><span style="font-family: harlow solid italic; font-size: 12pt; font-weight: normal;" class="panelti21">Department of Health, Executive Yuan, Republic of China</span><span class="panelti21"> </span></span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 466.2pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="12"> <p style="text-align: center; line-height: 150%;" class="a"><span style="color: #414141;"><span style="line-height: 150%; font-size: 12pt; font-weight: normal;" class="panelti21">LOT</span><span style="line-height: 150%; font-size: 12pt; font-weight: normal;" class="panelti21"> RELEASE CERTIFICATE</span><span class="panelti21"> </span></span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 311.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="8"> <p style="text-align: right;" class="a"><span style="color: #414141;"><span style="font-family: harlow solid italic; font-size: 12pt; font-weight: normal;" class="panelti21">No.</span><span class="panelti21"> </span></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 154.8pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;" class="panelti21">TFDA-RA-XXXXXXXXXX</span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 221.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 201.6pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: right;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;" class="panelti21">MMM. DD, YYYY</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 19.8pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;" class="panelti21"> </span></p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 23.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 442.8pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="10"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 14.4pt 9pt -5.25pt;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;">The lot referenced below meets the national requirements for lot release and conforms to the approved specifications. The lot has been tested on the basis of critical evaluation of the manufacture’s production and control protocols and on the basis of the evaluation of samples at the Food and Drug Administration. </span></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Product trade name</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Common name</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141;"><span style="font-size: 12pt; font-weight: normal;" class="panelti21">Lot</span><span style="font-size: 12pt; font-weight: normal;" class="panelti21"> number</span></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Expiry date</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Number of containers</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Number of doses per container</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Type of container</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Dosage form</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Strength of the product</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 41.4pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 207pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: left;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Name and address of manufacturer</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 180pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="4"> <p style="text-align: left;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 37.8pt; padding-right: 5.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 9.5pt;"><span style="color: #414141; font-size: 15.5pt; font-weight: normal;"> Signed by </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" rowspan="2" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p><span style="font-family: 標楷體;"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 12pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;">Director, Division of Research and Analysis </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 12pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;">Under the delegated authority of </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 12pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 13pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Director-General</span></p> <p style="text-align: left; line-height: 13pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Food and Drug Administration</span></p> <p style="text-align: left; line-height: 13pt;" class="a"><span style="color: #414141; font-size: 12pt; font-weight: normal;" class="panelti21">Department of Health, Executive Yuan, Republic of China</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體; text-decoration: none;"> </span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 1.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 14.4pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 243pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="6"> <p style="text-align: left; line-height: 13pt;" class="a"><span style="font-size: 12pt;" class="panelti21"><strong><span style="color: #414141;"> </span></strong></span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 92.25pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 116.55pt; padding-right: 5.4pt; height: 1.8pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="background-color: transparent; width: 18px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 10px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 22px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 220px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 16px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 5px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 12px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 66px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 63px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 118px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 30px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 43px;border-color: #f0f0f0;"></td> </tr> </tbody></table>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4488&type=0
藥政管ç†é¡ž,æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•æ³•è¦å‘½ä»¤ã€ˆæˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•ã€‰é™„件一<p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 18pt;">æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•ç¬¬äºŒæ¢é™„件一修æ£è¦å®š</span></b><b> </b></p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="727"> <tbody> <tr style="height: 403.45pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 545.4pt; padding-right: 5.4pt; height: 403.45pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <table style="margin: auto auto auto 1.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="717"> <tbody> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">劑別 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">主è¦æˆåˆ† </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">主è¦æ•ˆèƒ½ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="letter-spacing: 15pt; font-family: 標楷體; font-size: 12pt; text-fit: 139.5pt;">其他è¦å®š</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">一)解熱鎮痛劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乙醯水楊酸(Acetylsalicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å’–å•¡é¹¼(Caffeine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯芬尼拉明(Chlorpheniramine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">汎å¸(Acetaminophen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸胺(Salicylamide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">乙氧基苯醯胺</span><span style="font-family: 標楷體; font-size: 12pt;">(Ethoxybenzamide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æº´æ»‘åˆ©å°¿ç´ (Bromvalerylurea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è‘›æ ¹(Pueraria)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻黃(Ephedra)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å‡éº»(Cimicifugae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">柴胡(Bupleurum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¡‚çš®(Cinnamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">èŠè—¥(Paeonia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大棗(Zizyphus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">生薑(Zingiber)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘è‰(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桔梗</span><span style="font-family: 標楷體; font-size: 12pt;">(Platycodon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白芷</span><span style="font-family: 標楷體; font-size: 12pt;">(Angelica Glaurao)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">感冒ã€é ç—›ã€è§£ç†±ã€éŽ®ç—›ã€é¢¨æ¿•ç—…ã€ç¥žç¶“ç—›ã€é½’ç—›ã€å’½å–‰ç—…ã€è‚©ç—›ã€é¼»å¡žã€æµé¼»æ°´ã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">二)鎮咳袪痰劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化銨(Ammonium Chloride)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻黃鹼(Ephedrine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å’–å•¡é¹¼(Caffeine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">安æ¯é¦™é…¸éˆ‰(Sodium Benzoate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ±èŽ¨èªæµ¸è†(Extract Scopilia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">癒創木酚(Guaiacol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">諾å¸å¡è³“(Noscapine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç‡é…¸å¯å¾…å› (Codeine Phosphate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">美é å¿—(Senega)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯芬尼拉明(Chlorpheniramine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¾ç¯€æ²¹(Oleum Terebinthine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æä»(苦æä»Armeniaca Amara〠</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甜æä»Armeniaca Dulcis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">é å¿—(Polygala)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å°èŒ´é¦™(Foeniculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桔梗(Platycodon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">野櫻皮(Prunus Serotina)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">車å‰å(Plantaginis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻黃(Ephedra)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麥門冬(Ophiopogon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桑白皮(Morus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">åŠå»ˆ(Pinellia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">紫蘇(Perilla)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">厚朴(Magnolia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茯苓(Hoelen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">柴胡(Bupleurum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">陳皮(Citri Nobilis Cortex)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">石è†(Cypsum Fibrosum)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">咳嗽ã€æ„Ÿå†’支氣管炎引起之咳嗽ã€å–€ç—°ã€å’½å–‰ç‚Žå¼•èµ·ä¹‹å’³å—½ã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">三)胃腸藥劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">é…µæ¯(Yeast)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化é‹(Aluminum Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">矽酸é‹(Aluminium Silicate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鎂(Magnesium Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸é‰æˆ–ç¡é…¸é‰(Bismuth Carbonate or Nitxrate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鈣(Calcium Carbonate)</span></p> <p style="margin: 0cm 1cm 0pt 11.8pt; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">縮水蘋果酸氯芬尼拉明(Chlorpheniraamine Maleate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">二苯胺明(Diphenhydramine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸氫鈉(Sodium Bicarbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¾±ç²‰é…µç´ (Amylase)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ±èŽ¨èªæµ¸è†(Extract Scopoliae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">木溜油</span><span style="font-family: 標楷體; font-size: 12pt;">(Creosote)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">苦木</span><span style="font-family: 標楷體; font-size: 12pt;">(Picrasma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當藥</span><span style="font-family: 標楷體; font-size: 12pt;">(Swertiae Herba)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è–„è·è…¦</span><span style="font-family: 標楷體; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">黃連鹼</span><span style="font-family: 標楷體; font-size: 12pt;">(Coptisine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乳酸èŒè£½åŠ‘</span><span style="font-family: 標楷體; font-size: 12pt;">(Lactic Acid Preparation)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">顛茄葉</span><span style="font-family: 標楷體; font-size: 12pt;">(Belladonna)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">黃æŸ</span><span style="font-family: 標楷體; font-size: 12pt;">(Phellodendra)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白朮</span><span style="font-family: 標楷體; font-size: 12pt;">(Atractylodes Ovata)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蒼朮</span><span style="font-family: 標楷體; font-size: 12pt;">(Atractylodes Lancea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">é¾è†½</span><span style="font-family: 標楷體; font-size: 12pt;">(Gentiana)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç ‚ä»</span><span style="font-family: 標楷體; font-size: 12pt;">(Amomum Zanthioides)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">黃連</span><span style="font-family: 標楷體; font-size: 12pt;">(Coptis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘è‰</span><span style="font-family: 標楷體; font-size: 12pt;">(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å³èŒ±è¸</span><span style="font-family: 標楷體; font-size: 12pt;">(Evodia Rutacecarps)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蘆薈</span><span style="font-family: 標楷體; font-size: 12pt;">(Aloe)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大黃</span><span style="font-family: 標楷體; font-size: 12pt;">(Rheum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ä¸é¦™</span><span style="font-family: 標楷體; font-size: 12pt;">(Caryophyllum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">陳皮</span><span style="font-family: 標楷體; font-size: 12pt;">(Citri Nobilis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人åƒ</span><span style="font-family: 標楷體; font-size: 12pt;">(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">藿香</span><span style="font-family: 標楷體; font-size: 12pt;">(Agastache Rugosa)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茯苓</span><span style="font-family: 標楷體; font-size: 12pt;">(Hoelen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">åŠå¤</span><span style="font-family: 標楷體; font-size: 12pt;">(Pinellia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å°èŒ´é¦™</span><span style="font-family: 標楷體; font-size: 12pt;">(Foeniculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澤瀉</span><span style="font-family: 標楷體; font-size: 12pt;">(Alisma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç‰¡è £</span><span style="font-family: 標楷體; font-size: 12pt;">(Ostreae Testa)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">延胡索</span><span style="font-family: 標楷體; font-size: 12pt;">(Corydalis Tuber)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸鎂</span><span style="font-family: 標楷體; font-size: 12pt;">(Magnesium Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蓖麻åæ²¹</span><span style="font-family: 標楷體; font-size: 12pt;">(Castor Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鎂(Magnesium Oxide)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">胃痛ã€èƒƒè…¸ç‚Žã€èƒƒå…§ç•°å¸¸é†±é…µã€æ¶ˆåŒ–ä¸è‰¯ã€èƒƒé…¸éŽå¤šã€é£Ÿæ…¾ä¸æŒ¯ã€å˜”åã€ç€‰ç—¢ã€èƒƒéƒ¨è†¨æ»¿ã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å››)緩下劑(瀉藥)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大黃(Rheum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蘆薈(Aloe)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">麻åä»(Linum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æä»(苦Armeniaca Amaraã€ç”œArmeniaca Dulcis)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">番瀉葉(Senna)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">便秘ã€ç¿’慣性便秘ã€æ…¢æ€§ä¾¿ç§˜ã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">五)驅蟲劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">海人酸(Kainic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å±±é“å¹´</span><span style="font-family: 標楷體; font-size: 12pt;">(Santonin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">二乙烯二胺</span><span style="font-family: 標楷體; font-size: 12pt;">(Piperazine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">海人è‰</span><span style="font-family: 標楷體; font-size: 12pt;">(Digenea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">使å›å</span><span style="font-family: 標楷體; font-size: 12pt;">(Combretaceae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">石榴皮(Cranatum)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蛔蟲ã€èŸ¯èŸ²ã€å二脂腸蟲ã€çµ›èŸ²ä¹‹é©…除。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å…)營養劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">檸檬酸éµéŠ¨(Ferric Ammonium Citrate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">礦物質(Mineral)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氨基酸製劑(Amino Acid Prep.)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">éšè‚æ²¹(Cod Liver Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人åƒ(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當æ¸(Angelica)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å·èŠŽ(Cnidii Rhizoma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">äº”åŠ çš®(Acanthopanacis Cortex)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">山藥(Dioscorea)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大棗(Zizyphus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">女éšå(Ligustrum Lucidum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç¶ç”Ÿç´ B1, B2, B6é¡ž </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">éµåŠ‘(Iron Prep.)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蛋白質之補給ã€é£Ÿæ…¾å¢žé€²ã€ç‡Ÿé¤Šè£œçµ¦ã€è²§è¡€ã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">七)眼藥液劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸鋅(Zinc Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿克利諾兒(Acrinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç¡¼ç ‚(Borax)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">çµè†œç‚Žã€çœ¼çž¼ç·£ç‚Žã€æ·šå›Šç‚Žã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å…«)æ¼±å£åŠ‘ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿克利諾兒(Acrinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸氫鈉(Sodium Bicarbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¼±å£ï¼šå£å…§æ¶ˆæ¯’。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">ä¹)浣腸劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">緩解便祕。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">1.</span><span style="font-family: 標楷體; font-size: 12pt;">é©ç”¨ç¯„åœï¼šæ‰€ç¨±æµ£è…¸åŠ‘係指</span><span style="font-family: 標楷體; font-size: 12pt;">凡經由肛門投與，以緩解便祕為目的之製劑，å‡é©ç”¨æœ¬åŸºæº–</span><span style="font-family: 標楷體; font-size: 12pt;">。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2.</span><span style="font-family: 標楷體; font-size: 12pt;">有效æˆåˆ†ä¹‹ç¨®é¡žå«é‡ï¼š </span></p> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="346"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 79.35pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">有</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">效</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">æˆ</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">單方濃度範åœ</span> </p> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 新細明體; font-size: 12pt;">(w/v) </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">複方濃度範åœ</span> </p> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 新細明體; font-size: 12pt;">(w/v) </span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 79.35pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><b>12% ~ 50%</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><b>12% ~ 30%</b></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 79.35pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氯化鈉(Sodium Chloride)</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><b>0.9% ~ 15%</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; margin: 0cm 5.65pt 0pt;"><b>0.9% ~ 15%</b></p> </td> </tr> </tbody> </table> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">※所è¦ç¯„之浣腸劑為單一劑é‡ä¹‹ä½¿ç”¨ï¼Œæˆäºº</span><span style="font-family: 標楷體; font-size: 12pt;">æ¯å–®ä¸€åŠ‘é‡ï¼ˆé¡†ã€ç²’ã€ä¸¸…</span><span style="font-family: 新細明體; font-size: 12pt;">..</span><span style="font-family: 標楷體; font-size: 12pt;">）ä¸å¯å¤§æ–¼ä¸‰å毫å‡ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 新細明體; font-size: 12pt;">3. </span><span style="font-family: 標楷體; font-size: 12pt;">劑型：</span><span style="font-family: 標楷體; font-size: 12pt;">浣腸劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">4.</span><span style="font-family: 標楷體; font-size: 12pt;">用法åŠç”¨é‡ï¼š</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">1</span><span style="font-family: 標楷體; font-size: 12pt;">）將一劑注入直腸內，若未見效果時å¯å†æ³¨å…¥ä¸€åŠ‘，一天最多二劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">2</span><span style="font-family: 標楷體; font-size: 12pt;">）</span><span style="font-family: 標楷體; font-size: 12pt;">å二æ²ä»¥ä¸Šï¼Œé©ç”¨æˆäººåŠ‘é‡ã€‚三æ²ä»¥ä¸Šæœªæ»¿å二æ²ï¼Œé©ç”¨æˆäººåŠ‘é‡ä¹‹äºŒåˆ†ä¹‹ä¸€ã€‚三æ²ä»¥ä¸‹ä¹‹å¬°å¹¼å…’，請洽醫師診治。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">3</span><span style="font-family: 標楷體; font-size: 12pt;">）使用後之剩餘液需丟棄，ä¸å®œç•™å˜ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">5.</span> <span style="font-family: 標楷體; font-size: 12pt;">注æ„äº‹é …ï¼š</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（1）為防æ¢å…’童誤食請妥善ä¿ç®¡ã€‚ </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（2）é¿å…陽光直射，宜ä¿å˜æ–¼é™°æ¶¼ä¹‹è™•ã€‚ </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（3）除éžæœ‰é†«å¸«è—¥å¸«è—¥åŠ‘生指示，å•å©¦åŠæŽˆä¹³å©¦ä¸å»ºè°è‡ªè¡Œä½¿ç”¨ã€‚ </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（4）勿超éŽå»ºè°åŠ‘é‡ï¼Œè‹¥æœ‰ä¸é©æƒ…æ³ç”¢ç”Ÿï¼Œæ‡‰ç«‹å³åœè—¥å°±é†«ã€‚ </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（5）</span><span style="font-family: 標楷體; font-size: 12pt;">浣腸劑ä¸æ‡‰é•·æœŸä½¿ç”¨ï¼Œä¸€æ—¦æŽ’便æ£å¸¸ï¼Œå³æ‡‰åœè—¥ã€‚除éž<b>有醫師藥師藥劑生</b>指示，ä¸å¾—使用連續一星期以上，應儘é‡ä»¥å«çº–ç¶é£²é£Ÿï¼Œå……分æ”å–水分åŠé‹å‹•ä¾†æ”¹å–„便祕。 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">6.</span><span style="font-size: 12pt;"> </span><span style="font-family: 標楷體; font-size: 12pt;">è¦èªž</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">1</span><span style="font-family: 標楷體; font-size: 12pt;">）使用本藥時ä¸å¾—併用其他瀉劑。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（2）</span><span style="font-family: 標楷體; font-size: 12pt;">ç¦æ¢ç”¨æ–¼èƒƒè…¸é˜»å¡žã€è…¹ç—›ã€å˜”åã€å™å¿ƒä¹‹æ‚£è€…。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">3</span><span style="font-family: 標楷體; font-size: 12pt;">）若發生下列情æ³ï¼Œæ‡‰åœè—¥ç«‹å³å°±é†«ï¼š</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（i）</span><span style="font-family: 標楷體; font-size: 12pt;">腹瀉æŒçºŒä¸æ¢æˆ–åŠ åŠ‡ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">ii</span><span style="font-family: 標楷體; font-size: 12pt;">）有血便åŠè‡ªç™¼æ€§ç›´è…¸å‡ºè¡€ç‹€æ³ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（</span><span style="font-family: 新細明體; font-size: 12pt;">iii</span><span style="font-family: 標楷體; font-size: 12pt;">）使用一星期後無效者。</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å)外用皮膚藥 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鋅(Zinc Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿克利諾兒(Acrinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">苯甲酸鈉(Sodium Benzoate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">éšè‚æ²¹(Cod Liver Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">苯甲酸(Benzoic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫黃(Sulfur)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç¡¼ç ‚(Borax)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">紅汞(Mercurochrome)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¤ç‰©æ²¹(Vegetable Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">抗組織胺(Antihistamine)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">é¾è†½ç´«(Gentiana Violet)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è–„è·æ²¹(Menthol Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å°æ°¨åŸºè‹¯ç”²é…¸ä¹™é…¯(Ethyl-P-Aminobenzoate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å†¬ç¶ æ²¹(Methyl Salicylate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç´«è‰(Lithospermum Erythrorhizon)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當æ¸(Angelica)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ä¸é¦™æ²¹(Oleum Caryophylli)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮油(Oleum Cinnamomi)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">雷鎖辛(Resorcinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蓖麻油(Castor Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甲烯è—(Methylene Blue)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碘溶液(Iodine Solution)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碘化鉀(Pot Iodide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油(Glycerin)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¿•ç–¹ã€ç™©çš®ã€è†¿î‹ƒã€å‡å‚·ã€å‰µå‚·ã€æ±—ç–¹ã€æ¢ç—’。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å一)外用殺èŒåŠ‘ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫黃(Sulfur)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">明礬(Alum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">3% </span><span style="font-family: 標楷體; font-size: 12pt;">雙氧水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2% </span><span style="font-family: 標楷體; font-size: 12pt;">紅汞水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">1% </span><span style="font-family: 標楷體; font-size: 12pt;">紫藥水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2.5% </span><span style="font-family: 標楷體; font-size: 12pt;">稀碘酒 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">1% </span><span style="font-family: 標楷體; font-size: 12pt;">黃藥水 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">以上包è£éƒ½60ml以下。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">外用殺èŒã€æ¶ˆæ¯’。 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å二)外用制汗劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç¦é¦¬æž—(Formalin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">明礬(Alum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鋅(Zinc Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è–„è·è…¦(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">醋酸é‹(Aluminum Acetate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸(Boric Acid)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">制汗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å三)硬è†åŠ‘ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸銅(Cup. Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ±èŽ¨èªæµ¸è†(Ext Scopoliae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鉛(Lead Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¾è„‚(Resina Pini)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç–”ã€æ°´æ³¡ã€è…«å‚·ã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">åå››)脫毛劑 </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">脫毛為目的之外用劑，劑型原則上軟è†åŠ‘)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫化鋇(Barium Sulfide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫化鈉(Sodium Sulfide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化é¶(Strontium Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化鉀(Potassium Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氫氧化鈉(Sodium Hydroxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫醇基乙酸鈉(Thioglycolate Sodium)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫化鈣(Calcium Sulfide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">氧化鋅(Zinc Oxide)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">é»ƒè»ŸçŸ³è Ÿ(Petrolatum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白陶土(Kaolin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">滑石粉(Talc)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澱粉(Starch), etc.</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">除毛 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å五)婦人科藥劑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">鞣酸(Tannic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">當æ¸(Angelica)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">èŠè—¥(Paeonia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å·èŠŽ(Cnidii Rhizoma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">地黃(Rehmanniae Rhizoma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白朮(Atractylodes Ovata)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澤瀉(Alisma)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人åƒ(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¡‚çš®(Cinnamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘è‰(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茯苓(Hoelen)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">牡丹皮(Paeonia Moutan)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桃ä»(Prunus Persica)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">貧血ã€èµ¤ç™½å¸¶ã€æœˆç¶“ä¸é †ã€ç”¢å‰ç”¢å¾Œèª¿é¤Šã€é ç—›ã€é 暈ã€ä¸‹è…¹ç—›ã€å®‰èƒŽã€æœˆç¶“困難ã€è…°éƒ¨å¡žå†·ã€ç˜€è¡€ã€æ›´å¹´æœŸéšœå®³ã€‚ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> <tr style="height: 212.6pt;"> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 69.55pt; padding-right: 1.4pt; height: 212.6pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">åå…)å°å…’科藥劑 </span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 108.3pt; padding-right: 1.4pt; height: 212.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">茴香(Foeniculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">大黃(Rheum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硫酸鎂(Mag Sulfate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">牛黃(Benzoar Oriental)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蟾酥</span><span style="font-family: 標楷體; font-size: 12pt;">(Bufo Bufo)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">沉香</span><span style="font-family: 標楷體; font-size: 12pt;">(Aquilaria Agallocha)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人åƒ(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乳酸èŒ(Lactobacteria)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">滋養糖(Saccharum Amyl)</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 212.6pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">消化ä¸è‰¯ã€ç¶ 便ã€å°å…’夜å“。 </span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 270pt; padding-right: 1.4pt; height: 212.6pt; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> </td> </tr> </tbody> </table> </td> </tr> </tbody></table>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4489&type=0
藥政管ç†é¡ž,æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•æ³•è¦å‘½ä»¤ã€ˆæˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•ã€‰é™„件二<p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 18pt;">æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•ç¬¬äºŒæ¢é™„件二修æ£è¦å®š</span></b> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="727"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 545.4pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">劑別</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">主è¦æˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 11.35pt 0pt; layout-grid-mode: char; punctuation-wrap: simple;"><b><span style="font-family: 標楷體; font-size: 12pt;">主è¦æ•ˆèƒ½</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="text-fit: 139.5pt;"><b><span style="letter-spacing: 15.25pt; font-family: 標楷體;">其他è¦å®š</span></b></span><b> </b></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">一</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">清涼劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">乙醚</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Ether)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ°¯ä¸é†‡</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Chlorobutanol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蜂蜜</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Mel)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è‘‰ç¶ ç´ </span><span style="font-family: times new roman,serif; font-size: 12pt;">(Chlorophyll)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">阿仙è‰</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ç ‚ä»</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Amomum Xanthioides)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è–„è·è…¦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">豆蔻</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Elettaria Cardamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘è‰</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Glycyrrhiza)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å°èŒ´é¦™</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Foenlculum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">人åƒ</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Ginseng)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">木香</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Inula Helenium)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ä¸é¦™</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Caryophyllus)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">æ¡‚çš®</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Cinnamomum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">é¾è…¦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Borneal)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">èŠè—¥</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Paeonia)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">山椒</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Xanthoxylum Piperitum)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">生薑</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Zingiber)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">胃痛ã€å˜”åã€å£è‡ã€æ¸…涼ã€ä¸æš‘ã€å瀉ã€æšˆè»Šã€æšˆèˆ¹ã€è…¹ç—›ã€‚</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">二</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">外用軟油è†é¡ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">樟腦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Camphor)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è–„è·æ²¹</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å¤šç¶ æ²¹</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Methyl Salicylate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">ä¸é¦™æ²¹</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Eugenol)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">切傷ã€åˆ€å‚·ã€å‰µå‚·ã€ç«å‚·ã€èŸ²å’¬å‚·ã€é 暈。</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">三</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">外用撒布劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">桂皮油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Oleum Cassiae)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">白陶土</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Kaolin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鋅</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Zinc Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">碳酸鎂</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Magnesium Carbonate)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">滑石粉</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Talc)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">澱粉</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Starch)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">硼酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Boric Acid)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">防æ¢é«”è‡ã€æ¢ç™¢ã€å¸è‘—ã€æ”¶æ›ã€‚</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">å››</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">養毛髮劑</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">脫毛之防æ¢ã€è‚²æ¯›ç‚ºç›®çš„之外用劑，劑型原則上液劑為準</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">水楊酸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Salicylic Acid)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">雷鎖辛</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Resorcinol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">醇</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Alcohol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">甘油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Glycerin)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">蓖麻油</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Castor Oil)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">石ç‚é…¸</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Phenol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">è–„è·è…¦</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Menthol)</span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">抗組織胺</span><span style="font-family: times new roman,serif; font-size: 12pt;">(Antihistamine)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">育毛ã€è–„毛ã€åœ“形脫毛症ã€æ¢ç™¢ã€é 防脫毛ã€ä¿ƒé€²ç™¼æ¯›ã€é¤Šæ¯›ã€è„‚æ¼æ²»ç™‚（皮脂æ¼ï¼‰</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">(</span><span style="font-family: 標楷體; font-size: 12pt;">五</span><span style="font-family: times new roman,serif; font-size: 12pt;">)</span><span style="font-family: 標楷體; font-size: 12pt;">å«è—¥é…’é¡ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"></td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 62.75pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">（å…）漱å£æ°´åŠ‘</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 108pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #111111; font-size: 12pt;">氯己定葡糖酸鹽氯己定葡糖酸鹽</span><span style="font-family: 新細明體; font-size: 12pt;">（</span><span style="font-family: times new roman,serif; font-size: 12pt;">Chlorhexidine Gluconate</span><span style="font-family: 新細明體; font-size: 12pt;">） </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">åå…çƒ·åŸºæ°¯åŒ–ç ’å•¶</span><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">（</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium Chloride</span><span style="font-family: 標楷體; color: #000000; font-size: 12pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 90pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">å£è…”內之殺èŒã€æ¶ˆæ¯’ã€æ¸…æ½”ã€åŽ»é™¤å£è‡ã€‚</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 270pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: times new roman,serif; font-size: 12pt;">1.</span><span style="font-family: 標楷體; font-size: 12pt;">é©ç”¨ç¯„åœï¼šå‡¡ä»¥å£è…”內之清潔殺èŒç‰ç‚ºç›®çš„，且æˆåˆ†å«é‡ç¬¦åˆæœ¬åŸºæº–範åœè€Œè£½æˆä¹‹æ¼±å£æ°´åŠ‘å‡é©ç”¨æœ¬åŸºæº–。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"><span style="font-family: 標楷體; font-size: 12pt;">2.</span><span style="font-family: 標楷體; font-size: 12pt;">有效æˆåˆ†ä¹‹ç¨®é¡žå«é‡åŠé…åˆè¦å‰‡ï¼š </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 12pt;">（1）<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 12pt;">有效æˆåˆ†ä¹‹ç¨®é¡žå«é‡ï¼š </span></p> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> <table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="328"> <tbody> <tr style="page-break-inside: avoid; height: 24.05pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 24.05pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center;"><span style="font-family: 標楷體;">有 效 æˆ åˆ† </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 24.05pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;"><span style="font-family: 標楷體;">å«é‡ç¯„åœ (% w/v)</span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 26.55pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 26.55pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: 標楷體; color: #111111;">氯己定葡糖酸鹽氯己定葡糖酸鹽 </span></p> <p><span style="font-family: 新細明體,serif;">（</span>Chlorhexidine Gluconate<span style="font-family: 新細明體,serif;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 26.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">0.1 <span style="font-family: 新細明體,serif;">＜</span> <span style="font-family: 新細明體,serif;">≦</span> 0.2</p> </td> </tr> <tr style="page-break-inside: avoid; height: 27.8pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 147.35pt; padding-right: 1.4pt; height: 27.8pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p><span style="font-family: 標楷體; color: #000000;">åå…çƒ·åŸºæ°¯åŒ–ç ’å•¶</span><span style="font-family: 標楷體; color: #000000;">（</span>Cetylpyridinium Chloride<span style="font-family: 標楷體; color: #000000;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99pt; padding-right: 1.4pt; height: 27.8pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">0.045 <span style="font-family: 新細明體,serif;">≦</span> <span style="font-family: 新細明體,serif;">≦</span> 0.1</p> </td> </tr> </tbody> </table> <p style="layout-grid-mode: char; punctuation-wrap: simple;"> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 12pt;">（2）<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 12pt;">é…åˆè¦å‰‡ï¼šé™å–®æ–¹è£½åŠ‘。 </span></p> <ol> <li><span style="font-family: 標楷體; font-size: 12pt;">劑型：外用液劑。 </span></li> <li><span style="font-family: 標楷體; font-size: 12pt;">é©æ‡‰ç—‡ï¼šå£è…”內之殺èŒã€æ¶ˆæ¯’ã€æ¸…æ½”ã€åŽ»é™¤å£è‡ã€‚</span> </li> <li><span style="font-family: 標楷體; font-size: 12pt;">用法åŠç”¨é‡ï¼šæ¯æ¬¡ä»¥é©é‡ä¹‹æ¼±å£æ°´åŠ‘æ–¼å£è…”內漱洗並åœç•™ä¸‰å秒至å…å秒後å出，å¯æ–¼æ—©æ™šæˆ–需è¦æ™‚ä½¿ç”¨ã€‚æœ¬é¡žè£½åŠ‘é ˆåˆŠè¼‰å…·é«”ä½¿ç”¨æ–¹æ³•åŠç”¨é‡ã€‚</span> </li> <li><span style="font-family: 標楷體; font-size: 12pt;">注æ„äº‹é …ï¼š</span> </li> </ol> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（1） </span><span style="font-family: 標楷體; font-size: 12pt;">為防æ¢å…’童誤食請妥善ä¿ç®¡ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（2） </span><span style="font-family: 標楷體; font-size: 12pt;">é¿å…陽光直射，宜ä¿å˜æ–¼é™°æ¶¼ä¹‹è™•ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（3） </span><span style="font-family: 標楷體; font-size: 12pt;">未滿å…æ²å…’ç«¥ä¸å¾—使用，</span> <span style="font-family: 標楷體; font-size: 12pt;">å…æ²ä»¥ä¸Šå二æ²ä»¥ä¸‹å…’童需在大人指導下使用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（4） </span><span style="font-family: 標楷體; font-size: 12pt;">僅供漱洗，請勿åžæœã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（5） </span><span style="font-family: 標楷體; font-size: 12pt;">本產å“在æ£å¸¸ä½¿ç”¨ä¸‹æ˜¯å®‰å…¨çš„，但如有副作用的情形發生時（如ç¼ç†±æ„ŸåŠåˆºç—›æ„Ÿç‰ï¼‰ï¼Œè«‹ç«‹å³åœç”¨ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（6） </span><span style="font-family: 標楷體; font-size: 12pt;">å«é…’精之本類製劑，增列下述注æ„äº‹é …ï¼šæœ¬å“å«é…’ç²¾</span><span style="font-family: times new roman,serif; font-size: 12pt;">â—‹â—‹%</span><span style="font-family: 標楷體; font-size: 12pt;">，宜審慎使用。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（7） </span><span style="font-family: 標楷體; font-size: 12pt;">å£è…”æ½°ç˜è€…，請勿使用å«é…’ç²¾æˆåˆ†ä¹‹æœ¬é¡žè£½åŠ‘。</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（8） </span><span style="font-family: 標楷體; font-size: 12pt;">如ä¸æ…ŽéŽé‡ä½¿ç”¨åŠåžæœå¾Œï¼Œæ„Ÿè¦ºä¸é©è€…，請立å³å°±é†«ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體; font-size: 18px;">（9） </span><span style="font-family: 標楷體; font-size: 12pt;">使用後三å分é˜å…§è«‹å‹¿é€²é£Ÿã€å¸ç…™æˆ–æœç”¨é£²æ–™ã€‚</span> </p> <p style="layout-grid-mode: char; punctuation-wrap: simple; 36pt: ;"><span style="font-family: 標楷體;"><span style="font-size: 18px;">（10）</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 12pt;">å«</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium chloride</span><span style="font-family: 標楷體; font-size: 12pt;">之本類製劑，增列下述注æ„äº‹é …ï¼šéŽåº¦ä½¿ç”¨å«</span><span style="font-family: times new roman,serif; font-size: 12pt;">Cetylpyridinium chloride</span><span style="font-family: 標楷體; font-size: 12pt;">æ¼±å£æ°´åŠ‘å¯èƒ½ä½¿ç‰™é½’染色。</span> </p> </td> </tr> </tbody> </table> <p><span style="font-family: 標楷體;">備註：其他æˆä»½è¦–其藥å“å®‰å…¨æ€§ä¹‹ç¨‹åº¦ç”±è¡›ç”Ÿç½²å¯©å®šåŠ æ¸›ã€‚</span> </p> </td> </tr> </tbody></table>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4490&type=0
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則法è¦å‘½ä»¤ã€Œè—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則ã€ç¬¬å…«æ¢ã€ç¬¬å二æ¢ä¿®æ£æ¢æ–‡è©³å¦‚附件2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4491&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6070&type=0
臨床試驗類,è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則法è¦å‘½ä»¤ã€Œè—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則ã€é™„件+溶離相似性（f+2值）之計算方å¼åŠçµæžœèªå®š<p class="null" style="margin: auto 0cm auto 33pt;"><span style="font-family: 新細明體;"><b><span style="font-size: 10pt; color: #333333;">附件　溶離相似性（</span></b><b><span style="font-size: 10pt; color: #333333;">f <sub>2</sub></span></b><b><span style="font-size: 10pt; color: #333333;">值）之計算方å¼åŠçµæžœèªå®š</span></b> </span></p><p class="null" style="text-align: center; margin: auto 0cm auto 33pt;"><span style="font-family: times new roman,serif; position: relative; color: #333333; top: 48pt;"></span></p><p class="null" style="margin: auto 0cm;"><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;"><br /><img alt="" src="../Files/NewsUpload/2.png" /><br /><br />上列公å¼</span><span style="font-size: 10pt; color: #333333;">f <sub>2</sub></span><span style="font-size: 10pt; color: #333333;">溶離相似值，</span><span style="font-size: 10pt; color: #333333;">n</span><span style="font-size: 10pt; color: #333333;">為溶出之採樣點數，</span></span><span style="font-size: 10pt; font-family: 標楷體; position: relative; color: #333333; top: 5pt;"> </span><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;">ä¿‚å°ç…§è—¥å“æ–¼</span><span style="font-size: 10pt; color: #333333;">t</span><span style="font-size: 10pt; color: #333333;">時間點之平å‡æº¶å‡ºç™¾åˆ†æ¯”，</span></span><span style="font-size: 10pt; font-family: 標楷體; position: relative; color: #333333; top: 5pt;"> </span><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;">ä¿‚å—試藥å“æ–¼</span><span style="font-size: 10pt; color: #333333;">t</span><span style="font-size: 10pt; color: #333333;">時間點之平å‡æº¶å‡ºç™¾åˆ†æ¯”。</span> </span></p><p class="null" style="margin: auto 0cm;"><span style="font-size: 10pt; font-family: 新細明體; color: #333333;">In this equation <i>f</i> <sub>2</sub> is the similarity factor, n is the number of time points,</span><span style="font-size: 10pt; font-family: 標楷體; color: #333333;"> </span><span style="font-size: 10pt; color: #333333;"><span style="font-family: 新細明體;">is the mean percent drug dissolved of e.g. a reference product, and </span><span style="position: relative; top: 5pt;"></span><span style="font-family: 新細明體;"> is the mean percent drug dissolved of e.g. a test product.</span></span> </p><p class="null" style="margin: auto 0cm;"><span style="font-size: 10pt; font-family: 新細明體; color: #333333;"> </span></p><p class="null" style="margin: auto 0cm;"><span style="font-family: 新細明體;"><span style="font-size: 10pt; color: #333333;">f <sub>2</sub></span><span style="font-size: 10pt; color: #333333;">值≧</span><span style="font-size: 10pt; color: #333333;">50</span><span style="font-size: 10pt; color: #333333;">，為èªå®šå—試藥å“åŠå°ç…§è—¥å“溶離曲線比å°ç›¸ä¼¼ä¹‹å¿…è¦æ¢ä»¶ã€‚</span> </span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6090&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件一藥å“製劑包è£é™é‡è¡¨<p><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">附件一</span></b> </p><p><b><span style="font-size: 10pt; color: #333333;"> </span></b><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">è—¥å“製劑包è£é™é‡è¡¨</span></b> </p><table width="607" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">劑型</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">類別</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å–®ä½åŒ…è£æœ€å¤§é™é‡</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">éŒ åŠ‘ã€ä¸¸åŠ‘ã€è† 囊劑ã€å£å«éŒ ã€èˆŒä¸‹éŒ </span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥å“</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一åƒéŒ 以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">æˆè—¥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">äº”ç™¾éŒ ä»¥ä¸‹</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å£æœæ¶²</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師藥師藥劑生指示藥å“或æˆè—¥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å‡ä»¥ä¸€æ¬¡ç”¨å®Œç‚ºé™ä¸”ä¸å¾—超éŽä¸€ç™¾æ¯«å‡</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">注射劑</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">é™ç”±é†«å¸«ä½¿ç”¨</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">注射瓶è£æˆ–安瓿（</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">Vial or Ampoule</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">）å‡ä»¥æ¯ç›’一百支以下（溶劑ä¸åœ¨å…§ï¼‰</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">滴眼ã€é¼»ã€è€³åŠ‘ã€å™´é¼»ã€è€³ã€å–‰åŠ‘</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方ã€é†«å¸«è—¥å¸«è—¥åŠ‘生指示藥å“ã€æˆè—¥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百毫å‡ä»¥ä¸‹</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="3"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">軟è†åŠ‘</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥å“</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ä¸å«æŠ—ç”Ÿç´ </span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一åƒå…¬å…‹ä»¥ä¸‹</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å«æŠ—ç”Ÿç´ </span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">æˆè—¥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">æ “åŠ‘</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方ã€é†«å¸«è—¥å¸«è—¥åŠ‘生指示藥å“ã€æˆè—¥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一百顆以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">粉ã€é¡†ç²’劑（原料藥ä¸åœ¨æ¤é™ï¼‰</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥å“</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一åƒå…¬å…‹ä»¥ä¸‹</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">æˆè—¥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">五百公克以下</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 126.7pt; background-color: transparent;" rowspan="3"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">液劑ã€é…ŠåŠ‘ã€é…劑ã€é†‘劑ã€æ“¦åŠ‘ã€ç³–漿劑ã€æ‡¸æ¶²åŠ‘ã€ä¹³åŠ‘（原料藥ä¸åœ¨æ¤é™ï¼‰</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">醫師處方或醫師藥師藥劑生指示藥å“</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ä¸å«æŠ—ç”Ÿç´ </span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å››åƒæ¯«å‡ä»¥ä¸‹</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å«æŠ—ç”Ÿç´ </span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 74.55pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一åƒæ¯«å‡ä»¥ä¸‹</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 179.15pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">æˆè—¥</span> </p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 149.1pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">五百毫å‡ä»¥ä¸‹</span> </p> </td> </tr> </tbody></table><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">註１ã€</span><span style="font-size: 10pt; color: #333333;"> </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">è—¥å“許å¯è‰åŒ…è£æ¬„所載數é‡ï¼Œå¦‚超éŽè—¥å“製劑包è£é™é‡æ¨™æº–，惟曾經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å®šæœ‰æ¡ˆè€…，得繼續使用，無需更改。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ï¼’ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">è—¥å“包è£å‡¡ç¬¦åˆé™é‡è¦å®šè€…ï¼Œå» å•†å¾—é…åˆå¸‚å ´ä¸Šéœ€è¦ï¼Œè‡ªè¡Œèª¿æ•´ï¼Œå…申請變更登記。但超éŽé™é‡è¦å®šä¹‹åŒ…è£ï¼Œä»æ‡‰ä¾è¦å®šæª¢é™„醫療機構或å¸è¡“團體訂購è‰æ˜Žï¼Œç”³è«‹è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">３ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一般製劑之最å°åŒ…è£ï¼Œä»¥æˆäººäºŒæ—¥æœ€å°ç”¨é‡ç‚ºæº–。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ï¼”ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">液體製劑，ä¸å¾—以易開ç½ç“¶è£ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">５ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å£æœæ¶²åŠ‘以æˆäººä¸€æ¬¡åŠ‘é‡ä¸é ˆé‡å–å³ä¾›æ‚£è€…一次æœç”¨ï¼Œä¸¦å…¶å–®ä½åŒ…è£åŠ‘é‡é™ä¸€ç™¾æ¯«å‡ä»¥ä¸‹ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ï¼–ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">腹膜é€æžæ¶²ä¹‹å–®ä½åŒ…è£æœ€å¤§é™é‡ç‚ºäº”åƒæ¯«å‡ä»¥ä¸‹ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ï¼—ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">懸液劑åŠå‡è† 劑之é‹ç®”æˆ–å¡‘è† è¢‹è£ï¼Œä»¥ä¸€æ¬¡é‡åŒ…è£ç‚ºåŽŸå‰‡ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">８ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">注射劑如附有輸液套或輸注器，應於包è£æ¬„填明，並ä¾è¦å®šæª¢é€è¼¸æ¶²å¥—或輸注器四å份åŠå…¶æª¢é©—è¦æ ¼å‚™é©—ï¼Œå¦‚è©²è¼¸æ³¨å¥—è¼¸æ³¨å™¨å·²é ˜æœ‰è¨±å¯è‰è€…，得註明許å¯è‰å—號，å…予檢驗。</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ï¼™ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å…¨éœè„ˆç‡Ÿé¤ŠåŠ‘之單ä½åŒ…è£æœ€å¤§é™é‡ç‚ºä¸€åƒå››ç™¾æ¯«å‡ä»¥ä¸‹ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１ï¼ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">製劑原料最å°åŒ…è£ç‚ºé›¶é»žäº”公斤。但用é‡ç”šå¾®è€…ï¼Œä»¥è£½é€ ä¸€æ‰¹åè¬ç²’，注射劑一è¬æ”¯ï¼Œè»Ÿè†ä¸€è¬æ”¯ï¼Œæˆ–åè¬å…¬å…‹ä¹‹ç”¨é‡ç‚ºå…¶æœ€å°åŒ…è£ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１１ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">洗眼劑之單ä½åŒ…è£æœ€å¤§é™é‡ç‚ºäº”百毫å‡ä»¥ä¸‹ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１２ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å«å¯å¾…å› ï¼ˆç£·é…¸é¹½ï¼‰ç³–æ¼¿åŠ‘æŒ‡ç¤ºè—¥å“最大單ä½åŒ…è£ä¸å¾—超éŽä¸‰æ—¥ç”¨é‡ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１３ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">å«éº»é»ƒç´ 或å‡éº»é»ƒç´ ä¹‹éŒ åŠ‘åŠè† 囊劑，其包è£æ質以é‹ç®”ç›’è£ç‚ºé™ï¼Œå¦‚類別屬指示藥å“者，其最大包è£é‡ä¸¦ä»¥æˆäººä¸ƒæ—¥ç”¨é‡ç‚ºé™ï¼Œä¸”ä¸é©ç”¨æœ¬è¡¨è¨»ï¼‘åŠè¨»ï¼’之è¦å®šã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">１４ã€</span> <span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">感冒ã€è§£ç†±éŽ®ç—›ã€å’³å—½æ¶²åŠ‘，其包è£é™é‡ç‚ºæˆäººä¸€æ¬¡é‡è‡³å››åƒæ¯«å‡ã€‚</span> </p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6100&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件二新藥åŠæ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘查驗登記應檢附資料表<p style="layout-grid-mode: char; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">附件二</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體; color: #000000;">æ–°è—¥åŠæ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘查驗登記應檢附資料表</span> </p><table width="99%" style="border-collapse: collapse; margin: auto auto auto 1.4pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 182.1pt; page-break-inside: avoid;"> <td valign="top" style="height: 182.1pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent;border: windowtext 1pt solid;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">應檢é€è³‡æ–™ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è¦è²» </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è—¥å“æŸ¥é©—ç™»è¨˜ç”³è«‹æ›¸æ£ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">〠</span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">副本 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">切çµæ›¸ç”² </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">〠</span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ä¹™ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">標籤仿單é»è²¼è¡¨äºŒä»½ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è‰ç…§é»è²¼è¡¨ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">委託書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">出產國許å¯è£½å”®è‰æ˜Ž </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; color: #000000;">*1</span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">處方ä¾æ“šæˆ–處方è¨è¨ˆç ”究</span><span style="font-size: 10pt; color: #000000;">*2</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">有效æˆåˆ†æª¢é©—è¦æ ¼ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">賦形劑檢驗è¦æ ¼ã€ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">方法åŠæª¢é©—æˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æˆå“檢驗è¦æ ¼ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ã€æ–¹ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">法åŠæª¢é©—æˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸æˆ–æ‰¹æ¬¡è£½é€ ç´€éŒ„ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">分æžæ–¹æ³•ç¢ºæ•ˆè³‡æ–™äºŒä»½ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é—œéµæ€§è£½ç¨‹ç¢ºæ•ˆè³‡æ–™äºŒä»½ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; color: #000000;">*3</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">安定性試驗資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">採用è‰æ˜Ž </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é€ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é©— </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; color: #000000;">*4</span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 182.1pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">技 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è¡“ </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">性 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">資 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–™ </span></p> </td> </tr> <tr style="height: 15.3pt; page-break-inside: avoid;"> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 4.1%; background-color: transparent;" rowspan="12"> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–°</span> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è—¥</span> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–°æˆåˆ† </span></p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.42%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="21"> <p style="margin: 0cm -1.3pt 0pt 0cm; line-height: 13pt;"><span style="font-size: 24px; font-family: 標楷體;"> </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">ä¾ </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">附 </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">件 </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">三 </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">之 </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">è¦ </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">定 </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">檢 </span></p> <p style="text-align: center; line-height: 13pt;"> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 9pt; font-family: 標楷體; color: #000000;">附 </span></p> </td> </tr> <tr style="height: 9.85pt; page-break-inside: avoid;"> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 9.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 7.2pt; page-break-inside: avoid;"> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新使用途徑 </span></p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新療效 </span></p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新複方 </span></p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 4.1%; background-color: transparent;" rowspan="9"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–°</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">劑</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">åž‹</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ã€</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–°</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">使</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">用</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">劑</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é‡</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ã€</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–°</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å–®</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ä½</span> </p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å«</span> </p> <p style="layout-grid-mode: char; text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é‡</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">新劑型 </span></p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–°ä½¿ç”¨åŠ‘é‡ </span></p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–°å–®ä½å«é‡ </span></p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> <tr style="height: 19.85pt; page-break-inside: avoid;"> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.46%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> </tr> </tbody></table><p style="layout-grid-mode: char; text-align: justify; margin: 9pt 0cm 0pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註：○ è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ 　╳ 表示ä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*1</span><span style="font-size: 10pt; font-family: 標楷體;">如出產國許å¯è£½å”®è‰æ˜Žä¸æœªåˆŠè¼‰å®Œæ•´ä¹‹è£½é€ å» å€è€…，應å¦æª¢é€æœ€è¿‘一次GMPæŸ¥å» å ±å‘Šæ†‘æ ¸ã€‚ï¼ˆå¦‚åƒ…æœªåˆŠè¼‰éƒµéžå€è™Ÿæˆ–å€è€…ï¼Œå¾—ä»¥åŽŸå» å‡½èªªæ˜Žï¼‰ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*2</span><span style="font-size: 10pt; font-family: 標楷體;">ç”±åœ‹å…§è‡ªè¡Œç ”ç™¼ä¹‹æ–°è—¥ã€æ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘，å…附處方ä¾æ“šã€‚但應å¦é™„處方è¨è¨ˆç ”究。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*3</span><span style="font-size: 10pt; font-family: 標楷體;">申請輸入藥å“查驗登記，如係無èŒè£½åŠ‘產å“者，其關éµæ€§è£½ç¨‹ç¢ºæ•ˆæ‡‰å«æ»…èŒç¢ºæ•ˆè³‡æ–™ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt; 13: ;"><span style="font-size: 10pt; font-family: 標楷體;">*4</span><span style="font-size: 10pt; font-family: 標楷體;">ä¾ç¬¬äºŒåå››æ¢ç¬¬äºŒé …è¦å®šï¼Œé™¤ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¿…è¦é€é©—者外，得以書é¢å¯©æ ¸è€Œå…é€é©—樣å“。</span> </p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6099&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件三新藥åŠæ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘查驗登記應檢附之技術性資料表<p><span style="font-size: 10pt; font-family: 標楷體;">附件三</span> </p><p style="text-align: center;"><span style="font-family: 標楷體;">æ–°è—¥åŠæ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘查驗登記應檢附之技術性資料表</span> </p><table width="100%" style="border-collapse: collapse; width: 100%;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: center; margin: 3.6pt 0cm; line-height: 13pt;"> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.38%; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">èµ·æºã€ç™¼ç¾ç¶“éŽã€ 國外使用情形 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.1%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">物化 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">性質 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 31.36%; background-color: transparent; border-left-color: #f0f0f0;" colspan="9"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">安 å…¨ 性 試 é©— å ± å‘Š </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.6%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">è—¥ç†ä½œç”¨ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 11.58%; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">å¸æ”¶ã€åˆ†ä½ˆ </span></p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">ã€ä»£è¬ã€æŽ’泄</span><span style="font-size: 10pt; font-family: 標楷體;">è©¦é©—å ±</span> </p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">告（動物</span><span style="font-size: 10pt;">/</span><span style="font-size: 10pt; font-family: 標楷體;">人）</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 13.16%; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;"> </span><span style="font-size: 10pt; font-family: 標楷體;">臨床試驗 </span></p> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">å ±å‘Š </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">èµ·æºç™¼ç¾ç¶“éŽ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">國外使用情形 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">性質比較 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ§‹é€ å¼ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">物ç†åŒ–å¸æ€§è³ª </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">急性毒性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">亞急性毒性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">慢性毒性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">胚胎試驗 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">ä¾è³´æ€§ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">抗原性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">致çªè®Šæ€§ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">致癌性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">局部刺激性 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">有效性è‰æ˜Ž </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">ä¸€èˆ¬è—¥ç† </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">å¸æ”¶ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">分佈 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">ä»£è¬ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">排泄 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">生體å¯ç”¨çŽ‡ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">生體相ç‰æ€§</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">其他</span><span style="font-size: 10pt; font-family: 標楷體;">臨床試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">醫藥期刊 </span></p> </td> </tr> <tr style="height: 15.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 3.32%; background-color: transparent;" rowspan="12"> <p style="margin: 3.6pt 0cm; line-height: 13pt;"> </p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"> </p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ–° </span></p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"> </p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"> </p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"> </p> <p style="margin: 3.6pt 0cm; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">è—¥ </span></p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ–°æˆåˆ† </span></p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 15.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="height: 19.8pt; page-break-inside: avoid;"> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="height: 7.2pt; page-break-inside: avoid;"> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮å¸æ”¶åŠ‘åž‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新使用途徑 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮å¸æ”¶åŠ‘åž‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新療效 </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮å¸æ”¶åŠ‘åž‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> </tr> <tr style="height: 3.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新複方 </span></p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 3.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮å¸æ”¶åŠ‘åž‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 3.32%; background-color: transparent;" rowspan="10"> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ–° </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">劑 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">åž‹ </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">〠</span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ–° </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">使 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">用 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">劑 </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">é‡ </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">〠</span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ–° </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">å–® </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">ä½ </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">å« </span></p> <p style="layout-grid-mode: char; text-align: center; margin: 3.6pt 0cm 3.6pt -1.2pt; line-height: 10pt;"><span style="font-size: 10pt; font-family: 標楷體;">é‡ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新劑型 </span></p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">(</span><span style="font-size: 10pt; font-family: 標楷體;">控釋)</span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">新劑型 </span></p> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">(</span><span style="font-size: 10pt; font-family: 標楷體;">速放)</span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮å¸æ”¶åŠ‘åž‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ–°ä½¿ç”¨åŠ‘é‡ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮å¸æ”¶åŠ‘åž‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">æ–°å–®ä½å«é‡ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt;">Liposome</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 13pt;"><span style="font-size: 10pt; font-family: 標楷體;">經皮å¸æ”¶åŠ‘åž‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.14%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.98%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.3%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">â—Ž </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.24%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 13pt;"><span style="font-size: 10pt; font-family: 新細明體,serif;">╳ </span></p> </td> </tr> </tbody></table><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">註：○ è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ ╳ 表示ä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ </span><span style="font-family: 新細明體,serif;">â–³ </span><span style="font-size: 10pt; font-family: 標楷體;">表示視個案而定。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">◎表示ä¾ä¸‹è¿°æ–¹æ³•æ“‡ä¸€è¾¦ç†ï¼šï¼ˆ1）生體相ç‰æ€§è©¦é©—。（2）生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">一ã€ç”³è«‹ä¹‹è—¥å“如有療效或安全之顧慮者，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¦æ±‚，å¦æª¢é€ç›¸é—œè³‡æ–™ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">二ã€å…¶ä»–è‡¨åºŠè©¦é©—å ±å‘Šæ‡‰ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …è¦å®šè¾¦ç†ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">三ã€æ–°å–®ä½å«é‡å¦‚屬éžç›£è¦–æ–°è—¥æˆåˆ†è€…，得å…附生體相ç‰æ€§è©¦é©—，或生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—資料。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">å››ã€é†«è—¥æœŸåˆŠä¿‚指臨床文ç»å ±å‘Šã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">五ã€ã€Œåœ‹å¤–使用情形ã€ä¹™é …ï¼Œå¦‚ä¿‚åœ‹å…§è‡ªè¡Œç ”ç™¼è€…ï¼Œå…附。 </span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6098&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件四å¸å藥查驗登記應檢附資料表 - 複製<p style="layout-grid-mode: char; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">附件四</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt 48pt;"><span style="font-family: 標楷體;">å¸å<span style="color: #000000;">藥查驗登記應檢附資料表</span></span> </p><div style="text-align: center;"><table width="624" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 11.4pt; page-break-inside: avoid;"> <td style="border-top: windowtext 1pt solid; height: 11.4pt; border-right: black 1pt solid; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;" rowspan="3"> <p style="layout-grid-mode: char; text-align: justify; text-justify: distribute-all-lines; -11: ;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">應檢é€è³‡æ–™ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 11.4pt; border-right: windowtext 1pt solid; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 261.8pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="8"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">å¸ã€€ã€€ã€€ã€€ã€€ã€€ã€€ã€€å　　　　　　　　　　藥 </span></p> </td> </tr> <tr style="height: 6.15pt; page-break-inside: avoid;"> <td style="height: 6.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">監視藥å“(å«ç›£è¦–期間åŠç›£è¦–期滿藥å“)</span></p> </td> <td style="height: 6.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">一般å¸åè—¥ </span></p> </td> <td style="height: 6.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81.8pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; text-transform: uppercase; layout-grid-mode: line; color: #000000;">醫用氣體</span> </p> </td> </tr> <tr style="height: 10.15pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">輸入 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">國產 </span></p> </td> <td valign="top" style="height: 10.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; 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text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">è—¥å“查驗登記申請書æ£ã€å‰¯æœ¬ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; 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font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="height: 7.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼ˆåŒ…æ‹¬æ‰¹æ¬¡ç´€éŒ„ä¸ä¹‹ä¸‹æ–™é‡ï¼‰æˆ–æ‰¹æ¬¡è£½é€ ç´€éŒ„ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">有效æˆåˆ†æª¢é©—è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">賦形劑檢驗è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">æˆå“檢驗è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="height: 8.95pt; page-break-inside: avoid;"> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">安定性試驗資料 </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.95pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â–³ </span></p> </td> </tr> <tr style="height: 10.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹<sup>＊1</sup> </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">出產國許å¯è£½å”®è‰æ˜Ž </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="height: 10.6pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">委託書 </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 10.6pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> </tr> <tr style="height: 5.65pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">分æžæ–¹æ³•ç¢ºæ•ˆè³‡æ–™ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹<sup>＊1</sup> </span></p> </td> </tr> <tr style="height: 8.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">é—œéµæ€§è£½ç¨‹ç¢ºæ•ˆè³‡æ–™ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹<sup>＊1</sup> </span></p> </td> <td valign="top" style="height: 8.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: black 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">â—‹<sup>＊1</sup> </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">臨床試驗ã€ç”Ÿé«”å¯ç”¨çŽ‡è©¦é©—ã€ç”Ÿé«”相ç‰æ€§è©¦é©— </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋＋ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">＋＋ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 205.9pt; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">é€é©—＊2</span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: black 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 43.65pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">╳ </span></p> </td> </tr> <tr> <td style="width: 275px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 16px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 43px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 7px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 51px; background-color: transparent;border-color: #f0f0f0;"></td> <td style="width: 58px; background-color: transparent;border-color: #f0f0f0;"></td> </tr> </tbody></table></div><p style="layout-grid-mode: char; text-align: justify; margin: 9pt 0cm 0pt 20pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">è¨»ï¼šâ—‹ï¼šè¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ã€€â•³ï¼šè¡¨ç¤ºä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ã€€</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">△：</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">表示視個案而定。　 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 43.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt;">*1</span><span style="font-size: 10pt; font-family: 標楷體;">：表示應å¦ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç›¸é—œå…¬å‘Šè¦å®šè¾¦ç†ã€‚</span> </p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 43.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt;">*2</span><span style="font-size: 10pt; font-family: 標楷體;">：</span><span style="font-size: 10pt; font-family: 標楷體;">ä¾ç¬¬äºŒåå››æ¢ç¬¬äºŒé …è¦å®šï¼Œé™¤ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¿…è¦é€é©—者外，得以書é¢å¯©æ ¸è€Œå…é€é©—樣å“。</span> </p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 40.6pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＋：監視藥å“之å¸å藥，監視期間內應檢附與以新藥æ出查驗登記申請且å–得許å¯è‰ä¹‹å» 商相åŒæ¨™æº–ä¹‹åœ‹å…§è‡¨åºŠè©¦é©—å ±å‘Š</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">（å«éŠœæŽ¥æ€§è©¦é©—）；如å‰è¿°æ–°è—¥æ–¼æŸ¥é©—ç™»è¨˜æ ¸å‡†æ™‚æœªæª¢é€åœ‹å…§è‡¨åºŠè©¦é©—å ±å‘Šï¼ˆå«éŠœæŽ¥æ€§è©¦é©—）者，則其å¸å藥應檢é€ï¼ˆ1）生體相ç‰</span><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">æ€§è©¦é©—å ±å‘Šï¼Œæˆ–ï¼ˆ2）生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—å ±å‘Šã€‚</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">監視期滿藥å“，應檢é€ï¼ˆ1）生體相ç‰æ€§è©¦é©—å ±å‘Šï¼Œæˆ–ï¼ˆ2）生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—å ±å‘Šã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">＋＋：一般å¸å藥如係控釋劑型製劑或屬ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šé ˆåŸ·è¡Œç”Ÿé«”相ç‰æ€§è©¦é©—之å“目者，應檢é€ï¼ˆ1）生體相ç‰æ€§è©¦é©—å ±å‘Šï¼Œæˆ–ï¼ˆ2）生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—å ±å‘Šã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">一ã€åœ‹ç”¢ç®¡åˆ¶è—¥å“查驗登記應å¦æª¢é™„管制藥å“åŽŸæ–™ç”³è«‹æ ¸å‡†è‰æ˜Žæˆ–挪用è‰æ˜Žã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 41.3pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">二ã€å®‰å®šæ€§è©¦é©—資料包括書é¢ä½œæ¥ç¨‹åºã€è©¦é©—å ±å‘Šã€æŒ‡æ¨™ä¹‹å®šé‡åˆ†æžæ–¹æ³•åŠå…¶æ–¹æ³•ä¹‹é©—è‰ç‰å„一份。 </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">三ã€ç”³è«‹è¼¸å…¥è—¥å“查驗登記，如係無èŒè£½åŠ‘產å“者，其關éµæ€§è£½ç¨‹ç¢ºæ•ˆæ‡‰å«æ»…èŒç¢ºæ•ˆè³‡æ–™ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 51.1pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">å››ã€å§”è¨—è£½é€ æˆ–æª¢é©—è€…ï¼Œæ‡‰é™„å§”è¨—è£½é€ æˆ–æª¢é©—å¥‘ç´„æ›¸ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; margin: 0cm 4pt 0pt 41.3pt; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體;">五ã€é†«ç”¨æ°£é«”係指供醫療用且å«é‡å„為百分之ä¹åä¹ï¼Žâ—‹v/v以上之二氧化碳（CO<sub>2</sub>）ã€æ°§æ°£ï¼ˆO<sub>2</sub>）åŠæ°§åŒ–亞氮（N<sub>2</sub>O）ç‰ä¸‰å“é …ï¼Œå…¶ä¸äºŒæ°§åŒ–碳（CO<sub>2</sub>）åŠæ°§æ°£ï¼ˆO<sub>2</sub>ï¼‰ä¹‹è£½é€ æ–¹æ³•ä¿‚æºè‡ªå¤§æ°£åˆ†é›¢è€…，得å…é™„å®‰å®šæ€§è©¦é©—è³‡æ–™ï¼ŒæƒŸé ˆç•™å» å‚™æŸ¥ã€‚ </span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6097&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件五微脂粒（Liposome）åŠç¶“çš®å¸æ”¶åŠ‘åž‹å¸å藥查驗登記應檢附之技術性資料表<p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: #000000;">附件五</span><span style="color: #000000;"> </span><span style="font-family: 新細明體,serif; color: #000000;">微脂粒（</span><span style="color: #000000;">Liposome</span><span style="font-family: 新細明體,serif; color: #000000;">）</span><span style="font-family: 新細明體,serif; color: #000000; letter-spacing: -0.2pt;">åŠç¶“çš®å¸æ”¶åŠ‘åž‹å¸å藥查驗登記應檢附之技術性資料表</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;"> </span></p><table style="border-collapse: collapse; margin: auto auto auto 0.7pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent;border: windowtext 1pt solid;"> <p> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p class="null" style="text-align: center;"><span style="font-family: 新細明體;">èµ·æºã€ç™¼ç¾ã€ç¶“éŽã€åœ‹å¤–使用情形 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">物化</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">性質</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="9"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">安</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">å…¨</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">性</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">試</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">é©—</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">å ±</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">å‘Š</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">è—¥ç†</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">作用</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">å¸æ”¶ã€åˆ†ä½ˆã€ä»£è¬ã€æŽ’泄</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">è©¦é©—å ±å‘Š</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">（動物</span><span style="font-size: 11pt;">/</span><span style="font-size: 11pt; font-family: 新細明體,serif;">人）</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">臨床試驗</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">å ±å‘Š</span> </p> </td> </tr> <tr> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">èµ·æºç™¼ç¾ç¶“éŽ</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">國外使用情形</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">性質比較</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">æ§‹é€ å¼</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">物ç†åŒ–å¸æ€§è³ª</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">急性</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">亞急性毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">慢性毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">胚胎試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">ä¾è³´æ€§</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">抗原性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">致çªè®Šæ€§</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">致癌性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">局部刺激性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">有效性è‰æ˜Ž</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">一般藥ç†</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">å¸æ”¶</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">分佈</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">代è¬</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">排泄</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">生體å¯ç”¨çŽ‡</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">生體相ç‰æ€§</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">其他臨床試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">醫藥期刊</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">Liposome </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">å¸åè—¥(i) </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â–³</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">å¸åè—¥(ii) </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">經皮å¸æ”¶åŠ‘åž‹</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 7.2pt;"> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">å¸åè—¥</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—‹</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">â—Ž</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> </tbody></table><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">è¨»ï¼šâ—‹è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚â•³è¡¨ç¤ºä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚â–³è¡¨ç¤ºè¦–å€‹æ¡ˆè€Œå®šã€‚ </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">◎表示ä¾ä¸‹è¿°æ–¹æ³•æ“‡ä¸€è¾¦ç†ï¼š</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(1)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">生體相ç‰æ€§è©¦é©—。</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(2)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">å¸åè—¥</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(i)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">：主æˆåˆ†ç›¸åŒï¼Œä½†è³¦å½¢åŠ‘æˆåˆ†åŠå…¶æ¯”例ä¸åŒä¹‹å¸å藥。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">å¸åè—¥</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(ii)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">：主æˆåˆ†ã€è³¦å½¢åŠ‘æˆåˆ†åŠå…¶æ¯”例皆相åŒä¹‹å¸å藥。 </span></p><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">一ã€æ‰€ç”³è«‹è—¥å“如有療效或安全之顧慮者，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¦æ±‚，å¦æª¢é€ç›¸é—œè³‡æ–™ã€‚ </span></p><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">二ã€å…¶ä»–è‡¨åºŠè©¦é©—å ±å‘Šæ‡‰ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹è¦å®šè¾¦ç†ã€‚ </span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6096&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件å…生物藥å“查驗登記應檢附資料表<p style="layout-grid-mode: char; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">附件å…</span> </p><p style="layout-grid-mode: char; text-align: center; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">生物藥å“查驗登記應檢附資料表</span> </p><table width="722" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 10.85pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.85pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">應檢é€è³‡æ–™ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">åŸºå› å·¥ç¨‹è—¥å“（å«ç”Ÿç‰©ç›¸ä¼¼æ€§è—¥å“）</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊3</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ç–«è‹—é¡žè—¥å“ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">äººç”¨è¡€æ¼¿è—¥å“ </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">éŽæ•åŽŸè—¥å“ </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 10.85pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 0cm -41.75pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">其他類 </span></p> </td> </tr> <tr style="height: 6.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">è¦è²» </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 6.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; 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border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 6.9pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">切çµæ›¸ï¼ˆç”²ï¼‰ </span></p> </td> <td valign="top" style="height: 6.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; 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font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 10.9pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">仿單標籤é»è²¼è¡¨äºŒä»½ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; 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border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">æ‰¹æ¬¡è£½é€ ç´€éŒ„ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; 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padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">有效æˆåˆ†æª¢é©—è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸äºŒä»½ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">賦形劑檢驗è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸äºŒä»½ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">æˆå“檢驗è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸äºŒä»½ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">安定性試驗書é¢ä½œæ¥ç¨‹åºåŠå…¶æª¢é©—å ±å‘Š </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">採用è‰æ˜Žï¼Š1</span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">出產國許å¯è£½å”®è‰æ˜Žï¼ˆè¼¸å…¥ï¼‰ã€è™•æ–¹ä¾æ“šï¼ˆåœ‹ç”¢ï¼‰ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 10.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">委託書（輸入藥å“） </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 10.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 5.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 5.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 9.75pt; page-break-inside: avoid;"> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">分æžæ–¹æ³•ç¢ºæ•ˆè³‡æ–™äºŒä»½ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 9.75pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 5.5pt; page-break-inside: avoid;"> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">é—œéµæ€§è£½ç¨‹ç¢ºæ•ˆè³‡æ–™äºŒä»½ï¼Š2</span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹<b> </b></span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 5.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 19.15pt; page-break-inside: avoid;"> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">製程ä¸æ‰€ä½¿ç”¨å‹•ç‰©åŽŸæ–™ä¹‹åŽŸå» 動物原料來æºç®¡åˆ¶ä¹‹æ¨™æº–作æ¥ç¨‹åºåŠåŽŸæ–™ä¾†æºè‰æ˜Žï¼Œæˆ–åŽŸå» å‡ºå…·æ–¼è£½ç¨‹ä¸æœªä½¿ç”¨å‹•ç‰©æˆåˆ†ä¾†æºä¹‹è‰æ˜Ž </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 19.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 10.55pt; page-break-inside: avoid;"> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">é€é©—</span><span style="font-size: 10pt; layout-grid-mode: line;">＊4</span> </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 99pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line;">╳ </span></p> </td> <td valign="top" style="height: 10.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 56.25pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> </tr> <tr style="height: 6.3pt; page-break-inside: avoid;"> <td valign="top" style="height: 6.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 217.4pt; background-color: transparent;"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">技術性資料 </span></p> </td> <td valign="top" style="height: 6.3pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 324pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="5"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">ä¾ã€€ã€€é™„　　 件　　七　　之　　è¦ã€€ã€€å®šã€€ã€€æª¢ã€€ã€€é™„ </span></p> </td> </tr> </tbody></table><p style="margin: 9pt -1.3pt 0pt 0cm; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">è¨»ï¼šâ—‹è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ã€€ã€€ã€€â–³è¡¨ç¤ºè¦–å€‹æ¡ˆè€Œå®šã€‚ã€€ã€€ã€€ï¼¸è¡¨ç¤ºä¸é ˆæª¢é™„。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊1採用è‰æ˜Žä¹‹ç›¸é—œè¦å®šå¦‚下： </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 39.2pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å±¬åŸºå› å·¥ç¨‹è—¥å“（å«ç”Ÿç‰©ç›¸ä¼¼æ€§è—¥å“）ã€ç–«è‹—é¡žè—¥å“ã€äººç”¨è¡€æ¼¿è—¥å“與éŽæ•åŽŸè—¥å“ç‰å››é¡žç”Ÿç‰©è—¥å“： </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">一ã€å¦‚出產國屬美ã€æ—¥ã€åŠ 拿大ã€æ¾³æ´²ã€è‹±åœ‹ï¼ˆç¬¬ä¸€çµ„）åŠå¾·ã€æ³•ã€ç‘žå…¸ã€ç‘žå£«ã€æ¯”利時（第二組）ç‰å國ä¸ä¹‹ä¸€åœ‹ï¼Œä¸”已有類似（åŒä¾†æºã€åŒæˆåˆ†ï¼‰ç”¢å“上市，則其出產國許å¯è£½å”®è‰æ˜Žå¾—替代採用è‰æ˜Žã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">二ã€å¦‚出產國屬美ã€æ—¥ã€åŠ 拿大ã€æ¾³æ´²ã€è‹±åœ‹ï¼ˆç¬¬ä¸€çµ„）åŠå¾·ã€æ³•ã€ç‘žå…¸ã€ç‘žå£«ã€æ¯”利時（第二組）ç‰å國ä¸ä¹‹ä¸€åœ‹ï¼Œä½†ç„¡é¡žä¼¼ï¼ˆåŒä¾†æºã€åŒæˆåˆ†ï¼‰ç”¢å“ä¸Šå¸‚ï¼Œå‰‡é ˜è‰å‰é™¤æ‡‰æœ‰å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žå¤–，應有å¦ä¸€å大醫藥先進國之採用è‰æ˜Žã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">三ã€å¦‚出產國éžå±¬ç¾Žã€æ—¥ã€åŠ 拿大ã€æ¾³æ´²ã€è‹±åœ‹ï¼ˆç¬¬ä¸€çµ„）åŠå¾·ã€æ³•ã€ç‘žå…¸ã€ç‘žå£«ã€æ¯”利時（第二組）ç‰å國ä¸ä¹‹ä¸€åœ‹ï¼Œä½†å·²æœ‰é¡žä¼¼ï¼ˆåŒä¾†æºã€åŒæˆåˆ†ï¼‰ç”¢å“ä¸Šå¸‚ï¼Œå‰‡é ˜è‰å‰é™¤æ‡‰æœ‰å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žå¤–，應有å¦ä¸€å大醫藥先進國之採用è‰æ˜Žã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 57.3pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å››ã€å¦‚出產國éžå±¬ç¾Žã€æ—¥ã€åŠ 拿大ã€æ¾³æ´²ã€è‹±åœ‹ï¼ˆç¬¬ä¸€çµ„）åŠå¾·ã€æ³•ã€ç‘žå…¸ã€ç‘žå£«ã€æ¯”利時（第二組）ç‰å國ä¸ä¹‹ä¸€åœ‹ï¼Œä¸”無類似（åŒä¾†æºã€åŒæˆåˆ†ï¼‰ç”¢å“ä¸Šå¸‚ï¼Œå‰‡é ˜è‰å‰é™¤æ‡‰æœ‰å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žå¤–，應ä¾ç¾è¡Œè¦å®šè£œé½Šä¸‰åœ‹æŽ¡ç”¨è‰æ˜Žï¼ˆå³äºŒçµ„ä¸å„一國之採用è‰æ˜Žæˆ–å國ä¸ä¹‹ä¸‰åœ‹æŽ¡ç”¨è‰æ˜Žï¼‰ã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊2申請輸入藥å“查驗登記，如係無èŒè£½åŠ‘產å“者，其關éµæ€§è£½ç¨‹ç¢ºæ•ˆæ‡‰å«æ»…èŒç¢ºæ•ˆè³‡æ–™ã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊3生物相似性藥å“：指以生物技術è¡ç”Ÿä¹‹ç”Ÿç‰©è—¥å“，於å“質ã€å®‰å…¨åŠåŠŸæ•ˆä¸Šï¼Œèˆ‡åŽŸæœ¬ä½œç‚ºåƒè€ƒä¸¦å·²ç²å¾—我國上市許å¯ä¹‹ç”Ÿç‰©è—¥å“相似。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 38.5pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">＊4éŽæ•åŽŸè—¥å“，ä¾ç¬¬äºŒåå››æ¢ç¬¬äºŒé …è¦å®šï¼Œé™¤ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¿…è¦é€é©—者外，得以書é¢å¯©æ ¸è€Œå…é€é©—樣å“。 </span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6095&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件七生物藥å“查驗登記應檢附之技術性資料表<p style="layout-grid-mode: char; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">附件七</span> </p><p style="layout-grid-mode: char; text-align: center; 48pt: ;"><span style="font-family: 標楷體; color: #000000;">生物藥å“查驗登記應檢附之技術性資料表</span> </p><table width="100%" style="border-collapse: collapse; width: 100%;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6%; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="margin: 1pt 0cm;"> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 10.1%; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">èµ·æºã€ç™¼ç¾ç¶“éŽã€åœ‹å¤–使用情形 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 10.44%; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p style="margin: 0cm -1.3pt 0pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體;">物化性質ã€æª¢é©—方法ã€è¦æ ¼ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å®‰å®šæ€§è©¦é©—å ±å‘Š </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 37.28%; background-color: transparent; border-left-color: #f0f0f0;" colspan="9"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">éž è‡¨ 床 之 安 å…¨ 性 試 é©— å ± å‘Š </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.78%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è—¥ç† </span></p> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">作用 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 17.36%; background-color: transparent; border-left-color: #f0f0f0;" colspan="6"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å¸æ”¶ã€åˆ†ä½ˆã€ä»£è¬ã€æŽ’泄ã€ç”Ÿé«”å¯ç”¨çŽ‡ï¼ç”Ÿé«”相ç‰æ€§è©¦é©—å ±å‘Š </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.78%; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="layout-grid-mode: char;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è‡¨åºŠè©¦é©—å ±å‘Š </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="layout-grid-mode: char; text-align: center;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å…¶ ä»– 資 æ–™ </span></p> </td> </tr> <tr style="height: 73.55pt; page-break-inside: avoid;"> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">èµ·æºç™¼ç¾ç¶“éŽ </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國外使用情形 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">性質比較 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ§‹é€ å¼ </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">物ç†åŒ–å¸æ€§è³ª </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">檢驗è¦æ ¼æ–¹æ³• </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"> </p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">單一劑é‡æ¯’性 </span></p> </td> <td valign="top" style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">﹙三個月﹚ </span></p> <p style="layout-grid-mode: char; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é‡è¦†åŠ‘é‡æ¯’性 </span></p> </td> <td valign="top" style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ï¹™å…個月﹚ </span></p> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é‡è¦†åŠ‘é‡æ¯’性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">生殖毒性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ä¾è³´æ€§ </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">抗原性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">åŸºå› æ¯’æ€§ </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">致癌性 </span></p> </td> <td style="border-top-style: solid; border-left-style: solid; height: 73.55pt; border-right-width: 1pt; border-top-color: #f0f0f0; border-bottom-width: 1pt; padding-bottom: 0cm; border-bottom-color: windowtext; padding-top: 0cm; padding-left: 1.4pt; border-right-color: windowtext; padding-right: 1.4pt; layout-flow: vertical-ideographic; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">局部刺激性 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">有效性è‰æ˜Ž </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ä¸€èˆ¬è—¥ç† </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å¸æ”¶ </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">分佈 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ä»£è¬ </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">排泄 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">生體å¯ç”¨çŽ‡ </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">生體相ç‰æ€§ </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">臨床試驗 </span></p> </td> <td valign="top" style="height: 73.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">醫å¸æœŸåˆŠ </span></p> </td> </tr> <tr style="height: 8.15pt;"> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">åŸºå› å·¥ç¨‹è—¥å“ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註1</span></p> </td> </tr> <tr style="height: 12.15pt;"> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">ç”Ÿç‰©ç›¸ä¼¼æ€§è—¥å“ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註1</span></p> </td> </tr> <tr style="height: 8.45pt;"> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">ç–«è‹—é¡žè—¥å“ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 8.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註2</span></p> </td> </tr> <tr style="height: 11.55pt;"> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">äººç”¨è¡€æ¼¿è—¥å“ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 11.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註3</span></p> </td> </tr> <tr style="height: 7.55pt;"> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">éŽæ•åŽŸè—¥å“ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">Ｘ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 7.55pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">---</span></p> </td> </tr> <tr style="height: 12.85pt;"> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 6%; background-color: transparent;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">其他類 </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.32%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.4%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.22%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.28%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.58%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â–³ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 2.9%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">â—‹ </span></p> </td> <td valign="top" style="height: 12.85pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.02%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="layout-grid-mode: char; text-align: center; margin: 3pt 0cm;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">---</span></p> </td> </tr> </tbody></table><p><span style="font-size: 10pt; font-family: 標楷體;">â—‹è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ △表示視個案而定。 Ｘ表示ä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">è¨»ï¼‘ï¼šåŸºå› å·¥ç¨‹è—¥å“（å«ç”Ÿç‰©ç›¸ä¼¼æ€§è—¥å“）應檢附攜帶表ç¾åŸºå› ä¹‹è¼‰é«”æ§‹é€ èˆ‡ç‰¹æ€§ï¼Œå®¿ä¸»ä¹‹ç‰¹æ€§ï¼ŒMCB（Master Cell Bank</span></p><p><span style="font-size: 10pt; font-family: 標楷體;">）與MWCB（Manufacture Working Cell Bank）之敘述åŠè¼‰é«”之安定性，產å“收穫åŠç´”化éŽç¨‹ã€‚ </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">註２：疫苗類藥å“ä¹‹è£½é€ ç®¡åˆ¶ï¼Œæ‡‰ç¬¦åˆç¨®æºæ‰¹æ¬¡ç³»çµ±ï¼ˆSeed Lot System），並包括在分è£å‰ä¹‹è£½é€ éŽç¨‹å„階段å‡é©æ™‚å–樣， </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">完æˆåˆ†è£å‰ä¹‹å„é …è©¦é©—ï¼Œå«ç¨®èŒï¼ˆseed strain）ã€Master Seed Lot, Manufacturing Working Cell Bank（MWCB）ã€åŸ¹é¤ŠåŸºï¼ˆCell Culture Medium）ã€é†±é…µï¼ˆåŸ¹é¤Šï¼‰ç”¢ç‰©ã€ç´”化後產物ã€åˆ†è£å‰æº¶æ¶²åŠæœ€çµ‚產å“ç‰å„éšŽæ®µä¹‹è©¦é©—é …ç›®ï¼Œå¦ç´”化之方法亦應詳述。 </span></p><p><span style="font-size: 10pt; font-family: 標楷體;">註３：人用血漿藥å“應檢具血漿原料來æºæ¸…å–®ã€è¡€æ¼¿åŽŸæ–™è¦æ ¼ï¼ˆæ¯ä¸€è¡€è¢‹é ˆä½œï¼¢åž‹è‚炎表é¢æŠ—原ã€ï¼£åž‹è‚炎抗體åŠäººé¡žå…疫缺ä¹ç—…æ¯’ç¬¬â… åž‹åŠç¬¬â…¡åž‹æŠ—體篩檢），並檢附病毒去活化或去除æ¥é©Ÿä¹‹ç¢ºæ•ˆè³‡æ–™ã€‚血漿混åˆæ¶²ï¼ˆPlasma poolï¼‰æ‡‰æœ‰ä»¥æ ¸é…¸æ“´å¢žæŠ€è¡“ï¼ˆNucleic acid amplification technology; NAT）檢測，至少應有å°HCVã€HIVåŠHBVä¹‹ç—…æ¯’æ ¸é…¸ä¹‹NAT檢驗為陰性之çµæžœå ±å‘Šï¼Œè‹¥NAT檢測方法尚未於我國å–得許å¯è‰ï¼Œç”³è«‹å» 商應將其檢驗è¦æ ¼ã€æ–¹æ³•åŠéˆæ•åº¦ç‰ï¼Œä¾å…¶ä»–類查驗登記之è¦æ±‚，檢附相關資料供審查評估，且ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°‡åƒè€ƒå…¶ä»–國家之è¦å®šï¼Œå…¬å‘Šæ–°å¢žä¹‹ç¯©æª¢é …ç›®åŠè¦æ±‚。å¦è£½é€ 管制資料，應包括分è£å‰ä¹‹è£½é€ éŽç¨‹å„階段é©æ™‚å–樣，完æˆåˆ†è£å‰ä¹‹å„é …è©¦é©—ï¼ŒåŒ…æ‹¬å–®ä¸€è¡€è¢‹è¡€æ¼¿ã€æ··åˆè¡€æ¼¿ã€ç´”化後產物ã€åˆ†è£å‰æº¶æ¶²åŠæœ€çµ‚產å“ç‰å„éšŽæ®µä¹‹è©¦é©—é …ç›®ã€‚ </span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6094&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件八原料藥查驗登記應檢附資料表 - 複製<p style="layout-grid-mode: char; text-align: justify; margin: 0cm 0cm 12.5pt; text-justify: inter-ideograph; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">附件八</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 12.5pt; line-height: 12pt;"><span style="font-family: 標楷體;">原料藥查驗登記應檢附資料表</span> </p><div style="text-align: center;"><table width="582" style="border-collapse: collapse; margin: auto auto auto -65.75pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 33.15pt; page-break-inside: avoid;"> <td style="height: 33.15pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 8cm; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: justify; text-justify: inter-ideograph; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">應檢附資料</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 33.15pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; line-height: 14pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">一般原料藥</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 33.15pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 139.7pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; line-height: 14pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用原料藥</span> </p> </td> </tr> <tr style="height: 33.2pt; page-break-inside: avoid;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">éžè‡¨æ«ƒ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">臨櫃<sup>*3</sup> </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">è¦è²»</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">è—¥å“查驗登記申請書æ£æœ¬ã€å‰¯æœ¬</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">切çµæ›¸ï¼ˆç”²ï¼‰ã€åˆ‡çµæ›¸ï¼ˆä¹™ï¼‰</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用切çµæ›¸</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">外銷專用原料藥臨櫃查驗登記申請切çµæ›¸</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">仿單標籤é»è²¼è¡¨äºŒä»½</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">è‰ç…§é»è²¼è¡¨</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â–³<sup>*4</sup> </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">è¿‘äºŒå¹´å…§æŸ¥æ ¸ç¬¦åˆåŽŸæ–™è—¥</span><span style="font-size: 10pt;">GMP</span><span style="font-size: 10pt; font-family: 標楷體;">之è‰æ˜Žå½±æœ¬</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â–³ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">委託書（輸入藥å“）</span> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> <tr style="height: 33.15pt;"> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">出產國許å¯è£½å”®è‰æ˜Žï¼ˆè¼¸å…¥è—¥å“）</span> </p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.15pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">技術性資料</span><sup><span style="font-size: 10pt;">*1</span></sup><sup> </sup></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹<sup>*2</sup> </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹<sup>*2</sup> </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體;">â—‹<sup>*2</sup> </span></p> </td> </tr> <tr style="height: 33.2pt;"> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 8cm; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph; line-height: 12pt; text-autospace: ;"><span style="font-size: 10pt; font-family: 標楷體;">é€é©—</span><sup><span style="font-size: 10pt;">*5</span></sup> </p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 70.3pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 73.6pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> <td style="height: 33.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 66.1pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 10pt; font-family: 標楷體;">╳ </span></p> </td> </tr> </tbody></table></div><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 18pt;"> </p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">â—‹ è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">â–³ 表示視個案而定。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 31.5pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">╳：表示ä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*1 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">åƒè¦‹ã€ŒåŽŸæ–™è—¥æŸ¥é©—登記應檢附之技術性資料表ã€ã€‚ </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*2 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">應檢附技術性資料之份數，原則上，一般原料藥為å四份ã€å¤–銷專用者為二份。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*3 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">é™ç”³è«‹æ—¥å‰äºŒå¹´å…§ï¼Œç¶“æŸ¥æ ¸ç¬¦åˆåŽŸæ–™è—¥å» GMP者。 </span></p><p style="layout-grid-mode: char; margin: 0cm 7.55pt 0pt 46.2pt;"><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*4 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">å¦‚å·²é ˜æœ‰åŽŸæ–™è—¥è¨±å¯è‰ï¼Œä¸”許å¯è‰å°šåœ¨æœ‰æ•ˆæœŸé™å…§è€…，得å…附。 </span></p><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">*5 </span><span style="font-size: 11pt; font-family: 標楷體; color: #000000;">ä¾ç¬¬äºŒåå››æ¢ç¬¬äºŒé …è¦å®šï¼Œé™¤ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¿…è¦é€é©—者外，得以書é¢å¯©æ ¸è€Œå…é€é©—樣å“</span>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6093&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件ä¹åŽŸæ–™è—¥æŸ¥é©—登記應檢附之技術性資料表<p><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">附件ä¹</span></b> </p><p><b><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">　　　　　　　　　　　　　原料藥查驗登記應檢附之技術性資料表</span></b> </p><table width="607" style="border-collapse: collapse; width: 454.95pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 225pt; background-color: transparent;border: windowtext 1pt solid;" rowspan="2"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;"> </span></p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">一般原料藥</span> </p> </td> <td style="border-top: windowtext 1pt solid; height: 5.65pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 148.95pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">外銷專用原料藥</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">éžè‡¨æ«ƒ</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">臨櫃</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">外銷專用原料藥查驗登記臨櫃申請資料查檢表</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â—‹</span> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">æŠ€è¡“è³‡æ–™å·¥å» ç›¸é—œçµ„ç¹”åŠäººå“¡</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â–³</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â—‹</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;"> </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">æˆå“背景資料åŠè£½é€ 方法ä¾æ“š</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â–³</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â—‹</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;"> </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">è£½é€ ç®¡åˆ¶è³‡æ–™</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â–³</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â—‹</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;"> </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">è¦æ ¼ã€æª¢é©—è¨å‚™ã€æª¢é©—方法與檢驗紀錄</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â—‹</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â—‹</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;"> </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â–³</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*3</span></sup> </p> </td> </tr> <tr style="height: 5.65pt;"> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 225pt; background-color: transparent;"> <p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">安定性試驗資料</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 81pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â–³</span> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 72pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;"> </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">â—‹</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*1</span></sup> </p> </td> <td style="height: 5.65pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 76.95pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;"> </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">╳</span><sup><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2</span></sup> </p> </td> </tr> </tbody></table><p style="margin: 0cm 2.4pt 0pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">è¨»ï¼šâ—‹è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚â–³è¡¨ç¤ºè¦–å€‹æ¡ˆè€Œå®šã€‚â•³ï¼šè¡¨ç¤ºä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*1 </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">åŒæ„æ–¼é ˜è‰å¾Œä¸‰å€‹æœˆå…§ï¼Œè£œé½Šä¸‰å€‹æœˆ</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">40℃</span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">ä¹‹åŠ é€Ÿå®‰å®šæ€§è©¦é©—è³‡æ–™ï¼Œå…¶é¤˜å®‰å®šæ€§è©¦é©—è³‡æ–™ï¼Œç•™å» å‚™æŸ¥ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*2 </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">é€ä»¶ç”³è«‹æ™‚，得å…æª¢é™„ï¼Œä½†ç›¸é—œè³‡æ–™æ‡‰ç•™å» å‚™æŸ¥ã€‚</span> </p><p><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">*3 </span><span style="font-size: 10pt; font-family: 新細明體,serif; color: #333333;">é€ä»¶ç”³è«‹æ™‚，除應檢é€æª¢é©—è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸å¤–，其餘資料得å…æª¢é™„ï¼Œä½†æ‡‰ç•™å» å‚™æŸ¥ã€‚</span> </p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6092&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件åæ ¸é†«æ”¾å°„æ€§è—¥å“查驗登記應檢附資料表<p style="layout-grid-mode: char; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: #000000;">附件å</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: #000000;">æ ¸é†«æ”¾å°„æ€§è—¥å“查驗登記應檢附資料表</span> </p><table width="99%" style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 12.86%; background-color: transparent;border: windowtext 1pt solid;" colspan="2"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">應檢é€è³‡æ–™ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è¦è²» </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è—¥å“æŸ¥é©—ç™»è¨˜ç”³è«‹æ›¸æ£ </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">〠</span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">副 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">本 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">切çµæ›¸ç”² </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">〠</span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ä¹™ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">標籤仿單é»è²¼è¡¨äºŒä»½ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è‰ç…§é»è²¼è¡¨ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">委託書 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">出產國許å¯è£½å”®è‰æ˜Ž</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">1</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">處方ä¾æ“š</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">2</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">有效æˆåˆ†æª¢é©—è¦æ ¼ </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">賦形劑檢驗è¦æ ¼ã€ </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">方法åŠæª¢é©—æˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æˆå“檢驗è¦æ ¼ </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸æˆ–æ‰¹æ¬¡è£½é€ ç´€éŒ„ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">分æžæ–¹æ³•ç¢ºæ•ˆè³‡æ–™ </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é—œéµæ€§è£½ç¨‹ç¢ºæ•ˆè³‡æ–™</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">3</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">安定性試驗資料 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">採用è‰æ˜Ž</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">4</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">é€é©—</span><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">5</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">技 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">è¡“ </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">性 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">資 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">æ–™ </span></p> </td> </tr> <tr style="height: 19.45pt; page-break-inside: avoid;"> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">æ–°è—¥</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.34%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="6"> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">ä¾ </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">附 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">件 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">å </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">一 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">之 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">è¦ </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">定 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">檢 </span></p> <p style="layout-grid-mode: char; text-align: center; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 9pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">附</span> </p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">新劑型</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.45pt; page-break-inside: avoid;"> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">新劑é‡</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.45pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 2.94%; background-color: transparent;" rowspan="2"> <p style="layout-grid-mode: char; line-height: 12pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-size: 10pt; font-family: 標楷體; layout-grid-mode: line; color: #000000;">å¸åè—¥</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">國產</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> <td valign="top" style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.34%; background-color: transparent; border-left-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; line-height: 12pt;"> </p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; color: #000000;">*</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">6</span> </p> </td> </tr> <tr style="height: 19.5pt; page-break-inside: avoid;"> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 9.94%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">輸入</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.12%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.7%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.34%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.48%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.6%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.06%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 6.42%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 5.68%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 3.74%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.52%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">â—‹</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳</span> </p> </td> <td style="height: 19.5pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 4.1%; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 新細明體,serif; color: #000000;">╳ </span></p> </td> </tr> </tbody></table><p style="layout-grid-mode: char; margin: 9pt 0cm 0pt; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">註：○ è¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ ╳ 表示ä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ </span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*1 </span><span style="font-size: 10pt;">如出產國許å¯è£½å”®è‰æ˜Žä¸æœªåˆŠè¼‰å®Œæ•´ä¹‹è£½é€ å» å€è€…，應å¦é™„最近一次GMPæŸ¥å» å ±å‘Šæ†‘æ ¸</span><span style="font-size: 10pt;">。（如僅未刊載郵éžå€è™Ÿæˆ–å€è€…ï¼Œå¾—ä»¥åŽŸå» å‡½èªªæ˜Žï¼‰ </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*2 </span><span style="font-size: 10pt;">ç”±åœ‹å…§è‡ªè¡Œç ”ç™¼ä¹‹æ ¸é†«æ”¾å°„æ€§è—¥å“æ–°è—¥ã€æ–°åŠ‘åž‹ã€æ–°åŠ‘é‡ï¼Œå…附處方ä¾æ“šã€‚但應å¦é™„處方è¨è¨ˆç ”究åŠè©²è—¥å“之技術性資料。 </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*3 </span><span style="font-size: 10pt;">申請輸入藥å“查驗登記，如係無èŒè£½åŠ‘產å“者，其關éµæ€§è£½ç¨‹ç¢ºæ•ˆæ‡‰å«æ»…èŒç¢ºæ•ˆè³‡æ–™ã€‚ </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*4 </span><span style="font-size: 10pt;">åœ‹ç”¢ä¹‹æ ¸é†«æ”¾å°„æ€§è—¥å“æ–°è—¥ã€æ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘，å‡æ‡‰æª¢é™„處方è¨è¨ˆç ”究。 </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*5 </span><span style="font-size: 10pt;">ä¾ç¬¬äºŒåå››æ¢ç¬¬äºŒé …è¦å®šï¼Œé™¤ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¿…è¦é€é©—者外，得以書é¢å¯©æ ¸è€Œå…é€é©—樣å“。 </span></span></p><p style="text-align: left; margin: 0cm 7.55pt 6pt 14.7pt;"><span style="font-family: 標楷體;"><span style="font-size: 10pt;">*6</span><span style="font-size: 10pt;">監視藥å“之å¸å藥，監視期間內應檢附與以新藥æ出查驗登記申請且å–得許å¯è‰ä¹‹å» 商相åŒæ¨™æº–ä¹‹åœ‹å…§è‡¨åºŠè©¦é©—å ±å‘Šï¼ˆå«éŠœæŽ¥æ€§è©¦é©—）；如å‰è¿°æ–°è—¥æ–¼æŸ¥é©—ç™»è¨˜æ ¸å‡†æ™‚æœªæª¢é€åœ‹å…§è‡¨åºŠè©¦é©—å ±å‘Šï¼ˆå«éŠœæŽ¥æ€§è©¦é©—）者，則其å¸å藥應檢é€ï¼ˆ1）生體相ç‰æ€§è©¦é©—å ±å‘Šï¼Œæˆ–ï¼ˆ2）生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—å ±å‘Šã€‚ç›£è¦–æœŸæ»¿è—¥å“，應檢é€ï¼ˆ1）生體相ç‰æ€§è©¦é©—å ±å‘Šï¼Œæˆ–ï¼ˆ2）生體å¯ç”¨çŽ‡åŠè‡¨åºŠè©¦é©—å ±å‘Šã€‚ </span></span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6091&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤ã€Œè—¥å“查驗登記審查準則ã€é™„件åä¸€æ ¸é†«æ”¾å°„æ€§è—¥å“æ–°è—¥ã€æ–°åŠ‘åž‹ã€æ–°åŠ‘é‡æŸ¥é©—登記應檢附之技術性資料表<p style="margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: black;">附件å一 </span></p><p style="text-align: center; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: black;">æ ¸é†«æ”¾å°„æ€§è—¥å“æ–°è—¥ã€æ–°åŠ‘åž‹ã€æ–°åŠ‘é‡æŸ¥é©—登記應檢附之技術性資料表 </span></p><table style="width: 100%; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 4.12%; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="7"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">ç”³è«‹æ ¸é†«æ–°è—¥æŸ¥é©—ç™»è¨˜æ‡‰æª¢é™„è³‡æ–™ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">文件 </span></p> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">類別 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">èµ·æºç™¼ç¾ä¹‹ç¶“éŽåŠä½¿ç”¨æƒ…å½¢ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 23.36%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2" colspan="4"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">物ç†æ€§è³ªåŠåŒ–å¸æ€§è³ªä¹‹æª¢é©—方法åŠæª¢é©—è¦æ ¼ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 44.02%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="9"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">éžè‡¨åºŠå‹•ç‰©è©¦é©—å ±å‘Š </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 7.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">è‡¨åºŠè©¦é©—å ±å‘Š(應è£è¨‚æˆå†Šä¸¦é™„摘è¦ä¹™ä»½)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">輻射劑é‡å¸å ±å‘Š </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 23.64%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">å®‰å…¨æ€§è©¦é©—å ±å‘Š </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 7.68%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">藥效試驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 12.68%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">藥動試驗 </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 102.95pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">è—¥å“資料/新藥類別 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 9.06%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">性質åŠèˆ‡å…¶ä»–è—¥å“比較 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">外國使用情形 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">èµ·æºç™¼ç¾ç¶“éŽ </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">æ§‹é€ å¼ </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">物ç†åŒ–å¸æ€§è³ª </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">檢 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é©— </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">è¦ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">æ ¼ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">åŠ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">æ–¹ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">法 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">å«é‡å‡ä¸€åº¦è©¦é©— </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">溶離試驗 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">或æä¾›å°ç…§æ¨™æº–å“ </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">æ供新æˆä»½ä¹‹åŽŸæ–™è—¥å“ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">å–® </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">一 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é‡ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">毒 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">性 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é©— </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é‡ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">覆 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é‡ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">毒 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">性 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é©— </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">抗原性試驗 </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 9.06%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">局部刺激性試驗 </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">致çªè®Šæ€§ã€è‡´ç™Œæ€§è©¦é©— </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">胚胎試驗ã€ä¾è³´æ€§è©¦é©— </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">è¼» </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">å°„ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">生 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">物 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é©— </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">è‰ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">明 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">有 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">效 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">之 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é©— </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">一 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">般 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">è—¥ </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">ç† </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">試 </span></p> <p style="text-align: center; line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">é©— </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">代è¬ã€æŽ’泄〠</span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">å¸æ”¶ã€åˆ†ä½ˆã€ </span></p> </td> <td style="border-bottom-color: windowtext; padding-bottom: 0cm; border-right-width: 1pt; background-color: transparent; border-top-color: #f0f0f0; border-left-style: solid; padding-left: 1.4pt; width: 6.34%; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-style: solid; border-bottom-width: 1pt; height: 102.95pt; border-right-color: windowtext; border-left-color: #f0f0f0; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">生體相ç‰æ€§è©¦é©— </span></p> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">生體å¯ç”¨çŽ‡è©¦é©— </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; margin: 0cm 0.85pt 0pt 0cm; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">臨床試驗之è¨è¨ˆåŠçµæžœ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; margin: 0cm 0.85pt 0pt 0cm; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">ç ”ç©¶æ–‡ç»ä¹‹å›žé¡§åŠå‡ºè™• </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 102.95pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="line-height: 12pt; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.1%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">æ–°æˆåˆ† </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">診斷用 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">治療用 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">新使用途徑 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 15.75pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">æ–°é©æ‡‰ç—‡ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 15.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 105.15pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.12%; padding-right: 1.4pt; height: 105.15pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">æ ¸ </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">醫 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">æ–° </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">åž‹ </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">〠</span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">æ–° </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">劑 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">é‡ </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">查 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">é©— </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">ç™» </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">記 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">應 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">檢 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">附 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">資 </span></p> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; letter-spacing: -1pt; font-family: 標楷體; color: black; font-size: 9pt;">æ–™</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">新劑型 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 105.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 105.2pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 8.02%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">æ–°åŠ‘é‡ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4.32%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.44%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.62%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 9.06%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.82%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.86%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 6.34%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">╳ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 4%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 3.9%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â–³ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 3.52%; padding-right: 1.4pt; height: 105.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char; text-autospace: ; punctuation-wrap: simple;"><span style="layout-grid-mode: line; font-family: 標楷體; color: black; font-size: 9pt;">â—‹ </span></p> </td> </tr> </tbody></table><p style="margin: 9pt 0cm 0pt;"><span style="font-family: 標楷體; color: black; font-size: 10pt;">â—‹ï¼šè¡¨ç¤ºé ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ ╳：表示ä¸é ˆæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ â–³ï¼šè¡¨ç¤ºè¦–å€‹æ¡ˆè€Œæª¢é™„è©²é …ç›®ä¹‹è³‡æ–™ã€‚ </span></p>2013-12-03
化å¸è£½é€ 管制類,è—¥å“å„ªè‰¯è£½é€ ,è—¥ç‰©å„ªè‰¯è£½é€ è‰æ˜Žæ›¸ç”³è«‹è¾¦æ³•æ³•è¦å‘½ä»¤è—¥ç‰©å„ªè‰¯è£½é€ è‰æ˜Žæ›¸ç”³è«‹è¾¦æ³•<p style="layout-grid-mode: char; line-height: 150%;"><span style="font-size: 14pt; font-family: 標楷體;">第一æ¢ã€€ã€€æœ¬è¾¦æ³•ä¾è—¥äº‹æ³•ç¬¬äº”å七æ¢ç¬¬äº”é …è¦å®šè¨‚定之。 </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第二æ¢ã€€ã€€è—¥ç‰©å„ªè‰¯è£½é€ è‰æ˜Žæ›¸ä¹‹ç”³è«‹ç¨‹åºã€ç™¼çµ¦æ¢ä»¶åŠæ‡‰éµè¡Œäº‹é …， </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">ä¾æœ¬è¾¦æ³•ä¹‹è¦å®šï¼›æœ¬è¾¦æ³•æœªè¦å®šè€…，ä¾å…¶ä»–有關法令之è¦å®šã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第三æ¢ã€€ã€€ä¾è—¥ç‰©è£½é€ å·¥å» è¨å» 標準第三æ¢ç¬¬äºŒé …æˆ–ç¬¬ä¸‰é …è¦å®šè€Œ</span><span style="font-size: 14pt; font-family: 標楷體;">å–å¾— </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ç¯„è‰æ˜Žæ–‡ä»¶ä¹‹è—¥å•† </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">，得繳ç´è²»ç”¨ä¸¦å¡«å…·ç”³è«‹æ›¸è¡¨åŠç›¸é—œè³‡æ–™ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">ç”³é ˜è‰æ˜Žæ›¸ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第四æ¢ã€€ã€€å‰æ¢è‰æ˜Žæ›¸æ ¸ç™¼å¾Œ</span><span style="font-size: 14pt; font-family: 標楷體;">，如經主管機關後續檢查發ç¾æœ‰ä¸ç¬¦åˆè—¥ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">å“å„ªè‰¯è£½é€ è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ç¯„之情形而未於期é™å…§æ”¹ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">å–„</span><span style="font-size: 14pt; font-family: 標楷體;">，或經發ç¾æœ‰é‡å¤§å±å®³æˆ–é•è¦æƒ…節é‡å¤§è€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">得廢æ¢è©²è‰æ˜Žæ›¸ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第五æ¢ã€€ã€€è‰æ˜Žæ›¸æ ¸ç™¼å¾Œ</span><span style="font-size: 14pt; font-family: 標楷體;">ï¼Œå¦‚å…¶ç™»è¨˜äº‹é …æœ‰è®Šæ›´è€…ï¼ŒæŒæœ‰è‰æ˜Žæ›¸ä¹‹è—¥å•† </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">應繳ç´è²»ç”¨ä¸¦å¡«å…·ç”³è«‹æ›¸è¡¨åŠç›¸é—œè³‡æ–™ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">請變更</span><span style="font-size: 14pt; font-family: 標楷體;">。未ä¾è¦å®šç”³è«‹è®Šæ›´æˆ–未ç²æ ¸å‡†è®Šæ›´è€…</span><span style="font-size: 14pt; font-family: 標楷體;">，</span><span style="font-size: 14pt; font-family: 標楷體;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">關得廢æ¢è©²è‰æ˜Žæ›¸ã€‚<b> </b></span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第å…æ¢ã€€ã€€æœ¬è¾¦æ³•ä¹‹å„é …ç”³è«‹æ›¸è¡¨ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚ </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">　　　　　申請人填寫申請書表åŠæª¢é™„之資料，é™ç”¨ç¹é«”ä¸æ–‡åŠè‹±æ–‡ï¼› </span></p><p style="layout-grid-mode: char; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">如éžç¹é«”ä¸æ–‡æˆ–英文者，應å¦é™„ç¹é«”ä¸æ–‡æˆ–英文è¯æœ¬ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"><span style="font-size: 14pt; font-family: 標楷體;">第七æ¢ã€€ã€€</span><span style="font-size: 14pt; font-family: 標楷體;">本辦法自發布日施行。</span> </p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6079&type=0
查驗登記類,原料藥主檔案(DMF)æ ¸å‚™åŠåœ‹ç”¢åŽŸæ–™è—¥æŸ¥é©—登記精實é€å¯©æ–‡ä»¶è³‡æ–™æ³•è¦å‘½ä»¤DMFæ ¸å‚™åŠåŽŸæ–™è—¥ç²¾å¯¦é€å¯©è©³å¦‚附件2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4492&type=0
臨床試驗類,人類胚胎åŠèƒšèƒŽå¹¹ç´°èƒžç ”究倫ç†æ”¿ç–指引行政解釋人類胚胎åŠèƒšèƒŽå¹¹ç´°èƒžç ”究倫ç†æ”¿ç–指引詳如附件<br />2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4493&type=0
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臨床試驗類,人體細胞組織優良æ“作è¦ç¯„法è¦å‘½ä»¤äººé«”細胞組織優良æ“作è¦ç¯„<p style="margin-bottom: 12pt; text-align: center;"><span><strong>91.12.13<span style="font-family: 新細明體;">衛署醫å—第</span>0910078677<span style="font-family: 新細明體;">號公告</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">壹ã€</span> <span style="font-family: 新細明體;">總則</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">一ã€</span> <span style="font-family: 新細明體;">為é é˜²å› ä½¿ç”¨äººé«”ç´°èƒžçµ„ç¹”ç‰©è€Œå°Žå…¥ã€å‚³æ’åŠæ“´æ•£å‚³æŸ“病，特訂定本è¦ç¯„。<br /><br />本è¦ç¯„å”助機構確ä¿å…¶äººé«”細胞組織物未å«æœ‰å‚³æŸ“ç—…ç—…åŽŸï¼Œåœ¨è£½é€ éŽç¨‹ä¸æœªå—污染，且ä¸è‡´å› è£½é€ ä¸ç•¶è€Œå½±éŸ¿äººé«”細胞組織物效用與完整性</span> <span style="font-family: 新細明體;">。<br /><br />人體細胞組織優良æ“作è¦ç¯„（以下簡稱本è¦ç¯„）é©ç”¨æ–¼äººé«”ç´°èƒžçµ„ç¹”ç‰©ï¼Œå…¶è£½é€ æ‰€ä½¿ç”¨ä¹‹æ–¹æ³•ã€è¨æ–½åŠç®¡åˆ¶æŽªæ–½ï¼ŒåŒ…括人體細胞組織æ供者之篩檢與檢驗ã€äººé«”細胞組織物之採集ã€è™•ç†ã€è²¯å˜ã€æ¨™ç¤ºã€åŒ…è£åŠé…é€ç‰éŽç¨‹ã€‚<br /><br />有關人體細胞組織æ供者åˆé©æ€§ï¼ˆ</span>donor suitability<span style="font-family: 新細明體;">）之è¦ç¯„，å¦å®šä¹‹ã€‚</span> </strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二ã€</span> <span style="font-family: 新細明體;">人體細胞組織物屬於藥事法令è¦å®šä¹‹ç”Ÿç‰©è—¥å“或醫療器æ者，ä¾å…¶è¦å®šï¼Œä¸¦ä»¥è¦ç¯„åšç‚ºè£œå……è¦å®šã€‚<br /><br />人體細胞組織物屬於人體器官移æ¤æ¢ä¾‹</span> <span style="font-family: 新細明體;">ã€é†«ç™‚法</span> <span style="font-family: 新細明體;">或其他法令所è¦ç¯„者，ä¾å…¶è¦å®šï¼Œä¸¦ä»¥æœ¬è¦ç¯„åšç‚ºè£œå……è¦å®šã€‚<br /><br />人體細胞組織物éžå±¬æ–¼ç¾è¡Œæ³•ä»¤æ‰€è¦ç¯„者，或應é©ç”¨ä¹‹æ³•ä»¤ä¸æ˜Žç¢ºï¼Œæ–¼é‡æ¸…法令é©ç”¨ç–‘義之å‰ï¼Œé©ç”¨æœ¬è¦ç¯„。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三ã€</span> <span style="font-family: 新細明體;">本è¦ç¯„專用å詞定義如下：<br /><br />（一）</span> <span style="font-family: 新細明體;">人體細胞組織物：指用於æ¤å…¥</span>(implanted)<span style="font-family: 新細明體;">ã€ç§»æ¤</span>(transplanted)<span style="font-family: 新細明體;">ã€è¼¸æ³¨</span>(infused)<span style="font-family: 新細明體;">或轉æ¤</span>(transferred)<span style="font-family: 新細明體;">於人體之人體細胞ã€çµ„ç¹”ã€æˆ–以人體細胞或組織所構æˆä¹‹ç”¢å“（</span>human cell, tissue, or cellular or tissue-based product<span style="font-family: 新細明體;">）。如骨骼ã€éŸŒå¸¶ã€çš®è†šã€å¿ƒç“£è†œã€çœ¼è§’膜ã€å–自è‡å¸¶è¡€æˆ–å‘¨é‚Šè¡€æ¶²ä¹‹é€ è¡€å¹¹ç´°èƒžã€è‡ªé«”移æ¤ä½¿ç”¨ä¹‹è»Ÿéª¨ã€åˆæˆåŸºè³ªä¸Šä¹‹ä¸Šçš®ç´°èƒžã€ç²¾æ¶²æˆ–其他生殖組織ç‰é …ç›®</span> <span style="font-family: 新細明體;">ã€‚ä½†ä¸‹åˆ—é …ç›®ï¼Œä¸åœ¨æ¤é™ï¼š<br /><br /></span>1. <span style="font-family: 新細明體;">使用於移æ¤ï¼Œå¸¶æœ‰è¡€ç®¡ä¹‹äººé«”器官。<br /><br /></span>2. <span style="font-family: 新細明體;">全血ã€è¡€æ¶²æˆåˆ†è¡€æˆ–血液è¡ç”Ÿç”¢å“（</span>blood derivative product<span style="font-family: 新細明體;">）。<br /><br /></span>3. <span style="font-family: 新細明體;">人體分泌物或抽å–物，如乳æ±ã€è† 原åŠç´°èƒžå› å（</span>cell factors<span style="font-family: 新細明體;">）ç‰ï¼Œä½†ç²¾æ¶²å±¬æ–¼æœ¬è¦ç¯„所稱人體細胞組織物。<br /><br /></span>4. <span style="font-family: 新細明體;">äººé«”ç´°èƒžçµ„ç¹”ç‰©è£½é€ éŽç¨‹ä¹‹è¼”助物。<br /><br /></span>5. <span style="font-family: 新細明體;">人類以外動物之細胞ã€çµ„織或器官。<br /><br /></span>6. <span style="font-family: 新細明體;">體外使用之診斷用產å“。<br /><br />（二）</span> <span style="font-family: 新細明體;">機構（</span>establishment<span style="font-family: 新細明體;">）：指於一個管ç†éšŽå±¤ä¹‹æŽ§åˆ¶ä¸‹ï¼Œä½æ–¼ä¸€è™•æ‰€ï¼Œè€Œå¾žäº‹äººé«”ç´°èƒžçµ„ç¹”ç‰©è£½é€ ä¹‹äº‹æ¥ï¼Œå¦‚下列機構：<br /><br /></span>1<span style="font-family: 新細明體;">ã€å¾žäº‹è£½é€ 人體細胞組織物之個人ã€åˆå¤¥ã€å…¬å¸ã€æ³•äººåŠå…¶ä»–團體。<br /><br /></span>2<span style="font-family: 新細明體;">ã€æŽ¥å—è£½é€ è€…å§”è¨—ï¼Œæ供人員或è¨æ–½å¾žäº‹äººé«”ç´°èƒžçµ„ç¹”ç‰©è£½é€ ä¹‹å–®ä½æˆ–部門。<br /><br />（三）</span> <span style="font-family: 新細明體;">è£½é€ ï¼ˆ</span>manufacture<span style="font-family: 新細明體;">）：指人體細胞組織物之採集ã€è£½ç¨‹ã€è²¯å˜ã€æ¨™ç¤ºã€åŒ…è£ã€é…é€ã€å°æ供者之篩檢與檢驗ç‰éŽç¨‹ä¹‹ä¸€éƒ¨æˆ–全部。<br /><br />（四）</span> <span style="font-family: 新細明體;">æ贈者（</span>donor<span style="font-family: 新細明體;">）：指æä¾›ç´°èƒžæˆ–çµ„ç¹”ï¼Œä¾›è£½é€ äººé«”ç´°èƒžçµ„ç¹”ç‰©ä¹‹äººæˆ–å±é«”。<br /><br />（五）</span> <span style="font-family: 新細明體;">接å—者（</span>recipient<span style="font-family: 新細明體;">）：指接å—人體細胞組織物æ¤å…¥ã€ç§»æ¤ã€è¼¸æ³¨æˆ–轉æ¤ä¹‹äººã€‚<br /><br />（å…）</span> <span style="font-family: 新細明體;">å—貨人（</span>consignee<span style="font-family: 新細明體;">）：指於é…é€éŽç¨‹ä¸ï¼Œæ”¶å—人體細胞組織物之人。<br /><br />（七）</span> <span style="font-family: 新細明體;">採集（</span>recovery<span style="font-family: 新細明體;">）：指從æ贈者ç²å¾—細胞或組織之éŽç¨‹ã€‚<br /><br />（八）</span> <span style="font-family: 新細明體;">處ç†ï¼ˆ</span>processing<span style="font-family: 新細明體;">）：指任何作用於產å“上之行為，包括製備（</span>preparation<span style="font-family: 新細明體;">）ã€æ»…èŒï¼ˆ</span>sterilization<span style="font-family: 新細明體;">）ã€å¤–來病原之去活性化åŠç§»é™¤ï¼ˆ</span>steps to inactivate and remove adventitious agents<span style="font-family: 新細明體;">）ã€é˜²è…以備貯å˜ï¼ˆ</span>preservation for storage<span style="font-family: 新細明體;">）ã€è‡ªè²¯å˜ä¸å–出（</span>removal from storage<span style="font-family: 新細明體;">）ç‰ï¼Œä½†ä¸åŒ…括採集ã€è²¯å˜ã€æ¨™ç¤ºã€åŒ…è£ã€é…é€ã€å°æ贈者之篩檢與檢驗ç‰è¡Œç‚ºã€‚<br /><br />（ä¹ï¼‰</span> <span style="font-family: 新細明體;">貯å˜ï¼ˆ</span>storage<span style="font-family: 新細明體;">）：指ä¿å˜ç”¢å“以供未來之製程或é…é€ã€‚<br /><br />（å）</span> <span style="font-family: 新細明體;">é…é€ï¼ˆ</span>distribution<span style="font-family: 新細明體;">）：指產å“之é‹é€ï¼ˆåŒ…括進å£åŠå‡ºå£ï¼‰ï¼Œä½†ä¸ä»¥æŒæœ‰è©²ç”¢å“者為é™ã€‚<br /><br />（å一）</span> <span style="font-family: 新細明體;">產å“å差（</span>product deviation<span style="font-family: 新細明體;">）：指產å“表ç¾å‡ºå離本è¦ç¯„ã€ç¾è¡Œæ¨™æº–或è¦æ ¼ï¼Œç™¼ç”Ÿä¸è‰¯äº‹ä»¶ç‰æƒ…形。發生ä¸è‰¯äº‹ä»¶ï¼ŒæŒ‡è©²äº‹ä»¶å¯èƒ½ä½¿ç”¢å“傳æ’傳染病原或傳染病至接å—者ã€ä½¿ç”¢å“污染或使產å“之效用或完整性å—åˆ°è² é¢å½±éŸ¿è€…。<br /><br />（å二）</span> <span style="font-family: 新細明體;">客戶怨訴（</span>complaint<span style="font-family: 新細明體;">）：指客戶以書é¢ã€å£é 或電å通訊方å¼æ出之下列申訴：<br /><br /></span>1. <span style="font-family: 新細明體;">產å“傳æ’或å¯èƒ½å‚³æ’傳染病予接å—者。<br /><br /></span>2. <span style="font-family: 新細明體;">產å“之效用或完整性å—æ。<br /><br /></span>3. <span style="font-family: 新細明體;">其他任何å¯èƒ½é•å本è¦ç¯„之產å“相關å•é¡Œã€‚<br /><br /><br /><br />å››ã€</span> <span style="font-family: 新細明體;">本è¦ç¯„æ¢æ¬¾ä¹‹é©ç”¨åŽŸå‰‡<br /><br />（一）</span> <span style="font-family: 新細明體;">æ©Ÿæ§‹åƒ…å¾žäº‹éƒ¨åˆ†è£½é€ è¡Œç‚ºè€…ï¼Œå¾—åƒ…éµå®ˆè©²éƒ¨åˆ†è£½é€ 行為之相關è¦å®šã€‚但機構如以契約ã€å”è°æˆ–其他方å¼ï¼Œåˆ©ç”¨ä»–æ©Ÿæ§‹å¾žäº‹è£½é€ è€…ï¼Œä»æ‡‰ç¢ºä¿è©²è£½é€ 行為符åˆæœ¬è¦ç¯„之è¦å®šã€‚<br /><br />（二）</span> <span style="font-family: 新細明體;">æ ¸å®šç”¢å“符åˆæ”¾è¡Œæ¨™æº–並將其備妥供é…é€ä¹‹æ©Ÿæ§‹ï¼Œä¸è«–其是å¦è‡ªç‚ºé…é€ï¼Œæ‡‰ç¢ºä¿è©²ç”¢å“符åˆæœ¬è¦ç¯„åŠç›¸é—œæ³•ä»¤ä¹‹è¦å®šã€‚<br /><br />（三）</span> <span style="font-family: 新細明體;">本è¦ç¯„æ¢æ¬¾ç¨±ã€Œè¦–情æ³ã€ï¼ˆ</span>where appropriate<span style="font-family: 新細明體;">）時，推定其為強制è¦å®šï¼Œä½†æ©Ÿæ§‹å¾—è‰æ˜Žæœ‰å…¶ä»–é©ç•¶ä¹‹ä»£æ›¿æ–¹æ³•ã€‚惟本è¦ç¯„æ¢æ¬¾ä¹‹è¦å®šæ–¼ä¸‹åˆ—情形視為強制è¦å®šï¼Œå³æ©Ÿæ§‹è‹¥é•å該è¦å®šæ™‚，å¯åˆç†é 期其產å“將無法符åˆæœ‰é—œé˜²æ¢å‚³æŸ“ç—…åŠå…¶ç—…原之導入ã€å‚³æ’åŠæ“´æ•£ä¹‹è¦å®šï¼Œæˆ–é 期該機構將ä¸èƒ½åŸ·è¡Œå¿…è¦è£œæ•‘措施（</span>corrective actions<span style="font-family: 新細明體;">）。<br /><br /><br /><br /><br /></span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">è²³ã€å“質計畫之建立與ç¶æŒ</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五ã€æ©Ÿæ§‹æ‡‰ä¾å…¶æ‰€è£½é€ 人體細胞組織物之性質åŠè£½é€ éŽç¨‹ï¼Œå»ºç«‹ä¸¦ç¶æŒç¬¦åˆæœ¬è¦ç¯„è¦å®šä¹‹å“質計畫（</span>quality program<span style="font-family: 新細明體;">）。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…ã€å“質計畫係為確ä¿ä¸‹åˆ—äº‹é …ä¹‹å¯¦æ–½ï¼š<br /><br />（一）建立並ç¶æŒé©ç•¶çš„作æ¥ç¨‹åºï¼Œä¸”éµå®ˆæœ¬è¦ç¯„ç¬¬è‚†ç« æœ‰é—œç¨‹åºä¹‹è¦å®šã€‚<br /><br />（二）è¨ç½®ä¸‹åˆ—作æ¥ç¨‹åºï¼š<br /><br /></span>1. <span style="font-family: 新細明體;">接收ã€èª¿æŸ¥ã€è©•ä¼°åŠç´€éŒ„相關資訊。<br /><br /></span>2. <span style="font-family: 新細明體;">將任何有關產å“效用與完整性ã€ç”¢å“å¯èƒ½å—污染或有傳染疾病潛在å±éšªä¹‹è³‡è¨Šï¼Œé€šçŸ¥æ”¶ä»¶è€…或曾自åŒä¸€æ供者採集細胞或組織之機構。<br /><br /></span>3. <span style="font-family: 新細明體;">å°æ–¼ç”¢å“é…é€å¾Œæ‰ç²å¾—之資訊，評估其å°ç”¢å“之影響並通知該產å“之é…é€å°è±¡ï¼Œå¿…è¦æ™‚實施檢疫ã€å›žæ”¶ç”¢å“æˆ–é€šå ±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œã€‚<br /><br />（三）採å–å¿…è¦è£œæ•‘措施（</span>corrective actions<span style="font-family: 新細明體;">）（包括產å“缺失（</span>deficiency<span style="font-family: 新細明體;">）之å†ç¨½æ ¸ï¼ˆ</span>reaudits<span style="font-family: 新細明體;">））並製作紀錄。補救措施應為有效，且ä¸æœƒå°ç”¢å“有ä¸è‰¯å½±éŸ¿ã€‚補救措施應視情æ³åŒ…å«è™•ç†è©²å•é¡Œä¹‹ç«‹å³æŽªæ–½åŠé 防缺失å†ç™¼ç”Ÿä¹‹é•·æœŸæŽªæ–½ã€‚<br /><br />å‰é …紀錄，應視情æ³è¨˜è¼‰ä¸‹åˆ—äº‹é …ï¼š<br /><br /></span>1. <span style="font-family: 新細明體;">å—影響產å“之辨è˜åŠè™•ç½®ã€‚<br /><br /></span>2. <span style="font-family: 新細明體;">å•é¡Œä¹‹æ€§è³ªã€‚<br /><br /></span>3. <span style="font-family: 新細明體;">採å–之補救措施。<br /><br /></span>4. <span style="font-family: 新細明體;">採å–補救措施之日期。<br /><br />（四）人員å—到é©ç•¶ä¹‹æ•™è‚²è¨“練。<br /><br />（五）ä¾æœ¬è¦ç¯„è¦å®šå»ºç«‹ä¸¦ç¶æŒå¿…è¦çš„å“質監控機制。<br /><br />（å…）ä¾æœ¬è¦ç¯„è¦å®šå»ºç«‹ä¸¦ç¶æŒç´€éŒ„ä¿å˜æ©Ÿåˆ¶ã€‚<br /><br />（七）ä¾æœ¬è¦ç¯„或其他法令之è¦å®šï¼Œèª¿æŸ¥ã€ç´€éŒ„åŠé€šå ±ç”¢å“å差。上開調查，應包括產å“å差的審查ã€è©•ä¼°ã€åŽŸå› 之判斷ã€æŽ¡å–之補救措施。機構應æ¯å¹´è‡³å°‘一次定期回顧åŠåˆ†æžæ‰€æœ‰ç”¢å“å差，以辨明產å“å差之趨勢，並採å–é©ç•¶é 防措施。機構應ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¹‹é€šçŸ¥ï¼Œæ出分æžå ±å‘Šã€‚<br /><br />（八）實施評估ã€èª¿æŸ¥ã€ç¨½æ ¸åŠå…¶ä»–å¿…è¦æŽªæ–½ï¼Œä»¥ç¢ºä¿éµå®ˆæœ¬è¦ç¯„之è¦å®šã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">七ã€å“質計畫之專責人員<br /><br />æ©Ÿæ§‹æ‡‰æŒ‡æ´¾å°ˆè²¬äººå“¡ï¼Œä¸¦æŽˆæ¬Šå…¶è² è²¬ç¢ºä¿å“質計畫之有效建立與ç¶æŒã€‚該人員應å‘機構管ç†è€…å ±å‘Šå“質計畫之執行情形，æ¯å¹´è‡³å°‘一次。若該人員於機構ä¸å…¼ä»»å…¶ä»–工作，則å°è©²å·¥ä½œä¸å¾—自為最後之監ç£ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…«ã€ç¨½æ ¸<br /><br />（一）本è¦ç¯„所è¦å®šä¹‹å“è³ªç¨½æ ¸ï¼Œæ‡‰æ¯å¹´è‡³å°‘執行一次。必è¦æ™‚ï¼Œä¸¦æ‡‰åŸ·è¡Œç‰¹åˆ¥ç¨½æ ¸ã€‚ç¨½æ ¸æ‡‰ä¾ä¸€å®šç¨‹åºç‚ºä¹‹ï¼Œä»¥ç¢ºä¿å“質計畫之有效執行，辨èªç”¢å“å差之趨å‘åŠé‡è¤‡ç™¼ç”Ÿä¹‹å•é¡Œã€‚<br /><br />（二）å“è³ªç¨½æ ¸äººå“¡é ˆå…·å‚™ç›¸é—œçŸ¥è˜ã€è¨“ç·´èˆ‡ç¶“é©—ã€‚è¢«ç¨½æ ¸äº‹é …ä¹‹ç›´æŽ¥è² è²¬äººå“¡ï¼Œä¸å¾—è‡ªç‚ºç¨½æ ¸äººå“¡ã€‚<br /><br />ï¼ˆä¸‰ï¼‰ç¨½æ ¸æˆ–å†ç¨½æ ¸ä¹‹å ±å‘Šæ‡‰å¦¥ç‚ºä¿å˜ï¼Œäº¤ç”±æ©Ÿæ§‹ç®¡ç†è€…審閱，並製作審閱紀錄。</span> <br /><br /><br /><br /><span style="font-family: 新細明體;">ä¹ã€ä½¿ç”¨é›»è…¦æˆ–自動化資料處ç†è¨å‚™ï¼Œå¾žäº‹æœ‰é—œå“質計畫ã€è£½é€ 或追蹤產å“ã€è³‡æ–™ç´€éŒ„ç‰å·¥ä½œè€…，機構應ä¾è¨ˆç•«ï¼ˆ</span>protocol<span style="font-family: 新細明體;">）å°é›»è…¦è»Ÿé«”之é 期功能執行確效（</span>validate<span style="font-family: 新細明體;">）檢查。如有變更軟體，在批准與發布之å‰ä¹Ÿæ‡‰åŸ·è¡Œç¢ºæ•ˆæª¢æŸ¥ã€‚執行確效檢查與其çµæžœï¼Œæ‡‰è£½ä½œç´€éŒ„。<br /><br /><br /><br />åã€æ‡‰å»ºç«‹ä¸¦ç¶æŒåŸ·è¡Œå“質計畫（å«å“è³ªç¨½æ ¸ï¼‰ä¹‹ä½œæ¥ç¨‹åºã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">åƒã€çµ„織與人員</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å一ã€æ©Ÿæ§‹æ‡‰è¨ç½®é©ç•¶ä¹‹çµ„織架構åŠå……足之工作人員。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å二ã€å·¥ä½œäººå“¡æ‡‰å…·å‚™ç›¸é—œæ•™è‚²èˆ‡ç¶“驗，並僅執行其å¯å‹ä»»ä¹‹è·å‹™ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å三ã€å·¥ä½œäººå“¡æ‡‰æŽ¥å—訓練或繼續教育，並明çžåŸ·è¡Œè·å‹™ä¸ç•¶æ‰€å¯èƒ½é€ æˆçš„後果，如，散布傳染病或其病原之å±éšªã€èˆ‡å‚³æŸ“病或其病原有關之å±å®³ã€ç”¢å“效用與完整性å—ææ‰€é€ æˆä¹‹å±éšªã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">åå››ã€å·¥ä½œäººå“¡ä¹‹æ•™è‚²ã€ç¶“æ·ã€è¨“練與繼續教育之紀錄，應予ä¿å˜ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">肆ã€ä½œæ¥ç¨‹åº</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å五ã€æ©Ÿæ§‹æ‡‰å°±è£½é€ 人體細胞組織物之所有é‡è¦æ¥é©Ÿï¼Œå»ºç«‹ä¸¦ç¶æŒç›¸é—œä½œæ¥ç¨‹åºã€‚<br /><br />å‰é …程åºæ‡‰æ³¨æ„確ä¿ç”¢å“ä¸å«ç›¸é—œçš„傳染病病原ã€ç”¢å“於製程ä¸æœªå—污染ã€ç”¢å“ä¹‹æ•ˆç”¨èˆ‡å®Œæ•´æ€§æœªå› ä¸ç•¶è£½ç¨‹è€Œå—æ，以é¿å…å› ä½¿ç”¨ç”¢å“è€Œå¢žåŠ å°Žå…¥ã€å‚³æ’åŠæ•£å¸ƒå‚³æŸ“病之風險。<br /><br />ç¬¬ä¸€é …ä¹‹ç¨‹åºæ‡‰ç¢ºä¿ç¬¦åˆæœ¬è¦ç¯„之è¦å®šã€‚<br /><br />所有程åºæ–¼å¯¦æ–½å‰ï¼Œæ‡‰ç¶“è² è²¬äººå“¡å¯©æŸ¥ä¸¦æ ¸å‡†ã€‚æ‰€æœ‰ç¨‹åºï¼Œä¸¦æ‡‰æ¯å¹´å®šæœŸå¯©æŸ¥è‡³å°‘一次，必è¦æ™‚，應予修æ£ã€‚上開審查çµæžœï¼Œä¸¦æ‡‰è£½ä½œç´€éŒ„。<br /><br />ç¬¬ä¸€é …ä¹‹ç¨‹åºï¼ŒåŽŸå‰‡ä¸Šæ‡‰æ供相關工作人員於工作地點查閱。<br /><br />任何å離作æ¥ç¨‹åºä¹‹è¡Œç‚ºæ‡‰æœ‰æ£ç•¶ç†ç”±ï¼Œä¸”æ‡‰ç¶“è² è²¬äººå“¡æŒ‡ç¤ºï¼Œä¸¦è£½ä½œç´€éŒ„ã€‚<br /><br 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´æ‰€æ‡‰åŠƒåˆ†æˆå„ç¨ç«‹å·¥ä½œå€åŸŸæˆ–è¨ç½®ç®¡åˆ¶æ©Ÿåˆ¶ï¼Œä»¥é¿å…產å“之ä¸ç•¶æ¨™ç¤ºã€æ··é›œã€æ±¡æŸ“ã€äº¤å‰æ±¡æŸ“或æ„外暴露於傳染病原。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">åå…«ã€æ¸…潔與衛生<br /><br />ï¼ˆä¸€ï¼‰è£½é€ è¨æ–½æˆ–å ´æ‰€æ‡‰ä¿æŒæ¸…æ½”ã€è¡›ç”ŸåŠç§©åºã€‚<br /><br />（二）污水ã€åžƒåœ¾æˆ–其他廢棄物之清ç†ï¼Œæ‡‰æ³¨æ„時效ã€å®‰å…¨åŠè¡›ç”Ÿã€‚<br /><br />（三）機構應建立清潔衛生工作之作æ¥ç¨‹åºï¼Œè©²ç¨‹åºæ‡‰åˆ†æ´¾ç›¸é—œå·¥ä½œï¼Œä¸¦æ述具體工作方法與時間表。<br /><br />（四）主è¦çš„清潔åŠè¡›ç”Ÿå·¥ä½œï¼Œå‡æ‡‰è£½ä½œä¸¦ä¿å˜ç›¸é—œç´€éŒ„。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">陸ã€ç’°å¢ƒç®¡åˆ¶èˆ‡ç›£æŽ§</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">åä¹ã€ç•¶ç’°å¢ƒå¯èƒ½å°ç”¢å“之功能與完整性發生ä¸è‰¯å½±éŸ¿ï¼Œæˆ–引起產å“ã€è¨å‚™ä¹‹æ±¡æŸ“或交å‰æ±¡æŸ“，或使產å“æ„外æ›éœ²æ–¼å‚³æŸ“病病原，則應建立並ç¶æŒæœ‰é—œç’°å¢ƒç®¡åˆ¶ã€ç›£æŽ§åŠæä¾›é©ç•¶æ“作環境之作æ¥ç¨‹åºã€‚該程åºæ‡‰è¦–情æ³æ供下列管制åŠç›£æŽ§æ©Ÿåˆ¶ï¼š<br /><br />（一）溫度與濕度控制。<br /><br />（二）通風與空氣濾淨。<br /><br />（三）工作房與è¨å‚™ä¹‹æ¸…æ½”ã€æ¶ˆæ¯’，以確ä¿ç„¡èŒæ“作。<br /><br />（四）無èŒæ“作環境控制è¨å‚™ä¹‹ç¶è·ä¿é¤Šã€‚<br /><br />（五）環境ä¸ç”Ÿç‰©ï¼ˆ</span>organisms<span style="font-family: 新細明體;">）之監控。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二åã€ç’°å¢ƒç®¡åˆ¶æ©Ÿåˆ¶æ‡‰å®šæœŸæª¢æŸ¥ï¼Œè©•æ ¸å…¶å¦¥é©æ€§åŠåŠŸèƒ½ã€‚å¿…è¦æ™‚，應採å–é©ç•¶è£œæ•‘措施。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二å一ã€åŸ·è¡Œç’°å¢ƒç®¡åˆ¶åŠç›£æŽ§ï¼Œæ‡‰è£½ä½œä¸¦ä¿å˜ç›¸é—œç´€éŒ„。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">柒ã€è¨å‚™</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二å二ã€ä¾›è£½é€ 使用之è¨å‚™ï¼Œæ‡‰ä¾å…¶é 定功能妥為è¨è¨ˆã€å®‰è£ï¼Œä¸¦ç½®æ–¼é©ç•¶åœ°é»žä»¥ä¾¿æ“作（å«æ¸…潔與ç¶è·ï¼‰ï¼Œä¸”應ä¸è‡´å°ç”¢å“產生ä¸è‰¯å½±éŸ¿ã€‚供檢查ã€æ¸¬é‡æˆ–測試使用之自動化ã€æ©Ÿæ¢°å¼ã€é›»åå¼ã€é›»è…¦æˆ–其他è¨å‚™ï¼Œæ‡‰èƒ½ç”¢ç”Ÿæœ‰æ•ˆçµæžœã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二å三ã€ç‚ºé¿å…æ•…éšœã€æ±¡æŸ“ã€äº¤å‰æ±¡æŸ“ã€ç™¼ç”Ÿä½¿ç”¢å“暴露於傳染病病原之æ„外事件或其他å°ç”¢å“效用與完整性有ä¸è‰¯å½±éŸ¿ä¹‹äº‹ä»¶ï¼Œå°±è¨å‚™ä¹‹æ¸…æ½”ã€æ¶ˆæ¯’åŠä¿é¤Šå·¥ä½œï¼Œæ‡‰å»ºç«‹ä¸¦ç¶æŒå…¶ä½œæ¥ç¨‹åºã€‚è¨å‚™ä¹‹æ¸…æ½”ã€æ¶ˆæ¯’åŠä¿é¤Šï¼Œæ‡‰ä¾æ—¢å®šæ™‚間表實施。<br /><br />二åå››ã€ä¾›æª¢æŸ¥ã€æ¸¬é‡æˆ–測試使用之自動化ã€æ©Ÿæ¢°å¼ã€é›»åå¼ã€é›»è…¦æˆ–其他è¨å‚™ï¼Œæ‡‰ä¾æ—¢å®šä½œæ¥ç¨‹åºåŠæ™‚é–“è¡¨å¯¦æ–½æ ¡æº–ã€‚æ ¡æº–ä½œæ¥ç¨‹åºï¼Œæ‡‰åŒ…括明確之說明，åŠæœ‰ç„¡å¯ä¾›é©ç”¨ä¹‹æº–確度與精密度é™å€¼ã€‚ç•¶æ ¡æº–æœªé”到準確度與精密度之é™å€¼æ™‚，應採å–補救措施é‡æ–°è¨å®šé™å€¼ï¼Œä¸¦è©•ä¼°å…¶å°ç”¢å“之ä¸è‰¯å½±éŸ¿ã€‚<br /><br />二å五ã€æ‡‰å®šæœŸæª¢æŸ¥è¨å‚™ä¹‹æ½”淨度ã€è¡›ç”Ÿèˆ‡æ ¡æº–，以確ä¿è¨å‚™ä¿é¤Šå·¥ä½œæŒ‰è¡¨è½å¯¦ã€‚<br /><br />二åå…ã€æœ¬ç« è¦å®šä¹‹ä¿é¤Šã€æ¸…æ½”ã€è¡›ç”Ÿã€æ ¡æº–ç‰å·¥ä½œï¼Œå‡æ‡‰è£½ä½œä¸¦ä¿å˜ç›¸é—œç´€éŒ„。最近期間之紀錄應置於å„該è¨å‚™è™•ä¾›æŸ¥é–±ã€‚è¨å‚™ä¹‹ä½¿ç”¨ç´€éŒ„（包括該è¨å‚™æ‰€è£½é€ 產å“之辨è˜ç¢¼ï¼‰ï¼Œæ‡‰äºˆä¿å˜ã€‚<br /><br /><br /><br />æŒã€ç‰©æ–™èˆ‡è©¦åŠ‘</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二å七ã€æ©Ÿæ§‹å°±å—é ˜ä¾›è£½é€ äººé«”ç´°èƒžçµ„ç¹”ç‰©ä½¿ç”¨ä¹‹ç‰©æ–™èˆ‡è©¦åŠ‘ï¼Œæ‡‰å»ºç«‹åŠç¶æŒå…¶é€²è²¨ä½œæ¥ç¨‹åºï¼Œä¸¦æŸ¥æ ¸å…¶æ˜¯å¦ç¬¦åˆè¦æ ¼ï¼Œä¸”æ–¼æŸ¥æ ¸å®Œæˆå‰ï¼Œä¸å¾—使用。<br /><br />å‰é …è¦æ ¼ä¿‚指與é¿å…å› ç”¢å“污染ã€ç”¢å“效用與完整性å—æ所致導入ã€å‚³æ’ã€æ•£å¸ƒå‚³æŸ“ç—…ä¹‹é¢¨éšªå¢žåŠ æœ‰é—œä¹‹è¦æ ¼ã€‚<br /><br />ç¬¬ä¸€é …ä¹‹æŸ¥æ ¸å¾—ç”±è£½é€ æ©Ÿæ§‹æˆ–ä¾›æ‡‰å•†å¯¦æ–½ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二åå…«ã€è™•ç†æˆ–ä¿å˜äººé«”細胞組織物所使用之試劑，應具有與使用目相當之å“質ç‰ç´šï¼›å¿…è¦æ™‚，並應為無èŒã€‚æ©Ÿæ§‹è‡ªè£½è©¦åŠ‘è€…ï¼Œå…¶è£½é€ ç¨‹åºæ‡‰ç¶“ç¢ºæ•ˆæª¢æŸ¥ä¸”ï¼ˆæˆ–ï¼‰ç¶“æŸ¥æ ¸ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">二åä¹ã€ä¸‹åˆ—紀錄應予ä¿å˜ï¼š<br /><br />（一）進貨紀錄，包括類型ã€è£½é€ 商ã€æ‰¹è™Ÿï¼ˆ</span>lot number<span style="font-family: 新細明體;">）ã€é€²è²¨æ—¥æœŸåŠæœ‰æ•ˆæœŸé™ã€‚<br /><br />ï¼ˆäºŒï¼‰æŸ¥æ ¸ç´€éŒ„ï¼ˆåŒ…æ‹¬æŸ¥æ ¸çµæžœï¼‰ï¼Œå¦‚ç”±ä¾›æ‡‰å•†æŸ¥æ ¸ï¼Œå‰‡ç‚ºä¾›æ‡‰å•†å‡ºå…·ä¹‹æŸ¥æ ¸è‰æ˜Žã€‚<br /><br />ï¼ˆä¸‰ï¼‰ä½¿ç”¨ç´€éŒ„ï¼ŒåŒ…æ‹¬ä½¿ç”¨è©²ç‰©æ–™æˆ–è©¦åŠ‘æ‰€è£½é€ äººé«”ç´°èƒžçµ„ç¹”ç‰©ä¹‹è¾¨è˜ç¢¼ã€‚<br /><br />玖ã€è£½ç¨‹ç®¡åˆ¶</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三åã€é–‹ç™¼ã€å¯¦æ–½ã€ç®¡åˆ¶åŠç›£æŽ§è£½é€ 程åºæ™‚，應注æ„確ä¿å…¶äººé«”細胞組織物符åˆè¦æ ¼ï¼Œæœªå—污染，具有其效用與完整性，且é¿å…散布傳染病。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三å一ã€ç•¶è£½ç¨‹ä¸ä½¿ç”¨ä¹‹æ料，å¯èƒ½å°äººé«”細胞組織物之效用或完整性有ä¸è‰¯å½±éŸ¿æ™‚，機構應就該æ料之使用與移除工作，建立並ç¶æŒå…¶ä½œæ¥ç¨‹åºï¼Œä»¥ç¢ºä¿è©²æ料已被移除或控制在ä¸æœƒå°ç”¢å“效用或完整性有ä¸è‰¯å½±éŸ¿ä¹‹æ¿ƒåº¦å…§ã€‚該æ料之移除或控制，並應製作紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三å二ã€æŽ¡é›†è‡ªä¸åŒæ供者之細胞組織，ä¸æ‡‰åœ¨è£½é€ éŽç¨‹ä¸æ··é›œï¼ˆ</span>pooling<span style="font-family: 新細明體;">）（指物ç†ä¸Šä¹‹æŽ¥è§¸æˆ–在åŒä¸€å®¹å™¨å…§æ··åˆï¼‰ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三å三ã€æ©Ÿæ§‹æ‡‰è¦–情æ³å»ºç«‹ä¸¦ç¶æŒä¸€å®šä¹‹ä½œæ¥ç¨‹åºï¼Œä»¥ç¢ºä¿å…¶è£½ç¨‹ä¸ä¹‹ä¸é–“產å“是å¦ç¬¦åˆç‰¹å®šè¦æ ¼ã€‚該程åºæ‡‰ç¢ºä¿ä¸é–“產å“，於完æˆæª¢æŸ¥ã€æ¸¬è©¦æˆ–å…¶ä»–æŸ¥æ ¸å‰ï¼Œæˆ–æ–¼å–得批准åŠå…¶è¨˜éŒ„å‰ï¼Œå—到é©ç•¶ç®¡åˆ¶ã€‚ä¸é–“產å“之檢查å–樣，應足以代表擬被評估之æ料。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾ã€è£½ç¨‹è®Šæ›´</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三åå››ã€è£½ç¨‹ä¹‹è®Šæ›´ï¼Œæ‡‰å»ºç«‹ä¸¦ç¶æŒä¸€å®šä¹‹ä½œæ¥ç¨‹åºã€‚<br /><br />製程之變更應接å—æŸ¥æ ¸ï¼ˆ</span>verify<span style="font-family: 新細明體;">）或確效（</span>validate<span style="font-family: 新細明體;">）檢查，以確ä¿å…¶ä¸è‡´é€ æˆä¸è‰¯å½±éŸ¿ï¼Œä¸¦æ‡‰ç¶“具備相關專æ¥çŸ¥è˜ä¹‹è² è²¬äººå“¡æ ¸å‡†å¾Œï¼Œå§‹å¾—å¯¦æ–½ã€‚<br /><br />三å五ã€è£½ç¨‹ä¹‹è®Šæ›´æ‡‰è£½ä½œç´€éŒ„，包括變更之ç†ç”±ã€å¯¦æ–½æ—¥æœŸã€è®Šæ›´ä¹‹å…§å®¹ã€ä½µåŒä¿®æ£ä¹‹ç›¸é—œæ–‡ä»¶é¡žç›®ã€æ ¸å‡†è€…之簽åã€æ ¸å‡†æ—¥æœŸåŠç”Ÿæ•ˆæ—¥æœŸã€‚ç¶“æ ¸å‡†ä¹‹è£½ç¨‹è®Šæ›´æ‡‰åŠæ™‚通知相關人員。<br /><br /><br /><br />拾壹ã€è£½ç¨‹ä¹‹ç¢ºæ•ˆï¼ˆ</span>validation<span style="font-family: 新細明體;">）檢查</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三åå…ã€ç•¶æŸä¸€è£½ç¨‹ä¹‹çµæžœï¼Œç„¡æ³•è—‰ç”±å¾ŒçºŒçš„æª¢æŸ¥èˆ‡æ¸¬è©¦ï¼Œæ¾ˆåº•æŸ¥æ ¸ï¼Œå‰‡è©²è£½ç¨‹æ‡‰ä¾ä¸€å®šä½œæ¥ç¨‹åºåŸ·è¡Œç¢ºæ•ˆæª¢æŸ¥ï¼Œä¸¦ç¶“æ ¸å‡†ã€‚åŸ·è¡Œç¢ºæ•ˆæª¢æŸ¥ä¹‹å…§å®¹åŠçµæžœæ‡‰è£½ä½œç´€éŒ„ï¼Œç”±è² è²¬æ ¸å‡†äººå“¡ç°½åä¸¦åŠ è¨»æ—¥æœŸã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三å七ã€äººé«”細胞組織物標示或宣傳資料涉åŠè£½ç¨‹æ™‚，例如滅èŒæˆ–病毒去活性化ç‰ï¼Œè©²è£½ç¨‹æ‡‰ç¶“確效檢查。機構並應ä¿å˜ä¸Šé–‹ç¢ºæ•ˆè‰æ˜Žæ–‡ä»¶ï¼Œä¾›ä¸»ç®¡æ©Ÿé—œæŸ¥å» 時審閱。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三åå…«ã€è™•ç†ç¡¬è…¦è†œï¼ˆ</span>dura matter<span style="font-family: 新細明體;">）應採用經確效檢查之製程。上開製程應於ä¿æŒç”¢å“臨床效用åŒæ™‚，è¨æ³•é™ä½Žå‚³æŸ“性海棉狀腦病變（</span>transmissible spongiform encephalopathy<span style="font-family: 新細明體;">）之機率。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">三åä¹ã€å°æ–¼ç¶“確效之製程，應è¨ç½®ç›£æ¸¬åŠç®¡åˆ¶ä¹‹ä½œæ¥ç¨‹åºï¼Œä»¥ç¢ºä¿å…¶æŒçºŒéµå®ˆç›¸é—œè¦æ±‚。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››åã€å°æ–¼ç¶“確效之製程，如有變更原製程或å離原作æ¥ç¨‹åºä¹‹è¡Œç‚ºæ™‚，機構應予審查åŠè©•ä¼°ï¼Œè¦–情æ³åŸ·è¡Œå†ç¢ºæ•ˆï¼ˆ</span>revalidation<span style="font-family: 新細明體;">）檢查，並製作紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾貳ã€æ¨™ç¤ºç®¡åˆ¶</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››å一ã€äººé«”細胞組織物之標示，應有管制作æ¥ç¨‹åºï¼ˆå¦‚標示æ£ç¢ºæ€§ã€æ˜“讀性åŠå®Œæ•´æ€§ä¹‹æŸ¥æ ¸ï¼‰ï¼Œä»¥ç¢ºä¿ç”¢å“之辨è˜ä¸¦é˜²æ¢ç”¢å“混雜。上開程åºæ‡‰ç¢ºä¿ç”¢å“之標示符åˆæœ¬è¦ç¯„åŠç›¸é—œæ³•ä»¤è¦å®šï¼Œä¸¦ç¢ºä¿ç”¢å“æ–¼é…é€æ™‚ï¼Œé™„æœ‰æ ¸å®šæ供者åˆé©æ€§ï¼ˆ</span>donor suitability<span style="font-family: 新細明體;">）之文件。<br /><br />拾åƒã€è²¯å˜</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››å二ã€æ©Ÿæ§‹æ‡‰ç®¡åˆ¶è²¯å˜èˆ‡å€‰å„²å€åŸŸï¼Œä»¥é˜²æ¢äººé«”細胞組織物或物料之混雜ã€æ··æ·†ã€è®Šè³ªã€æ±¡æŸ“ã€äº¤å‰æ±¡æŸ“åŠä»»ä½•å°ç”¢å“效用與完整性之ä¸è‰¯å½±éŸ¿ï¼Œä¸¦é˜²æ¢ä¸ç•¶ä¹‹æ”¾è¡Œï¼ˆ</span>release for distribution<span style="font-family: 新細明體;">）。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››å三ã€æº«åº¦<br /><br />（一）</span> <span style="font-family: 新細明體;">人體細胞組織物應貯å˜æ–¼é©ç•¶ä¹‹æº«åº¦ï¼Œä¸”ä¸å¾—逾越貯å˜æœŸé™ã€‚<br /><br />（二）</span> <span style="font-family: 新細明體;">å„é …è£½ç¨‹ä¸ä¹‹è²¯å˜æº«åº¦ç¯„åœï¼Œæ‡‰äºˆç¢ºç«‹ï¼Œä»¥ç¢ºä¿ç”¢å“效用與完整性，防æ¢ç”¢å“變質，並抑制傳染病病原之生長。<br /><br />（三）</span> <span style="font-family: 新細明體;">貯å˜ä¹‹æº«åº¦æ‡‰å¦¥ç‚ºç¶æŒï¼Œä¸¦è£½ä½œç´€éŒ„。上開紀錄應定期檢查，以確ä¿æº«åº¦æœªé€¾è¶Šç¯„åœã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››åå››ã€äººé«”細胞組織物應視情æ³ä¾ä¸‹åˆ—å› ç´ è¨‚å®šå…¶æœ‰æ•ˆæœŸé–“ï¼š<br /><br />（一）</span> <span style="font-family: 新細明體;">產å“種類。<br /><br />（二）</span> <span style="font-family: 新細明體;">è£½é€ ç¨‹åºï¼ˆå«ä¿å˜æ–¹æ³•ï¼‰ã€‚<br /><br />（三）</span> <span style="font-family: 新細明體;">貯å˜æ¢ä»¶ã€‚<br /><br />（四）</span> <span style="font-family: 新細明體;">包è£ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››å五ã€å› 故無法符åˆè²¯å˜æ¢ä»¶æ™‚，應採å–矯æ£æŽªæ–½ä¸¦è£½ä½œç´€éŒ„。<br /><br /><br /><br />拾肆ã€æ”¶å—與é…é€</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››åå…ã€æ©Ÿæ§‹æ‡‰å°±äººé«”細胞組織物之收å—</span>/<span style="font-family: 新細明體;">進料（</span>receipt<span style="font-family: 新細明體;">）ã€é©—收或退回</span>(acceptance or rejection)<span style="font-family: 新細明體;">ã€é…é€ã€åŠéŠ·æ¯€æˆ–廢棄（</span>destruction or other disposition<span style="font-family: 新細明體;">），建立並ç¶æŒä½œæ¥ç¨‹åºï¼Œä¸”製作紀錄。<br /><br />å‰é …ç´€éŒ„æ‡‰è¨˜è¼‰ä¸‹åˆ—äº‹é …ï¼š<br /><br />（一）人體細胞組織物之辨è˜ç¢¼ã€‚<br /><br />（二）作æ¥å…§å®¹èˆ‡çµæžœã€‚<br /><br />（三）作æ¥æ—¥æœŸã€‚<br /><br />（四）人體細胞組織物數é‡ã€‚<br /><br />（五）人體細胞組織物之廢棄處置，如å—貨人資料（</span>identity of consignee<span style="font-family: 新細明體;">）。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››å七ã€ç‚ºè™•ç†ã€é…é€æˆ–å…¶ä»–è£½é€ ä½œæ¥ï¼Œè€Œæ”¶å—（進料）ã€é©—收或退回人體細胞組織物，應建立並ç¶æŒä¸€å®šä¹‹ä½œæ¥ç¨‹åºã€‚收å—äººé«”ç´°èƒžçµ„ç¹”ç‰©ï¼ˆé€²æ–™ï¼‰å¾Œï¼Œæ‡‰ç«‹åˆ»æŸ¥æ ¸å…¶ç•¶æ™‚ç‹€æ³ï¼ˆå¦‚有關檢疫ã€æ贈者篩檢與檢驗ã€ç”¢å“處ç†ä¹‹ç‹€æ³ï¼‰ï¼Œä¸¦ä¾ç”¢å“ç‹€æ³å¦¥ç‚ºè™•ç½®ã€‚收å—人體細胞組織物（進料）後，應ä¾ä¸€å®šç¨‹åºæª¢æŸ¥ç”¢å“有無æ害ã€æ±¡æŸ“ã€è®Šè³ªã€æˆ–完整性å—æ之ç¾è±¡ã€‚驗收或退回應製作紀錄。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››åå…«ã€äººé«”細胞組織物之é…é€ï¼Œæ‡‰å»ºç«‹ä¸¦ç¶æŒä¸€å®šä½œæ¥ç¨‹åºï¼ˆå¦‚產å“放行標準），å°æ–¼æª¢ç–«ä¸ã€å—到污染ã€å·²è®Šè³ªã€é•å本è¦ç¯„æ‰€è£½é€ ã€ä¾†è‡ªä¸åˆé©ä¹‹æ贈者ã€æˆ–未完æˆæ贈者åˆé©æ€§è©•å®šä¹‹ç”¢å“，應ä¸äºˆæ”¾è¡Œã€‚人體細胞組織物é…é€å‰ï¼Œæ©Ÿæ§‹æ‡‰æŸ¥æ ¸ä¸¦è¨˜éŒ„其是å¦ç¬¦åˆæ”¾è¡Œæ¨™æº–，且審閱該人體細胞組織物所有相關記錄。é…é€ä¹‹æ ¸å‡†æ‡‰ç”±è² è²¬äººå“¡è£½ä½œè¨˜éŒ„ä¸¦åŠ è¨»æ—¥æœŸã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å››åä¹ã€ç”¢å“包è£èˆ‡é‹é€å®¹å™¨ä¹‹è¨è¨ˆã€ç¢ºæ•ˆæª¢æŸ¥ã€è£½ä½œï¼Œæ‡‰ç¢ºä¿ç”¢å“效用與完整性，並防æ¢ç”¢å“在通常之處ç†ã€è²¯å˜ã€ä½œæ¥æˆ–é…é€éŽç¨‹ä¸ï¼Œç™¼ç”Ÿæ害ã€è®Šè³ªã€æ±¡æŸ“或其他ä¸è‰¯å½±éŸ¿ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五åã€æ‡‰è¨‚定é‹é€å„類人體細胞組織物應éµå®ˆä¹‹é‹é€æ¢ä»¶ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五å一ã€æ‡‰å»ºç«‹ä¸¦ç¶æŒçš„程åºï¼Œç•¶ç”¢å“被退回機構，據以決定該產å“是å¦åˆé©æ¸å…¥ç›¤å˜ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾ä¼ã€ç´€éŒ„</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五å二ã€ä¾æœ¬è¦ç¯„è¦æ±‚，執行é‡è¦æ¥é©Ÿï¼Œæ‡‰åŒæ¥ç¶æŒæ–½è¡Œæˆæ•ˆä¹‹ç´€éŒ„。æ¤è¦ç¯„ä¸è¿°åŠä¹‹è¡Œå‹•ï¼Œé ˆæœ‰æ–‡ä»¶åŒ–之è‰æ˜Žç´€éŒ„據以顯示守法性。所有紀錄應屬準確ã€ä¸å¾—銷毀與易讀。凡涉åŠç‰¹å®šäººé«”細胞組織物相關è¯ä¹‹äººï¼ˆéƒ¨é–€ã€åŸ·äº‹è€…）ã€äº‹ï¼ˆåŸ·è¡Œç¶“æ·ï¼‰ã€åœ°ã€ç‰©ã€æ™‚（日期ã€æ™‚間）詳細紀錄足供鑑別。紀錄之ä¿å…¨ç³»çµ±ï¼Œæ‡‰è¶³ä»¥ä¿è‰äººé«”細胞組織物的æ供者與接å—者資料的機密性。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五å三ã€æ‡‰å»ºç«‹åŠç¶æŒç´€éŒ„管ç†ç³»çµ±ã€‚在æ¤ç³»çµ±ä¹‹ä¸‹ï¼Œæœ‰é—œè£½é€ 特定人體細胞組織物的紀錄，應予ä¿å˜æ–¼æ·å²æª”案，有助於產å“經銷å‰ã€æˆ–å¿…è¦æ™‚å°ç”¢å“釋出後之審查，以作為追蹤評估或調查資料之一部分。附屬於生產æ¯ç¨®åž‹å¼äººé«”細胞組織物的紀錄（例如：程åºã€è¦æ ¼ã€æ¨™ç¤ºåŠåŒ…è£ç¨‹åºã€è¨å‚™æ—¥èªŒï¼‰æ‡‰åœ¨ç´€éŒ„管ç†ç³»çµ±ä¸‹é‹ä½œèˆ‡ç¶è·ä¹‹ã€‚倘紀錄分散多處ä¿ç®¡ï¼Œå‰‡ç´€éŒ„管ç†ç³»çµ±æ‡‰ç¶“è¨è¨ˆä»¥ä¿è‰èƒ½è¿…速辨èªã€å„²ä½åŠæª¢ç´¢æ‰€æœ‰ç´€éŒ„。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五åå››ã€æ‡‰å»ºç«‹ä¸¦ç¶æŒç¨‹åºï¼Œä»¥ä¿è‰éµå®ˆæœ¬è¦ç¯„è¦å®šä¿ç®¡ç´€éŒ„è¦æ±‚，並應ä¿å˜æœ‰é—œå‚³æŸ“病測試çµæžœèˆ‡è©®é‡‹æ–‡ä»¶ï¼Œå…¶ä¸åŒ…括測試實驗室的å稱與地å€ã€‚應建立篩檢æ供者相關傳染病之çµæžœèˆ‡è©®é‡‹æ–‡ä»¶ä¸¦ç¶æŒä¹‹ã€‚應ç¶æŒæ ¸æ±ºæ供者é©åˆ‡æ€§æ–‡ä»¶ï¼ŒåŒ…括權責者姓ååŠæ ¸æ±ºæ—¥æœŸã€‚有關æ供者身分åŠç›¸é—œé†«ç™‚紀錄ç‰è³‡è¨Šï¼Œæ‡‰ä½¿ç”¨ä¸æ–‡ï¼›å€˜æ–‡ä»¶ä½¿ç”¨å…¶ä»–語言，則應翻è¯æˆä¸æ–‡ï¼Œä¸¦é™„上該特定翻è¯æ–‡ä»¶ä¹‹ç¿»è¯è€…有關æ£ç¢ºç„¡è¨›çš„實ç†è²æ˜Žã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五å五ã€ç´€éŒ„得以電åå½¢å¼ã€åŽŸå§‹æ›¸é¢ç´€éŒ„或照片寫真ã€é¡¯å¾®åº•ç‰‡ç‰ˆã€æˆ–å¾®è† ç‰‡ä¿å˜ï¼Œåœ¨æ¤æƒ…æ³ä¸‹ï¼Œåˆé©çš„閱讀機或複製è¨å‚™æ‡‰èƒ½ä¾¿æ˜“地ç²å¾—。儲å˜æ–¼è‡ªå‹•è³‡æ–™è™•ç†ç³»çµ±ä¹‹ç´€éŒ„應有備份。電å文件與電åç°½ç« ï¼Œæ‡‰éµç…§é›»åç°½ç« æ³•åŠå…¶ä»–相關è¦å®šè¾¦ç†ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五åå…ã€ç´€éŒ„應ä¿å˜å年，然而，凡有關人體細胞組織物的紀錄，於產å“æ¤å…¥æ‰‹è¡“ã€ç”¢å“移æ¤æ‰‹è¡“ã€æˆ–注入與機轉æˆç”¢å“之日期以後，應還增長ä¿å˜æ™‚間至少å年；倘產å“æ¤å…¥æ‰‹è¡“ã€ç”¢å“移æ¤æ‰‹è¡“ã€æˆ–注入與機轉æˆç”¢å“之日期並ä¸ç¢ºå®šæ™‚，於產å“é…é€ã€å»¢æ£„或éŽæœŸä¹‹æ—¥æœŸä»¥å¾Œï¼Œè‡³å°‘å†ä¿å˜å年。腦膜樣本經é©ç•¶æ‹‹æ£„處置後，該腦膜樣本檔案應該è¦ä¿å˜å年。機構應é å‚™è¬ä¸€æ‡æ¥ä¹‹å¾Œï¼Œæ‰€æœ‰ç´€éŒ„ä»èƒ½ä¾ç…§è¦å®šè¦æ±‚之期é™ä¿å˜ä¹‹ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五å七ã€å¥‘ç´„ã€å§”è¨—ç”±å…¶ä»–æ©Ÿæ§‹è£½é€ åŠ å·¥ä¹‹å”è°ã€æˆ–是åˆè°å‡æ‡‰å»ºç«‹ä¸¦ç¶æŒã€‚該ç‰ç´€éŒ„應包å«å°æ–¹æ©Ÿæ§‹å稱ã€åœ°å€åŠåˆç´„ã€ä»¥åŠå”è°é—œä¿‚人之權責或其他åˆè°ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾陸ã€è¿½è¹¤</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五åå…«ã€æ©Ÿæ§‹è£½é€ äººé«”ç´°èƒžçµ„ç¹”ç‰©ï¼Œæ‡‰æ ¹æ“šæœ¬è¦ç¯„追蹤製程ä¸ä»»ä½•æ¥é©Ÿä¹‹æ¯å€‹ç”¢å“。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">五åä¹ã€ç”¢å“追蹤方法<br /><br />（一）機構應建立並ç¶æŒç”¢å“追蹤方法，據以追蹤人體細胞組織物：<br /><br /></span>1<span style="font-family: 新細明體;">ã€å¾žæ供者到接å—者ã€ä»¥è‡³æœ€çµ‚處置。<br /><br /></span>2<span style="font-family: 新細明體;">ã€æŽ¥å—者或æ供者的最終處置。<br /><br />（二）機構éžå®Œå…¨ç¨è‡ªåŸ·è¡Œäººé«”細胞組織物製程，部分æ¥é©Ÿä¿‚責æˆå…¶ä»–åˆ†åŒ…å•†åŸ·è¡Œï¼Œæ©Ÿæ§‹åƒ…é ˆç¬¦åˆæ¤ç¯€è¿½è¹¤æ–¹æ³•ä¹‹è¦å®šï¼Œå¾—由收託分包商就其製程部分，建立åŠç¶æŒè½„下產å“追蹤方法。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…åã€æ©Ÿæ§‹æ‡‰ä¿è‰æ‰€ç”Ÿç”¢æ¯å€‹äººé«”細胞組織物，å‡å—分派與標示明確之辨è˜ç¢¼ï¼Œä½œç‚ºè¿½è¹¤æ–¹æ³•ä¹‹ä¸€éƒ¨åˆ†ï¼Œä¾‹å¦‚，採行å—æ¯æ•¸å—é †åºã€é—œè¯ç”¢å“與æ供者以åŠäº¤ä»˜ç”¢å“之全部紀錄。除éžè‡ªè‡ªé«”æ贈或指定æ贈之情æ³ä¸‹ï¼Œé€™é¡žè™Ÿç¢¼å¿…é ˆç‰¹å®šè£½ä½œä»¥åˆ©è¿½è¹¤ï¼Œè€Œä¸”å¾—ä¸åŒ…å«å€‹äººçš„姓åã€å¥åº·ä¿éšªæˆ–ç—…æ·è™Ÿç¢¼ï¼Œæ©Ÿæ§‹å¾—採ç´å…¶ä»–åƒèˆ‡è£½é€ éŽç¨‹ä¹‹åˆ†åŒ…商所分派之編碼ã€æˆ–自行å†å¦æ–°åˆ†æ´¾ä»£ç¢¼ã€‚機構應該è¦å»ºç«‹ä¸¦ç¶æŒç¨‹åºï¼Œæ“šä»¥é—œé€£æ–°èˆŠä»£ç¢¼ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…å一ã€æ©Ÿæ§‹æ‡‰ä¿è‰ç¶“æ¤å…¥ã€ç§»æ¤ã€è¼¸å…¥ã€è½‰ç§»è‡³æŽ¥å—者之人體細胞組織物辨è˜ä»¶åŠåž‹å¼ï¼Œéƒ½è¨˜è¼‰æ–¼æŽ¥å—者之病æ·ã€æˆ–相關è¯ä¹‹ç´€éŒ„ï¼Œä½œç‚ºè¿½è¹¤æ–¹æ³•ä¹‹ä¸€éƒ¨åˆ†ï¼Œä½¿èƒ½å¤ è‡ªæŽ¥å—者追蹤至æ供者。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…å二ã€æ©Ÿæ§‹æ‡‰ç™»è¼‰ä¸¦ç¶æŒæ¯ä»¶äººé«”ç´°èƒžçµ„ç¹”ç‰©çš„æœ€çµ‚è™•ç½®ç´€éŒ„ï¼Œä½œç‚ºè¿½è¹¤æ–¹æ³•ä¹‹ä¸€éƒ¨åˆ†ï¼Œä½¿èƒ½å¤ è‡ªæ供者追蹤至接å—者或最終處置。必è¦æ™‚，應ç¶è·è³‡è¨Šï¼Œä½¿èƒ½å¤ 立刻鑑別產å“之接å—者。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…å三ã€æ©Ÿæ§‹å°‡äººé«”細胞組織物é…é€äºˆæ”¶ä»¶è€…時或之å‰ï¼Œæ‡‰ä»¥æ›¸é¢æ–¹å¼å‘ŠçŸ¥æ”¶ä»¶è€…æ¤ç¯€ä¹‹è¦å®šè¦æ±‚，åŠè©²æ”¶å—æ©Ÿæ§‹é ˆéµå®ˆè¦å®šå»ºç«‹ä¸¦ç¶æŒè¿½è¹¤æ–¹æ³•ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…åå››ã€ç¡¬è…¦è†œæ贈者特別è¦æ±‚<br /><br />æ¯ä½ç¡¬è…¦è†œæ贈者應ä¿ç®¡é©ç•¶ä¹‹æ¨£æœ¬å˜æª”，貯å˜åœ¨é©ç•¶ä¹‹æ¢ä»¶ç¯„åœï¼Œæ–¼è²¯å˜é©ç•¶ä¹‹æœŸé–“ï¼Œä½¿èƒ½å¤ æ¸¬è©¦å˜æª”物質是å¦å…·æœ‰å‚³æŸ“海綿性腦病變之的è‰æ“šï¼Œä»¥åŠå¿…è¦æ™‚，å°å—影響之硬腦膜作é©ç•¶çš„棄置。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾柒ã€æ€¨è¨´æª”案</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…å五ã€æ©Ÿæ§‹æ‡‰å»ºç«‹ä¸¦ç¶æŒç¨‹åºï¼Œæ“šä»¥ç«‹å³é€²è¡Œæ‰€æœ‰æ€¨è¨´ä¹‹å¯©æŸ¥ã€è©•ä¼°ï¼Œä¸¦äºˆä»¥æ–‡ä»¶åŒ–è‰æ˜Žï¼›å¿…è¦æ™‚，包å«èª¿æŸ¥æ´»å‹•ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…åå…ã€æ©Ÿæ§‹æ‡‰ç¶æŒæ‰€æ”¶åˆ°æ¯ä»¶æ€¨è¨´æª”案之紀錄，怨訴檔案，應包å«è¶³å¤ 之怨訴資訊，以便é©åˆçš„審查與評估怨訴，包括怨訴æåŠäººé«”細胞組織物的辨è˜ä»¶ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŽˆæ¬Šä¹‹äººå“¡è¦æ±‚下，怨訴檔案應能æ供審查åŠå½±å°ã€‚</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">å…å七ã€æ¯ä»¶æ€¨è¨´æ‡‰äºˆå¯©æŸ¥åŠè©•ä¼°ï¼Œä»¥åˆ¤åˆ¥è©²æ€¨è¨´æ˜¯å¦èˆ‡äººé«”細胞組織物的å差或ä¸è‰¯å應（</span>adverse reaction<span style="font-family: 新細明體;">）有關，ä¾è—¥ç‰©ä¸è‰¯é€šå ±ä½œæ¥ç³»çµ±æˆ–其他é©ç”¨è¦å‰‡æ±ºå®šæ˜¯å¦é ˆä½œé€šå ±ã€‚æ¯ä»¶æ€¨è¨´æ¶‰åŠé ˆé€šå ±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œäº‹ä»¶è€…，應åŠæ™‚審查ã€è©•ä¼°åŠèª¿æŸ¥ã€‚倘怨訴ä¸é ˆé€šå ±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œäº‹ä»¶è€…，應予審查ã€è©•ä¼°ä»¥æ±ºå®šæ˜¯å¦éœ€è¦èª¿æŸ¥ï¼›èª¿æŸ¥æ´»å‹•å¾—包å«è½‰é€æ€¨è¨´æ¡ˆå‰¯æœ¬è‡³å…¶ä»–涉åŠæ€¨è¨´æœ‰é—œè£½ç¨‹æ¥é©Ÿä¹‹æ©Ÿæ§‹ã€‚倘ä¸åŸ·è¡Œä»»ä½•ç ”究調查，則機構應ç¶æŒç´€éŒ„，包å«ç‚ºä½•ç ”究調查未執行之ç†ç”±åŠæ¬Šè²¬è€…之姓å。</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p style="margin-bottom: 12pt;"><span><strong><span style="font-family: 新細明體;">拾æŒã€é™„則</span></strong></span></p><p><span style="font-size: 9pt; font-family: verdana,sans-serif;"><strong> </strong></span></p><p><span><strong><span style="font-family: 新細明體;">å…åå…«ã€æœ¬è¦ç¯„實施日期å¦å…¬å‘Šä¹‹</span></strong></span></p><p><strong><span style="font-size: 13px; font-family: arial;"><span style="font-family: 新細明體,serif;">衛生署公告網å€</span>:</span></strong></p><p><span><strong><span style="font-size: 13px; font-family: arial;">http://www.doh.gov.tw/newverprog/proclaim/content.asp?class_no=0&now_fod_list_no=&array_fod_list_no=&level_no=1&doc_no=19364</span></strong></span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6086&type=0
臨床試驗類,人體試驗管ç†è¾¦æ³•æ³•è¦å‘½ä»¤äººé«”試驗管ç†è¾¦æ³•<p style="text-align: center;"><b> </b></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第一æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">本辦法ä¾é†«ç™‚法（以下稱本法）第七åä¹æ¢ä¹‹ä¸€è¦å®šè¨‚定之。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第二æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">æ–°è—¥å“ã€æ–°é†«ç™‚器æ於辦ç†æŸ¥é©—登記å‰ï¼Œæˆ–醫療機構將新醫療技術，列入常è¦é†«ç™‚è™•ç½®é …ç›®å‰ï¼Œæ‡‰æ–½è¡Œäººé«”è©¦é©—ç ”ç©¶ï¼ˆä»¥ä¸‹ç¨±äººé«”è©¦é©—ï¼‰ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第三æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">醫療機構施行人體試驗，應擬訂計畫，å‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œç”³è«‹æ ¸å‡†ã€‚ </span></p><p style="layout-grid-mode: char; 10: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …è¨ˆç•«ï¼Œæ‡‰è¼‰æ˜Žä¸‹åˆ—äº‹é …ï¼š </span></p><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€ä¸»é¡Œã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€ç›®çš„。 </span></pre><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€æ–¹æ³•ï¼š </span></pre><pre style="layout-grid-mode: char; margin-left: 89.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">（一）接å—人體試驗者（以下稱å—試者）之æ¢ä»¶ã€æ‹›å‹Ÿæ–¹æ³•åŠæ•¸ç›®ã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 89.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">（二）實施方å¼ã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 54pt;"><span style="font-size: 14pt; font-family: 標楷體;">（三）人體試驗期間åŠé 計進度。 </span></pre><pre style="layout-grid-mode: char; margin-left: 96pt;"><span style="font-size: 14pt; font-family: 標楷體;">（四）治療效果之評估åŠçµ±è¨ˆæ–¹æ³•ã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 96pt;"><span style="font-size: 14pt; font-family: 標楷體;">（五）å—試者之追蹤åŠå¿…è¦ä¹‹å¾©å¥è¨ˆç•«ã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 68.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">å››ã€å—試者åŒæ„書內容。 </span></pre><pre style="layout-grid-mode: char; margin-left: 82.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">五ã€ä¸»æŒäººåŠå”åŒä¸»æŒäººä¹‹å¸ã€ç¶“æ·åŠå…¶æ‰€å—訓練之資料。 </span></pre><pre style="layout-grid-mode: char; margin-left: 82.7pt;"><span style="font-size: 14pt; font-family: 標楷體;">å…ã€æœ‰é—œä¹‹åœ‹å…§ã€å¤–已發表之文ç»å ±å‘Šã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 82pt;"><span style="font-size: 14pt; font-family: 標楷體;">七ã€å…¶ä»–åœ‹å®¶å·²æ ¸å‡†æ–½è¡Œè€…ï¼Œå…¶è‰æ˜Žæ–‡ä»¶ã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 82pt;"><span style="font-size: 14pt; font-family: 標楷體;">å…«ã€æ‰€éœ€è—¥å“或儀器è¨å‚™ï¼ŒåŒ…æ‹¬å¿…é ˆé€²å£ä¹‹è—¥å“或儀器å稱ã€æ•¸é‡ã€‚ </span></pre><pre style="layout-grid-mode: char; margin-left: 82pt;"><span style="font-size: 14pt; font-family: 標楷體;">ä¹ã€é 期效果。 </span></pre><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 54pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">åã€å¯èƒ½å¼•èµ·ä¹‹æ害åŠå…¶æ•‘濟措施。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第四æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">å‰æ¢ä¹‹ä¸»æŒäººæ‡‰å…·ä¸‹åˆ—è³‡æ ¼ï¼š </span></p><p style="layout-grid-mode: char; 81pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€é ˜æœ‰åŸ·æ¥åŸ·ç…§ä¸¦å¾žäº‹è‡¨åºŠé†«ç™‚五年以上之醫師ã€ç‰™é†«å¸«æˆ–ä¸é†«å¸«ã€‚ </span></p><p style="layout-grid-mode: char; 81pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€æœ€è¿‘å…年曾å—人體試驗相關訓練三åå°æ™‚ä»¥ä¸Šï¼›æ–¼é«”ç´°èƒžæˆ–åŸºå› æ²»ç™‚äººé«”è©¦é©—ä¹‹ä¸»æŒäººï¼Œå¦åŠ 五å°æ™‚以上之有關訓練。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€æœ€è¿‘å…å¹´ç ”ç¿’é†«å¸å€«ç†ç›¸é—œèª²ç¨‹ä¹å°æ™‚以上。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">曾å—</span><span style="font-size: 14pt; font-family: 標楷體;">é†«å¸«æ‡²æˆ’è™•åˆ†ï¼Œæˆ–å› é•å人體試驗相關è¦å®šï¼Œå—åœæ¥ä¸€å€‹æœˆä»¥ä¸Šæˆ–廢æ¢åŸ·æ¥åŸ·ç…§è™•åˆ†è€…，ä¸å¾—擔任主æŒäººã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第五æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">ä¾æœ¬æ³•ç¬¬ä¸ƒåä¹æ¢ç¬¬ä¸€é …但書å¬å‹Ÿä¹‹æˆå¹´æˆ–å·²çµå©šæœªæˆå¹´ä¹‹å—試者，主æŒäººæ‡‰ä¾ä¸‹åˆ—é †åºå–得其關係人之åŒæ„： </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">一〠</span><span style="font-size: 14pt; font-family: 標楷體;">é…å¶ã€‚ </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">二〠</span><span style="font-size: 14pt; font-family: 標楷體;">父æ¯ã€‚ </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">三〠</span><span style="font-size: 14pt; font-family: 標楷體;">åŒå±…之æˆå¹´å女。 </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">四〠</span><span style="font-size: 14pt; font-family: 標楷體;">與å—試者åŒå±…之祖父æ¯ã€‚ </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">五〠</span><span style="font-size: 14pt; font-family: 標楷體;">與å—試者åŒå±…之兄弟姊妹。 </span></p><p style="layout-grid-mode: char; 60pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">å…〠</span><span style="font-size: 14pt; font-family: 標楷體;">最近一年有åŒå±…事實之其他親屬。 </span></p><p style="layout-grid-mode: char; 62: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …關係人之åŒæ„，ä¸å¾—é•åå—試者曾表示之æ„æ€ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第å…æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">ä¾æœ¬æ³•ç¬¬ä¸ƒåå…«æ¢ç¬¬ä¸‰é …è¦å®šæœƒåŒå¯©æŸ¥äººé«”試驗計畫（以下稱審查會）之人員åå–®åŠæœƒè°ç´€éŒ„，應予公開。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 54pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …審查，應訂定作æ¥è¦ç¯„並公開之。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第七æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">人體試驗計畫</span><span style="font-size: 14pt; font-family: 標楷體;">之審查，應注æ„ä¸‹åˆ—äº‹é …ï¼š</span> </p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€äººé«”試驗è¨è¨ˆæ‡‰ç¬¦åˆæœ€ä½Žé¢¨éšªåŽŸå‰‡ï¼Œä¸¦è€ƒé‡åˆç†ä¹‹é¢¨éšªã€åˆ©ç›Šã€‚ </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€åŸ·è¡Œæ–¹å¼åŠå…§å®¹ç¬¦åˆç§‘å¸åŽŸå‰‡ã€‚</span> </p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€</span><span style="font-size: 14pt; font-family: 標楷體;">å—試者之æ¢ä»¶åŠå¬å‹Ÿæ–¹å¼ã€‚ </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">å››ã€å—試者之醫療照è·åŠæ害補償或其他救濟機制。 </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">五ã€å—試者之隱ç§ä¿è·ã€‚ </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">å…ã€å—試者åŒæ„書內容åŠå‘ŠçŸ¥ç¨‹åºã€‚ </span></p><p style="layout-grid-mode: char; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">七ã€æ˜“å—傷害æ—群之ä¿è·ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 99pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">å…«ã€ä¿éšœå—試者安全之必è¦ç®¡ç†æŽªæ–½ã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第八æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">審查人員有下列情形之一者，應å³è¿´é¿ï¼š</span> </p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">一ã€ç‚ºäººé«”試驗計畫之主æŒäººã€å”åŒä¸»æŒäººæˆ–委託人。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€èˆ‡ä¸»æŒäººæœ‰é…å¶ã€å››è¦ªç‰å…§ä¹‹è¡€è¦ªæˆ–三親ç‰å…§ä¹‹å§»è¦ªæˆ–曾有æ¤é—œä¿‚。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€èˆ‡äººé«”試驗計畫委託人有è˜åƒ±é—œä¿‚。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">å››ã€å…¶ä»–經</span><span style="font-size: 14pt; font-family: 標楷體;">審查會</span><span style="font-size: 14pt; font-family: 標楷體;">èªæœ‰åˆ©ç›Šè¿´é¿ä¹‹å¿…è¦è€…。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第ä¹æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">審查會å°å…¶å¯©æŸ¥é€šéŽä¹‹äººé«”試驗應</span><span style="font-size: 14pt; font-family: 標楷體;">æ¯å¹´è‡³å°‘æŸ¥æ ¸ä¸€æ¬¡</span><span style="font-size: 14pt; font-family: 標楷體;">。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 44: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …æŸ¥æ ¸ç™¼ç¾æœ‰</span><span style="font-size: 14pt; font-family: 標楷體;">下列情事之一者，得令其é™æœŸæ”¹å–„或終æ¢äººé«”試驗： </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">ㄧã€æœªä¾è¦å®šç¶“審查會通éŽæˆ–ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å¯ï¼Œè‡ªè¡Œè®Šæ›´äººé«”試驗內容。 </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">二ã€é¡¯æœ‰å½±éŸ¿å—試者權益ã€å®‰å…¨ä¹‹äº‹å¯¦ã€‚ </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">三ã€ä¸è‰¯äº‹ä»¶ç™¼ç”Ÿæ•¸æˆ–åš´é‡åº¦é¡¯æœ‰ç•°å¸¸ã€‚ </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">å››ã€æœ‰è¶³ä»¥å½±éŸ¿äººé«”試驗æˆæžœè©•ä¼°ä¹‹äº‹ä»¶ã€‚ </span></p><p style="layout-grid-mode: char; 89: ;"><span style="font-size: 14pt; font-family: 標楷體;">五ã€äººé«”試驗未完æˆå‰ï¼Œæœ‰å…·é«”事實è‰æ˜Ž</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">並無實益ã€</span><span style="font-size: 14pt; font-family: 標楷體;">風險高於潛在利益</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">，或顯有實益致ä¸åˆ©æ–¼å°ç…§çµ„。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 44: ;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œçŸ¥æœ‰å‰é …情事，得令其終æ¢</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第åæ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">審查會應將</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗計畫</span><span style="font-size: 14pt; font-family: 標楷體;">ã€æœƒè°ç´€éŒ„ã€æŸ¥æ ¸ç´€éŒ„ç‰ç›¸é—œæ–‡ä»¶ï¼Œä¿å˜è‡³äººé«”試驗完æˆå¾Œè‡³å°‘三年。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第å一æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">醫療</span><span style="font-size: 14pt; font-family: 標楷體;">機構ä¸å¾—å‘å—試者收å–</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗有關之任何費用。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第å二æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">å—試者於</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗施行期間發生下列情事，或任何時間發生與</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">è©¦é©—æœ‰é—œä¹‹ä¸‹åˆ—æƒ…äº‹æ™‚ï¼Œé†«ç™‚æ©Ÿæ§‹æ‡‰é€šå ±ä¸å¤®ä¸»ç®¡æ©Ÿé—œï¼š</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">一ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">æ»äº¡ã€‚</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">二ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">å±åŠç”Ÿå‘½ã€‚</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">三ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">永久性身心障礙。</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">å››ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">å—試者之胎兒或新生兒先天性畸形。</span> </p><p style="layout-grid-mode: char; 90pt: ;"><span style="font-size: 14pt; color: #000000;">五ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">需ä½é™¢æˆ–延長ä½é™¢ä¹‹ä½µç™¼ç—‡ã€‚</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 90pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">å…〠</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">其他å¯èƒ½å°Žè‡´æ°¸ä¹…性傷害之併發症。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 45pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">å‰é …é€šå ±æ‡‰<span style="color: #000000;">於得知事實後七日內為之，</span></span><span style="font-size: 14pt; font-family: 標楷體;">並於å五日內檢具詳細調查資料é€ä¸å¤®ä¸»ç®¡æ©Ÿé—œã€‚ </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 45pt: ;"><span style="font-size: 14pt; font-family: 標楷體;">第å三æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—令施行</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗之醫療機構æä¾›</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體;">試驗計畫摘è¦ã€æ”¶æ¡ˆæ•¸ã€æ€§åˆ¥æ¯”ã€å¹´é½¡çµ±è¨ˆã€å—試者åŒæ„書審查çµæžœåŠå¯èƒ½é¢¨éšªç‰æœ‰é—œè³‡æ–™ï¼Œæˆ–å°é†«ç™‚機構進行必è¦ä¹‹æŸ¥æ ¸ï¼Œé†«ç™‚機構ä¸å¾—妨礙ã€è¦é¿æˆ–拒絕。 </span></p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 45pt: ;"><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">å‰é …æŸ¥æ ¸ï¼Œä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—委託相關團體為之。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第åå››æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">å—試者之生物檢體ã€å€‹äººè³‡æ–™æˆ–å…¶è¡ç”Ÿç‰©ï¼Œæ–¼</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗çµæŸå¾Œï¼Œæ‡‰å³éŠ·æ¯€ã€‚å—試者åŒæ„æä¾›å†åˆ©ç”¨è€…，應</span><span style="font-size: 14pt; font-family: 標楷體;">經審查會審查通éŽï¼ŒæœªåŽ»é€£çµè€…應</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">å†æ¬¡å–å¾—å—試者書é¢åŒæ„。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第å五æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">醫療機構於</span><span style="font-size: 14pt; font-family: 標楷體;">人體</span><span style="font-size: 14pt; font-family: 標楷體; color: #000000;">試驗期間，ä¸å¾—å°å¤–發表æˆæžœæˆ–為宣傳。</span> </p><p style="layout-grid-mode: char; text-align: justify; text-justify: inter-ideograph; 49: ;"><span style="font-size: 14pt; font-family: 標楷體;">第åå…æ¢<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 標楷體;">本辦法自發布日施行。 </span></p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6050&type=0
其他類,人體器官組織細胞輸入輸出管ç†è¾¦æ³•æ³•è¦å‘½ä»¤äººé«”器官組織細胞輸入輸出管ç†è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾äººé«”器官移æ¤æ¢ä¾‹ç¬¬åå››æ¢ä¹‹ä¸€ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">感染性器官ã€çµ„ç¹”ã€ç´°èƒžä¹‹è¼¸å…¥æˆ–輸出，應ä¾å‚³æŸ“病防治法åŠå…¶ç›¸é—œè¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官ã€çµ„ç¹”ã€ç´°èƒžï¼Œä»¥æ³•äººã€é†«ç™‚機構ã€æ•™å¸ç ”究機構åŠå…¶ä»–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入或輸出之器官ã€çµ„ç¹”ã€ç´°èƒžï¼Œå…¶ç”¨é€”以人體移æ¤ã€æ•™å¸ã€ç ”究ã€ä¿å˜åŠå…¶ä»–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官ã€çµ„ç¹”ã€ç´°èƒžä¾›äººé«”移æ¤è€…，其來æºæ‡‰ä»¥ç„¡å„Ÿæ贈方å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ»åˆ‘犯æ贈之器官ã€çµ„ç¹”ã€ç´°èƒžï¼Œä¸å¾—申請輸入或輸出。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬åœ‹ä¹‹äººé¡žèƒšèƒŽå¹¹ç´°èƒžæˆ–èƒšèƒŽå¹¹ç´°èƒžæ ªï¼Œä¸å¾—申請輸出。但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官ã€çµ„ç¹”ã€ç´°èƒžè€…ï¼Œæ‡‰å¡«å…·ç”³è«‹æ›¸ï¼Œè¼‰æ˜Žä¸‹åˆ—äº‹é …ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ出申請：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¼¸å…¥æˆ–輸出國別。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¼¸å…¥æˆ–輸出器官ã€çµ„ç¹”ã€ç´°èƒžé¡žåˆ¥åŠå…¶ç”¨é€”。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¼¸å…¥æˆ–輸出之期間。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¼¸å…¥æˆ–輸出之數é‡ã€å®¹é‡ã€æ‰¹æ¬¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è¼¸å…¥æˆ–輸出之é‹é€æ–¹å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入器官ã€çµ„ç¹”ã€ç´°èƒžè€…，應檢附下列文件：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¼¸å‡ºåœ‹ä¸»ç®¡æ©Ÿé—œå‡ºå…·åŒæ„輸出之文件或足以è‰æ˜Žè¼¸å‡ºåœ‹æœªç®¡åˆ¶è¼¸å‡ºä¹‹æ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¼¸å…¥å™¨å®˜ã€çµ„ç¹”ã€ç´°èƒžä¹‹æª¢é©—è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¶ä»–ä¾è¦å®šæ‡‰æª¢é™„之文件。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第二款之檢驗è‰æ˜Žæ–‡ä»¶ï¼Œæ‡‰åŒ…æ‹¬ä¹‹æª¢é©—é …ç›®å¦‚é™„è¡¨ï¼›å…¶ç”³è«‹åˆ†æ‰¹è¼¸å…¥è€…ï¼Œæª¢é©—è‰æ˜Žæ–‡ä»¶å¾—於輸入å‰ä¸ƒæ—¥å…§è£œæ£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入人體移æ¤ç”¨é€”之器官ã€çµ„ç¹”ã€ç´°èƒžè€…，除å‰é …文件外，應å¦æª¢é™„下列文件：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä¾†æºå–®ä½åˆæ³•è¨ç«‹ä¹‹è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¾†æºå–®ä½è‰æ˜Žæ贈者åŒæ„æ贈之文件。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ贈者年齡ã€å™¨å®˜çµ„織或細胞摘å–時間ç‰è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入眼角膜者，å‰é …第三款之文件得於輸入後三å日內補æ£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官ã€çµ„ç¹”ã€ç´°èƒžï¼Œå…¶æ ¸å‡†æ•ˆæœŸè‡³å¤šä»¥ä¸‰å¹´ç‚ºé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官ã€çµ„ç¹”ã€ç´°èƒžè€…ï¼Œå› æ¥å‹™è€ŒçŸ¥æ‚‰æˆ–æŒæœ‰ä»–人秘密，</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ä¸å¾—ç„¡æ•…æ´©æ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有下列情形之一者，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—撤銷或廢æ¢åŽŸæ ¸ç™¼ä¹‹è¼¸å…¥æˆ–è¼¸å‡ºæ ¸å‡†æ–‡ä»¶ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä»¥è™›å½ä¸å¯¦æ–‡ä»¶ç”³è«‹å–å¾—æ ¸å‡†æ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¼¸å…¥æˆ–輸出之器官ã€çµ„ç¹”ã€ç´°èƒžèˆ‡æ ¸å‡†æ–‡ä»¶ç™»è¼‰å…§å®¹ä¸ç¬¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é•åå‰æ¢è¦å®šï¼Œæ´©æ¼ä»–人秘密。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å°‡åŽŸç”³è«‹éžç§»æ¤ç”¨é€”之器官ã€çµ„織或細胞，轉為人體移æ¤ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人體移æ¤ç”¨å™¨å®˜ã€çµ„ç¹”ã€ç´°èƒžä¹‹è¼¸å…¥ï¼Œç”³è«‹å–®ä½æ‡‰å°±å¯¦éš›è¼¸å…¥æ•¸é‡ï¼Œä½¿ç”¨æˆ–分é…情形，製作紀錄妥為ä¿å˜è‡³å°‘å年，供ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入或輸出器官ã€çµ„ç¹”ã€ç´°èƒžï¼Œå…¶ç”³è«‹è€…有下列情形之一者，三年內ä¸å¾—輸入或輸出：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æœªç¶“æ ¸å‡†ï¼Œæ“…è‡ªè¼¸å…¥æˆ–è¼¸å‡ºå™¨å®˜ã€çµ„ç¹”ã€ç´°èƒžã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ›¾ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ’¤éŠ·æˆ–廢æ¢è¼¸å…¥æˆ–è¼¸å‡ºæ ¸å‡†æ–‡ä»¶äºŒæ¬¡ä»¥ä¸Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法發布施行å‰ï¼Œå·²å–å¾—ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç™¼ä¹‹è¼¸å…¥æˆ–è¼¸å‡ºæ ¸å‡†æ–‡ä»¶è€…ï¼Œå…¶æ ¸å‡†æ–‡ä»¶æœ‰æ•ˆæœŸé™å±†æ»¿å‰ï¼ŒåŽŸè¼¸å…¥ã€è¼¸å‡ºæ ¸å‡†äº‹é …ä»å±¬æœ‰æ•ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p>2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6087&type=0
臨床試驗類,藥動å¸è©¦é©—基準,å°å…’æ—群的藥動å¸è©¦é©—基準行政解釋å°å…’æ—群的藥動å¸è©¦é©—基準詳如附件2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4495&type=0
臨床試驗類,è—¥å“臨床試驗基準,內分泌åŠæ–°é™³ä»£è¬æ²»ç™‚è—¥å“臨床試驗基準行政解釋內分泌åŠæ–°é™³ä»£è¬æ²»ç™‚è—¥å“臨床試驗基準詳如附件2013-12-03https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4496&type=0
化å¸è£½é€ 管制類,指導手冊,分æžç¢ºæ•ˆä½œæ¥æŒ‡å°Žæ‰‹å†Šè¡Œæ”¿è§£é‡‹åˆ†æžç¢ºæ•ˆä½œæ¥æŒ‡å°Žæ‰‹å†Šè©³å¦‚附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4497&type=0
臨床試驗類,è—¥å“臨床試驗基準,心血管治療藥å“臨床試驗基準行政解釋心血管治療藥å“臨床試驗基準詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4498&type=0
查驗登記類,生物相似性藥å“查驗登記技術性資料審查é‡é»žè¡¨è¡Œæ”¿è§£é‡‹ç”Ÿç‰©ç›¸ä¼¼æ€§è—¥å“查驗登記技術性資料審查é‡é»žè¡¨è©³å¦‚附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4499&type=0
藥政管ç†é¡ž,生物檢體輸出輸入作æ¥è¦é»žè¡Œæ”¿è§£é‡‹ç”Ÿç‰©æª¢é«”輸入輸出作æ¥è¦é»žè©³å¦‚附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4501&type=0
藥政管ç†é¡ž,生物藥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•æ³•è¦å‘½ä»¤ç”Ÿç‰©è—¥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾è—¥äº‹æ³•ç¬¬ä¸ƒåå››æ¢ç¬¬ä¸€é …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法é©ç”¨ç¯„åœç‚ºå¾®ç”Ÿç‰©å¸ã€å…ç–«å¸å¸ç†è£½é€ 之血清ã€æŠ—æ¯’ç´ ã€ç–«è‹—ã€é¡žæ¯’ç´ åŠèŒæ¶²ç‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物藥å“è¼¸å…¥æˆ–è£½é€ å¾Œï¼Œè—¥å•†æ‡‰å¡«å…·ç”Ÿç‰©è—¥å“檢驗å°ç·˜ç”³è«‹æ›¸ï¼ˆæ ¼å¼å¦‚附件一），並檢附下列資料，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ出å°ç·˜ç”³è«‹ï¼Œä¸¦ä¾é€šçŸ¥ç¹³ç´å¯©æŸ¥è²»ï¼ˆå«æª¢é©—è²»ã€å°ç·˜è²»åŠæ—…é‹è²»ï¼‰ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¼¸å…¥åŒ…è£æ¸…單。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æˆ–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å¯æ–‡ä»¶ä¹‹å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç”Ÿç‰©è—¥å“原產國國家檢驗機關之檢定åˆæ ¼è‰æ˜Žã€‚ä½†åŽŸå» ç¶“å…¶åœ‹å®¶æª¢é©—æ©Ÿé—œæ ¸å‡†è‡ªè¡Œæª¢é©—è€…ï¼Œå¾—ä»¥åŽŸå» ä¹‹æª¢é©—ç´€éŒ„åŠæˆç¸¾æ›¸ä»£ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç”Ÿç‰©è—¥å“之製程ã€æª¢é©—方法ã€è¦æ ¼ã€æ¨™æº–å“åŠæœ‰é—œæ–‡ç»ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å‹•ç‰©åŽŸæ–™ä¾†æºç®¡åˆ¶ä¹‹æ¨™æº–æ“作程åºï¼ˆ</span><span style="font-family: calibri;">SOP</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">ã€åŠåŽŸæ–™ä¾†æºè‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æœ¬æ‰¹ç”Ÿç‰©è—¥å“製程之分è£æ•¸é‡ç´€éŒ„與檢定紀錄åŠæˆå“之檢定紀錄與æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">國產製å“ç”±å…¶è£½é€ å» è‡ªè¡Œæª¢é©—åˆæ ¼ä¸¦å®ŒæˆåŒ…è£å¾Œï¼Œæ出å‰é …申請，並å…附第一款åŠç¬¬ä¸‰æ¬¾è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">屬防疫或外銷用生物藥å“，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œå¾—於藥å“放行å‰è£œé½Šç¬¬ä¸€é …第å…款資料。</span> </p><p><span style="font-family: 新細明體,serif;">藥商未ä¾è¦å®šç¹³ç´å¯©æŸ¥è²»ã€æœªå¡«å…·ç”³è«‹æ›¸ã€æœªå‚™é½Šè³‡æ–™æˆ–有其他ä¸ç¬¦ç¬¬ä¸€é …è¦å®šä¹‹æƒ…形而得補æ£è€…，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè£œæ£é€šçŸ¥é€é”之日起二個月內補æ£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商未能於期é™å…§è£œæ£è€…，應於期é™å±†è‡³å‰ï¼Œä»¥æ›¸é¢æ•˜æ˜Žç†ç”±ç”³è«‹å»¶æœŸï¼›å…¶å»¶æœŸæœŸé™ï¼Œè‡ªæœŸé™å±†è‡³ç¿Œæ—¥èµ·ç®—一個月，且延期以一次為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商未於期é™å±†è‡³å‰è£œæ£æˆ–延期一個月後ä»é€¾æœŸæœªè£œæ£è€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ä¾ç¾æœ‰è³‡æ–™é€•ç‚ºå¯©æŸ¥ã€æª¢é©—與准é§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå—ç†æª¢é©—å°ç·˜ç”³è«‹å¾Œï¼Œç¶“æ´¾å“¡æŸ¥æ ¸ç”Ÿç‰©è—¥å“é‹é€åŠè²¯å˜ä¹‹æº«åº¦ç¬¦åˆè²¯è—æ¢ä»¶è€…，å³æŠ½å–é©é‡ç”Ÿç‰©è—¥å“供檢驗或留樣所需；剩餘生物藥å“則應予å°å˜ï¼Œä¸¦äº¤ç”±è—¥å•†è‡ªè¡Œä¿ç®¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ä¾æŠ½é©—生物藥å“類別åŠå¯¦éš›éœ€è¦åŸ·è¡Œæª¢é©—é …ç›®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">生物藥å“經檢驗åˆæ ¼è€…，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼å…¶åŒ…è£ä¸Šå€‹åˆ¥åŠ 貼藥物檢查è‰ï¼Œå§‹å¾—販售ã€ä¾›æ‡‰ã€‚ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¸¦æ‡‰æ ¸ç™¼ç”Ÿç‰©è—¥å“å°ç·˜è‰æ˜Žæ›¸ï¼ˆæ ¼å¼å¦‚附件二）或外銷用生物藥å“批次放行è‰æ˜Žï¼ˆæ ¼å¼å¦‚附件三）予申請å°ç·˜æª¢é©—之藥商。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é…åˆåœ‹å®¶é˜²ç–«æ”¿ç–æˆ–å› æ‡‰ç·Šæ€¥é‡å¤§äº‹ä»¶ã€ç‰¹æ®Šé†«ç™‚需è¦ä¹‹ç”Ÿç‰©è—¥å“，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å¯è€…，得ä¸é©ç”¨ç¬¬äº”æ¢æœ‰é—œæª¢é©—之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …生物藥å“，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥å…¶ç”³è«‹è³‡æ–™åŠæŸ¥æ ¸å…¶é‹é€èˆ‡è²¯å˜ä¹‹æº«åº¦ç¬¦åˆè²¯è—æ¢ä»¶å¾Œï¼Œä¸¦æ–¼å…¶åŒ…è£ä¸Šå€‹åˆ¥åŠ 貼藥物檢查è‰ï¼Œå§‹å¾—販售ã€ä¾›æ‡‰ã€‚ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¸¦æ‡‰æ ¸ç™¼ç”Ÿç‰©è—¥å“å°ç·˜è‰æ˜Žæ›¸æˆ–外銷用生物藥å“批次放行è‰æ˜Žäºˆç”³è«‹å°ç·˜æª¢é©—之藥商。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼å¿…è¦æ™‚得抽驗其生物藥å“或抽å–é©é‡ç”Ÿç‰©è—¥å“備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å› æ‡‰ç·Šæ€¥é†«ç™‚éœ€è¦ä¹‹ç”Ÿç‰©è—¥å“，藥商得檢附地å€é†«é™¢ä»¥ä¸Šä¹‹ä¸»æ²»é†«å¸«å‡ºå…·ä¹‹åˆ‡çµæ›¸æˆ–醫院申請書，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹ç·Šæ€¥æ”¾è¡Œæ‰€éœ€è¦ä¹‹æ•¸é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …生物藥å“，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥å…¶åŽŸå» 檢驗æˆç¸¾æ›¸å¾Œï¼Œå³å¾—於所申請放行數é‡ä¹‹ç”Ÿç‰©è—¥å“包è£ä¸Šå€‹åˆ¥åŠ 貼緊急放行è‰ï¼Œé€•äºˆæ”¾è¡Œï¼›å…¶é¤˜æœªæ”¾è¡Œéƒ¨åˆ†æ‡‰çºŒè¡Œè¾¦ç†æª¢é©—å°ç·˜ä½œæ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …ä¹‹åˆ‡çµæ›¸æˆ–申請書應載明病患急需使用之藥å“å稱ã€ä½¿ç”¨ç†ç”±åŠæ•¸é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商應將緊急放行生物藥å“之批號ã€ä¾›æ‡‰å°è±¡åŠæ•¸é‡ç‰è³‡æ–™ä¿å˜å‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—委任所屬食å“藥物管ç†å±€è¾¦ç†ç¬¬ä¸‰æ¢è‡³ç¬¬ä¸ƒæ¢æ‰€è¨‚生物藥å“檢驗å°ç·˜ç›¸é—œäº‹é 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臨床試驗類,è—¥å“臨床試驗基準,å¹´è€ç—…患的藥å“臨床試驗基準行政解釋年è€ç—…患的藥å“臨床試驗基準<div style="layout-grid: 18pt none;" class="WordSection1"><p><b><span style="font-family: 標楷體;">目錄</span></b> </p><p><b><span style="font-family: 標楷體;">ç¬¬ä¸€ç« ã€é€šè«–</span></b> </p><p><b><span style="font-family: 標楷體;">ç¬¬äºŒç« ã€è‡¨åºŠè©¦é©—之考é‡</span></b><b> </b></p><p><b><span style="font-family: 標楷體;">ç¬¬ä¸‰ç« ã€è—¥å‹•å¸è©¦é©—</span></b><b> </b></p><p><b><span style="font-family: 標楷體;">ç¬¬å››ç« ã€è—¥æ•ˆ</span></b><b><span style="font-family: times new roman,serif;">/</span></b><b><span style="font-family: 標楷體;">劑é‡</span></b><b><span style="font-family: times new roman,serif;">-</span></b><b><span style="font-family: 標楷體;">å應試驗</span></b><b> </b></p><p><b><span style="font-family: 標楷體;">åƒè€ƒæ–‡ç»</span></b><b> </b></p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><p><b><span style="font-family: 標楷體;">ç¬¬ä¸€ç« ã€é€šè«–</span></b> </p><p><span style="font-family: 標楷體;">一ã€ç›¸é—œæº–則</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　　　為æ昇國內臨床試驗水準，使執行臨床試驗有éµå¾ªä¹‹åŽŸå‰‡ï¼Œæœ¬ç½²ä¹ƒåƒè€ƒæœ¬ç½²å·²å…¬å‘Šä¹‹ã€Œè‡¨åºŠè©¦é©—基準ã€åŠ</span><span style="font-family: times new roman,serif;">ICH</span><span style="font-family: 標楷體;">（</span><span style="font-family: times new roman,serif;">International Conference on Harmonization</span><span style="font-family: 標楷體;">）藥å“ç ”ç™¼ç–略有關年è€ç—…患用藥的臨床試驗通則，制定本基準。</span> </p><p><span style="font-family: 標楷體;">二ã€èƒŒæ™¯</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">ã€€ã€€å› å¹´é½¡å°Žè‡´ç”¢ç”Ÿè—¥å“å應的差異性，å¯èƒ½ä¾†è‡ªè—¥å‹•å¸ä¹‹æ”¹è®Šï¼ˆè—¥å“之å¸æ”¶ã€åˆ†ä½ˆã€ä»£è¬ã€æŽ’泄）或是藥效å¸çš„改變（å°ç‰¹å®šè¡€ä¸æ¿ƒåº¦æˆ–其他組織濃度的藥å“å應）。è€å¹´äººçš„年齡並éžå”¯ä¸€æœƒå½±éŸ¿å…¶è—¥å‹•å¸æˆ–藥效å¸çš„å› ç´ ï¼Œå¤§éƒ¨åˆ†èˆ‡å¹´é½¡ç›¸é—œçš„å·®ç•°å¯èƒ½èˆ‡å¹´é½¡æœ¬èº«ç„¡é—œï¼Œè€Œæœƒç™¼ç”Ÿæ–¼æ‰€æœ‰çš„年齡層；例如腎臟或心臟功能之衰退ã€ä½µéš¨ä¹‹ç–¾ç—…åŠä½µæœ‰æ²»ç™‚，尤其是併用的藥å“。試驗執行者應åµæ¸¬ç—…患本身會影響藥å“療效的主è¦ç‰¹è³ªï¼Œä¸¦äº†è§£è©²ç‰¹è³ªä¹‹å½±éŸ¿åŠ›ï¼Œæ‰å¯èƒ½é¸æ“‡åˆé©åŠ‘é‡ä»¥æ²»ç™‚å¹´è€ç—…患。目å‰ç¾æœ‰èˆ‡å¹´é½¡ç›¸é—œçš„藥效å¸å·®ç•°è³‡æ–™ç›¸ç•¶å°‘，而且執行藥效å¸è©¦é©—以åµæ¸¬é€™äº›å·®ç•°çš„能力åˆä¸ç¢ºå®šï¼Œå› æ¤åªæœ‰åœ¨é€™äº›å·®ç•°æœ‰ç–‘慮時（如臨床試驗çµæžœï¼‰ï¼Œæˆ–當這些差異相當é‡è¦æ™‚ï¼ˆå¦‚å› ç‚ºç‹¹çª„çš„æ²»ç™‚æŒ‡æ¨™ï¼‰ï¼Œé¡å¤–çš„ç ”ç©¶ä»¥æŽ¢æ¸¬å¹´è¼•èˆ‡å¹´è€ç—…患血ä¸æ¿ƒåº¦ï¼å應的曲線之差異，æ‰æœ‰æ„義。如果在臨床試驗ä¸åŒ…括了年輕與年è€çš„病患，é©ç•¶çš„分æžæ¯å€‹ç—…人的血ä¸æ¿ƒåº¦è³‡æ–™ï¼Œæ‡‰å¯ä»¥æŽ¢æ¸¬èˆ‡å¹´é½¡æˆ–å…¶ä»–å› ç´ ç›¸é—œçš„é‡è¦è—¥æ•ˆå¸å·®ç•°ã€‚</span> </p><p><span style="font-family: 標楷體;">三ã€è€å¹´äººçš„定義</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　è€å¹´äººæ˜¯</span><span style="font-family: times new roman,serif;">65</span><span style="font-family: 標楷體;">æ²æˆ–以上的æ—群。執行å¯èƒ½ç”¨æ–¼è€å¹´äººçš„è—¥å“之臨床試驗時，儘å¯èƒ½å°‡å¹´ç´€è¶Šè€çš„ç—…æ‚£ç´å…¥è©¦é©—，且臨床試驗計畫書ä¸ä¸æ‡‰è¨å®šå¹´è€ç—…患的年齡上é™ã€‚æ¤å¤–，若無特殊需è¦ï¼Œè‡¨åºŠè©¦é©—也ä¸æ‡‰æŽ’é™¤ä½µæœ‰å…¶ä»–ç–¾ç—…ä¹‹ç—…æ‚£ï¼Œå› ç‚ºå”¯æœ‰ç´å…¥æ¤é¡žç—…患，æ‰å¯èƒ½åµæ¸¬å‡ºè©²è—¥å“與疾病的交互作用。若å¯èƒ½ä½¿ç”¨æ¤è—¥å“çš„æ—群為年齡較大之æ—群時，則ç´å…¥å¹´é½¡è¼ƒå¤§çš„è€å¹´äººçš„試驗è¨è¨ˆæ›´å½¢é‡è¦ã€‚</span> </p><p><span style="font-family: times new roman,serif;"> </span></p><p><b><span style="font-family: 標楷體;">ç¬¬äºŒç« ã€è‡¨åºŠè©¦é©—之考é‡</span></b><b><span style="font-family: times new roman,serif;"><br /><br /></span></b><b><span style="font-family: 標楷體;">　　</span></b><span style="font-family: 標楷體;">åƒåŠ 臨床試驗的病患應代表該藥å“在上市後使用的æ—ç¾¤ï¼Œå› æ¤å¯èƒ½ç”¨æ–¼è€å¹´äººçš„è—¥å“，臨床試驗時應ç´å…¥åˆç†æ•¸ç›®çš„å¹´è€ç—…患。通常，è€å¹´äººæ‡‰å’Œå¹´è¼•äººç´å…¥åŒä¸€è©¦é©—，這樣å¯ä»¥åšç›´æŽ¥æ¯”較。å°æ–¼ä¸æ˜¯åªç™¼ç”Ÿåœ¨è€å¹´äººçš„疾病，應ç´å…¥å¹´è€ç—…患至少</span><span style="font-family: times new roman,serif;">100</span><span style="font-family: 標楷體;">å，這樣的人數通常已足以檢測出臨床上é‡è¦çš„差異。一般較ä¸å¸¸è¦‹çš„疾病則å¯ç´å…¥è¼ƒå°‘çš„å¹´è€ç—…患。如果該藥å“之é©æ‡‰ç—‡èˆ‡å¹´é½¡ç›¸é—œï¼Œå‰‡å¯ä»¥è€ƒæ…®åªé‡å°å¹´è€æ—群執行臨床試驗，這包括特殊的監測æ¥é©Ÿï¼Œä¾‹å¦‚èªçŸ¥åŠŸèƒ½ã€‚å¦ä¸€ç¨®æ–¹æ³•æ˜¯å°‡å¹´è¼•èˆ‡å¹´è€ç—…æ‚£ç´å…¥åŒä¸€å€‹è‡¨åºŠè©¦é©—之下，但ä¾å¹´é½¡å€åˆ†ï¼Œå°å¹´é•·è€…應特別照è·æˆ–監測。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">ã€€ã€€è‡¨åºŠè©¦é©—å ±å‘Šå…§å®¹æ‡‰åŒ…å«ç™‚效ã€ä¸è‰¯å應ã€åŠ‘é‡å應和藥å“è¡€ä¸æ¿ƒåº¦ï¼å應的分æžï¼Œé€™äº›åˆ†æžæ‡‰è€ƒæ…®åŸºç¤Žäººå£ç‰¹æ€§ï¼ˆå¦‚年齡ã€æ€§åˆ¥ã€ç¨®æ—）以åŠç—…患特性（如腎功能ã€å¿ƒè‡ŸåŠŸèƒ½ã€è‚功能ã€ä½µæœ‰ç–¾ç—…åŠä½µç”¨è—¥å“，包å«é…’精和尼å¤ä¸ï¼‰çš„影響。在個別試驗åŠæ•´é«”的有效性ã€å®‰å…¨æ€§åˆ†æžä¸å‡æ‡‰åŸ·è¡Œä»¥ä¸Šåˆ†æžã€‚這些分æžçš„çµæžœå¯èƒ½é¡¯ç¤ºéœ€è¦æ›´å¤šé€²è¡Œæ–¼å¹´è€æ—群或其他æ—群的劑é‡ï¼å應</span><span style="font-family: times new roman,serif;">(dose-response) </span><span style="font-family: 標楷體;">或血ä¸æ¿ƒåº¦ï¼å應試驗。這些é¡å¤–的試驗是å¦åœ¨ä¸Šå¸‚之å‰æˆ–之後執行，å¯ä¾å…¶é‡è¦æ€§ä¾†æ±ºå®šã€‚</span> </p><p><span style="font-family: times new roman,serif;"> </span></p><p><b><span style="font-family: 標楷體;">ç¬¬ä¸‰ç« ã€è—¥å‹•å¸è©¦é©—</span></b><span style="font-family: times new roman,serif;"> <br /><br /></span><span style="font-family: 標楷體;">　　年齡åªæ˜¯å½±éŸ¿è€å¹´äººè—¥å‹•å¸çš„å› ç´ ä¹‹ä¸€ï¼Œä½†éžæœ€é‡è¦çš„å› å。å°å½±éŸ¿è—¥å‹•å¸æœ€é‡è¦çš„å› ç´ æ‡‰ç›´æŽ¥è©•ä¼°ï¼Œä¾‹å¦‚å°ç¶“腎排泄藥å“，腎功能是影響其藥動特性的é‡è¦å› ç´ ã€‚å…¶ä»–å¯èƒ½çš„影響如年齡，å¯ä»¥ä¾ä»¥ä¸‹ç¬¬ä¸€ç¯€ä¸æ‰€æ述的篩檢方法來評估。如果篩檢ä¸é©ç•¶æˆ–æœªåŸ·è¡Œï¼Œæˆ–è€…è©²ç¯©æª¢é¡¯ç¤ºå¹´é½¡æ˜¯ä¸€å½±éŸ¿å› ç´ ï¼Œå‰‡åš´è¬¹è€Œæ£å¼çš„藥動å¸è©¦é©—應在年è€ç—…患執行。</span> </p><p><span style="font-family: 標楷體;">一ã€è—¥å‹•å¸çš„篩檢</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　儘å¯èƒ½æ‰¾å‡ºæ”¹è®Šè—¥å‹•å¸çš„æ‰€æœ‰å› ç´ æ˜¯å¾ˆé‡è¦çš„。但是，實際上åªèƒ½åŸ·è¡Œæœ‰é™çš„特殊交互試驗（藥å“交互作用，藥å“與疾病交互作用），而且通常åªæœ‰æ‡·ç–‘有交互作用時，æ‰ä½œç ”究。使用藥動篩檢法，å¯å¾žæœªè¢«æ‡·ç–‘有ä¸å°‹å¸¸è—¥å‹•ç‰¹æ€§çš„ç—…æ‚£ä¸ï¼Œæ‰¾å‡ºå…·æœ‰ä¸å°‹å¸¸è—¥å‹•ç‰¹æ€§çš„次æ—群病患。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　å°æ–¼æ‰€æœ‰æˆ–大部分在第二階段臨床試驗或第三階段臨床試驗å—試驗者而言，藥動篩檢包å«å–得一個或數個穩定狀態時的藥å“è¡€ä¸æ¿ƒåº¦ï¼Œä»¥æ±ºå®šåœ¨ç‰¹å®šçµ¦è—¥æƒ…æ³ä¸‹ï¼Œè—¥å“è¡€ä¸æ¿ƒåº¦çš„變異性。關於上述藥動篩檢的方法與分æžå·²ç¶“發表於</span><span style="font-family: times new roman,serif;">Sheiner,L.B., and Benet, L.Z.:Clin. Pharm. Ther. 38:481-187(1985)</span><span style="font-family: 標楷體;">。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　åªè¦å—試驗者包括ä¸åŒå¹´é½¡ã€æ€§åˆ¥ã€ç¨®æ—ã€é«”é‡ã€èƒ–瘦程度ã€ç—…å²ã€ç…™é…’é‡ã€ä½µç”¨è—¥å“ç‰ï¼Œå³ä½¿åªæœ‰ä¸€æˆ–兩個穩定狀態下之最低藥å“è¡€ä¸æ¿ƒåº¦æ¸¬é‡çš„粗略篩檢，也能回ç”一些簡單但é‡è¦çš„å•é¡Œã€‚使用多線性迴æ¸åˆ†æžï¼ˆæˆ–其他方法如混åˆä½œç”¨æ¨¡å¼ï¼‰å¯æ±ºå®šå‡ºè—¥å“在ä¸åŒå€‹é«”é–“è—¥å“è¡€ä¸æ¿ƒåº¦ä¹‹å·®ç•°ï¼Œä»¥åŠç›¸é—œçš„臨床特性，如年齡ã€æ€§åˆ¥ã€ç¨®æ—ã€é«”é‡ã€åŽ»é™¤è„‚肪後之體é‡ï¼ˆ</span><span style="font-family: times new roman,serif;">lean body mass</span><span style="font-family: 標楷體;">），和穩定狀態下最低藥å“è¡€ä¸æ¿ƒåº¦çš„關係。亦å¯æ‰¾å‡ºå…·æœ‰æ¥µç«¯æ•¸å€¼çš„å—試驗者，這些病患往往需è¦é€²ä¸€æ¥ç ”究。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　由上述試驗å¯å¾—知是å¦è€å¹´äººèˆ‡å…¶ä»–年齡層的藥å“è¡€ä¸æ¿ƒåº¦æœ‰æ‰€å·®ç•°ï¼Œäº¦å¯å¾—知æ¤ç¨®å·®ç•°æ˜¯å¦åªå–®ç´”å› å¹´é½¡ä¸åŒï¼Œæˆ–è€…èˆ‡å¹´é½¡ç›¸é—œçš„å…¶ä»–å› ç´ æœ‰é—œã€‚åœ¨ç²—ç•¥ç¯©æª¢ä¹‹ä¸‹ï¼Œåªæœ‰ç›¸ç•¶å¤§çš„差別æ‰æœƒè¢«åµæ¸¬å‡ºä¾†ï¼Œä½†ä»¥è—¥å“è¡€ä¸æ¿ƒåº¦ä¹‹è®Šç•°è€Œè¨€ï¼Œä¹Ÿåªæœ‰ç›¸ç•¶å¤§çš„差別æ‰æ˜¯é‡è¦çš„。當å°å·®åˆ¥æ˜¯é‡è¦æ™‚，較嚴謹的篩檢å¯ä»¥æ¸¬å‡ºå¾®å°ä¹‹å·®åˆ¥ï¼ˆ</span><span style="font-family: times new roman,serif;">Sheiner and Benet L.Z.:Clin. Pharm. Ther. 38:481-187(1985)</span><span style="font-family: 標楷體;">），例如毒性與治療之藥å“è¡€ä¸æ¿ƒåº¦æ¯”例很低的藥å“。藥動篩é¸çš„一個å¯èƒ½é‡è¦ç™¼ç¾æ˜¯ï¼Œå°æ–¼å…·æœ‰ä¸åŒäººå£å¸ç‰¹æ€§ï¼ˆå¦‚年齡）或臨床特性（如使用其他藥å“）的次æ—群，å³ä½¿åŒ…å«è¶³å¤ çš„å—試者人數，å¯èƒ½ç™¼ç¾è—¥å“è¡€ä¸æ¿ƒåº¦ä¸¦ç„¡æ˜Žé¡¯å·®ç•°ã€‚</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　藥動篩檢的é‡è¦å„ªé»žæ˜¯ä¸éœ€è¦å‰ç½®å‡èªªï¼Œå³å¯èƒ½æ¸¬çŸ¥æœªé 期的çµæžœã€‚若篩檢時有ä¸å°‹å¸¸ä¸”é‡è¦çš„發ç¾ï¼Œæˆ–許需è¦æ›´é€²ä¸€æ¥çš„è©¦é©—ã€‚å› æ¤ï¼Œè‹¥æœ‰æ¬¡æ—群（如特定年齡範åœã€æŽ¥å—其他藥å“者）有顯著較高或較低的藥å“è¡€ä¸æ¿ƒåº¦ï¼Œå°¤å…¶æ˜¯é€™æœƒå¢žåŠ 毒性或減少藥效時，å¯èƒ½å¿…é ˆè‰å¯¦æ¤è§€å¯ŸåŠæŽ¢ç©¶å…¶åŽŸå› 。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　藥å“的治療指標ã€æ¯’性或藥效與藥å“è¡€ä¸æ¿ƒåº¦ä¹‹é—œä¿‚，將å¯æ±ºå®šæ¤æŸ¥è‰ä¹‹é‡è¦æ€§åŠæ™‚間點（藥å“å¯©æ ¸é€šéŽä¹‹å‰æˆ–在第四階段臨床試驗）。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　篩檢或許也å¯ä»¥å¹«åŠ©è§£é‡‹ç¬¬äºŒã€ä¸‰éšŽæ®µè‡¨åºŠè©¦é©—çš„çµæžœï¼ŒæŸäº›ä¸å°‹å¸¸çš„藥效或ä¸è‰¯å應å¯ç”¨ç—…患的藥å“è¡€ä¸æ¿ƒåº¦ä¾†è§£é‡‹ã€‚利用臨床數據åŠç¯©æª¢çµæžœæ‡‰å¯ä»¥è§€å¯Ÿå‡ºç²—略的藥å“濃度與å應間</span><span style="font-family: times new roman,serif;">(concentration-response)</span><span style="font-family: 標楷體;">的關係。</span> </p><p><span style="font-family: 標楷體;">二ã€åš´è¬¹è€Œæ£å¼çš„藥動å¸è©¦é©—</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　嚴謹而æ£å¼çš„藥動å¸è©¦é©—å¯ä»¥åœ¨å¥åº·çš„è€å¹´äººæˆ–å¹´è€ç—…患進行。é¸æ“‡ä¸€å€‹åªç´å…¥å°‘數å—試者的å°è¦æ¨¡è—¥å‹•å¸è©¦é©—，用來檢測在穩定狀態下</span><span style="font-family: times new roman,serif;">(steady state)</span><span style="font-family: 標楷體;">，年è€ç—…患與年輕病患</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">或å¥åº·çš„è€å¹´äººèˆ‡å¹´è¼•äººå—試者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">之間é”到一定程度的差異；或是採å–一個較大è¦æ¨¡ã€å–®ä¸€åŠ‘é‡çš„藥動å¸è©¦é©—，使年è€ç—…患與年輕病患</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">或å¥åº·çš„è€å¹´äººèˆ‡å¹´è¼•äººå—試者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">間，在統計上åšæœ‰æ„義的比較。ä¸ç®¡æ˜¯æŽ¡ç”¨é‚£ä¸€ç¨®è©¦é©—，如果發ç¾å¹´è€ç—…患與年輕病患</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">或å¥åº·çš„è€å¹´äººèˆ‡å¹´è¼•äººå—試者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">間，具與年齡相關且臨床上é‡è¦çš„å·®ç•°æ™‚ï¼Œå‰‡å¿…é ˆé€²ä¸€æ¥åŸ·è¡Œä¸€å€‹åœ¨ç©©å®šç‹€æ…‹ä¸‹ï¼Œæœ‰è¶³å¤ å—試者之多劑é‡è—¥å‹•å¸è©¦é©—，在統計上作有æ„義的比較。</span> </p><p style="margin-left: 18pt;"><span style="font-family: 標楷體;">三ã€è—¥å“與疾病和藥å“交互作用關係</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　　　若併有疾病與併用藥å“å°è©¦é©—用藥的藥動å¸æœ‰å¾ˆå¤§çš„影響，å¯ç”±è—¥å‹•ç¯©æª¢è§€å¯Ÿå‡ºä¾†ã€‚當試驗用藥之治療指標（毒性與治療劑é‡çš„比例）低，且該藥之é©æ‡‰ç—‡ä½µå˜å…¶ä»–疾病，併用其他治療的å¯èƒ½æ€§å¤§æ™‚，應執行特定的交互作用試驗，這些試驗ä¾å€‹æ¡ˆè€Œå®šï¼Œä½†æ‡‰åŒ…括：</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　</span> </p><p style="margin-left: 18pt;"><span style="font-family: 標楷體;">（一）</span> <span style="font-family: 標楷體;">交互作用試驗（</span><span style="font-family: times new roman,serif;">Interaction Studies</span><span style="font-family: 標楷體;">）</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　　　</span> </p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">１ã€</span><span style="font-family: times new roman,serif;">Digoxin</span><span style="font-family: 標楷體;">交互作用</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">許多藥å“會改變</span><span style="font-family: times new roman,serif;">digoxin </span><span style="font-family: 標楷體;">çš„è¡€ä¸æ¿ƒåº¦ï¼Œ</span><span style="font-family: times new roman,serif;">digoxin</span><span style="font-family: 標楷體;">經常使用在è€å¹´äººä¸¦å…·æ½›åœ¨æ¯’æ€§ï¼Œå› æ¤å°å¤§å¤šæ•¸è—¥å“而言，應該評估與</span><span style="font-family: times new roman,serif;">digoxin</span><span style="font-family: 標楷體;">的交互作用。</span><span style="font-family: times new roman,serif;"> </span></p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">ï¼’ã€æœƒå½±éŸ¿è‚臟代è¬çš„è—¥å“</span> </p><p style="margin-left: 36pt;"><span style="font-family: times new roman,serif;"> </span><span style="font-family: 標楷體;">主è¦ç¶“ç”±è‚臟代è¬çš„è—¥å“，應評估該藥與è‚è‡Ÿé…µç´ èª˜å°ŽåŠ‘ï¼ˆå¦‚</span><span style="font-family: times new roman,serif;">phenobarbital</span><span style="font-family: 標楷體;">）或抑制劑（如</span><span style="font-family: times new roman,serif;">cimetidine</span><span style="font-family: 標楷體;">）åˆä½µä½¿ç”¨ä¹‹äº¤äº’作用。特別值得一æ的如</span><span style="font-family: times new roman,serif;">cytochrome P-450 debrisoquin hydroxylase</span><span style="font-family: 標楷體;">會被</span><span style="font-family: times new roman,serif;">quinidine </span><span style="font-family: 標楷體;">åŠå…¶ä»–è—¥å“（如</span><span style="font-family: times new roman,serif;">propafenone</span><span style="font-family: 標楷體;">）抑制，使得病患原本快速代è¬è€…å› æœç”¨æ¤é¡žè—¥å“而表ç¾å‡ºç·©æ…¢ä»£è¬è€…çš„ç‰¹æ€§ï¼Œå› æ¤å¤§å¤šæ•¸æœƒè¢«æ¤é…µç´ 代è¬çš„è—¥å“，應探討其與</span><span style="font-family: times new roman,serif;">quinidine</span><span style="font-family: 標楷體;">的交互作用。</span><span style="font-family: times new roman,serif;"> </span></p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">３ã€å…¶ä»–è—¥å“</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">其他特別å¯èƒ½èˆ‡è©¦é©—用藥併用之藥å“，除éžè—¥å‹•ç¯©æª¢æˆ–交互作用篩檢å¯è‰æ˜Žé‡è¦çš„交互作用並ä¸å˜åœ¨ï¼Œå¦å‰‡æ‡‰ç ”究其藥å“交互作用。</span><span style="font-family: times new roman,serif;"> </span></p><p style="margin-left: 36pt;"><span style="font-family: 標楷體;">ï¼”ã€è›‹ç™½è³ªçµåˆè©¦é©—</span><span style="font-family: times new roman,serif;"> (Protein Binding Studies)<br /></span><span style="font-family: 標楷體;">會與血漿蛋白質大é‡çµåˆçš„試驗用藥å¯èƒ½æœƒå°‡å…¶ä»–è—¥å“ç”±çµåˆè™•å–代之，如éžé¡žå›ºé†‡é¡žè—¥å“</span><span style="font-family: times new roman,serif;">(NSAID's)</span><span style="font-family: 標楷體;">å–代</span><span style="font-family: times new roman,serif;">warfarin</span><span style="font-family: 標楷體;">，å之亦然。這種交互作用å¯ä»¥ç”±é›¢é«”試驗簡便地觀察出來，若臨床曾觀察到交互作用，蛋白質çµåˆè©¦é©—å¯ä»¥å¹«åŠ©äº†è§£æ¤æ©Ÿåˆ¶ã€‚</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　</span> </p><p style="margin-left: 18pt;"><span style="font-family: 標楷體;">（二）併有疾病åŠä½µç”¨è—¥å“與交互作用篩檢</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　　若試驗用藥會用在特定併有疾病很å¯èƒ½ç™¼ç”Ÿçš„情æ³æ™‚，治療æ—群應包括併有其他疾病之病患，藥動篩檢å¯å¹«åŠ©æ±ºå®šä½µæœ‰ç–¾ç—…是å¦æœƒå½±éŸ¿è©¦é©—用藥之血ä¸æ¿ƒåº¦ï¼Œè€Œè‡¨åºŠè§€å¯Ÿå‰‡å¯ä»¥æ¸¬å‡ºèˆ‡å…¶ä»–疾病相關的特殊ä¸è‰¯å應。åŒæ¨£åœ°ï¼Œå°æ–¼ä½µç”¨è—¥å“，篩檢å¯å¹«åŠ©è©•ä¼°å…¶ä»–è—¥å“是å¦æœƒå½±éŸ¿è©¦é©—用藥之藥動å¸ç‰¹è³ªã€‚在æŸäº›ç¶“常併用其他藥å“的情æ³ä¸‹ï¼Œæ‡‰åŸ·è¡Œæ£å¼çš„交互作用試驗。例如ä¸åŒé¡žåˆ¥çš„抗心絞痛藥å“（</span><span style="font-family: times new roman,serif;">nitrate, beta-blocker, calcium-antagonist</span><span style="font-family: 標楷體;">）併用時，å³æ‡‰æ£å¼ç ”究這些藥å“的併用時之藥效和è€å—性。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　　試驗用藥也å¯èƒ½æœƒå½±éŸ¿å…¶ä»–è—¥å“的藥動å¸ï¼Œé—œæ–¼æ¤å•é¡Œï¼Œç¬¬äºŒç¨®ç¯©æª¢æ©Ÿåˆ¶ã€Œäº¤äº’作用篩檢ã€å¯èƒ½æœ‰æ‰€åŠ©ç›Šï¼Œå¦‚果第三階段臨床試驗包括使用多種其他藥å“的病人，其他藥å“之最低血ä¸æ¿ƒåº¦å¯ä»¥åœ¨ä½¿ç”¨è©¦é©—用藥之å‰å¾—到，也å¯ä»¥åœ¨è©¦é©—用藥é”到穩定的血ä¸æ¿ƒåº¦ä¹‹å¾Œå¾—åˆ°ã€‚å› æ¤æ‡‰è©²å¯ä»¥æ¸¬å¾—試驗用藥å°å…¶ä»–併用藥å“的影響。執行上述試驗的障礙在於缺ä¹å¯ä¿¡çš„測é‡å…¶ä»–è—¥å“之血ä¸æ¿ƒåº¦çš„方法。</span> </p><p><span style="font-family: 標楷體;">å››ã€è…ŽåŠŸèƒ½ä¸å…¨çš„影響</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　凡顯著經由腎臟排泄的藥å“（原藥å“或其活性代è¬ç‰©ï¼‰æ‡‰å®šç¾©è…ŽåŠŸèƒ½æ”¹è®Šå°è©²è—¥å“藥動å¸çš„影響。應有資料è‰å¯¦ä¸åŒç¨‹åº¦è…ŽåŠŸèƒ½ä¸å…¨è€…çš„åˆç†åŠ‘é‡èª¿æ•´èªªæ˜Žã€‚如è¦ç›´æŽ¥å¾—到æ£ç¢ºçš„肌氨酸é…清除率</span> <span style="font-family: times new roman,serif;">(creatinine clearance</span><span style="font-family: 標楷體;">簡稱</span><span style="font-family: times new roman,serif;">CCr)</span><span style="font-family: 標楷體;">，åˆä¸å¿…讓病患ä½é™¢ä»¥æ”¶é›†å°¿æ¶²ï¼Œå¾€å¾€ä¸å¤§å®¹æ˜“ï¼Œå› æ¤åœ¨è©²è—¥å“的仿單ä¸ï¼Œæ‡‰æ¨™ç¤º</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">，其å¯ç”¨æ¸¬å®šè¡€ä¸è‚Œæ°¨é…¸é…濃度ä¾é«”é‡å’Œå¹´é½¡ä¾†è¨ˆç®—。以下由</span><span style="font-family: times new roman,serif;">Cockcroft </span><span style="font-family: 標楷體;">å’Œ</span><span style="font-family: times new roman,serif;">Gault</span><span style="font-family: 標楷體;">所定的公å¼ï¹</span><span style="font-family: times new roman,serif;">(Nephron 16:31-41 (1976)</span><span style="font-family: 標楷體;">﹞，是最常使用的。</span> </p><p><span style="font-family: 標楷體;">男性</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">　　ï¼ã€€ã€€é«”é‡</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">公斤</span><span style="font-family: times new roman,serif;">) x (140-</span><span style="font-family: 標楷體;">年齡</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">ï¼</span><span style="font-family: times new roman,serif;">72 x Cr (</span><span style="font-family: 標楷體;">毫克</span><span style="font-family: times new roman,serif;">/100</span><span style="font-family: 標楷體;">毫å‡</span><span style="font-family: times new roman,serif;">)</span></p><p><span style="font-family: 標楷體;">女性</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">　　ï¼ã€€ã€€</span><span style="font-family: times new roman,serif;">0.85 </span><span style="font-family: 標楷體;">　</span><span style="font-family: times new roman,serif;">x</span><span style="font-family: 標楷體;">　體é‡</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">公斤</span><span style="font-family: times new roman,serif;">) x (140-</span><span style="font-family: 標楷體;">年齡</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">ï¼</span><span style="font-family: times new roman,serif;">72 x Cr (</span><span style="font-family: 標楷體;">毫克</span><span style="font-family: times new roman,serif;">/100</span><span style="font-family: 標楷體;">毫å‡</span><span style="font-family: times new roman,serif;">)<br /></span><span style="font-family: 標楷體;">　　　　　　</span><span style="font-family: times new roman,serif;"> </span></p><p><span style="font-family: times new roman,serif;">Cr: serum creatinine</span></p><p><span style="font-family: 標楷體;">五ã€è‚功能ä¸å…¨çš„影響</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　</span> <span style="font-family: 標楷體;">主è¦ç”±è‚臟代è¬çš„è—¥å“，尤其是經由氧化代è¬æˆ–具活性代è¬ç‰©è€…，使用於病患時，包括年è€ç—…患，應特別謹慎的，並應進行特別的藥動å¸è©¦é©—以探討è‚功能é™ä½Žæ‰€é€ æˆçš„影響，並尋找å¯èƒ½çš„è—¥å“代è¬æˆ–è—¥å“交互作用之éºå‚³è®Šç•°ã€‚然而，目å‰ä¸¦ç„¡é¡žä¼¼</span><span style="font-family: times new roman,serif;">CCr</span><span style="font-family: 標楷體;">之於腎功能的è‚功能測定指標å¯é ä¼°è—¥å“排泄之變異如何改變，ä¸éŽç•¶å‡ºç¾è‚硬化時，表示藥å“的清除率（如</span><span style="font-family: times new roman,serif;">theophylline</span><span style="font-family: 標楷體;">）å¯èƒ½æœƒé™ä½Žã€‚在測é‡è‚功能時，建è°ä½¿ç”¨</span><span style="font-family: times new roman,serif;">FDA</span><span style="font-family: 標楷體;">基準ä¸æ‰€æŽ¨è–¦ä¹‹</span><span style="font-family: times new roman,serif;">Child-Pugh</span><span style="font-family: 標楷體;">分類法åŠåŠä¹³ç³–單點法（</span><span style="font-family: times new roman,serif;">Galactose Single Point Method,GSP</span><span style="font-family: 標楷體;">。用於評估國人常見è‚病病患殘餘è‚功能</span><span style="font-family: times new roman,serif;">[residual liver function]</span><span style="font-family: 標楷體;">的方法），來定義è‚功能åŠæª¢é©—特殊代è¬ç¼ºå¤±å°æ–¼æ–°è—¥å“藥動å¸çš„影響。（請åƒè€ƒæœ¬ç½²åˆ¶å®šä¹‹ã€Œè‚功能ä¸å…¨ç—…患的藥動å¸è©¦é©—基</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　準ï¼è‡¨åºŠè©¦é©—è¨è¨ˆã€æ•¸æ“šåˆ†æžä»¥åŠå°åŠ‘é‡èª¿æ•´èˆ‡æ¨™ç¤ºçš„影響。ã€ï¼‰</span> </p><p><span style="font-family: times new roman,serif;"> </span></p><p><b><span style="font-family: 標楷體;">ç¬¬å››ç« ã€è—¥æ•ˆ</span></b><b><span style="font-family: times new roman,serif;">/</span></b><b><span style="font-family: 標楷體;">劑é‡</span></b><b><span style="font-family: times new roman,serif;">-</span></b><b><span style="font-family: 標楷體;">å應試驗</span></b><b><span style="font-family: times new roman,serif;"><br /></span></b><b><span style="font-family: 標楷體;">　　</span></b><span style="font-family: 標楷體;">由年齡相關的藥效差異</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 標楷體;">例如在æŸç‰¹å®šä¹‹è—¥å“è¡€ä¸æ¿ƒåº¦ï¼Œå¹´é½¡å°è—¥æ•ˆæˆ–å‰¯ä½œç”¨ä¹‹å½±éŸ¿æ˜¯åŠ å¼·æˆ–æ¸›ä½Ž</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 標楷體;">，目å‰æ‰€çŸ¥å¤ªå°‘ï¼Œå› æ¤ç„¡éœ€ç‰¹åˆ¥åœ¨è€å¹´æ—群身上作常è¦çš„藥效或臨床試驗。從包å«æœ‰å¹´è¼•èˆ‡å¹´è€ç—…患的臨床試驗的觀察比全是è€å¹´äººçš„臨床試驗，更å¯æ¸¬å¾—是å¦æœ‰é‡è¦çš„年齡差異。將病患以年齡分層，則å¯å¾—到較æ•æ„Ÿçš„評估，是最好的試驗方法。</span><span style="font-family: times new roman,serif;"> <br /></span><span style="font-family: 標楷體;">　　但在æŸäº›æƒ…æ³ä¸‹ï¼Œå¦‚鎮定劑ã€å®‰çœ 藥和其他主è¦ä½œç”¨æ–¼ä¸æ¨žç¥žç¶“系統的藥å“ï¼Œå‰‡å¿…é ˆå–®ç¨æ–½è¡Œè€å¹´æ—群臨床試驗。其他臨床試驗的分æžçµæžœæœ‰æ™‚也會顯示單ç¨éœ€è¦å¹´è€ç—…患試驗。這些指標包å«ç•Œå®šè—¥æ•ˆã€ä¸è‰¯å應的劑é‡</span><span style="font-family: times new roman,serif;">─</span><span style="font-family: 標楷體;">å應關係，尤其是最低有效劑é‡åŠè¼ƒé«˜åŠ‘é‡å°ä¸æ¨žç¥žç¶“系統的影響ç‰ã€‚å¿…è¦æ™‚ï¼Œäº¦é ˆè€ƒæ…®åŸ·è¡Œç‰¹æ®Šè—¥å“與疾病的交互作用試驗。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　å°æ–¼å¹´è¼•èˆ‡å¹´è€ç—…æ‚£å¯èƒ½ç”¢ç”Ÿä¸åŒè—¥å“å應之評估é‡é»žï¼Œæ‡‰åœ¨æ–¼å¯èƒ½å˜åœ¨çš„藥動å¸å·®ç•°ï¼Œè©²è—¥å‹•å¸çš„差異通常比已知之藥效å¸å·®ç•°æ›´ç‚ºå¸¸è¦‹ã€‚大部分年è€ç—…患的用藥å•é¡Œä¾†è‡ªå› 年齡ä¸åŒè€Œç”¢ç”Ÿä¹‹è—¥å‹•å¸æ”¹è®Šï¼Œæˆ–是與年齡相關的狀æ³å¦‚腎功能ä¸å…¨ã€å¿ƒè‡Ÿè¡°ç«ã€ä½¿ç”¨å¤šç¨®è—¥å“ç‰ã€‚</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　æ¤å¤–，藥動å¸å·®ç•°è¼ƒæ˜“察覺，一旦建立測é‡è—¥å“åŠå…¶ä»£è¬ç‰©çš„方法（æ¤æ–¹æ³•é€šå¸¸åœ¨è—¥å“ç ”ç™¼æ—©æœŸå³å·²å»ºç«‹ï¼‰ï¼Œè©•ä¼°å—年齡相關的影響之技術å³å·²å˜åœ¨ã€‚æ£å¼çš„藥動å¸è©¦é©—å¯ä»¥è§£é‡‹ç‰¹æ®Šæ—群的疑å•ï¼Œè€Œåœ¨ç¬¬ä¸‰éšŽæ®µè‡¨åºŠè©¦é©—執行「藥動篩檢ã€</span><span style="font-family: times new roman,serif;">(Pharmacokinetic screen)</span><span style="font-family: 標楷體;">æ›´å¯ä»¥æ高å°æ–¼æ¬¡è¦æ—群åŠå€‹äººä¹‹è—¥å‹•å¸çš„åµæ¸¬ã€‚於第三階段臨床試驗的病患ä¸ï¼Œåƒ…採å–少數的血樣決定藥å“è¡€ä¸æ¿ƒåº¦ï¼Œå‰‡å¯èƒ½æ¸¬å‡ºå€‹äººçš„éžå…¸åž‹çš„藥動å¸åž‹æ…‹</span><span style="font-family: times new roman,serif;">(atypical pharmacokinetic behavior)</span><span style="font-family: 標楷體;">，例如</span><span style="font-family: times new roman,serif;">Encainide</span><span style="font-family: 標楷體;">的緩慢代è¬è€…，å¦å¤–，也å¯ä»¥æ¸¬å‡ºæ¬¡è¦æ—群ä¸çš„之細微差異，例如ä¸åŒå¹´é½¡ã€æ€§åˆ¥ã€ç¨®æ—或具有特殊疾病ã€ä½µç”¨è—¥å“ç‰ã€‚</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　新藥申請（</span><span style="font-family: times new roman,serif;">NDA, New Drug Application</span><span style="font-family: 標楷體;">）時，劑é‡å應ã€è¡€ä¸æ¿ƒåº¦å應資料是很é‡è¦çš„。å°ä¸€å€‹å¯æ¸¬é‡çš„藥效指標如血壓ã€å¿ƒå®¤éŽæ—©è·³å‹•çŽ‡ï¼ˆ</span><span style="font-family: times new roman,serif;">rate of ventricular premature beats</span><span style="font-family: 標楷體;">），是å¯é 期從ä¸åŒæ—群觀察到劑é‡å應，尤其這些差異å°è—¥å“的安全性ã€æœ‰æ•ˆæ€§æœ‰å¾ˆé‡è¦çš„影響。但是，當藥效指標無法立刻從一個å°æ—群評估時（例如治療憂鬱症ã€ç„¦æ…®ç—‡ï¼‰ï¼Œå¥½çš„劑é‡å應資料則ä¸æ˜“得到，在æ¤å°æ—群的次æ—群（例如è€å¹´äººï¼‰å‰‡æ›´ç”šã€‚è¦æ¸¬é‡ä¸åŒæ¬¡æ—群ä¸çš„臨床療效或ä¸è‰¯å應的差異是å¯èƒ½çš„，觀察到的差異å¯ä»¥åæ˜ è—¥å‹•å¸å·®ç•°æˆ–藥效å¸å·®ç•°ï¼Œä¾‹å¦‚å°è—¥å“ä¸å°‹å¸¸çš„è—¥ç†å應。</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　　最後è¦å¼·èª¿è—¥å‹•å¸è©•ä¼°ä¹‹é‡è¦æ€§çš„ç†ç”±åœ¨æ–¼ï¼šå‹™å¿…先執行藥動å¸è©•ä¼°ï¼Œæ–¹å¯æ£ç¢ºåœ°ç ”判藥效å¸çš„差異性或相關性。當æ—群與血ä¸æ¿ƒåº¦é–“有åˆç†çš„相關性å˜åœ¨æ™‚，å³å¯è©•ä¼°ä¸åŒçµ„間藥效å¸çš„差異性或是建立血ä¸æ¿ƒåº¦èˆ‡è—¥ç‰©åæ‡‰ä¹‹é—œä¿‚ã€‚å› æ¤å¿…é ˆæœ‰è¶³å¤ çš„è—¥å‹•å¸è³‡æ–™ï¼Œè®“試驗主æŒäººè—‰æ¤é¸æ“‡è¶³ä»¥åœ¨ä¸åŒæ¬¡æ—群ä¸é”到相當血ä¸æ¿ƒåº¦çš„é©ç•¶åŠ‘é‡ï¼Œæˆ–是調整劑é‡åˆ°ç›¸ä¼¼ä¹‹è¡€ä¸æ¿ƒåº¦ç›¸ä¼¼æƒ…æ³ä¸‹ï¼Œæ¯”較å°çµ„間的差異。</span> </p><p><span style="font-family: times new roman,serif;"> </span></p><p><b><span style="font-family: 標楷體;">åƒè€ƒæ–‡ç»</span></b> </p><p><span style="font-family: times new roman,serif;">1.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(1997). </span><span style="font-family: 標楷體;">è—¥å“è‡¨åºŠè©¦é©—ç”³è«‹é ˆçŸ¥ï¼ˆå°åŒ—）</span> </p><p><span style="font-family: times new roman,serif;">2.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(1999). </span><span style="font-family: 標楷體;">è—¥å“查驗登記審查準則（å°åŒ—）</span> </p><p><span style="font-family: times new roman,serif;">3.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2000). </span><span style="font-family: 標楷體;">è—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„（å°åŒ—）</span> </p><p><span style="font-family: times new roman,serif;">4.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2000). </span><span style="font-family: 標楷體;">臨床試驗基準（å°åŒ—）</span> </p><p><span style="font-family: times new roman,serif;">5.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2000). </span><span style="font-family: 標楷體;">è—¥å“éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„（å°åŒ—）</span> </p><p><span style="font-family: times new roman,serif;">6.</span><span style="font-family: 標楷體;">行政院衛生署</span><span style="font-family: times new roman,serif;">(2001). </span><span style="font-family: 標楷體;">è‚功能ä¸å…¨ç—…患的藥動å¸è©¦é©—基準（ï¼è‡¨åºŠè©¦é©—è¨è¨ˆã€æ•¸æ“šåˆ†æžä»¥åŠå°åŠ‘é‡èª¿æ•´èˆ‡</span><span style="font-family: times new roman,serif;"><br /></span><span style="font-family: 標楷體;">　標示的影響）</span> </p><p><span style="font-family: times new roman,serif;">7.Guideline for the Study of Drugs, Likely To Be Used in the Elderly. FDA, USA, 1989.</span></p><p><span style="font-family: times new roman,serif;">8.ICH E7: Studies in Support of Special Populations: Geriatrics, 1993</span></p>2013-12-04
藥政管ç†é¡ž,æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•æ³•è¦å‘½ä»¤æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾è—¥äº‹æ³•ç¬¬å…«æ¢è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘之管ç†ï¼Œé™¤è—¥äº‹æ³•å¦æœ‰è¦å®šè€…外，ä¾æœ¬è¾¦æ³•ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱æˆè—¥ä¿‚æŒ‡åŽŸæ–™è—¥ç¶“åŠ å·¥èª¿è£½ï¼Œä¸ç”¨å…¶åŽŸå稱，其摻入之麻醉藥藥å“ã€æ¯’劇藥å“，ä¸è¶…éŽä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€è¦å®šä¹‹é™é‡ï¼Œä½œç”¨ç·©å’Œã€ç„¡ç©è“„性ã€è€ä¹…儲å˜ã€ä½¿ç”¨ç°¡ä¾¿ï¼Œä¸å¾…醫師指示å³å¯ä¾›æ²»ç™‚疾病之用者。</span> </p><p><span style="font-family: 新細明體,serif;">æˆè—¥åˆ†ç”²ã€ä¹™å…©é¡žï¼Œå…¶ç¯„åœåŠå¯©æ ¸æ¨™æº–如基準表（附件一ã€äºŒï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æˆè—¥ä¸æ‘»ç”¨éº»é†‰è—¥å“，除嗎啡å«é‡æ‡‰åœ¨åƒåˆ†ä¹‹äºŒä»¥ä¸‹ï¼Œå¯å¡å› 應在åƒåˆ†ä¹‹ä¸€ä»¥ä¸‹å¤–，其他麻醉藥å“摻用é‡ç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ¯”照上述標準視其劑é‡æ ¸å®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æˆè—¥ä¸æ‘»ç”¨æ¯’劇藥å“，如為ä¸è¯è—¥å…¸æ‰€è¼‰è€…，ä¸å¾—超éŽå¸¸ç”¨é‡ä¸‰åˆ†ä¹‹ä¸€ï¼Œå…¶æœªç‚ºä¸è¯è—¥å…¸æ‰€è¼‰è€…，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱固有æˆæ–¹ä¿‚指我國固有醫藥習慣使用，具有療效之ä¸è—¥è™•æ–¹ï¼Œä¸¦ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¸å®šå…¬ä½ˆè€…而言。ä¾å›ºæœ‰æˆæ–¹èª¿è£½</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æˆä¹‹ä¸¸æ•£ã€è†ã€ä¸¹ç¨±ç‚ºå›ºæœ‰æˆæ–¹è£½åŠ‘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æˆè—¥åŠä»¥æ‰¹ç™¼æˆ–供人出售之固有æˆæ–¹è£½åŠ‘，應由藥å“è£½é€ æ¥è€…è£½é€ ã€‚ä¸è—¥è²©è³£æ¥è€…å¾—ä¾å›ºæœ‰æˆæ–¹æ‰€è¼‰ä¹‹åŽŸå稱ã€æˆåˆ†ã€è£½æ³•ã€æ•ˆèƒ½ã€ç”¨æ³•åŠç”¨é‡ï¼Œèª¿è£½</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有æˆæ–¹è£½åŠ‘但以於其營æ¥è™•æ‰€è‡ªè¡Œé›¶å”®ç‚ºé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">å¯©æ ¸åŠè¨±å¯</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ æ¥è€…調製æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘，應ä¾è—¥äº‹æ³•ç¬¬ä¸‰åä¹æ¢ã€ç¬¬å››å三æ¢ã€ç¬¬å››åå…æ¢è‡³ç¬¬å››åå…«æ¢ã€ç¬¬äº”åå…æ¢åŠç¬¬äº”å七æ¢ä¹‹è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æˆè—¥ä¾æˆè—¥åŸºæº–è¡¨å¯©æ ¸ä¹‹ï¼Œä½†å«è—¥é…’é¡žä¾å…¶æœ‰é—œè¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥è²©è³£æ¥è€…調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有æˆæ–¹è£½åŠ‘，應列具å稱ã€æˆåˆ†ã€è£½æ³•ã€æ•ˆèƒ½ã€ç”¨æ³•åŠç”¨é‡ï¼Œé€£åŒæœ‰é—œè³‡æ–™è‰ä»¶ï¼Œå‘該管直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關æå‡ºç”³è«‹ï¼Œç¶“æ ¸å‡†ç™»è¨˜ç™¼çµ¦ç™»è¨˜è‰å¾Œï¼Œå§‹å¾—製售。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …ç¶“æ ¸å‡†ç™¼çµ¦ç™»è¨˜è‰æ¡ˆä»¶ï¼Œç›´è½„市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‡‰æŒ‰æœˆåˆ—å†Šå ±è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥è²©è³£æ¥è€…調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固有æˆæ–¹è£½åŠ‘，應於其管ç†è—¥å“之ä¸é†«å¸«ç›£ç£ä¸‹ç‚ºä¹‹ã€‚但ä¸å«æ¯’劇藥å“者，å¯ç”±ç¢ºå…·ä¸è—¥åŸºæœ¬çŸ¥è˜åŠé‘‘別能力人員自行調製</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">固有æˆæ–¹è£½åŠ‘ä¸å¾—摻入防è…劑ã€è‰²ç´ ã€äººå·¥ç”˜å‘³åŠ‘ã€åŒ–å¸æº¶åŠ‘åŠå…¶ä»–æœ‰å®³æ·»åŠ ç‰©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æˆè—¥ä¹‹æ¨™ç±¤ã€ä»¿å–®æˆ–包è£æ‡‰æ¨™æ˜Žç”²é¡žæˆè—¥æˆ–乙類æˆè—¥ã€‚固有æˆæ–¹è£½åŠ‘應標明å稱åŠå›ºæœ‰æˆæ–¹å—樣。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">販賣之管ç†</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ æ¥è€…除å«è—¥é…’é¡žä¸å¾—以留置方å¼ä¾›éŠ·å®¶åºç”¨æˆ¶å¤–，得將自製之æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘，以留置方å¼ç›´æŽ¥ä¾›éŠ·å®¶åºç”¨æˆ¶ã€‚但以供銷民眾購用藥å“較為ä¸ä¾¿ä¹‹å僻地å€ç‚ºé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">家åºç•™ç½®æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘之地å€ï¼Œæ‡‰ç”±ç›´è½„市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關æ¯å¹´æŸ¥æ ¸ä¸€æ¬¡ï¼Œé€æ¥ç¸®æ¸›ç•™ç½®åœ°å€ç¯„åœã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ æ¥è€…將自製æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘留置於家åºç”¨æˆ¶è€…，應ä¾å·¦åˆ—å„款之è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”³è«‹ä¾›éŠ·å®¶åºç•™ç½®æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘，應事先檢具藥å“å清單</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">æ ¼å¼å¦‚附件三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">二份，申請直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¼Œè½‰å ±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¾›éŠ·ç•™ç½®æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘之日起åäº”æ—¥å…§é–‹å…·å·¦åˆ—äº‹é …ï¼Œå‘直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå ±å‚™ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ æ¥è€…之å稱ã€åœ°å€åŠè² 責人姓å。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">銷售地å€</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">列明直轄市ã€ç¸£å¸‚ã€é„‰éŽ®å¸‚å€æˆ–æ‘里å稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŠç•™ç½®æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘æœå‹™å“¡å冊</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">æ ¼å¼å¦‚附件四</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">一份。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">留置藥å“清單一份。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç•™ç½®ä¹‹æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘應è£ç½®åœ¨ã€Œå®¶åºè—¥å“留置袋ã€æˆ–「箱ã€å…§ï¼Œå…¶è¢‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ç®±</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰æŽ¡å …å›ºè€ç”¨æ料製æˆï¼Œä¸¦æ‡‰è¼‰æ˜Žè—¥å“è£½é€ æ¥è€…</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">藥商</span><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">å稱ã€åœ°å€èˆ‡ç•™ç½®è—¥å“之å“åã€è¨±å¯å—號ã€æ•ˆèƒ½ã€åƒ¹æ ¼ã€æ•¸é‡åŠæ³¨æ„äº‹é …ç‰</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">æ ¼å¼å¦‚附件五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。但所刊載文å—圖畫，ä¸å¾—有藥事法第å…åå…«æ¢æ‰€åˆ—å„款情事。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ‡‰ç™¼çµ¦ç•™ç½®æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘æœå‹™äººå“¡æœå‹™è‰</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">æ ¼å¼å¦‚附件å…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，並指定其æœå‹™å“¡å‹¤äºˆå·¡æª¢ç•™ç½®ä¹‹è—¥å“，æ¯æ¬¡é–“éš”ä¸å¾—逾三個月。</span> </p><p><span style="font-family: 新細明體,serif;">附件三</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ å» å•†å稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">家åºç•™ç½®æˆè—¥å›ºæœ‰æˆæ–¹è£½åŠ‘å“å清單</span> </p><p><span style="font-family: 新細明體,serif;">┌────┬───────┬───┬────┬────┬───â”</span> </p><p><span style="font-family: 新細明體,serif;">│許å¯å—號│藥</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">稱│劑</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">型│包括容é‡â”‚æ ¸å‡†æ•ˆèƒ½â”‚å‚™</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">考│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">├────┼───────┼───┼────┼────┼───┤</span> </p><p><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">│第</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">號│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">│</span> </p><p><span style="font-family: 新細明體,serif;">└────┴───────┴───┴────┴────┴───┘</span> </p><p><span style="font-family: 新細明體,serif;">註：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”³è«‹ç›´è½„市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè½‰å ±ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å®šåŠå‘直轄</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå ±å‚™ä¹‹æ¸…å–®å‡ä¾æ¤æ ¼å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å‘縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市ã€å±€</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå ±å‚™ä¹‹å“åæ¸…å–®ï¼Œé ˆåœ¨å‚™è€ƒæ¬„è¨»æ˜Žæ ¸å®š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ©Ÿé—œå稱åŠæ–‡è™Ÿã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å‚™</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">註：附件三之註一請åƒé–±è¡Œæ”¿é™¢å…¬å ±ç¬¬</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">å·</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">期</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">é </span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å‚™</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">註：附件三～å…è«‹åƒé–±ä¸è¯æ°‘國ç¾è¡Œæ³•è¦å½™ç·¨</span><span style="font-family: calibri;"> (83</span><span style="font-family: 新細明體,serif;">å¹´</span><span style="font-family: calibri;">5</span><span style="font-family: 新細明體,serif;">月版</span><span style="font-family: calibri;">) (</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三○</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20905</span><span style="font-family: 新細明體,serif;">～</span><span style="font-family: calibri;">20909 </span><span style="font-family: 新細明體,serif;">é </span><span style="font-family: calibri;">)</span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">家åºç•™ç½®æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘之æœå‹™å“¡ï¼Œæ–¼æŽ¨éŠ·æˆ–執行工作時，應é…帶æœå‹™è‰ï¼ŒæŒ‡å°Žç”¨æˆ¶å°‡è—¥å“留置袋</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ç®±</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">置於ä¸è¢«æ—¥æ™’ã€é›¨æ·‹ã€å—æ½®åŠä¸æ˜“為兒童ç²å–之處所。如發ç¾è¢‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ç®±</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">內藥å“有變質ã€æ²‰æ¾±ã€æ壞或其他ä¸è‰¯ç‹€æ³æ™‚，應å³æ”¶å›žæˆ–æ›å…¥æ–°å“。並ä¸å¾—將任何æˆè—¥æˆ–固有æˆæ–¹è£½åŠ‘拆å°æˆ–改è£åŠæ²¿é€”或è¨æ”¤è²©è³£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">乙類æˆè—¥å¾—由百貨店ã€é›œè²¨åº—åŠé¤æ—…æœå‹™å•†å…¼ç‡Ÿé›¶å”®ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">兼營零售乙類æˆè—¥è€…應ä¾å·¦åˆ—å„款之è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å°å…§æœåŠå¤–用æˆè—¥ï¼Œæ‡‰å„別專è¨æ«¥æ«ƒé™³åˆ—，妥善貯è—。但å«è—¥é…’é¡žä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å•†è™Ÿæˆ–招牌ä¸å¾—使用藥商å稱或易被誤èªç‚ºè—¥å•†ä¹‹å—樣。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¸å¾—è¨ç½®è—¥å“推銷員åŠæœ¬è¾¦æ³•æ‰€ç¨±ä¹‹æœå‹™å“¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¸å¾—å°‡æˆè—¥æ‹†é™¤åŒ…è£é›¶å”®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¸å¾—買賣來æºä¸æ˜Žä¹‹æˆè—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">檢查åŠå–ç· </span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關å°æ–¼æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘之檢查或抽驗，除ä¾è—¥äº‹æ³•æœ‰é—œè¦å®šè¾¦ç†å¤–，並得派員檢查或抽驗留置於家åºç”¨æˆ¶ä¹‹æˆè—¥ã€å›ºæœ‰æˆæ–¹è£½åŠ‘åŠå…¶è£ç½®ç”¨è¢‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ç®±</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å本辦法之è¦å®šæˆ–涉åŠå½è—¥ã€åŠ£è—¥ã€ç¦è—¥è€…，ä¾è—¥äº‹æ³•æœ‰é—œè¦å®šè™•ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6052&type=0
其他類,血液製劑æ¢ä¾‹æ³•å¾‹è¡€æ¶²è£½åŠ‘æ¢ä¾‹<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為æ昇血液製劑之安全與å“質åŠç¢ºä¿å…¶ç©©å®šä¾›æ‡‰ï¼Œä»¥ç¶è·åœ‹æ°‘å¥åº·ï¼Œç‰¹åˆ¶å®šæœ¬æ¢ä¾‹ã€‚本æ¢ä¾‹æœªè¦å®šè€…，ä¾é†«ç™‚法ã€è—¥äº‹æ³•åŠå…¶ä»–相關法律之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本æ¢ä¾‹æ‰€ç¨±ä¸»ç®¡æ©Ÿé—œï¼šåœ¨ä¸å¤®ç‚ºè¡Œæ”¿é™¢è¡›ç”Ÿç½²ï¼›åœ¨ç›´è½„市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本æ¢ä¾‹æ‰€ç¨±è¡€æ¶²è£½åŠ‘ï¼ŒæŒ‡ä»¥äººé¡žè¡€æ¶²ç¶“åŠ å·¥èª¿è£½ï¼Œè£½æˆä¸€å®šåŠ‘åž‹åŠåŠ‘é‡ä¹‹è—¥å“。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">血液製劑原料，應以國內æ血而得。但國內原料供應ä¸è¶³æ™‚ï¼Œè¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…得經ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œè‡ªåœ‹å¤–輸入。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">主管機關為é”到血液製劑之國內自製自給，應ç©æ¥µæŽ¨è¡Œæ血教育åŠå®£å°ŽæŽªæ–½ï¼Œé¼“勵民眾æ血。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œç‚ºç¢ºä¿è¡€æ¶²è£½åŠ‘安全ã€å“質åŠç©©å®šä¾›æ‡‰ï¼Œä¸¦ä¿ƒé€²è¡€æ¶²è£½åŠ‘å®‰å…¨æ€§æŠ€è¡“ä¹‹ç ”ç™¼åŠç™¼å±•åœ‹å…§è¡€æ¶²è£½åŠ‘產æ¥ï¼Œæ‡‰è¨‚定血液製劑發展方案。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構應致力推展æ血工作，æ昇血液製劑原料安全，å”助確ä¿ç©©å®šä¾›æ‡‰åŠæŽ¡è¡Œä¿è·æ血者å¥åº·æŽªæ–½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…，應符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„，æ供安全åŠå„ªè‰¯å“質之血液製劑。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構ã€é†«å¸«ä½¿ç”¨è¡€æ¶²è£½åŠ‘時，應優先使用國內æè¡€è£½é€ ä¹‹è¡€æ¶²è£½åŠ‘ï¼Œä¸¦æ供病人血液製劑之用藥資訊。</span> </p><p><span style="font-family: 新細明體,serif;">為尊é‡ç—…人使用之æ„願，以其他原料ã€æ–¹æ³•æˆ–åŸºå› å·¥ç¨‹æ‰€è£½æˆä¹‹è£½åŠ‘，使用時ä¸å—å‰é …è¦å®šä¹‹é™åˆ¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構應訂定年度採集血液計畫，包括æè¡€é‡ã€é†«ç™‚用血é‡ã€ä¾›è¡€æ¶²è£½åŠ‘è£½é€ ä¹‹åŽŸæ–™è¡€é‡åŠè¾¦ç†æŽ¨å±•æè¡€äº‹å®œï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¡€æ¶²è£½åŠ‘è£½é€ ã€è¼¸å…¥æ¥è€…，應定期將其é ä¼°åŠå¯¦éš›è£½é€ 或輸入之血液製劑數é‡ï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰è¨‚定年度血液製劑é 估需求計畫，並公告之。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …年度é ä¼°éœ€æ±‚è¨ˆç•«ï¼Œæ‡‰åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¡€æ¶²è£½åŠ‘之種類。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¹´åº¦æ‰€éœ€è£½é€ 與輸入血液製劑之種類åŠç›®æ¨™é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¡€æ¶²è£½åŠ‘è£½é€ ä¹‹ç›®æ¨™é‡æ‰€éœ€è¡€æ¶²åŽŸæ–™é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¡€æ¶²è£½åŠ‘之替代性醫藥å“é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å…¶ä»–æœ‰é—œè¡€æ¶²åŽŸæ–™æœ‰æ•ˆåˆ©ç”¨äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構å°æ–¼æ‰€æŽ¡é›†ä¹‹è¡€æ¶²åŽŸæ–™ï¼Œå¾—è‡ªç‚ºè¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…或經ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†å¾Œï¼Œæä¾›å…¶ä»–è¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">æ血機構æä¾›å…¶ä»–è¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…，得收å–工本費用；其費é¡ï¼Œæ‡‰å ±ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構採集血液應å°æ血者實施å¥åº·ç¯©æª¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æ血者å¥åº·è¦ä»¶ä¹‹æ¨™æº–åŠå‰é …å¥åº·ç¯©æª¢ä¹‹é …目，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構於必è¦æ™‚，應æä¾›è¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…相關血液原料之採集時間ã€æª¢é©—é …ç›®èˆ‡çµæžœåŠæ血者資料ç‰å¿…è¦è³‡è¨Šï¼Œä»¥é˜²æ¢è¡€æ¶²åŽŸæ–™ç™¼ç”Ÿå¥åº·å±å®³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第åæ¢ã€ç¬¬å一æ¢è¦å®šè€…，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œè™•æ–°è‡ºå¹£äºŒè¬å…ƒä»¥ä¸Šåè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦ä»¤å…¶é™æœŸæ”¹å–„，屆期未改善者，按次連續處罰。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ¢ä¾‹æ‰€è™•ä¹‹ç½°é°ï¼Œç¶“é™æœŸç¹³ç´ï¼Œå±†æœŸæœªç¹³ç´è€…，ä¾æ³•ç§»é€å¼·åˆ¶åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本æ¢ä¾‹æ–½è¡Œç´°å‰‡ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本æ¢ä¾‹è‡ªå…¬å¸ƒå¾Œä¸€å¹´æ–½è¡Œã€‚</span> </p>2013-12-04
查驗登記類,國產創新藥å“查驗登記專案試辦計畫行政解釋國產創新藥å“查驗登記專案試辦計畫詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4516&type=0
化å¸è£½é€ 管制類,指導手冊,國際醫藥å“稽查å”約組織藥å“å„ªè‰¯è£½é€ è¦ç¯„指導手冊行政解釋國際醫藥å“稽查å”約組織(PIC_S)_GMP-第一部åŠé™„則詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4517&type=0
化å¸è£½é€ 管制類,指導手冊,國際醫藥å“稽查å”約組織藥å“å„ªè‰¯è£½é€ è¦ç¯„指導手冊行政解釋國際醫藥å“稽查å”約組織(PIC_S)_GMP-第二部（原料藥）詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4518&type=0
其他類,血液製劑æ¢ä¾‹æ–½è¡Œç´°å‰‡æ³•è¦å‘½ä»¤è¡€æ¶²è£½åŠ‘æ¢ä¾‹æ–½è¡Œç´°å‰‡<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本細則ä¾è¡€æ¶²è£½åŠ‘æ¢ä¾‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本æ¢ä¾‹</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第åå…«æ¢è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本æ¢ä¾‹ç¬¬å››æ¢æ‰€ç¨±è¡€æ¶²è£½åŠ‘原料，應以國內æè¡€è€Œå¾—ï¼ŒæŒ‡åœ‹å…§è£½é€ æ¥è€…è£½é€ è¡€æ¶²è£½åŠ‘ï¼Œä¾›æ‡‰åœ‹å…§ä½¿ç”¨è€…ï¼Œæ‡‰ä»¥åœ‹å…§æ血為其之主è¦åŽŸæ–™ä¾†æºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…ä¾æœ¬æ¢ä¾‹ç¬¬å››æ¢è¦å®šå‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œç”³è«‹è‡ªåœ‹å¤–輸入血液製劑原料，應檢具下列文件：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”³è«‹è¼¸å…¥è¡€æ¶²è£½åŠ‘åŽŸæ–™å ±å‘Šæ›¸ï¼ŒåŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">國內血液製劑原料供應ä¸è¶³åˆ†æžã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">擬輸入血液製劑原料總é‡ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">擬輸入血液製劑原料來æºåœ‹ååŠè©²åœ‹è¨±å¯è¼¸å‡ºä¹‹è‰æ˜Žã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ“¬è£½é€ è¡€æ¶²è£½åŠ‘ç¨®é¡žåŠæ•¸é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“專案進å£ç”³è«‹æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“è£½é€ è¨±å¯è‰å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¡€æ¶²è£½åŠ‘原料檢驗è¦æ ¼æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">國外輸入之血液製劑原料，ä¸å¾—與國內æ血所得之原料混用。</span> </p><p><span style="font-family: 新細明體,serif;">國內血液製劑產å“，應於標籤仿單åŠåŒ…è£æ˜Žé¡¯æ¨™ç¤ºåŽŸæ–™ä¾†æºï¼Œä¸¦å€åˆ†åœ‹å…§ã€åœ‹å¤–原料來æºï¼Œç‚ºä¸åŒä¹‹åŒ…è£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構應ä¾æœ¬æ¢ä¾‹ç¬¬åæ¢è¦å®šï¼Œæ–¼æ¯å¹´ä¸ƒæœˆä¸‰å一日å‰æå‡ºæ¬¡å¹´åº¦ä¹‹æŽ¡é›†è¡€æ¶²è¨ˆç•«ï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¡€æ¶²è£½åŠ‘è£½é€ æ¥è€…åŠè¡€æ¶²è£½åŠ‘輸入æ¥è€…，應ä¾æœ¬æ¢ä¾‹ç¬¬å一æ¢è¦å®šï¼Œæ–¼æ¯å¹´ä¸€æœˆåŠä¸ƒæœˆå°‡ä¸‹åˆ—äº‹é …å ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æœªä¾†å…個月</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«å ±å‘Šç•¶æœˆ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è£½é€ æˆ–è¼¸å…¥ä¹‹è¡€æ¶²è£½åŠ‘é 估數é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å‰å…個月</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¸å«å ±å‘Šç•¶æœˆ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å¯¦éš›è£½é€ æˆ–è¼¸å…¥ä¹‹è¡€æ¶²è£½åŠ‘æ•¸é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾æœ¬æ¢ä¾‹ç¬¬å二æ¢è¦å®šè¨‚定年度血液製劑é 估需求計畫，應於å‰ä¸€å¹´å二月三å一日å‰å…¬å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …年度血液製劑é 估需求計畫得以一至三年為期訂定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構ä¾æœ¬æ¢ä¾‹ç¬¬å三æ¢ç¬¬ä¸€é 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罕見疾病類,罕見疾病防治åŠè—¥ç‰©æ³•æ³•å¾‹ç½•è¦‹ç–¾ç—…防治åŠè—¥ç‰©æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為防治罕見疾病之發生，åŠæ—©è¨ºæ–·ç½•è¦‹ç–¾ç—…ï¼ŒåŠ å¼·ç…§é¡§ç½•è¦‹ç–¾ç—…ç—…äººï¼Œå”助病人å–得罕見疾病é©ç”¨è—¥ç‰©åŠç¶æŒç”Ÿå‘½æ‰€éœ€ä¹‹ç‰¹æ®Šç‡Ÿé¤Šé£Ÿå“，並çŽ</span> <span style="font-family: 新細明體,serif;">勵與ä¿éšœè©²è—¥ç‰©åŠé£Ÿå“之供應ã€è£½é€ èˆ‡ç ”ç©¶ç™¼å±•ï¼Œç‰¹åˆ¶å®šæœ¬æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">本法未è¦å®šè€…，é©ç”¨å…¶ä»–有關法律之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱主管機關：在ä¸å¤®ç‚ºè¡Œæ”¿é™¢è¡›ç”Ÿç½²ï¼›åœ¨ç›´è½„市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱罕見疾病，係指疾病盛行率在ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘ŠåŸºæº–ä»¥ä¸‹æˆ–å› æƒ…æ³ç‰¹æ®Šï¼Œç¶“第四æ¢æ‰€å®šå§”員會審è°èªå®šï¼Œä¸¦ç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œæŒ‡å®šå…¬å‘Šè€…。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱罕見疾病藥物，係指ä¾æœ¬æ³•æ出申請，經第四æ¢æ‰€å®šå§”員會審è°èªå®šï¼Œä¸¦ç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šï¼Œå…¶ä¸»è¦é©æ‡‰ç—‡ç”¨æ–¼é 防ã€è¨ºæ–·ã€æ²»ç™‚罕見疾病者。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱ç¶æŒç”Ÿå‘½æ‰€éœ€ä¹‹ç‰¹æ®Šç‡Ÿé¤Šé£Ÿå“，係指經第四æ¢æ‰€å®šå§”員會審è°èªå®šï¼Œä¸¦ç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šï¼Œä¸»è¦é©ç”¨æ–¼ç½•è¦‹ç–¾ç—…病人營養之供應者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œç‚ºå¯©è°ç½•è¦‹ç–¾ç—…æœ‰é—œäº‹é …ï¼Œæ‡‰è¨ç½•è¦‹ç–¾ç—…åŠè—¥ç‰©å¯©è°å§”員會</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">以下簡稱委員會</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，其組織åŠæœƒè°ï¼Œä¾ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">委員會委員，由政府機關代表ã€é†«äº‹å¸è€…專家åŠç¤¾æœƒå…¬æ£äººå£«çµ„æˆï¼Œå…¶ä¸å§”å“¡åé¡ï¼Œè‡³å°‘應有三分之二以上為醫事å¸è€…專家。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">委員會任務如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç½•è¦‹ç–¾ç—…èªå®šä¹‹å¯©è°åŠé˜²æ²»ä¹‹è«®è©¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç½•è¦‹ç–¾ç—…藥物åŠç¶æŒç”Ÿå‘½æ‰€éœ€ä¹‹ç‰¹æ®Šç‡Ÿé¤Šé£Ÿå“èªå®šä¹‹å¯©è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç½•è¦‹ç–¾ç—…藥物查驗登記之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç½•è¦‹ç–¾ç—…藥物åŠç¶æŒç”Ÿå‘½æ‰€éœ€ä¹‹ç‰¹æ®Šç‡Ÿé¤Šé£Ÿå“補助åŠç ”發之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç½•è¦‹ç–¾ç—…國際醫療åˆä½œä¹‹å¯©è°ã€å”助åŠè«®è©¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ²»ç™‚特定疾病之éžç½•è¦‹ç–¾ç—…藥物之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å…¶ä»–èˆ‡ç½•è¦‹ç–¾ç—…æœ‰é—œäº‹é …ä¹‹è«®è©¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">委員會執行å‰é …任務，應徵詢其他相關å¸è€…專家ã€ç”¢æ¥æˆ–罕見疾病病人代表之æ„見。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰è¾¦ç†ç½•è¦‹ç–¾ç—…ä¹‹é˜²æ²»èˆ‡ç ”ç©¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫事人員發ç¾ç½¹æ‚£ç½•è¦‹ç–¾ç—…ä¹‹ç—…äººæˆ–å› è€Œè‡´æ»è€…，應å‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œå ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæŽ¥ç²å‰æ¢å ±å‘Šæˆ–發ç¾å…·æœ‰ç½•è¦‹éºå‚³ç–¾ç—…缺陷者，經病人或其法定代ç†äººåŒæ„，得派é£å°ˆæ¥äººå“¡è¨ªè¦–，告知相關疾病之影響，並æ供照è·è«®è©¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">從事å‰äºŒæ¢æ¥å‹™ä¹‹æ©Ÿé—œã€æ©Ÿæ§‹ã€åœ˜é«”åŠå…¶äººå“¡ï¼Œæ‡‰æ³¨æ„執行之態度åŠæ–¹æ³•ï¼Œå°Šé‡ç—…äººä¹‹äººæ ¼èˆ‡è‡ªä¸»ï¼Œä¸¦ç¶è·å…¶éš±ç§èˆ‡ç¤¾æœƒç”Ÿæ´»ä¹‹ç¶“營。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …äººå“¡ï¼Œå› æ¥å‹™çŸ¥æ‚‰æˆ–æŒæœ‰ä¹‹ç½•è¦‹ç–¾ç—…資料，應予ä¿å¯†ï¼Œä¸å¾—ç„¡æ•…æ´©æ¼æˆ–交付。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰çŽå‹µå„ç´šé†«ç™‚æˆ–ç ”ç©¶æ©Ÿæ§‹å¾žäº‹ç½•è¦‹ç–¾ç—…é˜²æ²»å·¥ä½œï¼Œè£œåŠ©ç›¸é—œäººåŠ›åŸ¹è‚²ã€ç ”究åŠè¨å‚™æ‰€éœ€ç¶“費。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è¦å®šï¼Œç›´è½„市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關得準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">主管機關應辦ç†ç½•è¦‹ç–¾ç—…之教育åŠå®£å°Žï¼Œä¸¦ç”±æ©Ÿé—œã€å¸æ ¡ã€åœ˜é«”åŠå¤§çœ¾å‚³æ’媒體å”助進行。</span> </p><p><span style="font-family: 新細明體,serif;">主管機關於罕見疾病病人發生就å¸ã€å°±æ¥æˆ–就養å•é¡Œæ™‚，得å”調相關機關</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">構</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å”助之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">罕見疾病病人或其法定代ç†äººå¾—備具申請書ã€ç¬¬åæ¢è¦å®šä¹‹é†«ç™‚æˆ–ç ”ç©¶æ©Ÿæ§‹å‡ºå…·ä¹‹è‰æ˜Žæ›¸ã€è¨ºç™‚計畫書åŠç›¸é—œè‰æ˜Žæ–‡ä»¶ï¼Œå‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ出申請，經委員會審è°é€šéŽå¾Œï¼Œä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—æ供補助至國外進行國際醫療åˆä½œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫療åˆä½œç‚ºä»£è¡Œæª¢é©—é …ç›®è€…ï¼Œå¾—ç”±ç¬¬åæ¢è¦å®šä¹‹é†«ç™‚æˆ–ç ”ç©¶æ©Ÿæ§‹ç”³è«‹è£œåŠ©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰äºŒé …補助之申請程åºã€æ‡‰å‚™ä¹‹æ›¸è‰è³‡æ–™åŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">除本法å¦æœ‰è¦å®šå¤–，罕見疾病藥物éžç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œæŸ¥é©—登記，並發給藥物許å¯è‰ï¼Œä¸å¾—è£½é€ æˆ–è¼¸å…¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">主è¦é©æ‡‰ç—‡ç”¨æ–¼é 防ã€è¨ºæ–·æˆ–治療罕見疾病者，得申請查驗登記為罕見疾病藥物。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …申請查驗登記應備之書è‰è³‡æ–™ã€å¯©æŸ¥ç¨‹åºåŠç›¸é—œäº‹é …之準則，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請罕見疾病藥物查驗登記者，ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ–¼å¿…è¦æ™‚，得è¦æ±‚其進行國內臨床試驗，並應å°è‡¨åºŠè©¦é©—之申請內容åŠçµæžœäºˆä»¥é©ç•¶ä¹‹å…¬é–‹èªªæ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">罕見疾病藥物ä¾æœ¬æ³•æŸ¥é©—登記發給藥物許å¯è‰è€…，其許å¯è‰æœ‰æ•ˆæœŸé–“為å年。有效期間內，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå°æ–¼åŒé¡žè—¥ç‰©æŸ¥é©—登記之申請，應ä¸äºˆå—ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …罕見疾病藥物於å年期滿後ä»é ˆè£½é€ 或輸入者，應事先申請ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†å±•å»¶ï¼Œæ¯æ¬¡å±•å»¶ä¸å¾—超éŽäº”年。展延期間，åŒé¡žè—¥ç‰©å¾—申請ä¸å¤®ä¸»ç®¡æ©Ÿé—œæŸ¥é©—登記。</span> </p><p><span style="font-family: 新細明體,serif;">罕見疾病藥物ä¾æœ¬æ³•æŸ¥é©—登記發給許å¯è‰å¾Œï¼Œå¦‚經ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¸å†åˆ—屬罕見疾病藥物者，其許å¯è‰ä¹‹å±•å»¶ï¼Œé©ç”¨è—¥äº‹æ³•æœ‰é—œè¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¾ç¬¬ä¸€é …è¦å®šå–得許å¯è‰ä¹‹æ‰€æœ‰äººæ–¼ç‰¹è¨±æ™‚間內擬åœæ¢è£½é€ 或輸入罕見疾病藥物者，應於åœæ¢æ—¥å‰å…個月以書é¢é€šçŸ¥ä¸å¤®ä¸»ç®¡æ©Ÿé—œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有下列情形之一者，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—ä¸å—å‰æ¢ç¬¬ä¸€é …è¦å®šä¹‹é™åˆ¶ï¼Œå—ç†å…¶ä»–åŒé¡žè—¥ç‰©ä¹‹æŸ¥é©—登記申請，並發給許å¯è‰ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ–°ç”³è«‹äººå–得經查驗登記許å¯ç‚ºç½•è¦‹ç–¾ç—…藥物之權利人授權åŒæ„。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å…·ç›¸åŒé©æ‡‰ç—‡ä¸”本質類似之罕見疾病藥物之新申請案，其安全性或有效性確優於已許å¯ä¹‹ç½•è¦‹ç–¾ç—…藥物。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æŒæœ‰ç½•è¦‹ç–¾ç—…藥物許å¯è‰è€…無法供應該藥物之需求。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç½•è¦‹ç–¾ç—…藥物售價經ä¸å¤®ä¸»ç®¡æ©Ÿé—œèªå®šé¡¯ä¸åˆç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¾å‰é …第二款至第四款è¦å®šç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œæŸ¥é©—登記發給許å¯è‰è€…，é©ç”¨å‰æ¢ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">罕見疾病藥物未經查驗登記或有å‰æ¢ç¬¬ä¸€é …第三款ã€ç¬¬å››æ¬¾æƒ…形之一</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">者，政府機關ã€é†«ç™‚機構ã€ç½•è¦‹ç–¾ç—…病人與家屬åŠç›¸é—œåŸºé‡‘會ã€å¸æœƒã€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å”會，得專案申請ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ã€‚但ä¸å¾—作為營利用途。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …專案申請，ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ–¼å¿…è¦æ™‚，得委託或指定相關機構或團</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">體辦ç†ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰äºŒé …專案申請應備之書è‰è³‡æ–™ã€å¯©æŸ¥ç¨‹åºåŠå…¶ä»–應éµè¡Œäº‹é …之辦</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">罕見疾病藥物經èªå®šæœ‰å±å®³äººé«”å¥åº·ä¹‹æƒ…事或有å±å®³ä¹‹è™žè€…，ä¸å¤®ä¸»</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">管機關得命藥商或專案申請者於期é™å…§å›žæ”¶ã€‚å¿…è¦æ™‚，並得廢æ¢è©²è—¥</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">物之許å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">經ä¾æœ¬æ³•æ ¸å‡†ä¸Šå¸‚或專案申請之罕見疾病藥物，應由ä¸å¤®ä¸»ç®¡æ©Ÿé—œç·¨</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åˆ—å¹´å ±ï¼Œè¼‰æ˜Žå…¶ä½¿ç”¨æ•¸é‡ã€äººæ•¸ã€ä¸è‰¯å應åŠå…¶ä»–ç›¸é—œå ±å‘Šç‰è³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商åŠå°ˆæ¡ˆç”³è«‹è€…應æ供相關資料，é…åˆå‰é …å¹´å ±ä¹‹è¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éžç½•è¦‹ç–¾ç—…藥物ä¾è—¥äº‹æ³•è¦å®šè£½é€ 或輸入我國確有困難，且經委員會</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審è°èªå®šæœ‰åŠ©æ–¼ç‰¹å®šç–¾ç—…之醫療者，準用本法有關查驗登記åŠå°ˆæ¡ˆç”³</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">請之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">罕見疾病åŠè—¥ç‰©ä¹‹èªå®šã€è¨±å¯ã€æ’¤éŠ·åŠå»¢æ¢ï¼Œä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰å®šæœŸå…¬</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">告之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•ç”³è«‹æŸ¥é©—登記ã€è‡¨åºŠè©¦é©—ã€è¨±å¯è‰ä¹‹æ ¸ç™¼ã€å±•å»¶æˆ–專案申請者，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應繳ç´å¯©æŸ¥è²»ã€ç™»è¨˜è²»æˆ–è‰ç…§è²»ï¼›å…¶è²»é¡ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">主管機關得çŽå‹µç½•è¦‹ç–¾ç—…藥物或ç¶æŒç”Ÿå‘½æ‰€éœ€ä¹‹ç‰¹æ®Šç‡Ÿé¤Šé£Ÿå“之供</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應ã€è£½é€ åŠç ”究發展；其çŽå‹µå°è±¡ã€æ–¹å¼æˆ–被çŽå‹µè€…應éµå¾ªäº‹é …之辦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法，由主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ“…è‡ªè£½é€ ã€è¼¸å…¥æœªç¶“許å¯ä¹‹ç½•è¦‹ç–¾ç—…藥物者，或明知未經許å¯ä¹‹ç½•è¦‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疾病藥物，而販賣ã€ä¾›æ‡‰ã€èª¿åŠ‘ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„圖販</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">賣而陳列者，ä¾è—¥äº‹æ³•ç¬¬å…«å二æ¢ã€ç¬¬å…«å三æ¢è¦å®šè™•ç½°ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第åå…æ¢è¦å®šè€…，處新å°å¹£ä¸‰è¬å…ƒä»¥ä¸Šå五è¬å…ƒä»¥ä¸‹ç½°é°ï¼›å…¶æƒ…</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">節é‡å¤§è€…，藥商於二年內ä¸å¾—å†ç”³è«‹è©²è—¥ç‰©ä¹‹æŸ¥é©—登記，並得處醫療</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">機構一個月以上一年以下åœæ¥è™•åˆ†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請罕見疾病藥物查驗登記或展延登記，æä¾›ä¸å¯¦ä¹‹æ›¸è‰è³‡æ–™è€…，處</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ–°å°å¹£äºŒè¬å…ƒä»¥ä¸Šåè¬å…ƒä»¥ä¸‹ä¹‹ç½°é°ï¼ŒäºŒå¹´å…§ä¸å¾—å†ç”³è«‹è©²è—¥ç‰©ä¹‹æŸ¥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—ç™»è¨˜ï¼›å…¶å·²é ˜å–該藥物許å¯è‰è€…，撤銷之；其涉åŠåˆ‘責者，移é€å¸</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法機關辦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第åä¹æ¢ç¬¬ä¸€é …è¦å®šï¼Œå°‡å°ˆæ¡ˆç”³è«‹ä¹‹ç½•è¦‹ç–¾ç—…藥物充作營利用途</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">者，處新å°å¹£ä¸‰è¬å…ƒä»¥ä¸Šå五è¬å…ƒä»¥ä¸‹ç½°é°ï¼›å…¶ç²å–之利益，沒入之；</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二年內並ä¸å¾—å†è¡Œæ出罕見疾病藥物之專案申請。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å主管機關ä¾ç¬¬äºŒåæ¢è¦å®šä»¤å…¶é™æœŸå›žæ”¶ä¹‹å‘½ä»¤è€…，處新å°å¹£ä¸‰è¬</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">元以上å五è¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦æŒ‰æ¬¡é€£çºŒè™•ç½°è‡³å›žæ”¶ç‚ºæ¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第二å一æ¢ç¬¬äºŒé …è¦å®šï¼Œè—¥å•†è™•æ–°å°å¹£ä¸€è¬å…ƒä»¥ä¸Šäº”è¬å…ƒä»¥ä¸‹ä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç½°é°ï¼›å°ˆæ¡ˆç”³è«‹è€…，其å†ç”³è«‹ç½•è¦‹ç–¾ç—…藥物，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—ä¸äºˆè¨±</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所定之罰é°ï¼Œç”±ä¸»ç®¡æ©Ÿé—œè™•ç½°ä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …ç½°é°ç¶“é™æœŸç¹³ç´ï¼Œå±†æœŸæœªç¹³ç´è€…，ä¾æ³•ç§»é€å¼·åˆ¶åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰ç·¨åˆ—é 算，補助罕見疾病é 防ã€ç¯©æª¢ã€ç ”究之相關經</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è²»åŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾å…¨æ°‘å¥åº·ä¿éšªæ³•ä¾æ³•æœªèƒ½çµ¦ä»˜ä¹‹ç½•è¦‹ç–¾ç—…診斷ã€æ²»ç™‚ã€è—¥ç‰©èˆ‡ç¶æŒ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生命所需之特殊營養å“ã€å±…家醫療照è·å™¨æ費用。其補助方å¼ã€å…§å®¹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠå…¶ä»–ç›¸é—œäº‹é …ä¹‹è¾¦æ³•ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …補助經費，得由è¸å“å¥åº·ç¦åˆ©æ之分é…收入支應或接å—機構ã€åœ˜</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">體之æ助。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構得專案申請輸入罕見疾病病人ç¶æŒç”Ÿå‘½æ‰€éœ€ä¹‹ç‰¹æ®Šç‡Ÿé¤Šé£Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“；其應備之書è‰è³‡æ–™ã€ç”³è«‹å¯©æŸ¥ç¨‹åºåŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 35 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法施行細則，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 36 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法自公布日起å…個月施行。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法修æ£æ¢æ–‡è‡ªå…¬å¸ƒæ—¥æ–½è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 37 </span><span style="font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-family: calibri;"> </span></p>2013-12-04
罕見疾病類,罕見疾病防治åŠè—¥ç‰©æ³•æ–½è¡Œç´°å‰‡æ³•è¦å‘½ä»¤ç½•è¦‹ç–¾ç—…防治åŠè—¥ç‰©æ³•æ–½è¡Œç´°å‰‡<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本細則ä¾ç½•è¦‹ç–¾ç—…防治åŠè—¥ç‰©æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第三å五æ¢è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱罕見疾病病患ç¶æŒç”Ÿå‘½æ‰€éœ€ä¹‹ç‰¹æ®Šç‡Ÿé¤Šé£Ÿå“，其å“ç›®åŠé©ç”¨ä¹‹ç–¾ç—…，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法第三æ¢ç¬¬ä¸€é …所稱疾病盛行率，指ä¸å¤®ä¸»ç®¡æ©Ÿé—œåƒç…§é†«äº‹äººå“¡ä¾æœ¬æ³•ç¬¬ä¸ƒæ¢è¦å®šå ±å‘Šä¹‹è³‡æ–™åŠå…¨æ°‘å¥åº·ä¿éšªå°±é†«è³‡æ–™æ‰€è¨ˆç®—之疾病年盛行率。</span> </p><p><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œå°æ–¼å‰é …疾病盛行率之公告標準，至少æ¯ä¸‰å¹´æª¢è¨Žä¸€æ¬¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法第三æ¢ç¬¬ä¸€é …所稱情æ³ç‰¹æ®Šï¼ŒæŒ‡ç–¾ç—…盛行率超éŽä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šæ¨™æº–，或難以計算，而其診斷治療所需之方法或藥物å–得確有困難，經ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾æœ¬æ³•ç¬¬å››æ¢è¦å®šè¨ç½®ä¹‹ç½•è¦‹ç–¾ç—…åŠè—¥ç‰©å¯©è°å§”員會èªå®šè€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•ç¬¬ä¸ƒæ¢è¦å®šè² æœ‰å ±å‘Šç¾©å‹™ä¹‹é†«äº‹äººå“¡ï¼Œæ‡‰æ–¼ç™¼ç¾ç½•è¦‹ç–¾ç—…患者或å±é«”之日起一個月內，å‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œé™³å ±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰å°‡ç½•è¦‹ç–¾ç—…人å£ä¹‹è®Šé·è³‡æ–™ï¼Œç´å…¥è¡›ç”Ÿçµ±è¨ˆã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法第八æ¢æ‰€ç¨±å„ªç”Ÿä¿å¥è«®è©¢ä¸å¿ƒï¼ŒæŒ‡ç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œå§”託，辦ç†ç½•è¦‹éºå‚³ç–¾ç—…防治ã€ç ”究åŠå„ªç”Ÿä¿å¥è«®è©¢æœå‹™ä¹‹é†«ç™‚機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®åŠç›´è½„市主管機關ä¾æœ¬æ³•ç¬¬å一æ¢è¦å®šè¾¦ç†ç½•è¦‹ç–¾ç—…之防治教育與宣導，應å”åŒæ•™è‚²ã€ç¤¾æ”¿åŠæ–°èžä¸»ç®¡æ©Ÿé—œè¨‚定計畫，據以實施。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œå°æ–¼ä¾æœ¬æ³•ç¬¬å三æ¢ç¬¬ä¸€é …è¦å®šå”助至國外進行國際醫療åˆä½œè€…，得比照全民å¥åº·ä¿éšªç·Šæ€¥å‚·ç—…è‡ªå¢Šé†«ç™‚è²»ç”¨æ ¸é€€è¾¦æ³•æ‰€å®šæ ¸é€€æ¨™æº–ï¼Œäºˆä»¥è£œåŠ©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">本法第å三æ¢ç¬¬äºŒé …æ‰€ç¨±ä»£è¡Œæª¢é©—é …ç›®ï¼Œä»¥å°ç–¾ç—…治療方å¼æˆ–éºå‚³è«®è©¢å»ºè°æœ‰é‡å¤§å½±éŸ¿è€…為é™ï¼›ä¸å¤®ä¸»ç®¡æ©Ÿé—œå°å…¶è£œåŠ©ä¹‹é¡åº¦ï¼Œæ¯”照全民å¥åº·ä¿éšªé†«ç™‚費用支付標準之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">下列藥物，為本法第å七æ¢ç¬¬ä¸€é …ã€ç¬¬äºŒé …åŠç¬¬åå…«æ¢ç¬¬ä¸€é …所稱之åŒé¡žè—¥ç‰©ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æœ‰æ•ˆæˆåˆ†åŠé©æ‡‰ç—‡èˆ‡ä¾æœ¬æ³•æŸ¥é©—登記發給許å¯è‰ä¹‹ä¸€èˆ¬åŒ–å¸è—¥ç‰©ç›¸åŒè€…，包括其çµæ§‹ä¸Šä¹‹ç•°æ§‹ç‰©ã€éŒ¯åŒ–物ã€é¹½é¡žã€é…¯é¡žã€èž¯åˆç‰©æˆ–其他éžå…±åƒ¹éµè¡ç”Ÿç‰©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¸»åˆ†åçµæ§‹åŠé©æ‡‰ç—‡èˆ‡ä¾æœ¬æ³•æŸ¥é©—登記發給許å¯è‰ä¹‹ç”Ÿç‰©è£½åŠ‘或大分å藥物相åŒè€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法第åå…«æ¢ç¬¬ä¸€é …ç¬¬ä¸€æ¬¾æ‰€ç¨±ç½•è¦‹ç–¾ç—…è—¥ç‰©ä¹‹æ¬Šåˆ©äººï¼ŒæŒ‡é ˜æœ‰ç½•è¦‹ç–¾ç—…è—¥ç‰©è¨±å¯è‰è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•ç¬¬åå…«æ¢ç¬¬ä¸€é …第二款è¦å®šå‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œç”³è«‹æŸ¥é©—登記者，應檢附足以è‰æ˜Žè©²æ–°ç”³è«‹ç½•è¦‹ç–¾ç—…藥物之安全性或有效性優於已許å¯ä¹‹ç½•è¦‹ç–¾ç—…藥物之資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法第åå…«æ¢ç¬¬ä¸€é …第三款所稱無法供應該藥物之需求，指權利人未能充分供應該罕見疾病藥物，經ä¸å¤®ä¸»ç®¡æ©Ÿé—œä»¤å…¶é™æœŸæ”¹å–„，屆期ä»æœªæ”¹å–„者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾æœ¬æ³•ç¬¬åå…«æ¢ç¬¬ä¸€é …第四款è¦å®šç‚ºç½•è¦‹ç–¾ç—…藥物售價åˆç†èˆ‡å¦ä¹‹èªå®šæ™‚，應åƒè€ƒæ–°ç”³è«‹äººåŠæ¬Šåˆ©äººæª¢é€ä¹‹å”®åƒ¹åˆ†æžè³‡æ–™ã€ä¸å¤®å¥åº·ä¿éšªå±€å…¬å‘Šä¹‹è—¥åƒ¹åŸºæº–åŠå…¶ä»–相關資料為之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法åŠæœ¬ç´°å‰‡æ‰€å®šæ–‡æ›¸æ ¼å¼ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本細則自ä¸è¯æ°‘國八åä¹å¹´å…«æœˆä¹æ—¥æ–½è¡Œã€‚</span> </p>2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6055&type=0
罕見疾病類,罕見疾病藥物,ç½•è¦‹ç–¾ç—…è—¥ç‰©ä¾›æ‡‰è£½é€ åŠç ”究發展çŽå‹µè¾¦æ³•æ³•è¦å‘½ä»¤ç½•è¦‹ç–¾ç—…è—¥ç‰©ä¾›æ‡‰è£½é€ åŠç ”究發展çŽå‹µè¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾ç½•è¦‹ç–¾ç—…防治åŠè—¥ç‰©æ³•ç¬¬äºŒå五æ¢è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">具有下列情形之一者，得ä¾æœ¬è¾¦æ³•ç”³è«‹çŽå‹µï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å¼•é€²ç½•è¦‹ç–¾ç—…藥物ã€æˆ–將罕見疾病藥物列入處方集ã€æˆ–專案申請罕見疾病藥物，å°ç½•è¦‹ç–¾ç—…藥物之供應，著有貢ç»è€…。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è£½é€ 符åˆåœ‹å…§éœ€æ±‚ã€æœ¬åœŸç‰¹æœ‰ã€ä¸æ˜“進å£ã€ç•¶æ™‚無法充分供應或其售價顯ä¸åˆç†ä¹‹ç½•è¦‹ç–¾ç—…è—¥ç‰©ï¼Œå˜‰æƒ ç—…æ‚£ï¼Œè‘—æœ‰æ•ˆç›Šè€…ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åœ¨åœ‹å…§è‡ªè¡Œç ”發新罕見疾病藥物，經å–得國內ã€å¤–之專利</span> <span style="font-family: 新細明體,serif;">或授權，或å–得國內ã€å¤–æ–°ç½•è¦‹ç—…è—¥ç‰©ä¹‹å°ˆåˆ©æˆ–æŽˆæ¬Šï¼Œä¸¦åœ¨åœ‹å…§é€²è¡Œè‡¨åºŠè©¦é©—ç ”ç©¶ï¼Œå°ç½•è¦‹ç–¾ç—…è—¥ç‰©ä¹‹ç ”ç©¶ç™¼å±•ï¼Œè‘—æœ‰æˆæ•ˆè€…。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å…¶ä»–å°ç½•è¦‹ç–¾ç—…藥物之供應ã€è£½é€ åŠç ”究發展，有特殊貢ç»è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çŽå‹µæ–¹å¼ä»¥é ’發çŽé‡‘為之，但情形特殊者，得改予或併予其他çŽå‹µã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é ’ç™¼çŽé‡‘之é¡åº¦åŠå…¶ä»–çŽå‹µæ–¹å¼ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¦–年度é ç®—ã€ç›¸é—œç¶“è²»åŠå¯¦éš›éœ€è¦å¦å®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çŽå‹µä»¥æ¯å¹´å®šæœŸè¾¦ç†ä¸€æ¬¡ç‚ºåŽŸå‰‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">符åˆç¬¬äºŒæ¢æ‰€å®šè³‡æ ¼è€…，得於è¦å®šæœŸé™å…§ï¼Œé€•å‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œç”³è«‹çŽå‹µï¼›ç›¸é—œä¹‹å…¬æœƒã€åœ˜é«”，亦得薦請ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸äºˆçŽå‹µã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çŽå‹µæ¡ˆä»¶æ‡‰å…ˆæ交罕見疾病åŠè—¥ç‰©å¯©è°å§”員會審è°å¾Œï¼Œå†è¡Œé™³è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">相åŒä¹‹ç ”究或發明分別申請çŽå‹µæ™‚，應就最先æ出申請者çŽå‹µä¹‹ã€‚二個以上çŽå‹µå°è±¡å°±åŒä¸€äº‹å¯¦å…±åŒç”³è«‹çŽå‹µæ™‚，所ç²å¾—之çŽå‹µæ‡‰ç”±å…¨é«”申請人所共有。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">所需çŽå‹µç¶“費，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œç·¨åˆ—é 算支應，並得接å—團體ã€å–®ä½æˆ–個人之æ助。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">被çŽå‹µè€…所æ供事蹟若有虛å½ä¸å¯¦ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œäºˆä»¥æ’¤éŠ·çŽå‹µä¸¦è¿½å›žçŽå‹µé‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自ä¸è¯æ°‘國八åä¹å¹´å…«æœˆä¹æ—¥æ–½è¡Œã€‚</span> </p><p><span style="font-family: calibri;"> </span></p>2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6065&type=0
藥政管ç†é¡ž,藥事法行政解釋公告å«propoxypheneæˆåˆ†è—¥å“安全性å†è©•ä¼°çµæžœåŠç›¸é—œäº‹å®œè©³å¦‚附件2013-12-16
罕見疾病類,罕見疾病藥物,罕見疾病藥物專案申請辦法法è¦å‘½ä»¤ç½•è¦‹ç–¾ç—…藥物專案申請辦法<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾ç½•è¦‹ç–¾ç—…防治åŠè—¥ç‰©æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第åä¹æ¢ç¬¬ä¸‰é …åŠç¬¬äºŒå二æ¢è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">罕見疾病藥物未經查驗登記，或æŒæœ‰è¨±å¯è‰è€…無法供應，或該藥物售價經ä¸å¤®ä¸»ç®¡æ©Ÿé—œèªå®šé¡¯ä¸åˆç†æ™‚ï¼Œå…¶è£½é€ æˆ–è¼¸å…¥å¾—ç”±æ”¿åºœæ©Ÿé—œã€é†«ç™‚機構ã€ç½•è¦‹ç–¾ç—…病人與家屬åŠç›¸é—œåŸºé‡‘會ã€å¸æœƒã€å”會，ä¾æœ¬æ³•ç¬¬åä¹æ¢ç¬¬ä¸€é …è¦å®šï¼Œå°ˆæ¡ˆç”³è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">éžç½•è¦‹ç–¾ç—…藥物ä¾è—¥äº‹æ³•è¦å®šè£½é€ 或輸入我國確有困難，且經罕見疾病åŠè—¥ç‰©å¯©è°å§”員會èªå®šæœ‰åŠ©æ–¼ç‰¹å®šç–¾ç—…之醫療者，準用å‰é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾å‰æ¢è¦å®šå°ˆæ¡ˆç”³è«‹ç½•è¦‹ç–¾ç—…藥物，應填具申請書，並檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”±ç½•è¦‹ç–¾ç—…病患或家屬æ出申請者：病患身分è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€é†«ç™‚機構出具之診斷è‰æ˜Žæ›¸æˆ–處方ã€è©²è—¥ç‰©å‡ºç”¢åœ‹ä»¿å–®ï¼Œæˆ–有關之安全或療效資料。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç”±æ”¿åºœæ©Ÿé—œã€é†«ç™‚機構åŠç›¸é—œåŸºé‡‘會ã€å¸æœƒã€å”會æ出申請者：病患åŒæ„書ã€é†«ç™‚機構æ出之治療計畫書或出具之診斷è‰æ˜Žæ›¸ã€è©²è—¥ç‰©å‡ºç”¢åœ‹ä»¿å–®ï¼Œæˆ–有關之安全或療效資料。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå§”託或指定之機關ã€åœ˜é«”æ出申請者：病患åŒæ„書ã€é†«ç™‚機構æ出之治療計畫書或出具之診斷è‰æ˜Žæ›¸ã€è©²è—¥ç‰©å‡ºç”¢åœ‹ä»¿å–®ï¼Œæˆ–有關之安全或療效資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰æ–¼æ”¶å—專案申請書件三å日內，完æˆå¯©æŸ¥ä½œæ¥ï¼Œä¸¦å°‡å¯©æŸ¥çµæžœä»¥æ›¸é¢é€šçŸ¥ç”³è«‹äººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">專案申請藥物，æ¯æ¬¡ä»¥è¶³ä¾›ä¸€ç—…患二年之用é‡ç‚ºé™ï¼Œä¸¦å¾—視實際需è¦åˆ†æ‰¹è¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自ä¸è¯æ°‘國八åä¹å¹´å…«æœˆä¹æ—¥æ–½è¡Œã€‚</span> </p>2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6066&type=0
罕見疾病類,罕見疾病藥物,罕見疾病藥物èªå®šç”³è«‹è¦é»žè¡Œæ”¿è§£é‡‹ç½•è¦‹ç–¾ç—…藥物èªå®šç”³è«‹è¦é»žè©³å¦‚附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4504&type=0
臨床試驗類,藥動å¸è©¦é©—基準,è‚功能ä¸å…¨ç—…患的藥動å¸è©¦é©—基準行政解釋è‚功能ä¸å…¨ç—…患的藥動å¸è©¦é©—基準<div style="layout-grid: 18pt none;" class="WordSection1"><p style="text-align: center; line-height: 12pt;"> </p><p style="text-align: center; line-height: 12pt;"> </p><p style="text-align: center; line-height: 12pt;"> </p><p style="text-align: center; line-height: 12pt;"> </p><p style="text-align: center; line-height: 12pt;"> </p><p style="text-align: center;"><span style="font-family: 新細明體,serif; color: black; font-size: 20pt;">è‚功能ä¸å…¨ç—…患的藥動å¸è©¦é©—基準</span> </p><p style="text-align: center;"><span style="font-family: 新細明體,serif; color: black; font-size: 20pt;">ï¼è‡¨åºŠè©¦é©—è¨è¨ˆã€æ•¸æ“šåˆ†æžä»¥åŠå°åŠ‘é‡èª¿æ•´èˆ‡æ¨™ç¤ºçš„影響</span> </p><p style="text-align: center; line-height: 12pt;"> </p><h1 style="text-align: center;"><span style="color: black; font-size: 16pt; text-decoration: underline; text-underline: none;">GUIDANCE FOR PHARMACOKINETICS IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION: STUDY DESIGN, DATA ANALYSIS, AND IMPACT ON DOSING AND LABELING</span></h1><p style="text-align: center;"> </p><p style="text-align: center;"><span style="font-family: 新細明體,serif; font-size: 16pt;">è¡Œ</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">政</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">院</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">è¡›</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">生</span> <span style="font-family: 新細明體,serif; font-size: 16pt;">ç½²</span> </p><p style="text-align: center;"><span style="font-family: 新細明體,serif; font-size: 16pt;">ä¸è¯æ°‘國ä¹å年七月</span> </p></div><span style="font-family: times new roman,serif; font-size: 16pt;"><br style="page-break-before: always;" clear="all" /></span><div style="layout-grid: 18pt none;" class="WordSection2"><p style="text-align: center;"><span style="font-family: 新細明體,serif; color: black; font-size: 16pt;">目錄</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">ç¬¬ä¸€ç« ã€å‰è¨€</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">ç¬¬äºŒç« ã€èƒŒæ™¯</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">ç¬¬ä¸‰ç« ã€æ±ºå®šæ˜¯å¦é ˆæ–¼è‚功能ä¸å…¨ç—…患執行臨床試驗</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">ç¬¬å››ç« ã€è‡¨åºŠè©¦é©—è¨è¨ˆ</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">ç¬¬äº”ç« ã€æ•¸æ“šåˆ†æž</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">第å…ç« ã€æ¨™ç¤º</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">åƒè€ƒæ–‡ç»</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 150%;"><span style="line-height: 150%; font-family: 新細明體,serif; color: black; font-size: 14pt;">附錄：è‚功能的評估</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 10pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 12pt;"><b><span style="font-family: 新細明體,serif; color: black;">ç¬¬ä¸€ç« ã€å‰è¨€</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 11.9pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 11.9pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">本基準的目的在å”助試驗委託者執行評估è‚功能ä¸å…¨å°è—¥å“藥動å¸</span><span style="color: black; font-size: 11pt;">(pharmacokinetics)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">性質之影響的試驗</span><span style="font-family: 新細明體,serif; font-size: 11pt;">，並且ä¾æ“šè©¦é©—çµæžœä½œé©ç•¶çš„劑é‡èª¿æ•´èˆ‡æ¨™ç¤ºï¼Œ<span style="color: black;">å¿…è¦æ™‚也將評估è‚功能ä¸å…¨å°æ–¼è—¥å“藥效å¸ï¼ˆ</span></span><span style="color: black; font-size: 11pt;">pharmacodynamics</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）性質之影響。æ¤å¤–，é‡å°æ¤ä¸€ç‰¹æ®Šç¾¤é«”所åšçš„試驗分æžçµæžœäº¦å¯ä½œç‚ºéŠœæŽ¥æ€§è©¦é©—的考é‡å› ç´ ä¹‹ä¸€ã€‚æœ¬åŸºæº–çš„å…§å®¹åŒ…å«ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">何時應執行藥å“在è‚功能ä¸å…¨ç—…患的藥動å¸è©¦é©—</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è¨è¨ˆèˆ‡åŸ·è¡Œè—¥å“在è‚功能ä¸å…¨ç—…患的藥動å¸è©¦é©—</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">臨床試驗群體之特性</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 1.4pt 0pt 48pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">n<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">臨床試驗çµæžœçš„分æžã€è§£é‡‹åŠå ±å‘Šï¼Œä»¥åŠå¦‚何在標示</span><span style="color: black; font-size: 11pt;">(labeling)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä¸æ述這些çµæžœ</span> </p><p style="margin: 0cm 1.4pt 0pt 12pt;"><span style="font-family: 新細明體,serif; font-size: 11pt;">本基準並ä¸æ供如何評估藥å“在治療è‚臟疾病的安全性åŠæœ‰æ•ˆæ€§ï¼Œä¹Ÿä¸æ供如何評估藥å“是å¦æœƒå¼•èµ·è‚毒性。</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">ç¬¬äºŒç« ã€èƒŒæ™¯</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚臟與許多藥å“的清除（</span><span style="color: black; font-size: 11pt;">clearance</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）有關，它å¯ç¶“ç”±ä¸åŒçš„代è¬é€”徑或經由膽æ±æŽ’泄的途徑排除原藥å“或其代è¬ç‰©ã€‚è‚功能ä¸å…¨æ‰€å¼•èµ·è—¥å“排泄或代è¬é€ŸçŽ‡çš„æ”¹è®Šï¼Œæœƒé€ æˆè—¥å“è“„ç©æˆ–阻礙藥å“å½¢æˆæ´»æ€§ä»£è¬ç‰©ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　許多文ç»é¡¯ç¤ºè‚病會改變藥å“的藥動å¸åŠè—¥æ•ˆå¸æ€§è³ªã€‚é€™äº›å ±å‘Šä¸çš„試驗å°è±¡æ˜¯æ‚£æœ‰å¸¸è¦‹è‚病的病患。我國常見之è‚病包括慢性</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型或</span><span style="color: black; font-size: 11pt;">C</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åž‹è‚炎或è‚硬化ã€è„‚肪è‚ã€æ€¥æ€§</span><span style="color: black; font-size: 11pt;">A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">型或</span><span style="color: black; font-size: 11pt;">D</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åž‹è‚ç‚Žã€é…’精性è‚病（</span><span style="color: black; font-size: 11pt;">alcoholic liver disease</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）以åŠåŽŸç™¼åž‹è†½æ±æ€§è‚硬化（</span><span style="color: black; font-size: 11pt;">primary biliary cirrhosis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）。由於國情環境的差異，美國</span><span style="color: black; font-size: 11pt;">FDA</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">所列舉的常見è‚ç—…ä¸çš„急性</span><span style="color: black; font-size: 11pt;">E</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åž‹è‚ç‚Žã€åŽŸç™¼åž‹ç¡¬åŒ–性膽é“炎（</span><span style="color: black; font-size: 11pt;">primary sclerosing cholangitis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）與</span><span style="font-family: symbol; color: black; font-size: 11pt;">a</span><sub><span style="color: black; font-size: 11pt;">1</span></sub><span style="color: black; font-size: 11pt;">-</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">æŠ—èƒ°è›‹ç™½é…µç´ ç¼ºä¹ç—‡ï¼ˆ</span><span style="font-family: symbol; color: black; font-size: 11pt;">a</span><sub><span style="color: black; font-size: 11pt;">1</span></sub><span style="color: black; font-size: 11pt;">-antitrypsin deficiency</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）在國人則相當罕見，而急性</span><span style="color: black; font-size: 11pt;">D</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åž‹è‚炎則是國人常見的一種è‚病。è‚病也å¯èƒ½æœƒå½±éŸ¿è…ŽåŠŸèƒ½ï¼Œä»¥è‡³æ–¼å³ä½¿è‚臟並éžæŸäº›è—¥å“的主è¦æ¸…除途徑，ä»ç„¶æœƒå¼•èµ·è—¥å“åŠå…¶ä»£è¬ç‰©çš„è“„ç©ã€‚è‚ç—…ä¹Ÿæœƒé€ æˆè—¥å“藥效（</span><span style="color: black; font-size: 11pt;">PD effects</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）的改變，例如æŸäº›è—¥å“æœƒå¢žåŠ è‚è¡°ç«ç—…患之è‚腦病變。至於其他疾病å°æ–¼è‚功能的特定影響，尤其在評估å°æ–¼è—¥å“藥動åŠè—¥æ•ˆçš„影響上，通常åªè¢«ç°¡ç•¥çš„æ述，而且其çµè«–ä¹‹å·®ç•°æ€§é —å¤§ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　å°æ–¼ä¸»è¦ç¶“由腎臟排除的藥å“，測é‡è‚Œæ°¨é…¸é…</span><span style="color: black; font-size: 11pt;">(creatinine)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或其清除率則常被用來調整æ¤é¡žè—¥å“的劑é‡ã€‚åŒæ¨£çš„ï¼Œè†½ç´…ç´ ï¼ˆ</span><span style="color: black; font-size: 11pt;">bilirubin</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€ç™½è›‹ç™½ï¼ˆ</span><span style="color: black; font-size: 11pt;">albumin</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€å‰å‡è¡€é…µç´ 時間（</span><span style="color: black; font-size: 11pt;">prothrombin time</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€</span><span style="color: black; font-size: 11pt;">antipyrine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">indocyanine green</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">ICG</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€</span><span style="color: black; font-size: 11pt;">monoethylglycinexylidide</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">MEGX</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）åŠåŠä¹³ç³–（</span><span style="color: black; font-size: 11pt;">galactose</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ç‰é€£çºŒæ€§è®Šæ•¸ä¹Ÿæ›¾è¢«ç”¨ä¾†æ¸¬é‡è‚功能。æ¤å¤–，類別性的臨床變數也曾被用來評估è‚功能。這些臨床變數包括腹水（</span><span style="color: black; font-size: 11pt;">ascites</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€è…¦ç—…變（</span><span style="color: black; font-size: 11pt;">encephalopathy</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€ç‡Ÿé¤Šç‹€æ³ã€é€±é‚Šæ°´è…«</span><span style="color: black; font-size: 11pt;">(peripheral edema)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€ç—…ç†å¸ä¸Šè‚纖ç¶åŒ–的程度，或是變數的組åˆï¼Œå¦‚</span><span style="color: black; font-size: 11pt;">Child-Pugh </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法用於å°é…’精性è‚硬化</span><span style="color: black; font-size: 11pt;">(alcoholic cirrhosis) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åŠé–€è„ˆé«˜è¡€å£“</span><span style="color: black; font-size: 11pt;">(portal hypertension)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">Mayo risk scores</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">用於å°åŽŸç™¼åž‹è†½æ±æ€§è‚硬化（</span><span style="color: black; font-size: 11pt;">primary biliary cirrhosis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）åŠåŽŸç™¼åž‹ç¡¬åŒ–性膽管炎</span><span style="color: black; font-size: 11pt;">(primary sclerosing cholangitis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，以åŠ</span><span style="color: black; font-size: 11pt;">Maddrey</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼</span><span style="color: black; font-size: 11pt;">Carithers discriminant function</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">用於å°æ€¥æ€§é…’精性è‚炎（</span><span style="color: black; font-size: 11pt;">acute alcoholic hepatitis</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ç‰ï¼ˆè©³è¦‹é™„錄：è‚功能評估方法）。然而，å³ä½¿æœ‰ä¸Šè¿°çš„努力，目å‰ä»ç„¡ä»»ä½•ä¸€ç¨®æ–¹æ³•ï¼Œå·²åœ¨è‡¨åºŠä¸Šè¢«å»£æ³›ç”¨ä¾†é 測è‚功能ä¸å…¨å°æ–¼è—¥å“藥動å¸åŠè—¥æ•ˆå¸æ€§è³ªçš„影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">雖然臨床上並無有效的è‚功能測é‡æ–¹æ³•è¢«å»£æ³›ç”¨ä¾†é 測藥å“的藥動å¸åŠè—¥æ•ˆå¸æ€§è³ªï¼Œè—¥å“æ–¼ç ”ç™¼éšŽæ®µåœ¨è‚功能ä¸å…¨ç—…患上所執行的臨床試驗，ä»è¶³ä»¥æ供有用的資訊來決定æ¤è—¥å“在è‚功能ä¸å…¨ç—…患的起始劑é‡ã€‚但使用這些資訊必得é…åˆä»”細觀察åŠåŠ‘é‡é€æ¥èª¿æ•´ï¼ˆ</span><span style="color: black; font-size: 11pt;">dose titration</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）以ç²è‡´å€‹åˆ¥ç—…人之最佳使用劑é‡ã€‚</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">ç¬¬ä¸‰ç« ã€æ±ºå®šæ˜¯å¦é ˆæ–¼è‚功能ä¸å…¨ç—…患執行臨床試驗</span> </b></p><h2 style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一ã€ä½•æ™‚å¯èƒ½é ˆæ–¼è‚功能ä¸å…¨ç—…患執行臨床試驗</span> </h2><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當藥å“或其活性代è¬ç‰©é¡¯è‘—經由è‚臟代è¬æˆ–排泄，本基準建è°æ–¼è‚功能ä¸å…¨ç—…患執行藥動å¸è©¦é©—。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當藥å“或其活性代è¬ç‰©å…·æœ‰ç‹¹çª„治療範åœï¼ˆ</span><span style="color: black; font-size: 11pt;">narrow therapeutic range</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）或å¯èƒ½ç”¨æ–¼è…Žè¡°ç«ç—…患時，è‚臟代è¬ä¹‹é€”徑變得較為é‡è¦ï¼Œå³ä½¿å…¶åŽŸä¾†æœªé¡¯è‘—（</span><span style="color: black; font-size: 11pt;"><20</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">﹪）經è‚臟代è¬æˆ–排除，本基準也建è°æ–¼è‚功能ä¸å…¨ç—…患執行臨床試驗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當藥å“的代è¬ä¸æ˜Žï¼Œä¸”缺ä¹å…¶å®ƒè³‡æ–™é¡¯ç¤ºè‚排除途徑之比例較低時<b>，</b>應考慮該藥å¯èƒ½æœƒè¢«è‚臟顯著代è¬ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å››</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當è‚病種類與藥å“原開發國ä¸åŒæ™‚，應考慮該藥å“在è‚臟之代è¬å¯èƒ½æœƒå› 而å—到影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><h2 style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二ã€ä½•æ™‚å¯èƒ½ä¸é ˆæ–¼è‚功能ä¸å…¨ç—…患執行臨床試驗</span> </h2><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å°æ–¼æŸäº›è—¥å“，è‚功能ä¸å…¨ä¸å¤ªå¯èƒ½æ˜Žé¡¯æ”¹è®Šå…¶è—¥å‹•å¸æ€§è³ªï¼Œè€Œé ˆèª¿æ•´åŠ‘é‡ï¼›åœ¨é€™äº›æ³ä¸‹ï¼Œæ¤é¡žè‡¨åºŠè©¦é©—å¯èƒ½æœ‰ç›Šæ–¼é 測藥å“性質但並éžå¿…è¦ã€‚下述藥å“的性質å¯èƒ½æœ‰åŠ©æ–¼åˆ¤æ–·ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“完全經由腎臟排除且與è‚臟無關。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“åªæœ‰å°‘部份（＜</span><span style="color: black; font-size: 11pt;">20</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">﹪）被è‚臟代è¬ï¼Œä¸”其治療範åœå¾ˆå»£ï¼Œå› æ¤è‚功能ä¸å…¨ä¸¦ä¸æœƒç”¢ç”Ÿæ¯’æ€§æˆ–å¢žåŠ è©²è—¥èˆ‡å…¶ä»–è—¥å“間的交互作用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">氣態或æ®ç™¼æ€§è—¥å“，且該藥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©ä¸»è¦ç¶“由肺臟排除。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å››</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å°æ–¼å–®æ¬¡ä½¿ç”¨çš„è—¥å“，除éžæœ‰è‡¨åºŠä¸Šçš„考慮，也許ä¸é ˆä»¥è‚功能ä¸å…¨ç—…患進行臨床試驗。</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">ç¬¬å››ç« ã€è‡¨åºŠè©¦é©—è¨è¨ˆ</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">試驗è¨è¨ˆçš„é‡é»žå¦‚下</span><span style="color: black; font-size: 11pt;">:</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一ã€ç°¡å¼è‡¨åºŠè©¦é©—è¨è¨ˆ</span><span style="color: black; font-size: 11pt;">(Reduced Study Design)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二ã€åŸºæœ¬å®Œæ•´çš„臨床試驗è¨è¨ˆ</span><span style="color: black; font-size: 11pt;">(Basic Full Study Design)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三ã€ç¾¤é«”藥動處ç†æ–¹å¼</span><span style="color: black; font-size: 11pt;">(Population PK Approach)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一ã€ç°¡å¼è‡¨åºŠè©¦é©—è¨è¨ˆ</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）ã€å—試者</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">FDA</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">在調查</span><span style="color: black; font-size: 11pt;">1995</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">1998</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">年間為了新藥申請</span><span style="color: black; font-size: 11pt;"> (New Drug Applications, NDAs) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">所執行的</span><span style="color: black; font-size: 11pt;">57</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個é‡å°è‚功能ä¸å…¨ç—…患進行的藥動å¸ç ”究時發ç¾ï¼Œå…¶ä¸çš„</span><span style="color: black; font-size: 11pt;">55% </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">使用</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法來評估è‚功能。在這</span><span style="color: black; font-size: 11pt;">57</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗ä¸æœ‰</span><span style="color: black; font-size: 11pt;">19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗包括藥å“在å„種å—試者上的å£æœæ¸…除率；這些å—試者包括具有æ£å¸¸è‚功能åŠè‚功能ä¸å…¨çš„病患（ä¾</span><span style="color: black; font-size: 11pt;">Child-Pugh </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類為輕度ã€ä¸åº¦åŠé‡åº¦ï¼‰ã€‚而這</span><span style="color: black; font-size: 11pt;">19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗ä¸çš„</span><span style="color: black; font-size: 11pt;">17</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗çµæžœé¡¯ç¤ºå£æœè—¥å“清除率與è‚功能ä¸å…¨çš„åš´é‡ç¨‹åº¦å‘ˆè² 相關</span><span style="color: black; font-size: 11pt;"> (</span><span style="font-size: 11pt;">r<sup>2</sup> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">介於</span><span style="color: black; font-size: 11pt;">0.5 </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å’Œ</span><span style="color: black; font-size: 11pt;">1.0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之間</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。åŒæ™‚，這</span><span style="color: black; font-size: 11pt;">19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗ä¸çš„</span><span style="color: black; font-size: 11pt;">16</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個試驗çµæžœé¡¯ç¤ºåœ¨</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類為ä¸åº¦è‚功能ä¸å…¨çš„病患有è‚臟代è¬æ©Ÿèƒ½ä¸å…¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å°±åƒä½¿ç”¨è¡€æ¸…肌氨酸é…的濃度或肌氨酸é…清除率來評估腎功能ä¸å…¨çš„程度一樣，我們建è°ç”¨</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法來評估è‚功能ä¸å…¨çš„程度。這就åƒç”¨è¡€æ¸…肌氨酸é…的濃度或肌氨酸é…清除率來評估腎功能ä¸å…¨çš„程度一樣。但是單用æ¤åˆ†é¡žæ³•æˆ–任何一種分類法ä»å«Œä¸è¶³ï¼Œç‚ºäº†å¯ä»¥æ›´æœ‰æ•ˆåœ°é 測è‚功能ä¸å…¨å°è—¥å“藥動å¸èˆ‡è—¥æ•ˆå¸æ€§è³ªä¹‹å½±éŸ¿ï¼Œæ‰€ä»¥å»ºè°åœ¨ä½¿ç”¨</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法的åŒæ™‚，併用其他å¯èƒ½é©ç”¨æ–¼è©•ä¼°è‚åŠŸèƒ½çš„æ–¹æ³•ï¼Œä¾‹å¦‚ï¼šæˆ‘åœ‹ç ”ç©¶è€…æ–¼</span><span style="color: black; font-size: 11pt;">1992</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">年所發表的åŠä¹³ç³–單點法（</span><span style="color: black; font-size: 11pt;">Galactose Single Point, GSP</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）已為</span><span style="color: black; font-size: 11pt;">FDA</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">基準ä¸æ‰€æŽ¨è–¦ï¼Œä¸”已在國人常見è‚ç—…é©—è‰éŽçš„一種用來評估殘餘之è‚功能（</span><span style="color: black; font-size: 11pt;">residual liver function</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）的極為簡便å¯è¡Œçš„方法（詳見附錄﹔è‚功能的評估）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">基於上述的數據，簡å¼è‡¨åºŠè©¦é©—è¨è¨ˆå¦‚能包括è‚功能æ£å¸¸çš„å—試者與</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類為ä¸åº¦è‚功能ä¸å…¨çš„ç—…æ‚£ï¼Œä¸€èˆ¬è€Œè¨€å·²ç¶“è¶³å¤ ã€‚åœ¨é€™ç¨®æƒ…å½¢ä¸‹ï¼Œåœ¨ä¸åº¦è‚功能ä¸å…¨çš„病患的發ç¾å°‡å¯æ‡‰ç”¨æ–¼è¼•åº¦è‚功能ä¸å…¨çš„病患，而é‡åº¦è‚功能ä¸å…¨çš„病患則通常列為ç¦å¿Œ</span><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">詳見</span><span style="color: black; font-size: 11pt;"> “</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">標示</span><span style="color: black; font-size: 11pt;">” </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">部份</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。然而å°æ–¼æ²»ç™‚範åœç‹¹çª„çš„è—¥å“則應考慮進行基本完整的試驗è¨è¨ˆï¼Œä¸¦é…åˆè‡¨åºŠè©¦é©—çš„çµæžœä¾†ä¿®è¨‚標示。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">本基準的主è¦ç›®çš„是希望能決定是å¦ä¸€å€‹è—¥å“或其代è¬ç‰©çš„藥動å¸åŠ</span><span style="color: black; font-size: 11pt;">/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或藥效å¸è¢«æ”¹è®Šçš„程度，已é”到需è¦èª¿æ•´è©²è—¥åœ¨è‚功能ä¸å…¨ç—…患的使用劑é‡ã€‚基於這個ç†ç”±ï¼ŒæŽ§åˆ¶çµ„çš„å—試者應是è‚功能æ£å¸¸çš„病患而ä¸ä¸€å®šéœ€è¦å¹´è¼•å¥åº·çš„自願者。而且，控制組的年齡ã€é«”é‡åŠæ€§åˆ¥æ‡‰å„˜å¯èƒ½çš„與è‚功能ä¸å…¨çµ„é¡žä¼¼ã€‚æ ¹æ“šè—¥å“的性質，其他å¯èƒ½é¡¯è‘—影響藥å“è—¥å‹•ä¹‹å› ç´ </span><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例如</span><span style="color: black; font-size: 11pt;">: </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">飲食ã€æŠ½ç…™ã€é…’ç²¾æ”å–é‡ã€ä½µç”¨è—¥å“ã€ç¨®æ—</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">也應該考慮進去。å°æ–¼å·²çŸ¥å…·æœ‰éºå‚³å¤šå½¢æ€§</span><span style="color: black; font-size: 11pt;">(genetic polymorphism</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，例如</span><span style="color: black; font-size: 11pt;">: CYP2D6</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">CYP2C19</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">é…µç´ åƒèˆ‡ä»£è¬çš„è—¥å“</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，試驗委託者於分æžçµæžœæ™‚應考慮到å—試者本身的代è¬ç‹€æ…‹ã€‚除了在åƒèˆ‡è‡¨åºŠè©¦é©—å‰æ‰€ä½œçš„æ¨™æº–æª¢é©—é …ç›®å¤–ï¼Œè©¦é©—å§”è¨—è€…å¯è€ƒæ…®åˆ©ç”¨æ¨™èªŒç‰©å¦‚åŠä¹³ç³–ã€</span><span style="color: black; font-size: 11pt;">ICG</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">antipyrine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">MEGX</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">來評估è‚è¡€æµ</span><span style="color: black; font-size: 11pt;">(hepatic blood flow)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或內在清除率</span><span style="color: black; font-size: 11pt;">(intrinsic clearance)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（詳見附錄：è‚功能的評估）。æ¤å¤–ï¼Œæ‡‰è©²æ‹›å‹Ÿè¶³å¤ æ•¸ç›®çš„å—試者，俾能收集到æ¯çµ„至少</span><span style="color: black; font-size: 11pt;">8</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä½å¯è©•ä¼°å—試者的數據。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）ã€è—¥å“的給予</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä¸€å€‹ç ”ç©¶è‚功能ä¸å…¨å°è—¥å“處置</span><span style="color: black; font-size: 11pt;">(drug disposition)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">影響的臨床試驗，å¯è¨è¨ˆç‚ºè©•ä¼°åœ¨çµ¦äºˆå–®ä¸€æˆ–多次劑é‡è—¥å“後，該藥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©çš„藥動å¸æ€§è³ªã€‚å°æ–¼çµ¦äºˆå¤šæ¬¡åŠ‘é‡è©¦é©—，應於給藥的第一天以åŠé”到穩定狀態</span><span style="color: black; font-size: 11pt;">(steady state)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">時評估其藥動å¸æ€§è³ªã€‚如果曾有數據顯示由給予單一劑é‡çš„藥動å¸æ€§è³ªï¼Œå¯æ£ç¢ºçš„推算出給予多次劑é‡æ™‚è—¥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©çš„藥動性質，則åªé ˆåŸ·è¡Œå–®ä¸€åŠ‘é‡çš„臨床試驗。若於å—試者所使用的藥å“劑é‡ç¯„åœå…§ï¼Œè©²è—¥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©å‘ˆç·šæ€§ä¸”ä¸å—時間影響的藥動å¸æ€§è³ªæ™‚則屬æ¤é¡žã€‚當藥å“或其活性代è¬ç‰©å‘ˆéžç·šæ€§æˆ–會å—時間影響的藥動å¸æ€§è³ªæ™‚，則給予多次劑é‡çš„è‡¨åºŠè©¦é©—å‰‡æ˜¯å¿…é ˆçš„ã€‚é›–ç„¶ï¼Œè‡¨åºŠè©¦é©—è¨ˆç•«ä¸æ‰€ä½¿ç”¨çš„臨床劑é‡é€šå¸¸æ˜¯æ¨™ç¤ºä¸Šæ‰€æ•˜è¿°çš„劑é‡ï¼Œå¦‚å°è©¦é©—å—è©¦è€…å› è‚功能ä¸å…¨è€Œè—¥å“è¡€ä¸æ¿ƒåº¦å¢žåŠ 所致的毒性有所顧慮時，則å¯é™ä½Žçµ¦äºˆåŠ‘é‡ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（三）ã€æ¨£å“採集與分æž</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">血液樣å“的採樣期程應足以決定藥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©ä¹‹æœ«ç›¸åŠè¡°æœŸ</span><span style="color: black; font-size: 11pt;"> (terminal half-life)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，而且這個期程è¨è¨ˆæ‡‰å¯åŒæ™‚é©ç”¨æ–¼æŽ§åˆ¶çµ„以åŠç—…患。å°æ–¼è¢«è‚臟高度抽å–çš„è—¥å“</span><span style="color: black; font-size: 11pt;">( extraction ratio > 0.7)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以åŠèˆ‡è¡€æ¼¿è›‹ç™½è³ªé«˜åº¦çµåˆçš„è—¥å“</span><span style="color: black; font-size: 11pt;"> (fraction unbound < 20%)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，至少在該藥血漿濃度最低</span><span style="color: black; font-size: 11pt;">(trough)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">與最高</span><span style="color: black; font-size: 11pt;">(maximal)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">時，測é‡å…¶æœªçµåˆç‹€æ…‹çš„比例。清除率åŠé«”ç©åƒæ•¸</span><span style="color: black; font-size: 11pt;">(volume parameters)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">應以藥å“於血漿åŠ</span><span style="color: black; font-size: 11pt;">/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或血清ä¸æ¿ƒåº¦</span><span style="color: black; font-size: 11pt;">(total concentration)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åŠæœªçµåˆç‹€æ…‹æ¿ƒåº¦ä¾†è¡¨ç¤ºã€‚分æžæ–¹æ³•æ‡‰æœ‰è¶³å¤ çš„éˆæ•åº¦èˆ‡ç‰¹ç•°æ€§ä¿¾èƒ½æª¢æ¸¬å‡ºè—¥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©ã€‚å°æ–¼å…·æœ‰ç«‹é«”化å¸ç‰¹æ€§çš„è—¥å“，藥å“代è¬çš„立體化å¸é¸æ“‡æ€§ä»¥åŠé¡åƒç•°æ§‹ç‰©</span><span style="color: black; font-size: 11pt;">(enantiomers)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">與蛋白質çµåˆçš„情形也應列入考慮。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二ã€åŸºæœ¬å®Œæ•´çš„臨床試驗è¨è¨ˆ</span></b><b><span style="color: black; font-size: 11pt;"> (Basic Full Study Design) </span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">為了在標示ä¸è¨»æ˜Žå°å„種è‚功能ä¸å…¨ç—…患的建è°åŠ‘é‡ï¼ŒåŸºæœ¬å®Œæ•´çš„臨床試驗è¨è¨ˆæ‡‰åŒ…括控制組以åŠä¾æ“š</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法分類為輕度ã€ä¸åº¦èˆ‡é‡åº¦çš„病患，å°æ–¼æ²»ç™‚範åœç‹¹çª„之藥å“宜é…åˆé™„錄ä¸çš„方法來定é‡è‚功能，並ä¾çµæžœä¿®æ£åŠ‘é‡èˆ‡æ¨™ç¤ºã€‚æ¤è©¦é©—æ‡‰è©²æ‹›å‹Ÿè¶³å¤ æ•¸ç›®çš„å—試者，俾能æ¯çµ„ä¸è‡³å°‘有</span><span style="color: black; font-size: 11pt;">6</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä½å¯è©•ä¼°å—試者的數據以供評估。æ¤å¤–ï¼Œæ–¼æœ¬åŸºæº–ç¬¬å››ç« ç¬¬ä¸€ç¯€ä¸è€ƒé‡çš„ç¨®ç¨®å› ç´ ï¼Œä¹Ÿæ‡‰åœ¨æ¤è‡¨åºŠè©¦é©—è¨è¨ˆåˆ—入考慮。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三ã€ç¾¤é«”藥動處ç†æ–¹å¼</span></b><b><span style="color: black; font-size: 11pt;">(Population PK Approach)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果在第二階段或第三階段臨床試驗ä¸æœªæŽ’除è‚功能ä¸å…¨çš„ç—…æ‚£ï¼Œè€Œä¸”æœ‰è¶³å¤ çš„è—¥å‹•å¸è³‡æ–™ä¾†æ述這些病患è‚功能ä¸å…¨çš„特性，則從第二階段或第三階段臨床試驗ä¸ç¾¤é«”藥動å¸çš„篩é¸ï¼Œå¯èƒ½æœ‰åŠ©æ–¼è©•ä¼°ä¸åŒè‚功能的變數</span><span style="color: black; font-size: 11pt;">(covariates)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å°è—¥å‹•å¸çš„影響。如果決定使用群體藥動å¸è™•ç†æ–¹å¼ï¼Œå‰‡å¿…é ˆè©•ä¼°ç¬¬äºŒéšŽæ®µæˆ–ç¬¬ä¸‰éšŽæ®µè‡¨åºŠè©¦é©—ä¸ç—…患的腦病變</span><span style="color: black; font-size: 11pt;">(encephalopathy)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€è…¹æ°´</span><span style="color: black; font-size: 11pt;">(ascites)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€è¡€æ¸…è†½ç´…ç´ </span><span style="color: black; font-size: 11pt;"> (serum bilirubin)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€è¡€æ¸…白蛋白</span><span style="color: black; font-size: 11pt;">(serum albumin)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€å‰å‡è¡€é…µç´ 時間</span><span style="color: black; font-size: 11pt;">(prothrombin time) (</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以上是</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åˆ†é¡žæ³•çš„æª¢æ¸¬é …ç›®</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€æˆ–是其他類似組åˆçš„è‚功能檢測。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一個群體藥動å¸ç ”究應該包括</span><span style="color: black; font-size: 11pt;">:</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）é 先計畫好的分æžæ–¹æ³•</span><span style="color: black; font-size: 11pt;">(pre-planned analysis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">來分æžè‚功能ä¸å…¨çš„影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）å°æ–¼è‚ç—…åš´é‡ç¨‹åº¦çš„評估。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼ˆä¸‰ï¼‰è¶³å¤ æ•¸ç›®çš„ç—…æ‚£ä»¥åŠè¶³ä»¥ä»£è¡¨å„種ä¸åŒè‚功能ä¸å…¨çš„病患，以åµæ¸¬åˆ°é ˆè¦èª¿æ•´åŠ‘é‡çš„藥動變化。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（四）必è¦æ™‚，檢測未çµåˆç‹€æ…‹çš„è—¥å“濃度。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（五）檢測藥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果試驗委託者打算利用上述測試的çµæžœä¾†æ”¯æŒæ¨™ç¤ºä¸è¨»æ˜Žè‚功能ä¸å…¨ç—…æ‚£ä¸é ˆèª¿æ•´åŠ‘é‡ï¼Œä»¥ä¸Šçš„臨床試驗計畫特性將會éžå¸¸é‡è¦ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å››ã€è—¥æ•ˆå¸è©•ä¼°</span></b><b><span style="color: black; font-size: 11pt;"> (Pharmcodynamic Assessments)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å°æ–¼ä¸€å€‹ç ”究計畫是在評估è‚åŠŸèƒ½æ”¹è®Šæ‰€é€ æˆçš„影響時，尤其是在沒有濃度å應相關性的數據</span><span style="color: black; font-size: 11pt;"> (concentration-response data)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或是擔心è‚功能改變也å¯èƒ½é€ æˆè—¥æ•ˆå應的改變時，藥效å¸è©•ä¼°è©¦é©—是å¯èƒ½éžå¸¸æœ‰ç”¨çš„。藥效å¸è©•ä¼°æŒ‡æ¨™</span><span style="color: black; font-size: 11pt;"> (pharmacodynamic endpoints) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">çš„é¸æ“‡æ‡‰å–決於藥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©çš„è—¥ç†ç‰¹æ€§ã€‚</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">ç¬¬äº”ç« ã€æ•¸æ“šåˆ†æž</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">數據分æžçš„主è¦ç›®çš„在於評估è‚功能ä¸å…¨å°æ–¼è—¥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©è—¥å‹•å¸æ€§è³ªçš„影響。如果å¯èƒ½çš„話，建立æŸä¸€ç‰¹å®šæˆ–æŸç¾¤è‚功能評估方法（如</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或附錄ä¸å…¶ä»–è‚功能之定é‡æ¸¬å®šæ–¹æ³•ï¼‰å’Œç›¸é—œè—¥å‹•å¸æ¸¬é‡åŠ</span><span style="color: black; font-size: 11pt;">/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或åƒæ•¸çš„相關性，進而從這些資料建立è‚功能ä¸å…¨ç—…患的建è°åŠ‘é‡ã€‚</span> </p><p style="line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一ã€åƒæ•¸é 測</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分æžè¡€ä¸æˆ–å°¿ä¸è—¥å“濃度以é 測藥å“åŠå…¶æ´»æ€§ä»£è¬ç‰©çš„藥動å¸åƒæ•¸ï¼Œé€™äº›åƒæ•¸åŒ…括曲線下é¢ç©ï¼ˆ</span><span style="color: black; font-size: 11pt;">AUC</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），最高濃度（</span><span style="color: black; font-size: 11pt;">C<sub>max</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），擬似清除率（</span><span style="color: black; font-size: 11pt;">apparent clearance CL/F</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），腎åŠéžè…Žæ¸…除率（</span><span style="color: black; font-size: 11pt;">CL<sub>R</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åŠ</span><span style="color: black; font-size: 11pt;">CL<sub>NR</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">），擬似分佈體ç©ï¼ˆ</span><span style="color: black; font-size: 11pt;">V<sub>dz</sub> or V<sub>dss</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）åŠåŠè¡°æœŸï¼ˆ</span><span style="color: black; font-size: 11pt;">t<sub>1/2</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）。必è¦æ™‚，這些åƒæ•¸å¯ä»¥è—¥å“çš„éžçµåˆæ…‹è¡¨ç¤ºï¼ˆå¦‚</span> <span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">：</span><span style="color: black; font-size: 11pt;">CL<sub>u</sub>/F=Dose/AUC<sub>u</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼›</span><span style="color: black; font-size: 11pt;">u</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表未çµåˆæ…‹è—¥å“）。éžå®¤æ€§æ¨¡å¼</span><span style="color: black; font-size: 11pt;">(Noncompartment) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或室性模å¼</span><span style="color: black; font-size: 11pt;">(compartment) </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">çš„æ–¹å¼éƒ½å¯ç”¨ä¾†è©•ä¼°é€™äº›åƒæ•¸ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二ã€è‚功能測é‡èˆ‡è—¥å‹•å¸ä¹‹ç›¸é—œæ€§</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">éŽåŽ»ç¶“驗顯示，臨床上å„種è‚功能的測é‡ï¼Œä¸¦ç„¡æ³•åƒè…ŽåŠŸèƒ½æ¸¬é‡èˆ¬æˆåŠŸçš„é 測藥å“藥動å¸æ€§è³ªçš„改變<b>。</b>用線性åŠéžç·šæ€§çš„模å¼å¯å°‡è‚功能異常與特定的藥動å¸åƒæ•¸å»ºç«‹ç›¸é—œæ€§ï¼Œè‚功能異常的測é‡ä¾‹å¦‚測é‡è‚è¡€æµé‡ã€è¡€æ¸…白蛋白濃度ã€å‰å‡è¡€é…µç´ 時間</span><span style="color: black; font-size: 11pt;">(prothrombin time)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法åŠå…¶å®ƒå®šé‡æ–¹æ³•ï¼ˆå¦‚åŠä¹³ç³–單點法）ç‰ä¾†åˆ¤å®šï¼Œè—¥å‹•å¸åƒæ•¸å‰‡åŒ…括總體清除率ã€å£æœæ¸…除率ã€æ“¬ä¼¼åˆ†ä½ˆé«”ç©ã€æœªçµåˆæ…‹è—¥å“的清除率或劑é‡æ¨™æº–化後的未çµåˆæ…‹è—¥å“曲線下é¢ç©ç‰ã€‚使用迴æ¸æ–¹æ³•åˆ†æžè‚功能ä¸å…¨åŠè—¥å‹•å¸åƒæ•¸ç‰é€£çºŒæ€§è®Šæ•¸æ˜¯é©ç•¶çš„，但è¦äº†è§£æœ‰äº›ç›¸é—œæ€§ä»æœ‰è³´æ–¼é¡žåˆ¥è®Šæ•¸ï¼ˆå¦‚</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或附錄ä¸å…¶ä»–è‚功能之定é‡æ¸¬å®šæ–¹æ³•ï¼‰ã€‚如果採模å¼åŒ–分æžï¼Œçµæžœæ‡‰åŒ…å«æ‰€é¸æ“‡æ¨¡å¼åƒæ•¸çš„é 測值åŠæ¸¬é‡ç²¾ç¢ºåº¦ï¼ˆå¦‚標準誤差或信賴å€é–“）。誤差值的估計亦有助於模å¼é©åˆæ€§çš„評估。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三ã€å»ºè°åŠ‘é‡çš„建立</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨ç—…患臨床試驗的主è¦ç›®çš„在於æ供有關病患併有è‚病時，藥å“之起始劑é‡ã€çµ¦èˆ‡é–“隔是å¦æ‡‰åšæ”¹è®Šçš„建è°ï¼Œä¸¦ä¸”了解å°æ¤ç¾¤é«”ä»é ˆå°å¿ƒèª¿æ•´åŠ‘é‡ã€‚ä¾æ“šè‡¨åºŠè©¦é©—çš„çµæžœï¼Œè©¦é©—å—試者或å¯æ–¼æ¨™ç¤ºä¸å®£ç¨±è‚功能ä¸å…¨ä¸¦ä¸æœƒå½±éŸ¿è—¥å“的藥動å¸æ€§è³ªã€‚åŸºæ–¼é€™äº›è‡¨åºŠè©¦é©—çš„æœ¬è³ªæ˜¯å±¬æ–¼æ¯”è¼ƒæ€§è³ªçš„ï¼Œå› æ¤è©•ä¼°é€™é¡žçµæžœï¼Œä»¥ä¿¡è³´å€é–“（</span><span style="color: black; font-size: 11pt;">Confident interval </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">表示方法將優於以顯著檢定方法（</span><span style="color: black; font-size: 11pt;">Significance test</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）表示。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">建è°åŠ‘é‡çš„建立一般å¯åŸºæ–¼ä¸‹åˆ—考é‡ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）如果è‚功能ä¸å…¨å°è—¥å‹•å¸æœ‰æ˜Žé¡¯å½±éŸ¿ï¼ˆä¾‹å¦‚å¢žåŠ </span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å€ä»¥ä¸Šï¼‰ï¼Œå¿…è¦çš„劑é‡èª¿æ•´æ‡‰è¨»æ˜Žæ–¼æ¨™ç¤ºä¸ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）如果試驗å—試者欲宣稱è‚功能ä¸å…¨ä¸¦ä¸æœƒå½±éŸ¿è—¥å“的藥動å¸æ€§è³ªï¼Œå‰‡å¿…é ˆå…·å‚™ä¸‹åˆ—æ¢ä»¶ä¹‹ä¸€ï¼šï¼ˆ</span><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼‰æ ¹æ“šè©¦é©—ç”¨è—¥å·²æœ‰çš„è³‡æ–™ï¼ˆå¦‚åŠ‘é‡åŠï¼æˆ–濃度與療效å應試驗），在試驗å‰æè¿°</span><span style="color: black; font-size: 11pt;">”</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">無影響界é™</span><span style="color: black; font-size: 11pt;">”</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">no effect boundaries</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）；（</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）在缺ä¹å…¶ä»–足以èªå®šä¸åŒç›¸ç‰å€é–“（</span><span style="color: black; font-size: 11pt;">equivalence interval</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）之資訊時，å¯ä»¥æ¨™æº–çš„</span><span style="color: black; font-size: 11pt;">90%</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä¿¡è³´å€é–“</span><span style="color: black; font-size: 11pt;">(</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å³</span><span style="color: black; font-size: 11pt;">AUC</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">é ˆè½æ–¼</span><span style="color: black; font-size: 11pt;">80-125%</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的範åœå…§ï¼Œè€Œä¸”</span><span style="color: black; font-size: 11pt;">Cmax</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">é ˆè½æ–¼</span><span style="color: black; font-size: 11pt;">70-143%</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的範åœå…§</span><span style="color: black; font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">來é©ç”¨æ–¼è©¦é©—ç”¨è—¥ã€‚å› è‚功能ä¸å…¨ç—…患臨床試驗通常å—è©¦è€…äººæ•¸è¼ƒå°‘ï¼Œå› æ¤ä¸¦ä¸æ˜“確定於æŸä¸€ä¿¡è³´å€é–“範åœå…§ï¼Œè—¥å‹•å¸åƒæ•¸ä»ç¶æŒåœ¨æŸä¸€</span><span style="color: black; font-size: 11pt;">”</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">無影響界é™</span><span style="color: black; font-size: 11pt;">”</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">內。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼ˆä¸‰ï¼‰å› ç‚ºä¸»è¦å•é¡Œç‚ºè™•æ–¹ç”¨æ³•ã€ç”¨é‡ï¼Œç¾¤é«”相ç‰æ€§ä¹‹æ¨™æº–（éžå€‹é«”相ç‰æ€§æ¨™æº–）å°é©ç”¨æ–¼æŽ§åˆ¶çµ„ä¸è—¥å‹•å¸æ¸¬é‡æˆ–åƒæ•¸çš„變異性，å¯èƒ½æœ‰æ‰€å¹«åŠ©ã€‚æ¤æ¨™æº–並ä¸é ˆé‡è¦†è©¦é©—è¨è¨ˆã€‚</span> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black;">第å…ç« ã€æ¨™ç¤º</span> </b></p><p style="text-align: center; line-height: 20pt;"><b></b></p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“標示應å應è‚功能ä¸å…¨å°è—¥å“藥動å¸èˆ‡è—¥æ•ˆå¸çš„影響。雖然藥å“的性質åŠè‚功能ä¸å…¨å°è—¥å“的影響使得標示ä¸æ˜“，但å°ä½¿ç”¨</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法，並é…åˆé™„錄ä¸å…¶ä»–定é‡æ¸¬å®šæ–¹æ³•è©•ä¼°è‚功能之後，列為ä¸åº¦è‚功能ä¸å…¨ç—…患，如試驗用藥å“之清除率有顯著é™ä½Žæ™‚，應減低其藥å“劑é‡ã€‚一般而言，ä¾</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法æ¸é¡žç‚ºè¼•åº¦è‚功能ä¸å…¨çš„病患也應作類似的劑é‡èª¿æ•´ã€‚ä¾æ“šè—¥å“的使用åŠæ²»ç™‚指標</span><span style="color: black; font-size: 11pt;">(therapeutic index)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的寬窄，å°</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法æ¸é¡žç‚ºé‡åº¦è‚功能ä¸å…¨ç—…患，å¯èƒ½è¦åˆ—為「ç¦å¿Œã€æˆ–特別å°å¿ƒä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å之，如果臨床試驗çµæžœé¡¯ç¤ºä¸åº¦è‚功能ä¸å…¨ç—…患的藥å“排除率並無顯著改變，則藥å“å¯ç”¨æ–¼è¼•åº¦åŠä¸åº¦è‚功能ä¸å…¨ç—…患而無需調整其劑é‡ã€‚ä¾æ“šè—¥å“的使用與治療指標的寬窄，通常å°é‡åº¦è‚功能ä¸å…¨ç—…患應標示å°å¿ƒä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　　</span> </p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果ä¾æ“šç¬¬ä¸‰ç« 第二節ä¸æ‰€åˆ—çš„ç†ç”±è€Œä¸é ˆåŸ·è¡Œè‚功能ä¸å…¨ç—…患之臨床試驗，則標示ä¸æ‡‰æ¨™æ˜Žè‚功能ä¸å…¨å°è—¥å“的影響未曾測試且å¯èƒ½ä¸é ˆè¦èª¿æ•´åŠ‘é‡ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">一ã€è‡¨åºŠè—¥ç†å¸</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（一）藥動å¸</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">藥動å¸æ‡‰åŒ…括藥å“的：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚è‡ŸæŽ’é™¤çš„æ©Ÿè½‰ï¼ˆé…µç´ é€”å¾‘ï¼Œå°¿ç”˜é…¸åŒ–çµåˆåº¦</span><span style="color: black; font-size: 11pt;">(glucuronidation)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åŠè†½æ±æŽ’除ç‰ï¼‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“被è‚臟排除的比例。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代è¬ç‰©åœ¨è‚功能ä¸å…¨ç—…患之藥動å¸ï¼ˆå¦‚æžœé©ç”¨ï¼‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm -7.7pt 0pt 72pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°è—¥å“åŠå…¶ä»£è¬ç‰©ä¹‹è›‹ç™½è³ªçµåˆåº¦çš„影響（如果é©ç”¨ï¼‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: wingdings; color: black; font-size: 11pt;">l<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°æ¶ˆæ—‹ç•°æ§‹ç‰©ä¸é¡åƒç•°æ§‹ç‰©çš„ç«‹é«”é¸æ“‡è™•ç½®ï¼ˆå¦‚果有è‰æ“šé¡¯ç¤ºä¸åŒç«‹é«”異構物ä¸æœ‰ä¸åŒæ´»æ€§æˆ–毒性）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（二）特殊群體（</span><span style="color: black; font-size: 11pt;">Special Populations</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">應簡çŸçš„é‡è¿°è—¥å‹•å¸ä¹‹è®ŠåŒ–åŠèªªæ˜Žè‚功能ä¸å…¨ç—…患藥效性質之改變åŠåŠ‘é‡ä¹‹èª¿æ•´ã€‚這些訊æ¯æ‡‰åŸºæ–¼ä¾æœ¬åŸºæº–所建è°å„é …è©¦é©—æˆ–å¯æŽ¥å—之替代試驗所得的çµæžœã€‚å¿…è¦ä¹‹è³‡è¨Šäº¦æ‡‰æ¨™ç¤ºæ–¼è¦èªžï¼ˆ</span><span style="color: black; font-size: 11pt;">WARNINGS</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€æ³¨æ„äº‹é …ï¼ˆ</span><span style="color: black; font-size: 11pt;">PRECAUTIONS</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ã€ç¦å¿Œï¼ˆ</span><span style="color: black; font-size: 11pt;">CONTRAINDICATIONS</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）åŠç”¨æ³•ç”¨é‡ï¼ˆ</span><span style="color: black; font-size: 11pt;">DOSAGE AND ADMINISTRATION</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ç‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例一：</span><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">最簡單的情形是在è‚功能ä¸å…¨ç—…患執行臨床試驗，çµæžœé¡¯ç¤ºè—¥å“的藥動å¸åŠè—¥æ•ˆå¸ç”šå°‘或並未改變，標示內容建è°å¦‚下：</span> </p><p style="line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åœ¨ä¸€é …æ¯”è¼ƒ</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">8</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個ä¸åº¦è‚功能ä¸å…¨ç—…患（ä¾</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">Child-Pugh</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法評估，並é…åˆé™„錄ä¸å…¶ä»–è‚功能之定é‡æ¸¬å®šæ–¹æ³•æ‰€å¾—數據評估è‚功能）與</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">8</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">個æ£å¸¸è‚功能å—試者的臨床試驗ä¸ï¼Œçµ¦äºˆå–®ä¸€åŠ‘é‡åŠ</span></i><i><span style="font-family: times new roman,serif; color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或多次劑é‡ï¼Œï¼ˆËè—¥å“å稱）於è‚功能ä¸å…¨ç—…患，並未發ç¾è—¥å‹•ï¼è—¥æ•ˆå¸æ€§è³ªæ”¹è®Šï¼Œå› æ¤æ–¼è¼•åº¦åŠä¸åº¦è‚功能ä¸å…¨ç—…患並ä¸éœ€èª¿æ•´ç”¨æ³•ç”¨é‡ã€‚</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例二：</span><span style="color: black; font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當è‚功能ä¸å…¨æœƒå½±éŸ¿è—¥å“的藥動å¸åŠè—¥æ•ˆå¸æ€§è³ªæ™‚，ä¾æ“šå·²çŸ¥çš„è—¥å“性質（例如消旋異構物ä¸å…·ä¸åŒæ´»æ€§çš„立體異構物，包括活性或毒性的代è¬ç‰©ï¼‰ä»¥åŠä¾æ“šæœ¬åŸºæº–所執行的臨床試驗所得到的çµæžœï¼Œå¯é©åº¦ä¿®æ”¹æ¨™ç¤ºå¦‚下：</span> </p><p style="line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">比較（Ëè—¥å“å稱）在è‚功能ä¸å…¨ç—…æ‚£åŠæ£å¸¸è‚功能å—試者的藥動性質，（Ëè—¥å“å稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代è¬ç‰©çš„全體清除率在ä¸åº¦è‚功能ä¸å…¨ç—…患（經</span></i><i><span style="color: black; font-size: 11pt;">Child-Pugh</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分類法評估）é™ä½Žäº†Ë（％）；在ä¸åº¦è‚功能ä¸å…¨ç—…患，（Ëè—¥å“å稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代è¬ç‰©çš„åŠè¡°æœŸå»¶é•·äº†</span></i><i><span style="color: black; font-size: 11pt;">__(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">時間</span></i><i><span style="color: black; font-size: 11pt;">)</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。（Ëè—¥å“å稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代è¬ç‰©çš„蛋白質çµåˆçŽ‡åœ¨è‚功能ä¸å…¨ç—…患上有（或無）改變。在長期給藥後，（Ëè—¥å“å稱）</span></i><i><span style="color: black; font-size: 11pt;">/</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代è¬ç‰©åœ¨è‚功能ä¸å…¨ç—…患會蓄ç©åˆ°</span></i><i><span style="color: black; font-size: 11pt;">___</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之程度。在輕度åŠä¸åº¦è‚功能ä¸å…¨ç—…患，（Ëè—¥å“å稱）的劑é‡æ‡‰é™ä½Žã€‚在é‡åº¦è‚功能ä¸å…¨ç—…患，（Ëè—¥å“å稱）的使用應特別注æ„或ç¦æ¢ä½¿ç”¨</span></i><i><span style="color: black; font-size: 11pt;">(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è«‹åƒç…§ç”¨æ³•ç”¨é‡</span></i><i><span style="color: black; font-size: 11pt;">)</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">例三：</span><span style="color: black; font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">當無è‚功能ä¸å…¨ç—…患的資料來作為標示的ä¾æ“šæ™‚，標示的內容如下：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“ä¸ç¶“éŽè‚臟排除</span><span style="color: black; font-size: 11pt;">(elimination)</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°ï¼ˆËè—¥å“åç¨±ï¼‰è—¥å‹•æ€§è³ªçš„å½±éŸ¿æœªç¶“è©•ä¼°ã€‚å› ç‚ºå¤§æ–¼</span></i><i><span style="color: black; font-size: 11pt;">90%</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的給藥劑é‡ä»¥åŽŸåž‹ç¶“由尿液排出，è‚功能ä¸å…¨æ‡‰ä¸è‡³é¡¯è‘—影響（Ëè—¥å“å稱）之排除。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i></i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">少部份經由è‚臟排除（</span><span style="color: black; font-size: 11pt;">Hepatic elimination <20</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">﹪）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(1)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標較廣的藥å“</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°ï¼ˆËè—¥å“åç¨±ï¼‰è—¥å‹•æ€§è³ªçš„å½±éŸ¿æœªç¶“è©•ä¼°ã€‚å› ç‚ºå¤§æ–¼</span></i><i><span style="color: black; font-size: 11pt;">80%</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的給藥劑é‡ä»¥åŽŸåž‹ç¶“由尿液排出，è‚功能ä¸å…¨æ‡‰ä¸è‡³é¡¯è‘—影響（Ëè—¥å“å稱）血ä¸æ¿ƒåº¦è€Œå½±éŸ¿å…¶å®‰å…¨æ€§ã€‚如果病患也有腎衰ç«çš„情形，è‚臟排除藥å“çš„é‡è¦æ€§æœƒå¢žåŠ 。相較於è‚功能æ£å¸¸ä¹‹å—試者，å¯èƒ½éœ€è¦é™ä½Žè‚功能ä¸å…¨ç—…患之起始åŠç¶æŒåŠ‘é‡æˆ–者延長給藥間隔</span></i><i><span style="color: black; font-size: 11pt;">(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è«‹åƒç…§æ³¨æ„äº‹é …</span></i><i><span style="color: black; font-size: 11pt;">)</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i></i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(2)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標狹窄的藥å“</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°ï¼ˆËè—¥å“å稱）的藥動å¸æ€§è³ªå½±éŸ¿æœªç¶“è©•ä¼°ï¼Œå› ç‚ºæ¤è—¥çš„一般治療劑é‡èˆ‡å¼•èµ·è—¥å“ä¸è‰¯å應之劑é‡ç›¸è¿‘。而且從體內（</span></i><i><span style="color: black; font-size: 11pt;">in vivo</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）或體外（</span></i><i><span style="color: black; font-size: 11pt;">in vitro</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）的è‰æ“šä¸é¡¯ç¤ºï¼Œï¼ˆËè—¥å“å稱）會經由è‚è‡ŸæŽ’é™¤ï¼Œå› æ¤è‚功能ä¸å…¨å¯èƒ½æœƒå¢žåŠ è—¥å“ä¸è‰¯å應的發生機率。相較於è‚功能æ£å¸¸ä¹‹å—試者，å¯èƒ½éœ€è¦é™ä½Žï¼ˆËè—¥å“å稱）在è‚功能ä¸å…¨ç—…患的起始åŠç¶æŒåŠ‘é‡æˆ–是延長其給藥間隔。如果病患有腎衰ç«çš„ç¾è±¡ï¼Œè‚臟排除藥å“çš„é‡è¦æ€§æœƒå› è€Œå¢žåŠ ï¼Œæ‰€ä»¥æ¤é¡žç—…患應é¿å…使用（Ëè—¥å“åç¨±ï¼‰ï¼Œå¦‚é ˆä½¿ç”¨ï¼ˆËè—¥å“åç¨±ï¼‰å¿…é ˆç‰¹åˆ¥å°å¿ƒç›£è¦–。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　　</span><i> </i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">主è¦ç¶“ç”±è‚臟排除</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(1)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標較廣之藥å“</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°æ–¼ï¼ˆËè—¥å“å稱）藥動å¸æ€§è³ªçš„å½±éŸ¿æœªç¶“è©•ä¼°ã€‚å› ç‚ºæœ‰é«”å…§åŠé«”外的è‰æ“šé¡¯ç¤ºï¼ˆËè—¥å“å稱）主è¦ç¶“ç”±è‚臟代è¬ï¼Œå› æ¤é 期è‚功能ä¸å…¨å¯èƒ½æœƒé¡¯è‘—改變（Ëè—¥å“å稱）的藥動å¸æ€§è³ªã€‚</span></i><i> </i></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">相較於è‚功能æ£å¸¸ä¹‹å—試者，在è‚功能ä¸å…¨ç—…患使用æ¤è—¥æ‡‰ç‰¹åˆ¥å°å¿ƒï¼Œè€Œä¸”å¯èƒ½å¿…é ˆé™ä½Žèµ·å§‹åŠç¶æŒåŠ‘é‡æˆ–是延長其給藥間隔。</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　　　　</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">(2)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療指標狹窄之藥å“</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°æ–¼ï¼ˆËè—¥å“å稱）的藥動å¸æ€§è³ªçš„å½±éŸ¿æœªç¶“è©•ä¼°ã€‚å› ç‚ºå°æ–¼</span></i><i><span style="color: black; font-size: 11pt;">20%</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的給藥劑é‡æœƒä»¥åŽŸåž‹ç¶“由尿液排出，而且有體外åŠé«”內的è‰æ“šé¡¯ç¤ºè©²è—¥å“主è¦ç¶“ç”±è‚臟代è¬ã€‚è‚功能ä¸å…¨å¯èƒ½æœƒé¡¯è‘—影響（Ëè—¥å“å稱）的藥動å¸æ€§è³ªã€‚（Ëè—¥å“å稱）應ä¸èƒ½ä½¿ç”¨æ–¼è‚功能ä¸å…¨ç—…æ‚£ï¼Œå¦‚å¿…é ˆè¦ç”¨ï¼Œæ‡‰ç‰¹åˆ¥å°å¿ƒã€‚</span></i><i><span style="color: black; font-size: 11pt;">(</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è«‹åƒç…§ç¦å¿Œ</span></i><i><span style="color: black; font-size: 11pt;">)</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i></i></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚臟排除尚ä¸æ˜Žç¢º</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">在這種情形下，æ¤è—¥å“視為會顯著經由è‚臟代è¬è€Œé©ç”¨ä¸Šè¿°æ¨™ç¤ºã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">二ã€æ³¨æ„äº‹é …åŠè¦èªž</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果è‚功能ä¸å…¨ç—…患會引起藥動å¸åŠè—¥æ•ˆå¸è‡¨åºŠä¸Šçš„é‡è¦æ”¹è®Šï¼Œå‰‡é€™äº›è¨Šæ¯æ‡‰åŒ…括在「注æ„äº‹é …ã€ä¸¦åƒè€ƒã€Œç”¨æ³•ç”¨é‡ã€ã€‚如果已知藥å“有狹窄的治療指標，則應在「è¦èªžã€æˆ–「ç¦å¿Œã€ä¸è¨»æ˜Žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">三ã€ç”¨æ³•ç”¨é‡</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">應於é©ç•¶è™•è¨»æ˜Žä¸‹åˆ—æ–‡å—，例如：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è‚功能ä¸å…¨å°ï¼ˆËè—¥å“å稱）的藥動å¸æˆ–藥效å¸æ€§è³ªçš„影響並ä¸é¡¯è‘—ï¼Œå› æ¤ä¸é ˆèª¿æ•´åŠ‘é‡ã€‚</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">æƒŸå› è‚功能ä¸å…¨è€Œé ˆèª¿æ•´åŠ‘é‡æ™‚，ä»æ‡‰åˆ—å…¥é©ç•¶çš„資訊。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">æ¤å¤–ï¼Œè¤‡æ–¹è£½åŠ‘ä¹Ÿé ˆç‰¹åˆ¥è€ƒé‡ã€‚å¦‚æžœæœ‰è¶³å¤ çš„è‰æ“šé¡¯ç¤ºè‚功能ä¸å…¨ç—…æ‚£å°æ–¼è¤‡æ–¹ä¸å€‹åˆ¥æˆåˆ†çš„藥動å¸æ€§è³ªæœ‰é¡žä¼¼çš„影響，則應ä¾è‚功能ä¸å…¨ä¹‹ç¨‹åº¦é©åº¦èª¿æ•´åŠ‘é‡ã€‚å¦å‰‡ï¼Œæ‡‰ä¾ä»¥ä¸‹çš„æ–‡å—標示：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><table style="margin: auto auto auto 55.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 362.7pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å› ç‚ºåœ¨å›ºå®šæ¯”ä¾‹çš„è¤‡æ–¹è£½åŠ‘ä¸ï¼Œå„別æˆä»½ç„¡æ³•è¨‚定，è‚功能ä¸å…¨æœƒé™ä½Žè—¥å“清除率，而å°è¤‡æ–¹ä¸</span></i><i><span style="color: black; font-size: 11pt;">A</span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">æˆåˆ†çš„影響é 大於å°è¤‡æ–¹ä¸</span></i><i><span style="color: black; font-size: 11pt;">B </span></i><i><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">æˆåˆ†çš„影響，所以è‚功能ä¸å…¨ç—…患應é¿å…使用æ¤è¤‡æ–¹ï¼ˆå¿…è¦æ™‚，詳見「注æ„äº‹é …ã€èˆ‡ã€Œè¦èªžã€ï¼‰ã€‚</span></i> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果複方ä¸å„æˆä»½çš„比例ä¸åŒï¼Œä¸”有å„æˆä»½æ¯”例ä¸åŒçš„複方製劑å¯ä¾›é¸æ“‡ï¼Œå‰‡å„˜å¯èƒ½è¦æ±‚醫師使用較少經由è‚臟代è¬æˆä»½çš„產å“。</span> </p></div><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åƒè€ƒæ–‡ç»</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">1.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(1997). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“è‡¨åºŠè©¦é©—ç”³è«‹é ˆçŸ¥ï¼ˆå°åŒ—）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">2.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(1999). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“查驗登記審查準則（å°åŒ—）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">3.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(2000). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„（å°åŒ—）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">4.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(2000). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">臨床試驗基準（å°åŒ—）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">5.</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">行政院衛生署</span><span style="color: black; font-size: 11pt;">(2000). </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è—¥å“éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„（å°åŒ—）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">6.Draft Guidance for Inducstry, Pharmacokinetics in Patients with Impaired Hepatic Function:Study Design, Data Analysis, and Impact on Dosing and Labeling. FDA, USA, 1999.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">7.Hu O.Y-P., Tang, H.S., and C.L. Chang, 1994, "The Influence of Chronic Lobular Hepatitis on Pharmacokinetics of Cefoperazone</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼</span><span style="color: black; font-size: 11pt;">A Novel Galactose Single-point Method as a Measure of Residual Liver Function." <i>Biopharm. Drug Dispos, 15(7): 563-576</i>.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">8.Hu O.Y-P., Tang, H.S., and C.L. Chang, 1995, "Novel Galactose Single-point Method as a Measure of Residual Liver Function:Example of Cefoperazone Kinetics in Patients with Liver Cirrhosis." <i>J. Clin. Pharmacol. 35(3): 250-258</i>.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">9.Shargel L. and A. Yu. 1999. <i>Applied Biopharmaceutics & Pharmacokinetics. 4<sup>th</sup> ed., p.566,</i> Prentice-Hall International, Inc.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 24pt;"><span style="color: black; font-size: 11pt;">10.Tang, H. -S., O.Y.-P. Hu., 1992, "Assessment of Liver Function Using a Novel Galactose Single Point Method," <i>Digestion, 52:222-231</i>.</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><span style="font-family: times new roman,serif; color: black; font-size: 11pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">附錄：è‚功能的評估</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">系統</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 281.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">觀察çµæžœæ‰€å¾—點數</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">腦病變程度</span><span style="color: black; font-size: 11pt;">*</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç„¡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç´š</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">或</span><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç´š</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">腹水</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç„¡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">輕度</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä¸åº¦</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è¡€æ¸…è†½ç´…ç´ æ¿ƒåº¦ï¼ˆ</span><span style="color: black; font-size: 11pt;">mg/dl</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＜</span><span style="color: black; font-size: 11pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＞</span><span style="color: black; font-size: 11pt;">3</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">血清白蛋白濃度（</span><span style="color: black; font-size: 11pt;">g/dl</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＞</span><span style="color: black; font-size: 11pt;">3.5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2.8</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">3.5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＜</span><span style="color: black; font-size: 11pt;">2.8</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 136.4pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å‰å‡è¡€é…µç´ 時間延長秒數</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＜</span><span style="color: black; font-size: 11pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">至</span><span style="color: black; font-size: 11pt;">6</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.55pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">＞</span><span style="color: black; font-size: 11pt;">6</span></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">*0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：æ„è˜ã€äººæ ¼ã€ç¥žç¶“å¸æª¢æŸ¥ã€è…¦é›»åœ–å‡æ£å¸¸</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> 1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：ä¸å®‰ï¼Œç¡çœ ä¸è‰¯ï¼Œæ˜“å—刺激，èºå‹•ã€å››è‚¢é¡«æŠ–，無法寫å—，腦波出ç¾</span><span style="color: black; font-size: 11pt;">5Hz</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">慢波</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> 2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：嗜ç¡ï¼Œæ™‚é–“èªçŸ¥å·®ï¼Œæƒ…感表ç¾ä¸é©ï¼Œé‹å‹•éšœç¤™ï¼Œé‹å‹•å¤±èª¿ï¼Œè…¦æ³¢å‡ºç¾ä¸‰ç›¸æ…¢æ³¢</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> 3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：倦ç¡ï¼Œæœ¨åƒµï¼Œå°åœ°æ–¹èªçŸ¥å·®ï¼Œå射增強，僵直，腦波出ç¾æ…¢æ³¢</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> 4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">級：無法喚醒的æ˜è¿·ï¼Œäººæ ¼åŠè¡Œç‚ºå–ªå¤±ï¼ŒåŽ»å¤§è…¦å§¿å‹¢ï¼Œè…¦æ³¢å‡ºç¾</span><span style="color: black; font-size: 11pt;">2-3Hz</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">慢波</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">è©•ä¼°çµæžœç‚º</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">5-6</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分：表示低開刀風險，å³è‚功能å—æ較輕微；</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">7-9</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分：表示ä¸åº¦é–‹åˆ€é¢¨éšªï¼Œå³è‚功能å—æ為ä¸åº¦ï¼›</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">10-15</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分：表示高開刀風險，å³è‚功能å—æ較嚴é‡ï¼ˆæ¤ç‚ºé…’精性è‚硬化病人之外科手術評估）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€åŠä¹³ç³–單點法（</span><span style="color: black; font-size: 11pt;">Galactose Single Point, GSP</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; font-size: 11pt;">本法乃是由å”鴻舜åŠèƒ¡å¹¼åœƒç™¼è¡¨æ–¼</span><span style="font-size: 11pt;">1992</span><span style="font-family: 新細明體,serif; font-size: 11pt;">年之</span><span style="font-size: 11pt;">Digestion</span><span style="font-family: 新細明體,serif; font-size: 11pt;">期刊ä¸ã€‚</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">為於空腹時，三分é˜å¿«é€Ÿéœè„ˆè¼¸æ³¨</span><span style="font-size: 11pt;">0.5 g/kg</span><span style="font-family: 新細明體,serif; font-size: 11pt;">çš„åŠä¹³ç³–，經éŽ</span><span style="font-size: 11pt;">60</span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜å¾Œï¼Œæ¸¬é‡å—試者血ä¸åŠä¹³ç³–的濃度，å³ç‚ºå…¶</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值（單ä½ç‚º</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">）。血ä¸åŠä¹³ç³–濃度，和è‚功能異常有éˆæ•çš„相關性，且實驗數據顯示</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值與è‚功能異常的程度有éžå¸¸é¡¯è‘—çš„é—œä¿‚ã€‚å› æ¤ï¼Œå¯ç¶“ç”±å—試者的</span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值來評估其è‚臟的剩餘功能，評估方法如下：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-size: 11pt;">(1)<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值å°æ–¼</span><span style="font-size: 11pt;">280</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">：è‚功能æ£å¸¸æˆ–å—æ輕微。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-size: 11pt;">(2)<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值介於</span><span style="font-size: 11pt;">280</span><span style="font-family: 新細明體,serif; font-size: 11pt;">與</span><span style="font-size: 11pt;">480</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">之間：è‚功能å—æ為ä¸åº¦ï¼ˆå¯èƒ½ç‚ºæ…¢æ€§è‚炎患者）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-size: 11pt;">(3)<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 11pt;">GSP</span><span style="font-family: 新細明體,serif; font-size: 11pt;">值大於</span><span style="font-size: 11pt;">480</span><span style="font-family: symbol; font-size: 11pt;">m</span><span style="font-size: 11pt;">g/ml</span><span style="font-family: 新細明體,serif; font-size: 11pt;">：è‚功能å—æ較嚴é‡ï¼ˆå¯èƒ½ç‚ºè‚硬化或è‚癌患者）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">Maddrey</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">辨è˜åŠŸèƒ½</span><span style="color: black; font-size: 11pt;">( Maddrey Discriminant Function, df )</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼</span><span style="color: black; font-size: 11pt;">4.6×</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å‰å‡è¡€é…µç´ æ™‚é–“ï¼ˆç§’ï¼‰ï¼‹è¡€æ¸…ç¸½è†½ç´…ç´ ï¼ˆ</span><span style="color: black; font-size: 11pt;">mg/dl</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值來評估急性酒精性è‚炎病人之病情å¯åˆ†ä¸‹åˆ—情形：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span> <span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值å°æ–¼</span><span style="color: black; font-size: 11pt;">54</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，則該疾病並ä¸åš´é‡</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值介於</span><span style="color: black; font-size: 11pt;">55</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">到</span><span style="color: black; font-size: 11pt;">92</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之間，則該疾病嚴é‡</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">如果</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值大於或ç‰æ–¼</span><span style="color: black; font-size: 11pt;">93</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，如ä¸æ²»ç™‚則å¯èƒ½è‡´æ»</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span><span style="color: black; font-size: 11pt;"> Carithers</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç‰äººæ›¾å°</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的計算法作以下修æ£ï¼šå‰å‡è¡€é…µç´ 改為比æ£å¸¸å‡è¡€æ™‚é–“å»¶é•·ä¹‹ç§’æ•¸ï¼Œä¸¦å°‡è¡€æ¸…è†½ç´…ç´ å€¼é™¤ä»¥</span><span style="color: black; font-size: 11pt;">17.1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以å–å¾—</span><span style="color: black; font-size: 11pt;">mmol/L</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å–®ä½ï¼Œä»£å…¥ä¸Šå¼è€Œè¨ˆç®—ä¿®æ£å¾Œçš„</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值，修æ£å¾Œç—…人的</span><span style="color: black; font-size: 11pt;">df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值大於或ç‰æ–¼</span><span style="color: black; font-size: 11pt;">32</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的病人，則被ç´å…¥</span><span style="color: black; font-size: 11pt;">methylprednisolone</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">治療試驗（相當於</span><span style="color: black; font-size: 11pt;">Maddrey df</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">值約</span><span style="color: black; font-size: 11pt;">106</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><b></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">Mayo</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å°åŽŸç™¼åž‹è†½æ±è‚硬化</span><span style="color: black; font-size: 11pt;">(Primary Biliary Cirrhosis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">之å˜æ´»æ¨¡å¼</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">Mayo</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å˜æ´»æ¨¡å¼ä¹ƒåŸºæ–¼é 測æ»äº¡å› åçš„</span><span style="color: black; font-size: 11pt;">Cox</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">æ£æ¯”å±å®³å›žæ¸åˆ†æžï¼ˆ</span><span style="color: black; font-size: 11pt;">Cox proportional hazard regression analyses</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）而得，æ¤è¤‡é›œçš„å…¬å¼æŽ¡ç”¨</span><span style="color: black; font-size: 11pt;">5</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">é …æœ€å…·å½±éŸ¿åŠ›çš„è®Šç•°æ•¸è¨ˆç®—è‡´æ»å±éšªæ€§ï¼ˆ</span><span style="color: black; font-size: 11pt;">R</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）來é 測å˜æ´»æ™‚é–“</span><span style="color: black; font-size: 11pt;">S</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> S ( t )</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼</span><span style="color: black; font-size: 11pt;">{S<sub>o</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span><span style="color: black; font-size: 11pt;">}<sup>exp(R-5.07)</sup></span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><sup><span style="color: black; font-size: 11pt;"> </span></sup><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å…¶ä¸</span><span style="color: black; font-size: 11pt;">S</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）å³</span><span style="color: black; font-size: 11pt;">t </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">å¹´çš„å˜æ´»æ©ŸçŽ‡</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">　</span><span style="color: black; font-size: 11pt;"> R</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼</span><span style="color: black; font-size: 11pt;">0.871 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">2.53 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.039</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">Y</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.859</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">E</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">2.38 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">PT</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä»£è¡¨è†½ç´…ç´ ï¼Œ</span><span style="color: black; font-size: 11pt;">mg/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼›</span><span style="color: black; font-size: 11pt;">A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表白蛋白，</span><span style="color: black; font-size: 11pt;">g/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼›</span><span style="color: black; font-size: 11pt;">Y</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表年齡；</span><span style="color: black; font-size: 11pt;">E</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表水腫；</span><span style="color: black; font-size: 11pt;">PT</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">代表å‰å‡è¡€é…µç´ 時間，秒）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> S<sub>o</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）值是由</span><span style="color: black; font-size: 11pt;">418</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä½ç—…人所觀察到的å˜æ´»çµæžœè€Œå¾—之平å‡å±éšªåˆ†æ•¸å€¼ï¼ˆå‡è¨</span><span style="color: black; font-size: 11pt;">R=5.07</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）：</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">t years</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">6</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">7</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">S<sub>o</sub></span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">t</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.970</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.941</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.883</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.883</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.25pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.774</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.721</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 52.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">0.651</span></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç¨å¾Œ</span><span style="color: black; font-size: 11pt;">Wiesner</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç‰äººç ”究</span><span style="color: black; font-size: 11pt;">174</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ä½åŽŸç™¼ç¡¬åŒ–性膽é“ç‚Ž</span><span style="color: black; font-size: 11pt;">(primary sclerosing cholangitis)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的病人並發展出å¦ä¸€ç¨®åˆ†æžæ¨¡å¼ã€‚除年齡åŠè¡€æ¸…è†½ç´…ç´ ã€ˆæœ€é«˜æŽ¡ç”¨</span><span style="color: black; font-size: 11pt;">10 mg/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">〉外，æ¤å›žæ¸åˆ†æžæ³•é‚„確èªè¡€ä¸è¡€ç´…ç´ æ¿ƒåº¦ï¼ˆ</span><span style="color: black; font-size: 11pt;">Hb</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，</span><span style="color: black; font-size: 11pt;">g/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">，在</span><span style="color: black; font-size: 11pt;">12g/dL</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">以下），發炎性腸é“疾病（</span><span style="color: black; font-size: 11pt;">IBD</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">：</span><span style="color: black; font-size: 11pt;">1</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">表示有，</span><span style="color: black; font-size: 11pt;">0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">表示沒有）和組織切片è‚纖ç¶åŒ–程度（</span><span style="color: black; font-size: 11pt;">S,0</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">到</span><span style="color: black; font-size: 11pt;">4</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ç‰é‡è¦å› å：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">R</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ï¼</span><span style="color: black; font-size: 11pt;">0.85 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">B</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.06</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">Y</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）ï¼</span><span style="color: black; font-size: 11pt;">4.39 ln</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">Hb</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">1.59</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">IBD</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）＋</span><span style="color: black; font-size: 11pt;">0.51S</span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="color: black; font-size: 11pt;">5</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">Monoethylglycinexylidide</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">（</span><span style="color: black; font-size: 11pt;">MEGX</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">æ¤ä¸€åŒ–åˆç‰©æ˜¯</span><span style="color: black; font-size: 11pt;">lidocaine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">經由è‚臟</span><span style="color: black; font-size: 11pt;">CYP3A</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">é…µç´ ç³»çµ±ä»£è¬å¾Œçš„主è¦ä»£è¬ç‰©ã€‚在連續</span><span style="color: black; font-size: 11pt;">2</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分é˜éœè„ˆè¼¸æ³¨</span><span style="color: black; font-size: 11pt;">1mg/</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ãŽçš„</span><span style="color: black; font-size: 11pt;">lidocaine</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">後，測é‡å…¶</span><span style="color: black; font-size: 11pt;">15</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ã€</span><span style="color: black; font-size: 11pt;">30</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">åŠ</span><span style="color: black; font-size: 11pt;">60</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">分é˜æ™‚之濃度，其çµæžœèˆ‡</span><span style="color: black; font-size: 11pt;">Child-Pugh</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">的得分çµæžœæœ‰è‰¯å¥½çš„相關性</span><span style="color: black; font-size: 11pt;">(Testa </span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">ç‰</span><span style="color: black; font-size: 11pt;">1997)</span><span style="font-family: 新細明體,serif; color: black; font-size: 11pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"> </p>2013-12-04
其他類,人體器官組織細胞輸入輸出管ç†è¾¦æ³•è¡Œæ”¿è§£é‡‹é™„è¡¨äººé¡žå™¨å®˜çµ„ç¹”ç´°èƒžè¼¸å…¥æ‡‰æª¢é©—é …ç›®<p style="line-height: 15pt; margin: auto 0cm;" class="null"><span style="font-family: 新細明體;"><b><span style="color: black; font-size: 10pt;">é™„è¡¨ï¼šäººé¡žå™¨å®˜çµ„ç¹”ç´°èƒžè¼¸å…¥æ‡‰æª¢é©—é …ç›®</span></b> </span></p><table style="margin: auto 6.75pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" align="left"> <tbody> <tr style="page-break-inside: avoid; height: 22.25pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 67.1pt; padding-right: 1.4pt; height: 22.25pt; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">用　途</span> </p> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">屬　性</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="text-align: right; layout-grid-mode: char;"><span style="font-size: 10pt;">Test Items </span></p> <p style="layout-grid-mode: char;"><span style="font-size: 10pt;">Type </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 95.4pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">Hepatitis </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 95.3pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">HIV </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">TP </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 22.25pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">TSE </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20.15pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">B </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 10pt;">C </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">１</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">ï¼’</span> </p> </td> </tr> <tr style="height: 27.35pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.1pt; padding-right: 1.4pt; height: 27.35pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">ä¸ä½¿ç”¨æ–¼äººé«”</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">ç ”ç©¶ã€æ•™å¸ã€</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">ä¿å˜ç”¨é€”</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;"> </span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 27.35pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;"> </span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 20.7pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.1pt; padding-right: 1.4pt; height: 20.7pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">人體醫療用（移æ¤ç”¨ï¼‰</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">移æ¤ç”¨é€”之器官ã€çµ„ç¹”ã€ç´°èƒž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span><span style="text-decoration: underline;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 20.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;"> </span><span style="text-decoration: underline;"> </span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 31.5pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">硬腦膜</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-size: 10pt;">Dura mater </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;"> </span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 31.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 8.5pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 99.25pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">其他</span><span style="font-size: 10pt;">other </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.75pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.65pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 48.1pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 13.5pt;">ˇ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 47.7pt; padding-right: 1.4pt; height: 8.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; layout-grid-mode: char;"><span style="font-size: 13.5pt;"> </span> </p> </td> </tr> <tr style="height: 86.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 452.85pt; padding-right: 1.4pt; height: 86.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 10pt;">æª¢é©—é …ç›®ï¼š</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Hepatitis</span><span style="font-family: 新細明體,serif; font-size: 10pt;">：è‚炎病毒（</span><span style="font-size: 10pt;">B</span><span style="font-family: 新細明體,serif; font-size: 10pt;">åž‹è‚炎病毒，</span><span style="font-size: 10pt;">C</span><span style="font-family: 新細明體,serif; font-size: 10pt;">åž‹è‚炎病毒）</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Human immunodeficiency virus</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">HIV</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）：第一型人類å…疫缺æ病毒（</span><span style="font-size: 10pt;">HIV-I</span><span style="font-family: 新細明體,serif; font-size: 10pt;">），第二型人類å…疫缺æ病毒（</span><span style="font-size: 10pt;">HIV-II</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Treponema pallidum</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">TP</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）：</span><span style="font-family: 新細明體,serif; font-size: 10pt;">梅毒螺旋體</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-size: 10pt;">Transmissible spongiform encephalopathy</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">TSE</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）：</span><span style="font-family: 新細明體,serif; font-size: 10pt;">傳染性海綿狀腦病</span> </p> </td> </tr> <tr style="height: 85.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 452.85pt; padding-right: 1.4pt; height: 85.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="8"> <p><span style="font-family: 新細明體,serif; font-size: 10pt;">其他注æ„äº‹é …</span><span style="font-family: 新細明體,serif; font-size: 10pt;">：</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 9: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-family: 新細明體,serif; font-size: 10pt;">供人體移æ¤é†«ç™‚ç”¨çš„å™¨å®˜çµ„ç¹”ç´°èƒžçš„æª¢é©—é …ç›®ï¼Œå…¶æ‰€æ“¬è¼¸å…¥å™¨å®˜ã€çµ„ç¹”ã€ç´°èƒžä¹‹è‚炎（</span><span style="font-size: 10pt;">Hepatitis</span><span style="font-family: 新細明體,serif; font-size: 10pt;">ï¼‰æª¢é©—é …ç›®çµæžœä¹‹ä¸€ç‚ºé™½æ€§</span><span style="font-size: 10pt;">Postive</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">+</span><span style="font-family: 新細明體,serif; font-size: 10pt;">），若å—贈者之è‚炎檢驗å°æ‡‰é …目亦為陽性</span><span style="font-size: 10pt;">Postive</span><span style="font-family: 新細明體,serif; font-size: 10pt;">（</span><span style="font-size: 10pt;">+</span><span style="font-family: 新細明體,serif; font-size: 10pt;">）之情æ³ä¸‹ï¼Œå¾—æ•˜æ˜ŽåŽŸå› ç”³è«‹è¼¸å…¥ã€‚</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-family: 新細明體,serif; font-size: 10pt;">醫師應就移æ¤æ‰€è‡´ä¹‹æ½›åœ¨æ„ŸæŸ“å±éšªæ€§ï¼Œç›¡è©³å¯¦ä¹‹å‘ŠçŸ¥ç¾©å‹™ã€‚</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; layout-grid-mode: char; 15: ;"><span style="font-family: wingdings; font-size: 10pt;">l</span><span style="font-family: 新細明體,serif; font-size: 10pt;">本署得ä¾å…¶ä»–傳染病之發生，於必è¦æ™‚，公告自該疫å€è¼¸å…¥ä¹‹äººé«”å™¨å®˜çµ„ç¹”ç´°èƒžè€…ï¼Œæ‡‰æª¢é™„ä¹‹æª¢é©—é …ç›®ã€‚</span> </p> </td> </tr> </tbody></table>2013-12-04
臨床試驗類,éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„行政解釋éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„<p style="text-align: center; punctuation-wrap: simple;"><b><span style="font-family: 新細明體,serif; font-size: 14pt;">éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„</span></b><b> </b></p><p style="punctuation-wrap: simple;"><strong><span style="font-family: 新細明體,serif; font-size: 13pt;">ï¹</span><span style="font-size: 13pt;">Good Laboratory Practice for Nonclinical Laboratory Studies</span><span style="font-family: 新細明體,serif; font-size: 13pt;">﹞</span> </strong></p><p style="punctuation-wrap: simple;"> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ç¬¬ä¸€ç« </span> <span style="font-family: 新細明體,serif;">總則</span> </p><p style="vertical-align: top; punctuation-wrap: simple; 58: ;"><span style="font-family: 新細明體,serif;">一ã€</span>(<span style="font-family: 新細明體,serif;">一</span>) <span style="font-family: 新細明體,serif;">éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„</span>(<span style="font-family: 新細明體,serif;">以下簡稱本è¦ç¯„</span>)<span style="font-family: 新細明體,serif;">，係æä¾›è—¥ç‰©ç ”ç™¼è©•ä¼°ï¼Œåšç‚ºè—¥ç‰©æŸ¥é©—登記申請文件ä¸çš„éžè‡¨åºŠè©¦é©—應éµå¾ªä¹‹è¦ç¯„，以確ä¿å„é …è©¦é©—æ•¸æ“šä¹‹å“質åŠè©¦é©—之完整性與å¯ä¿¡åº¦ã€‚</span> </p><p style="punctuation-wrap: simple; 55pt: ;"><span> (</span><span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">本è¦ç¯„未è¦å®šè€…或其他法令有特別è¦å®šè€…，é©ç”¨å…¶ä»–有關法令之è¦å®šã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 9pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二ã€æœ¬è¦ç¯„專有å詞之定義如下：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 2.5pt; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">一</span>) <span style="font-family: 新細明體,serif;">實驗室優良æ“作è¦ç¯„</span>(Good Laboratory Practice, GLP)</p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">實驗室優良æ“作è¦ç¯„係指有關實驗室試驗之計畫ã€åŸ·è¡Œã€ç›£æ¸¬ã€è¨˜éŒ„ã€å ±å‘ŠåŠæª”案的組織架構åŠè¦ç¯„。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 2.5pt; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">éžè‡¨åºŠè©¦é©—</span>(Nonclinical Laboratory Study)</p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 2.5pt 61.1pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">éžè‡¨åºŠè©¦é©—</span>(<span style="font-family: 新細明體,serif;">以下簡稱試驗</span>)<span style="font-family: 新細明體,serif;">係指於實驗æ¢ä»¶ä¸‹ä¹‹è©¦é©—體系，用活體內或</span><span> </span><span style="font-family: 新細明體,serif;">活體外試驗來測試試驗物質的安全性。æ¤è©¦é©—並ä¸åŒ…括人體試驗或臨床試驗。亦ä¸åŒ…括測試試驗物質是å¦å…·æœ‰ä»»ä½•æ½›åœ¨ç”¨é€”æ‰€ä½œçš„åŸºç¤Žæ€§ç ”ç©¶ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">三</span>) <span style="font-family: 新細明體,serif;">試驗機構</span> (Testing Facility)</p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">試驗機構係指包括執行試驗所需之人員<span style="letter-spacing: -1pt;">ã€è¨æ–½ã€è¨å‚™åŠä½œæ¥éƒ¨é–€ã€‚</span></span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å››</span>) <span style="font-family: 新細明體,serif;">試驗機構管ç†éšŽå±¤</span><span> (Management)<br /></span><span style="font-family: 新細明體,serif;">試驗機構管ç†éšŽå±¤ä¿‚指管ç†è©²è©¦é©—機構整體作æ¥ä¹‹è² 責人員。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">五</span>) <span style="font-family: 新細明體,serif;">試驗主æŒäºº</span><span> (Study Director)<br /></span><span style="font-family: 新細明體,serif;">試驗主æŒäººä¿‚æŒ‡åŸ·è¡Œè©²è©¦é©—ä¹‹è² è²¬äººã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å…</span>) <span style="font-family: 新細明體,serif;">試驗委託者</span><span> (Sponsor)<br /></span><span style="font-family: 新細明體,serif;">試驗委託者係指æ供試驗之財務或其他資æºï¼›æˆ–將試驗çµæžœå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹è—¥ç‰©æŸ¥é©—登記之個人或法人，亦å¯ç‚ºåŸ·è¡Œè©¦é©—之試驗機構。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">七</span>) <span style="font-family: 新細明體,serif;">å“質ä¿è‰å–®ä½</span><span> (Quality Assurance Unit)<br /></span><span style="font-family: 新細明體,serif;">å“質ä¿è‰å–®ä½ä¿‚指為確ä¿è©¦é©—符åˆæœ¬è¦ç¯„之è¦å®šï¼Œç”±è©¦é©—機構管ç†éšŽå±¤æŒ‡å®šåŸ·è¡Œå“質ä¿è‰å·¥ä½œä¹‹æœªåƒèˆ‡æ¤ç ”究之人員或組織。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å…«</span>) <span style="font-family: 新細明體,serif;">試驗體系</span><span> (Test System)<br /></span><span style="font-family: 新細明體,serif;">試驗體系係指試驗ä¸ç”¨ä¾†æ¸¬è©¦è©¦é©—物質或å°ç…§ç‰©è³ªä¹‹å‹•ç‰©ã€æ¤ç‰©ã€å¾®ç”Ÿç‰©ã€ç´°èƒžæˆ–其組æˆéƒ¨ä»½ï¼ŒåŒ–å¸æˆ–物ç†ç‰é«”系或其åˆä½µé«”系。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">ä¹</span>) <span style="font-family: 新細明體,serif;">試藥與溶液</span><span> (Reagents and Solutions)<br /></span><span style="font-family: 新細明體,serif;">試藥與溶液係包括試藥ã€è©¦æ¶²ã€æº¶åŠ‘ã€æŒ‡ç¤ºåŠ‘ã€è©¦ç´™ã€æ¯”色溶液åŠå®¹é‡åˆ†æžæº¶æ¶²ç‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å</span>) <span style="font-family: 新細明體,serif;">試驗物質</span><span> (Test Article)<br /></span><span style="font-family: 新細明體,serif;">試驗物質係指任何待測之藥物ã€åŒ–å¸ã€ç”Ÿç‰©ç‰©è³ªæˆ–其混åˆç‰©ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 53: ;">(<span style="font-family: 新細明體,serif;">å一</span>) <span style="font-family: 新細明體,serif;">å°ç…§ç‰©è³ª</span><span> (Control Article or Reference Article)<br /></span><span style="font-family: 新細明體,serif;">å°ç…§ç‰©è³ªä¿‚指於試驗期間，用以與試驗物質比較之藥物ã€åŒ–å¸ã€ç”Ÿç‰©ç‰©è³ªæˆ–其混åˆç‰©ã€‚</span> </p><p style="punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">å二</span>) <span style="font-family: 新細明體,serif;">賦形體</span> (Vehicle or Carrier)</p><p style="punctuation-wrap: simple; 48: ;"><span> </span><span style="font-family: 新細明體,serif;">賦行體係指用於混åˆã€åˆ†æ•£æˆ–溶解之媒介物質，以利於試驗體系ä¸è©¦é©—物質或å°ç…§ç‰©è³ªä¹‹æŠ•äºˆã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 58: ;">(<span style="font-family: 新細明體,serif;">å三</span>) <span style="font-family: 新細明體,serif;">批</span><span> (Lot (or Batch))<br /></span><span style="font-family: 新細明體,serif;">批係指如本è¦ç¯„第å…ç« ç¬¬ä¸€é …æ‰€è¿°ä¹‹ç‰¹å®šæ•¸é‡ä¹‹è©¦é©—物質或å°ç…§ç‰©è³ªï¼Œå…¶å…·æœ‰å‡ä¸€ä¹‹ç‰¹æ€§èˆ‡å“質。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 58: ;">(<span style="font-family: 新細明體,serif;">åå››</span>)<span style="font-family: 新細明體,serif;">樣å“</span><span> (Sample)<br /></span><span style="font-family: 新細明體,serif;">樣å“係指定é‡ä¹‹è©¦é©—物質或å°ç…§ç‰©è³ªã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å五</span>)<span style="font-family: 新細明體,serif;">標本</span><span> (Specimen)<br /></span><span style="font-family: 新細明體,serif;">標本係指由試驗體系è¡ç”Ÿè€Œä¾†ç”¨æ–¼æª¢æŸ¥æˆ–分æžä¹‹ç‰©è³ªã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">åå…</span>)<span style="font-family: 新細明體,serif;">原始數據</span><span> (Raw Data)<br /></span><span style="font-family: 新細明體,serif;">原始數據係指於試驗éŽç¨‹ä¸ç‚ºæ•´ç†æˆ–è©•ä¼°è©¦é©—å ±å‘Šæ‰€éœ€ä¿ç•™ä¹‹ä»»ä½•è§€å¯Ÿçµæžœã€åŽŸå§‹ç´€éŒ„ã€æ–‡ä»¶æˆ–其精確複å°æœ¬ã€‚原始數據å¯åŒ…括相片ã€å¾®ç¸®å½±ç‰‡ã€é›»è…¦åˆ—å°å ±è¡¨ã€ç£æ€§åª’é«”åŠè‡ªå‹•è£ç½®ç‰æ‰€å¾—到之觀察數據或其紀錄。</span> </p><p style="punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å七</span>) <span style="font-family: 新細明體,serif;">藥物</span><span> (Medicament)<br /></span><span style="font-family: 新細明體,serif;">ä¾è—¥äº‹æ³•ç¬¬å››æ¢ä¹‹è¦å®šï¼Œä¿‚指藥å“åŠé†«ç™‚器æ。藥å“之定義ä¾è—¥äº‹æ³•ç¬¬å…æ¢ã€é†«ç™‚器æ之定義ä¾è—¥äº‹æ³•ç¬¬å三æ¢ã€‚</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">三ã€</span><span style="font-family: 新細明體,serif;">試驗委託者å°å—託試驗機構之通知</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗委託者申請å—è¨—è©¦é©—æ©Ÿæ§‹é€²è¡Œè©¦é©—æ™‚ï¼Œè©¦é©—å§”è¨—è€…å¿…é ˆäº‹å…ˆé€šçŸ¥å—託試驗機構éµç…§æœ¬è¦ç¯„進行試驗。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">å››ã€æŸ¥æ ¸</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構應接å—ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŒ‡å®šæŸ¥æ ¸äººå“¡ï¼Œé€²è¡ŒåŒ…括ä¾æœ¬è¦ç¯„之è¨æ–½åŠä¿å˜ä¹‹æ–‡æ›¸ç´€éŒ„ã€æ¨™æœ¬ç‰ä¹‹æŸ¥æ ¸ï¼›æŸ¥æ ¸äººå“¡å¾—å½±å°æˆ–以其他é©ç•¶æ–¹æ³•è¤‡è£½è©²æ–‡æ›¸ç´€éŒ„或其副本。</span> </p><p style="punctuation-wrap: simple;"> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ç¬¬äºŒç« çµ„ç¹”èˆ‡äººäº‹</span> </p><p style="punctuation-wrap: simple; 24pt: ;"><span>一ã€</span><span style="font-family: 新細明體,serif;">組織</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構內置試驗機構管ç†éšŽå±¤è² 責整體試驗之管ç†ï¼Œä¸”æ¯ä¸€è©¦é©—計畫應有一試驗主æŒäººè² 責試驗之執行，並應è¨å“質ä¿è‰å–®ä½ç¨½æŸ¥å„é …è©¦é©—å·¥ä½œä»¥ç¢ºä¿å…¶åŸ·è¡ŒéŽç¨‹å‡ç¬¦åˆæœ¬è¦ç¯„之è¦æ±‚。</span> </p><p style="text-align: left; punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">二ã€äººå“¡ç®¡ç†</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 61.1pt; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">一</span>) <span style="font-family: 新細明體,serif;">åƒèˆ‡åŸ·è¡Œçš„æ¯ä¸€ä½äººå“¡åŠè² 有監ç£è²¬ä»»è€…å¿…é ˆå…·å‚™ç›¸ç•¶ä¹‹æ•™è‚²ã€è¨“ç·´ã€ç¶“驗或兼具而能å‹ä»»å…¶è·å‹™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;">(<span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">應以書é¢åˆ¶è¨‚試驗機構內æ¯ä¸€è·ä½ä¹‹å·¥ä½œè·è²¬ï¼Œä¸¦æ‡‰ç¢ºå¯¦éµè¡Œä¹‹ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">三</span>) <span style="font-family: 新細明體,serif;">應ä¿å˜å¯¦éš›åƒèˆ‡è©¦é©—者之å¸æ·èƒŒæ™¯ã€ç¶“æ·ã€æ›¾æŽ¥å—有關訓練åŠå·¥ä½œè·è²¬ç‰ä¹‹æœ€æ–°è³‡æ–™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;">(<span style="font-family: 新細明體,serif;">å››</span>) <span style="font-family: 新細明體,serif;">應ä¾æ“šè©¦é©—計畫書之è¦æ±‚，æä¾›è¶³å¤ ä¹‹äººå“¡åƒèˆ‡è©¦é©—工作。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">五</span>) <span style="font-family: 新細明體,serif;">應制訂新進åŠåœ¨è·äººå“¡æ‡‰æœ‰ä¹‹è¨“練程åºï¼Œä»¥ç¢ºä¿æ¯ä¸€ä½è©¦é©—人員å‡èƒ½å‹ä»»å…¶è·å‹™ï¼Œä¸”應將訓練內容åŠçµæžœä½œæˆå®Œæ•´ä¹‹ç´€éŒ„。</span> </p><p style="punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å…</span>)<span style="font-family: 新細明體,serif;">試驗æ“作人員應注æ„個人衛生åŠå¥åº·ï¼Œä»¥é˜²æ¢æ±¡æŸ“試驗物質ã€å°ç…§ç‰©è³ªåŠè©¦é©—</span><span> </span><span style="font-family: 新細明體,serif;">體系ç‰ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">七</span>)<span style="font-family: 新細明體,serif;">åƒèˆ‡è©¦é©—者發ç¾ç½¹æ‚£è¶³ä»¥å½±éŸ¿è©¦é©—å¯ä¿¡åº¦ä¹‹ç–¾ç—…æ™‚ï¼Œæ‡‰å ±å‘Šå…¶ç›£ç£è€…，並é¿å…åƒèˆ‡è©¦é©—，與試驗物質ã€å°ç…§ç‰©è³ªåŠè©¦é©—體系接觸，以å…影響試驗å“質åŠå…¶å®Œæ•´æ€§ï¼Œç›´è‡³å…¶æ¢å¾©å¥åº·ç‹€æ³ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">å…«</span>)<span style="font-family: 新細明體,serif;">åƒèˆ‡è©¦é©—者應é…åˆå·¥ä½œæ€§è³ªç©¿è‘—é©ç•¶ä¹‹å·¥ä½œè¡£ç‰©</span>(<span style="font-family: 新細明體,serif;">包括è·é¡ã€ä¿è·è¡£ã€å£ç½©ã€æ‰‹å¥—ã€éž‹ã€è¥ªç‰</span>)<span style="font-family: 新細明體,serif;">執行工作，並ä¾éœ€è¦ç¶“常æ›æ´—，以防æ¢ä¾†è‡ªè©¦é©—物質ã€å°ç…§ç‰©è³ªåŠè©¦é©—體系之微生物ã€æ”¾å°„性物質或化å¸æ€§ç‰©è³ªç‰ä¹‹æ±¡æŸ“。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;">(<span style="font-family: 新細明體,serif;">ä¹</span>)<span style="font-family: 新細明體,serif;">試驗</span><span style="font-family: 新細明體,serif;">人員應é…åˆå·¥ä½œæ€§è³ªæŽ¥å—定期å¥åº·æª¢æŸ¥ã€‚</span> </p><p style="punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">å</span>)<span style="font-family: 新細明體,serif;">è©¦é©—äººå“¡å¿…é ˆéµå®ˆå¯¦é©—室安全åŠå…¶æœ‰é—œè¦å®šåŸ·è¡Œè©¦é©—。</span> </p><p style="punctuation-wrap: simple; 27: ;"><span style="font-family: 新細明體,serif;">三ã€è©¦é©—機構管ç†éšŽå±¤</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">試驗機構管ç†éšŽå±¤æ‡‰ç¢ºä¿è©¦é©—機構ä¾ç…§æœ¬è¦ç¯„執行，並確ä¿ä¸‹åˆ—äº‹é …ï¼š</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）æ¯ä¸€è©¦é©—開始å‰æŒ‡å®šå¦‚æœ¬ç« ç¬¬å››é …æ‰€è¿°ä¹‹è©¦é©—ä¸»æŒäººè² 責該試驗之執行。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span> (</span><span style="font-family: 新細明體,serif;">二</span>) <span style="font-family: 新細明體,serif;">試驗éŽç¨‹ä¸è¦–需è¦å¯å³æ™‚æ›´æ›è©¦é©—主æŒäººï¼ŒæƒŸå…¶æ›´æ›äº‹å®œæ‡‰ä½œæˆæ›¸é¢ç´€éŒ„。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;">(<span style="font-family: 新細明體,serif;">三</span>) <span style="font-family: 新細明體,serif;">制訂實驗安全措施以確ä¿å¯¦é©—室安全。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span> (</span><span style="font-family: 新細明體,serif;">å››</span>) <span style="font-family: 新細明體,serif;">è¨ç«‹å¦‚æœ¬ç« ç¬¬äº”é …æ‰€è¿°ä¹‹å“質ä¿è‰å–®ä½ï¼Œä¸¦ç¢ºä¿å…¶åŠŸèƒ½ç¬¦åˆæœ¬è¦ç¯„之è¦å®šã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">(<span style="font-family: 新細明體,serif;">五</span>) <span style="font-family: 新細明體,serif;">試驗物質ã€å°ç…§ç‰©è³ªæˆ–其混åˆç‰©æ–¼å¿…è¦æ™‚進行é©ç•¶ä¹‹é‘‘別，並測試其å«é‡ã€ç´”度ã€å®‰å®šæ€§åŠå‡ä¸€æ€§ç‰è©¦é©—。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（å…）人員ã€è©¦é©—ææ–™ã€ç¶“è²»ã€è¨æ–½ã€è¨å‚™ã€ææ–™åŠè©¦é©—方法å‡ä¾æ—¢å®šè¨ˆç•«åŸ·è¡Œä¹‹ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（七）æ¯ä¸€è©¦é©—å‡ä¾æ—¢å®šä¹‹æ¨™æº–æ“作程åºåŸ·è¡Œï¼Œè€Œå…¶å®‰å…¨åŠè¡›ç”Ÿè¦å®šçš†ç¬¦åˆåœ‹å®¶æœ‰é—œæ³•ä»¤ä¹‹è¦æ±‚。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（八）試驗人員都確切明çžå…¶åŸ·è¡Œä¹‹å·¥ä½œã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（ä¹ï¼‰ç•¶è©¦é©—執行與本è¦ç¯„有所å差時，å“質ä¿è‰å–®ä½æ‡‰é€šçŸ¥è©¦é©—主æŒäººæŽ¡å–改善補救措施並作æˆæ›¸é¢ç´€éŒ„。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（å）必è¦æ™‚與試驗委託者共åŒåŒæ„試驗計畫書。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（å一）試驗計畫書ã€æœ‰é—œä¹‹æ¨™æº–æ“作程åºåŠå…¶åˆ¶è¨‚æ·ç¨‹æª”案å‡å¦¥å–„ä¿å˜ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（å二）試驗計畫書之修訂確經åŒæ„並予以詳確記錄。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（å三）應指定一ä½ç¶“æŽˆæ¬Šä¹‹äººå“¡è² è²¬æª”æ¡ˆç®¡ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è©¦é©—主æŒäºº</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰ç”±å…·å‚™ç›¸ç•¶æ•™è‚²ã€è¨“ç·´ã€ç¶“驗或兼具之科技專æ¥äººå“¡æ“”任。試驗主æŒäººå°è©¦é©—之執行åŠç®¡åˆ¶ï¼Œè©¦é©—çµæžœä¹‹è§£é‡‹ã€åˆ†æžã€ç´€éŒ„åŠå ±å‘Šç‰è² 整體之責任<b>，</b>並應確ä¿ä¸‹åˆ—事宜：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 24.45pt;"><span style="font-family: 新細明體,serif;">（一）試驗計畫書åŠå…¶ä»»ä½•è®Šæ›´äº‹é …，å‡ä¾ç…§æœ¬è¦ç¯„ç¬¬ä¸ƒç« ä¹‹è¦å®šåŸ·è¡Œã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（二）所有試驗數據包括試驗體系ä¸éžé 期之觀察çµæžœï¼Œå‡ç¶“詳確記錄åŠç¢ºèªã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（三）試驗éŽç¨‹ä¸ï¼Œè¶³ä»¥å½±éŸ¿è©¦é©—å“質åŠå…¶å®Œæ•´æ€§ä¹‹çªç™¼ç‹€æ³èˆ‡æ‰€æŽ¡å–之補救措施，å‡ç¶“詳確記錄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（四）所使用之試驗體系符åˆè©¦é©—計畫書之è¦å®šã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 新細明體,serif;">（五）試驗程åºå‡ä¾æœ¬è¦ç¯„è¦å®šåŸ·è¡Œã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（å…）所有原始數據ã€ç´€éŒ„ã€è©¦é©—計畫書ã€æ¨™æœ¬åŠæœ€çµ‚è©¦é©—å ±å‘Šç‰ï¼Œæ–¼è©¦é©—éŽç¨‹æˆ–試驗終了å‡äºˆä»¥æ¸æª”。</span> </p><p style="punctuation-wrap: simple; 51: ;"><span style="font-family: 新細明體,serif;">五ã€å“質ä¿è‰å–®ä½</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗機構應è¨å“質ä¿è‰å–®ä½ï¼Œè² 責稽查試驗計畫之執行éŽç¨‹ï¼Œä»¥ç¢ºä¿å…¶è¨æ–½ã€è¨å‚™ã€å„€å™¨ã€äººå“¡ã€è©¦é©—方法ã€å„é …ç®¡åˆ¶åŠç´€éŒ„ç‰ç¬¦åˆæœ¬è¦ç¯„之è¦æ±‚。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）執行å“質ä¿è‰å·¥ä½œäººå“¡æ‡‰ç†Ÿæ‚‰è©²è©¦é©—，且經相關訓練，並由ä¸åƒèˆ‡è©²è©¦é©—之人員擔任。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（三）å“質ä¿è‰å–®ä½ä¹‹è·è²¬åŠä½œæ¥ç¨‹åºï¼š</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">1.</span><span style="font-family: 新細明體,serif;">è² è²¬ä¿å˜ä¸€ä»½æ‰€æœ‰åœ¨è©¦é©—機構è£é€²è¡Œè©¦é©—之主計畫進度表</span><span style="font-family: times new roman,serif;">(</span><span style="font-family: 新細明體,serif;">ä¾è©¦é©—物質製作索引</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 新細明體,serif;">，內容包括試驗體系ã€è©¦é©—性質，試驗開始日期ã€å„試驗階段ã€è©¦é©—委託者ã€è©¦é©—主æŒäººå§“ååŠæœ€çµ‚è©¦é©—å ±å‘Šæƒ…å½¢ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 36.65pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">2.</span><span style="font-family: 新細明體,serif;">å°è² 責稽查之試驗ä¿å˜å…¶è©¦é©—計畫書影本。</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">3.</span><span style="font-family: 新細明體,serif;">定期稽查å„試驗階段以確ä¿æ‰€åŸ·è¡Œä¹‹è©¦é©—符åˆè©¦é©—計畫書åŠæ¨™æº–æ“作程åºï¼Œå°‡ç¨½æŸ¥è©¦é©—çµæžœåŠå…§å®¹ã€ç¨½æŸ¥æ‰€ç™¼ç¾å•é¡Œä¹‹ç¼ºå¤±åŠæ”¹é€²æŽªæ–½èˆ‡å†ç¨½æŸ¥æ—¥æœŸç‰è£½ä½œæˆå ±å‘Šä¸¦ç°½ç½²å¾Œä¿å˜ã€‚試驗期間應以é©ç•¶çš„間隔進行稽查，以確ä¿è©¦é©—之å¯ä¿¡åº¦åŠå®Œæ•´æ€§ã€‚稽查éŽç¨‹ä¸å¦‚發ç¾å½±éŸ¿è©¦é©—å¯ä¿¡åº¦åŠå®Œæ•´æ€§ä¹‹é‡è¦å•é¡Œæ™‚ï¼Œæ‡‰ç«‹åˆ»å ±å‘Šè©¦é©—ä¸»æŒäººåŠè©¦é©—機構管ç†éšŽå±¤ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">4.</span><span style="font-family: 新細明體,serif;">應å°è² 責稽查之試驗定期æ出稽查試驗之ç¾éšŽæ®µæ›¸é¢å ±å‘Šï¼Œç°½å…·å•é¡Œç¼ºå¤±åŠå…·é«”ä¿®æ£æŽªæ–½ï¼Œä¸¦é€äº¤è©¦é©—機構管ç†éšŽå±¤åŠè©¦é©—主æŒäººã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">5.</span><span style="font-family: 新細明體,serif;">應確定所稽查之試驗其執行與標準æ“作程åºæˆ–æ ¸å‡†ä¹‹è©¦é©—è¨ˆç•«æ›¸ç„¡æœªç¶“æŽˆæ¬Šä¹‹ä»»ä½•å差發生。</span> </p><p style="margin: 5.4pt 0cm 0pt 51.95pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">6.</span><span style="font-family: 新細明體,serif;">ç¨½æŸ¥æœ€çµ‚è©¦é©—å ±å‘Šæ™‚æ‡‰ç¢ºå®šè©²å ±å‘Šæ£ç¢ºåœ°è¨˜è¼‰è©¦é©—方法，且其çµæžœæ£ç¢ºåæ˜ è©¦é©—ä¹‹åŽŸå§‹æ•¸æ“šã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 51.95pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">7.</span><span style="font-family: 新細明體,serif;">ç¨½æŸ¥çµ‚äº†æ‡‰ç°½ç½²ä¸€ä»½å ±å‘Šï¼Œä¸¦ä½µåŒæœ€çµ‚è©¦é©—å ±å‘Šäº¤é€è©¦é©—機構管ç†éšŽå±¤åŠè©¦é©—主æŒäººï¼Œæ–¼è©²å ±å‘Šä¸æ‡‰è¼‰æ˜Žç¨½æŸ¥æ—¥æœŸåŠç¨½æŸ¥éŽç¨‹ä¸æ‰€ç™¼ç¾ä¹‹ç¼ºå¤±ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 9pt 0cm 0pt 61.1pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（四）å“質ä¿è‰å–®ä½ä¹‹è·è²¬åŠå…¶ä½œæ¥ç¨‹åºä»¥åŠç·¨ç´¢æœ‰é—œç´€éŒ„的方法å‡æ‡‰åˆ¶è¨‚標準æ“作程åºä¸¦ä¿å˜éµè¡Œä¹‹ã€‚所有ä¿å˜ä¹‹ç´€éŒ„應包括稽查日期ã€è©¦é©—å稱或代號ã€è©¦é©—階段åŠç¨½æŸ¥è€…之簽åã€ç°½è¨»æ—¥æœŸã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（五）所有å“質ä¿è‰å–®ä½ä¿å˜ä¹‹ç´€éŒ„應å˜æ”¾æ–¼è©¦é©—機構備查。</span> </p><p style="punctuation-wrap: simple;"> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ç¬¬ä¸‰ç« </span> <span style="font-family: 新細明體,serif;">è¨æ–½</span> </p><p style="punctuation-wrap: simple; 24pt: ;"><span>一ã€</span><span style="font-family: 新細明體,serif;">一般è¦å®š</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構應具有é©ç•¶ä¹‹é…ç½®ã€ç©ºé–“åŠæ§‹é€ 以利試驗之執行，且其è¨è¨ˆé ˆæœ‰é©ç•¶ç¨‹åº¦ä¹‹éš”離，以é¿å…任何功能或活動å°è©¦é©—產生ä¸è‰¯çš„影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24pt: ;"><span>二ã€</span><span style="font-family: 新細明體,serif;">動物管ç†è¨æ–½</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）動物管ç†è¨æ–½ä¹‹è¨è¨ˆã€æ§‹é€ åŠé…置應以å°è©¦é©—之干擾é™è‡³æœ€ä½Žç‚ºåŽŸå‰‡ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）為確ä¿å‹•ç‰©å“種</span>(<span style="font-family: 新細明體,serif;">ç³»</span>)<span style="font-family: 新細明體,serif;">或試驗體系之å€åˆ†ã€å€‹åˆ¥è¨ˆç•«ä¹‹ç¨ç«‹ã€å‹•ç‰©æª¢ç–«ä¹‹éš”離ã€ä¸€èˆ¬æˆ–特定動物之飼養，必è¦æ™‚應è¨è¶³å¤ çš„å‹•ç‰©é£¼é¤Šå ´æ‰€ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）當使用之試驗體系或試驗物質åŠå°ç…§ç‰©è³ªå…·æœ‰ç”Ÿç‰©å±éšªæ€§</span> (<span style="font-family: 新細明體,serif;">包括æ®ç™¼æ€§ã€æ”¾å°„性ã€å‚³æŸ“性物質åŠå™´éœ§åŠ‘ç‰</span>)<span style="font-family: 新細明體,serif;">æ™‚ï¼Œæ‡‰å…·è¶³å¤ ä¹‹å‹•ç‰©é£¼é¤Šå ´æ‰€ä»¥ä¾›èˆ‡å‰æ¬¾ä¹‹å ´æ‰€åˆ†é–‹ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）應æä¾›é©ç•¶çš„å ´æ‰€ä½œç‚ºè¨ºç™‚åŠæŽ§åˆ¶è©¦é©—動物疾病之用，且應æ供已知或疑似染有疾病之動物ã€å¸¶èŒè€…èˆ‡å…¶ä»–å‹•ç‰©ä½œæœ‰æ•ˆéš”é›¢çš„å ´æ‰€ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">ï¼ˆäº”ï¼‰å‹•ç‰©é£¼é¤Šå ´æ‰€æ‡‰æœ‰æ”¶é›†åŠè¡›ç”Ÿè™•ç†è©¦é©—體系所產生之排泄物ã€å»¢æ£„物之è¨æ–½ï¼Œè‹¥ç„¡å‰è¿°è¨æ–½å‰‡æ–¼é‹å‡ºè©¦é©—機構å‰æ‡‰äºˆå®‰å…¨ä¸”衛生之儲å˜ã€‚該處ç†è¨æ–½æ‡‰å…·æœ‰å°‡ç–¾ç—…ã€æ°£å‘³ã€å®³èŸ²å³ç”Ÿå’Œç’°å¢ƒæ±¡æŸ“é™è‡³æœ€ä½Žä¹‹åŠŸèƒ½ã€‚</span> </p><p style="margin: 6pt 0cm 0pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">三ã€å‹•ç‰©ç”¨å“供給è¨æ–½</span> </p><p style="punctuation-wrap: simple; 12: ;"><span> </span><span style="font-family: 新細明體,serif;">試驗機構內必è¦æ™‚應具備儲å˜é£¼æ–™ã€åºŠæ•·ã€å¢Šæ–™ã€é£¼é¤Šç”¨å“åŠå™¨å…·ä¹‹å ´æ‰€ï¼Œä¸”飼料ã€åºŠæ•·åŠå¢Šæ–™çš„儲å˜å ´æ‰€èˆ‡è©¦é©—é«”ç³»ä¹‹é£¼é¤Šå ´æ‰€æ‡‰åˆ†é–‹ï¼Œä»¥é˜²æ¢æ±¡æŸ“。易è…爛之用å“或飼料應以é©ç•¶æ–¹æ³•å„²å˜ä¹‹ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">å››ã€è©¦é©—物質åŠå°ç…§ç‰©è³ªä¹‹ç®¡ç†è¨æ–½</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（一）為防æ¢æ±¡æŸ“åŠæ··æ·†ï¼Œè©¦é©—機構應有下列å€åŸŸï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">1.<span style="font-family: 新細明體,serif;">試驗物質åŠå°ç…§ç‰©è³ªä¹‹é©—收ã€å„²å˜åŠè™•ç†å ´æ‰€ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">2.<span style="font-family: 新細明體,serif;">試驗物質ã€å°ç…§ç‰©è³ªèˆ‡è³¦å½¢é«”之混和åˆå ´æ‰€ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span> 3.</span><span style="font-family: 新細明體,serif;">å‰è¿°æ··åˆç‰©ä¹‹å„²å˜å ´æ‰€ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）å‰æ¬¾æ‰€åˆ—工作å€åŸŸæ‡‰èˆ‡è©¦é©—é«”ç³»ä¹‹é£¼é¤Šå ´æ‰€éš”é›¢ï¼Œä¸¦ç¢ºä¿è©¦é©—物質或å°ç…§ç‰©è³ªåŠå…¶æ··åˆç‰©ä¹‹åŠ›åƒ¹ã€ç´”度ã€å‡ä¸€æ€§åŠå®‰å®šæ€§ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">五ã€è©¦é©—æ“作å€åŸŸ</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗機構應具有足敷試驗所需之è¨æ–½ï¼Œä¸”應視需è¦æä¾›é©ç•¶ä¹‹éš”é›¢è©¦é©—å ´æ‰€ï¼Œä»¥åŸ·è¡Œæ‰€éœ€ä¹‹ä¾‹è¡Œå·¥ä½œåŠç‰¹å®šå·¥ä½œï¼Œå…¶è©¦é©—å ´æ‰€ä¹‹è¨ç½®æ¢ä»¶æ‡‰é…åˆå·¥ä½œä¹‹éœ€è¦ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">å…ã€æ¨™æœ¬ã€ç´€éŒ„èˆ‡å ±å‘Šä¹‹ç®¡ç†è¨æ–½</span> </p><p style="punctuation-wrap: simple; 18: ;"><span> </span><span style="font-family: 新細明體,serif;">應æä¾›å˜æ”¾èˆ‡æª¢ç´¢æ‰€æœ‰è©¦é©—計畫書ã€åŽŸå§‹æ•¸æ“šã€æ¨™æœ¬ã€æ¨£å“ã€æ–‡æ›¸ç´€éŒ„èˆ‡å ±å‘Šä¹‹å ´æ‰€ï¼Œæ¤å ´æ‰€éžç¶“授權ä¸å¯é€²å…¥ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">七ã€å¯¦é©—室安全åŠå»¢æ£„物處ç†è¨æ–½</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">實驗室之安全防è·åŠå»¢æ£„物之處ç†æ‡‰ç¬¦åˆæœ‰é—œæ³•ä»¤è¦ç« 。</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ç¬¬å››ç« </span> <span style="font-family: 新細明體,serif;">è¨å‚™</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一ã€ä¸€èˆ¬è¦å®š</span> </p><p style="margin: 6pt 0cm 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">（一）用於數據之產生ã€è™•ç†åŠè©•ä¼°ä¹‹å„€å™¨æˆ–器具以åŠç’°å¢ƒç®¡åˆ¶æ‰€éœ€ä¹‹æ©Ÿå™¨ï¼Œæ‡‰å…·æœ‰é©ç•¶çš„è¨è¨ˆåŠè¶³å¤ 功能，且其é…置應便於æ“作ã€æª¢æŸ¥ã€æ¸…潔與ç¶è·ã€‚</span> </p><p style="margin: 6pt 0cm 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">（二）有關物ç†ã€åŒ–å¸åŠç”Ÿç‰©ç‰å„é …è©¦é©—ï¼Œæ‡‰è¦–å…¶éœ€è¦è¨ç½®æ‰€éœ€ä¹‹è¨å‚™ï¼Œä¸”å…¶è¨ç½®ä¹‹æ¢ä»¶æ‡‰èƒ½é…åˆå·¥ä½œéœ€è¦ï¼Œä¸¦å¦¥ç‚ºé…ç½®åŠç¶è·ã€‚</span> </p><p style="margin: 6pt 0cm 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph1"><span style="font-family: 新細明體,serif;">（三）</span><span style="font-family: 新細明體,serif;">用於試驗之儀器åŠå™¨æé¸æ“‡ä»¥å°è©¦é©—體系或試驗目的之干擾é™è‡³æœ€ä½Žã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二ã€ç¶è·èˆ‡æ ¡æ£</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）用於數據之產生ã€è™•ç†æˆ–評估之è¨å‚™æ‡‰äºˆé©ç•¶ä¹‹æ¸…æ½”ã€å®šæœŸç¶è·åŠæ ¡æ£ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）有關è¨å‚™å®šæœŸä¹‹ç¨½æŸ¥ã€æ¸…æ½”ã€ç¶è·ã€æ¸¬è©¦ã€æ ¡æ£åŠæ¨™æº–化，應訂定相關標轉æ“作程åºï¼Œä¸¦æ–¼è©²ç¨‹åºä¸è©³è¼‰å…¶æ–¹æ³•ã€ææ–™åŠæ™‚程。標準æ“作程åºä¸å°æ–¼å‰è¿°å„é …å·¥ä½œæ‡‰æŒ‡å®šå°ˆäººè² è²¬ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）å‰æ¬¾è¨å‚™ç¶“æ ¡æ£ï¼Œè‹¥ç™¼ç¾æœªèƒ½ç¬¦åˆå…¶ç²¾ç¢ºåº¦ç•Œé™ï¼Œæ‡‰é™åˆ¶ä½¿ç”¨ä¸¦æŽ¡å–補救措施。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）所有儀器æ“作ã€ç¨½æŸ¥ã€ç¶è·åŠæ ¡æ£ç´€éŒ„å‡æ‡‰äºˆä¿å˜ï¼Œå‰è¿°ç´€éŒ„應å«å„é …å·¥ä½œä¹‹æ—¥æœŸï¼Œä¸¦è¨»æ˜Žå…¶æ“作ç¶è·æ˜¯å¦ä¾ç…§æ—¢å®šä¹‹æ¨™æº–æ“作程åºé€²è¡Œã€‚è‹¥å› å„€å™¨åŠŸèƒ½å¤±å¸¸æ‰€åŸ·è¡Œä¹‹éžä¾‹è¡Œæ€§ä¿®è·å·¥ä½œï¼Œå…¶ç´€éŒ„應記載該缺點發生時間ã€åŽŸå› 以åŠæ‰€æŽ¡å–之補救措施。</span> </p><p style="punctuation-wrap: simple; 61: ;"> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ç¬¬äº”ç« </span> <span style="font-family: 新細明體,serif;">試驗機構之æ“作</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一ã€æ¨™æº–æ“作程åº</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）為æ高試驗數據之å“質åŠç¢ºä¿è©¦é©—之完整ã€å®‰å…¨æ€§ï¼Œæ‡‰ä¾æœ¬è¦ç¯„制訂å„é …æ¨™æº–æ“作程åºï¼Œä¸¦ç¶“試驗機構管ç†éšŽå±¤æ ¸å‡†å¾Œå¯¦æ–½ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）標準æ“作程åºæ‡‰å˜æ”¾æ–¼å„æœ‰é—œä¹‹è©¦é©—å ´æ‰€ã€‚å…¶ä»–ç™¼è¡¨ä¹‹æ–‡ç»ã€æ›¸ç±æˆ–實驗手冊ç‰å¯ä½œç‚ºæ¨™æº–æ“作程åºä¹‹è£œéºã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）試驗ä¸å„é …æ“作與既定之標準æ“作程åºæœ‰æ‰€å差時應予記錄，並由試驗主æŒäººä½œåˆç†çš„判釋。é‡å¤§çš„è®Šæ›´å‰‡å¿…é ˆç¶“è©¦é©—æ©Ÿæ§‹ç®¡ç†éšŽå±¤æŽˆæ¬Šï¼Œä¸¦ä¿å˜æ›¸é¢ç´€éŒ„。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）標準æ“作程åºä¿®è¨‚時，å‡æ‡‰ç¶“試驗機構管ç†éšŽå±¤æ ¸å‡†ã€‚有關標準æ“作程åºä¹‹åˆ¶è¨‚æ·ç¨‹åŠä¿®è¨‚版應予ä¿ç•™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">（五）標準æ“作程åºåŽŸå‰‡ä¸Šéœ€æ¶µè“‹ä¸‹åˆ—å„æ¬¾æœ‰é—œé …ç›®ï¼š</span> </p><p style="punctuation-wrap: simple; 23: ;">1. <span style="font-family: 新細明體,serif;">器具之使用ã€ç¶è·ã€æ¸…æ½”åŠæ ¡æ£ã€‚</span> </p><p style="punctuation-wrap: simple;">2. <span style="font-family: 新細明體,serif;">機器åŠè¨å‚™ä¹‹ä½¿ç”¨èˆ‡ç®¡ç†ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">3. <span style="font-family: 新細明體,serif;">試藥åŠæº¶æ¶²ä¹‹ç®¡åˆ¶ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">4.<span style="font-family: 新細明體,serif;">試驗物質åŠå°ç…§ç‰©è³ªä¹‹ç®¡åˆ¶ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">5.<span style="font-family: 新細明體,serif;">試驗方法。</span> </p><p style="punctuation-wrap: simple;">6.<span style="font-family: 新細明體,serif;">動物åŠå‹•ç‰©æˆ¿ä¹‹ç®¡ç†ã€‚</span> </p><p style="punctuation-wrap: simple;">7.<span style="font-family: 新細明體,serif;">實驗動物之鑑別ã€å‹•ç‰©é£¼è‚²å®¤ã€é…ç½®åŠé‹é€ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">8.<span style="font-family: 新細明體,serif;">試驗體系之觀察åŠèª¿æŸ¥ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">9.<span style="font-family: 新細明體,serif;">瀕æ»åŠæ»äº¡å‹•ç‰©ä¹‹è™•ç†ã€‚</span> </p><p style="punctuation-wrap: simple;">10.<span style="font-family: 新細明體,serif;">實驗動物之活體解剖åŠæ»é«”解剖之檢查。</span> </p><p style="punctuation-wrap: simple; 23: ;">11.<span style="font-family: 新細明體,serif;">標本之收集ã€é‘‘定åŠç®¡ç†ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">12.<span style="font-family: 新細明體,serif;">組織病ç†å¸ä¹‹æª¢æŸ¥ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">13.<span style="font-family: 新細明體,serif;">ç´€éŒ„èˆ‡å ±å‘Šä¹‹ç®¡ç†ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">14.<span style="font-family: 新細明體,serif;">å“質ä¿è‰å·¥ä½œä¹‹åŸ·è¡Œã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">15.<span style="font-family: 新細明體,serif;">試驗安全衛生管制。</span> </p><p style="punctuation-wrap: simple; 23: ;">16.<span style="font-family: 新細明體,serif;">廢棄物處ç†ã€‚</span> </p><p style="punctuation-wrap: simple; 23: ;">17.<span style="font-family: 新細明體,serif;">å…¶ä»–æœ‰é—œäº‹é …ä¹‹ç®¡åˆ¶ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二ã€ç”Ÿç‰©è©¦é©—體系</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）進å£ã€è³¼è²·ã€é£¼</span>(<span style="font-family: 新細明體,serif;">培</span>)<span style="font-family: 新細明體,serif;">養或使用動物ã€æ¤ç‰©ã€å¾®ç”Ÿç‰©åŠç´°èƒžç‰ï¼Œæ‡‰ä¾æ“šåœ‹å®¶ç›¸é—œæ³•è¦è¾¦ç†ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）動物ã€æ¤ç‰©ã€å¾®ç”Ÿç‰©åŠç´°èƒžä¹‹è³¼è²·ã€é£¼</span>(<span style="font-family: 新細明體,serif;">培</span>)<span style="font-family: 新細明體,serif;">養åŠä½¿ç”¨æ‡‰å…·æœ‰æ¨™æº–æ“作程åºï¼Œä¸¦ä¿å˜å…¶ç´€éŒ„以供追溯çžè§£å…¶ä½¿ç”¨æ·ç¨‹ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）新購進之動物ã€æ¤ç‰©ç‰åœ¨æœªè©•ä¼°å…¶å¥åº·ç‹€æ…‹å‰æ‡‰äºˆéš”離檢疫，若觀察期間有異常疾病或æ»äº¡æ™‚，該批動物ã€æ¤ç‰©ç‰ä¸å¾—供試驗使用，並予é©ç•¶è™•ç½®ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）動物ã€æ¤ç‰©ã€å¾®ç”Ÿç‰©åŠç´°èƒžç‰æ–¼è©¦é©—å‰ï¼Œæ‡‰ç¶“é©ç•¶ä¹‹é©æ‡‰æœŸå¾Œå§‹å¾—供試驗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（五）在試驗開始時，動物ä¸æ‡‰æœ‰å¹²æ“¾è©¦é©—之任何疾病或ä¸è‰¯å¥åº·ç‹€æ³ç™¼ç”Ÿï¼Œè‹¥æ–¼è©¦é©—ä¸æœ‰ä¸Šè¿°æƒ…形發生，則該動物應予隔離，必è¦æ™‚å°å·²æ„ŸæŸ“疾病或有疾病徵兆之動物應予治療，而æ¤æ²»ç™‚ä¸å¾—å°è©¦é©—有任何干擾，診療éŽç¨‹åŠæ—¥æœŸå‡æ‡‰äºˆè¨˜éŒ„ä¿å˜ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（å…）試驗éŽç¨‹å¿…é ˆé•·æœŸè™•ç†æˆ–è§€å¯Ÿï¼Œæˆ–å› å„ç¨®åŽŸå› å¿…é ˆå¾žç± ä¸å–出或é€å›žä¹‹æº«è¡€å‹•ç‰©</span>(<span style="font-family: 新細明體,serif;">未斷乳之囓齒類動物除外</span>)<span style="font-family: 新細明體,serif;">，應有明確之è˜åˆ¥æ–¹æ³•ã€‚æ¯ä¸€å‹•ç‰©é£¼é¤Šå®¹å™¨å¤–應有明顯之標è˜ï¼Œä»¥ç¢ºèªå®¹å™¨å…§æ¯ä¸€è©¦é©—動物。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（七）ä¸åŒå“種</span>(<span style="font-family: 新細明體,serif;">ç³»</span>)<span style="font-family: 新細明體,serif;">的動物必è¦æ™‚æ‡‰åˆ†åˆ¥é£¼é¤Šæ–¼å€‹åˆ¥çš„å ´æ‰€ï¼Œè€Œç›¸åŒå“種</span>(<span style="font-family: 新細明體,serif;">ç³»</span>)<span style="font-family: 新細明體,serif;">用於ä¸åŒè©¦é©—的動物，若å¯èƒ½å› </span> <span style="font-family: 新細明體,serif;">ä¸æ…Žæš´éœ²æ–¼è©¦é©—物質ã€å°ç…§ç‰©è³ªæˆ–其混åˆç‰©è€Œå½±éŸ¿è©¦é©—çµæžœæ™‚，原則上ä¸å¯ç½®æ–¼åŒä¸€å®¤ï¼Œè‹¥å¿…é ˆç½®æ–¼åŒä¸€å®¤è€…，則應有é©ç•¶ç©ºé–“之隔離åŠæ˜Žç¢ºæ¨™ç¤ºã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">ï¼ˆå…«ï¼‰å‹•ç‰©é£¼é¤Šå ´æ‰€ã€å‹•ç‰©ç± ã€æž¶åŠå…¶ä»–附屬器皿ã€è£ç½®ç‰æ‡‰å®šæœŸæ¸…洗與衛生處ç†ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（ä¹ï¼‰å‹•ç‰©ç± 或盤內所使用之床敷ã€å¢Šæ–™æ‡‰ä¸å¾—干擾試驗目的或試驗進行，且應視需è¦äºˆä»¥æ›´æ›ï¼Œä»¥ä¿è‰å‹•ç‰©è™•æ–¼ä¹¾ç‡¥å’Œæ¸…潔之環境。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（å）動物飲水åŠé£¼æ–™æ‡‰å®šæœŸåˆ†æžï¼Œä»¥ç¢ºå®šå°è©¦é©—產生å¯èƒ½å¹²æ“¾ä¹‹æ±¡æŸ“物無超éŽè©¦é©—計畫書內è¦å®šçš„容許範åœï¼Œå…¶çµæžœæ‡‰ä»¥åŽŸå§‹æ•¸æ“šä¹‹æ–¹å¼ä¿å˜ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（å一）用殺蟲劑時應予記錄，若清潔劑åŠæ®ºèŸ²åŠ‘會干擾試驗時則ä¸å¯ä½¿ç”¨ã€‚</span> </p><p style="punctuation-wrap: simple; 24: ;"><span>三ã€</span><span style="font-family: 新細明體,serif;">藥與溶液之管制</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">試驗ä¸ä½¿ç”¨ä¹‹è©¦è—¥èˆ‡æº¶æ¶²æ‡‰æ¨™ç¤ºå…¶å…§å®¹ç‰©ã€æ¿ƒåº¦ã€å„²å˜æ¢ä»¶ã€é…製日期åŠæœ‰æ•ˆæœŸé™ã€‚未標示有效期é™ä¹‹è©¦è—¥èˆ‡æº¶æ¶²æ‡‰äºˆé‡è¡Œæª¢é©—。變質或超éŽæœ‰æ•ˆæœŸé™è€…ä¸å¾—使用。</span> </p><p style="punctuation-wrap: simple; 24: ;"> </p><p style="punctuation-wrap: simple; 37: ;"><span style="font-family: 新細明體,serif;">第å…ç« </span> <span style="font-family: 新細明體,serif;">試驗物質åŠå°ç…§ç‰©è³ª</span> </p><p style="punctuation-wrap: simple; 40: ;"><span style="font-family: 新細明體,serif;">一ã€è©¦é©—物質與å°ç…§ç‰©è³ªä¹‹ç‰¹æ€§</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗開始å‰æ‡‰ç¢ºå®šæ¯æ‰¹è©¦é©—物質或å°ç…§ç‰©è³ªä¹‹æœ¬è³ªã€åŠ›åƒ¹ã€ç´”度ã€çµ„æˆæˆ–其他å¯ä»¥ç¢ºåˆ‡é¡¯ç¤ºè©²ç‰ç‰©è³ªä¹‹ç‰¹æ€§ï¼Œä¸¦ä»¥è¨˜éŒ„。試驗機構或試驗委託者應記錄試驗物質åŠå°ç…§ç‰©è³ªä¹‹åˆæˆã€è£½é€ 方法或來æºã€‚若以市售商å“為å°ç…§ç‰©è³ªï¼Œå¯ç”¨å…¶ç”¢å“標示確èªå…¶ç‰¹æ€§ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）試驗機構或試驗委託者應在開始進行å„é …è©¦é©—å‰ï¼Œç¢ºå®šè©¦é©—物質或å°ç…§ç‰©è³ªä¹‹å®‰å®šæ€§ï¼›æˆ–ä¾æ“šæ—¢å®šä¹‹æ¨™æº–æ“作程åºå®šæœŸæª¢é©—之。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）試驗物質åŠå°ç…§ç‰©è³ªä¹‹æ¯ä¸€è²¯å˜å®¹å™¨å‡æ¨™ç¤ºå…¶å稱ã€ç·¨è™Ÿ</span>(<span style="font-family: 新細明體,serif;">代碼</span>)<span style="font-family: 新細明體,serif;">ã€æ‰¹è™ŸåŠæœ‰æ•ˆæœŸé™ï¼Œå¿…è¦æ™‚應標示儲å˜æ¢ä»¶ã€‚試驗éŽç¨‹ä¸ç‰¹å®šè©¦é©—物質應置於é©ç•¶å®¹å™¨è²¯å˜ä¹‹ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）試驗物質之留樣</span><span><br /></span><span style="font-family: 新細明體,serif;">試驗物質與å°ç…§ç‰©è³ªæ¯ä¸€æ‰¹å‡æ‡‰ç•™å˜å…·ä»£è¡¨æ€§ä¹‹å„²å‚™æ¨£å“，其å˜æ”¾æ¢ä»¶æ‡‰èˆ‡æ¨™ç¤ºè€…相åŒã€‚儲備樣å“之ä¿å˜æœŸé™è‡³å°‘應予留å˜è‡³è©¦é©—çµæŸï¼›ç•¶è©¦é©—期間超éŽå››é€±æ™‚，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹è—¥ç‰©æŸ¥é©—登記者，其儲備樣å“ä¿å˜è‡³æ ¸å‡†ä¸Šå¸‚後至少二年；其未申請者亦應ä¿å˜è‡³è©¦é©—完æˆæˆ–終æ¢å¾Œè‡³å°‘二年。於儲å˜éŽç¨‹ä¸æ˜“è…壞或ä¸å®‰å®šè€…應ä¿å˜è‡³è©²ç‰©è³ªä¹‹å“質å¯è©•ä¼°ä¹‹æœ€å¾ŒæœŸé™ã€‚</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">二ã€è©¦é©—物質與å°ç…§ç‰©è³ªä¹‹ç®¡åˆ¶</span> </p><p style="punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">應制訂試驗物質åŠå°ç…§ç‰©è³ªä¹‹ç®¡åˆ¶ä½œæ¥ç¨‹åºï¼Œä¸¦ç¢ºä¿ä¸‹åˆ—å„äº‹é …</span> </p><p style="punctuation-wrap: simple; 24pt: ;"><span style="font-family: 新細明體,serif;">（一）é©ç•¶ä¹‹å„²å˜ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）處ç†åŠè¼¸é€éŽç¨‹å…·æœ‰é©ç•¶ä¹‹æ¨™è˜ï¼Œä¸”確ä¿æœªå—任何污染ã€è®Šè³ªæˆ–æ毀。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）具有驗收ã€å–樣ã€å„²å˜åŠè™•ç†ä¹‹æ¨™æº–æ“作程åºåŠç´€éŒ„，æ¤ç´€éŒ„應å«å“åã€æ•¸é‡ã€æ—¥æœŸåŠè™•ç†ç‹€æ³ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">å››ã€è©¦é©—物質ã€å°ç…§ç‰©è³ªèˆ‡è³¦å½¢é«”之混åˆ</span> </p><p style="punctuation-wrap: simple; 60: ;"><span style="font-family: 新細明體,serif;">（一）æ¯æ‰¹è©¦é©—物質ã€å°ç…§ç‰©è³ªèˆ‡è³¦å½¢é«”之混åˆï¼Œæ‡‰ä»¥é©ç•¶æ–¹æ³•åˆ†æžä¸‹è¿°å„é …ï¼š</span> </p><p style="margin: 0cm 5.65pt 0pt 61.1pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph5">1. <span style="font-family: 新細明體,serif;">確定試驗物質或å°ç…§ç‰©è³ªèˆ‡è³¦å½¢é«”æ··åˆç‰©ä¹‹å‡ä¸€æ€§ï¼Œä¸¦å®šæœŸæ¸¬è©¦æ··åˆç‰©ä¸è©¦é©—物質或å°ç…§ç‰©è³ªä¹‹æ¿ƒåº¦ã€‚</span> </p><p style="punctuation-wrap: simple; 53: ;">2. <span style="font-family: 新細明體,serif;">ä¾æ“šè©¦é©—æ¢ä»¶ï¼Œåœ¨é–‹å§‹é€²è¡Œå„é …è©¦é©—å‰ï¼Œæ‡‰ç¢ºå®šè³¦å½¢é«”æ··åˆç‰©ä¸è©¦é©—物質或å°ç…§ç‰©è³ªä¹‹å®‰å®šæ€§ï¼›æˆ–éµ</span> <span style="font-family: 新細明體,serif;">照既定之標準æ“作程åºå®šæœŸæª¢é©—之。</span> </p><p style="punctuation-wrap: simple; 60: ;"><span style="font-family: 新細明體,serif;">（二）試驗物質或å°ç…§ç‰©è³ªä¹‹è³¦å½¢é«”æ··åˆç‰©ä¸æœ‰ä¸€æˆåˆ†å…·æœ‰æ•ˆæœŸé™ï¼Œå‰‡æ‡‰åŠ 以標示該期é™ï¼Œè‹¥ä¸åªä¸€æˆåˆ†å…·æœ‰æ•ˆæœŸé™è€…，應以其最早失效日期標示之。</span> </p><p style="punctuation-wrap: simple; 60: ;"> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ç¬¬ä¸ƒç« </span> <span style="font-family: 新細明體,serif;">試驗計畫書åŠè©¦é©—之執行</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一ã€è©¦é©—計畫書</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）å„é …è©¦é©—æ‡‰æ’°å¯«æ˜Žç¢ºé¡¯ç¤ºè©¦é©—ç›®çš„åŠæ–¹æ³•è©¦é©—計畫書，並經試驗機構管ç†éšŽå±¤</span>(<span style="font-family: 新細明體,serif;">å«è©¦é©—委託者</span>)<span style="font-family: 新細明體,serif;">æ ¸å‡†åŠä¿å˜ä¹‹ã€‚上述試驗計畫書得視需è¦è¨˜è¼‰ä¸‹åˆ—æœ‰é—œäº‹é …ï¼š</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 1.</span><span style="font-family: 新細明體,serif;">試驗å稱ã€æ€§è³ªåŠç›®çš„。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 2.</span><span style="font-family: 新細明體,serif;">執行試驗之試驗機構åŠè©¦é©—委託者之å稱åŠä½å€ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 3.</span><span style="font-family: 新細明體,serif;">試驗主æŒäººå§“å。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 4.</span><span style="font-family: 新細明體,serif;">主è¦æ¸¬è©¦äººåŠ›éœ€æ±‚。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 5.</span><span style="font-family: 新細明體,serif;">試驗開始åŠçµæŸé 定日與é 定進度。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 6.</span><span style="font-family: 新細明體,serif;">å°ç…§ç‰©è³ªåŠè©¦é©—物質應有足以è˜åˆ¥ä¹‹å稱ã€ç·¨è™Ÿæˆ–代碼。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 7.</span><span style="font-family: 新細明體,serif;">試驗è¨è¨ˆä¹‹æ•˜è¿°ï¼ŒåŒ…括å–樣計畫åŠå差管制的方法。</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 8.</span><span style="font-family: 新細明體,serif;">試驗ã€åˆ†æžåŠæ¸¬é‡ä¹‹ç¨®é¡žåŠé »çŽ‡ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 9.</span><span style="font-family: 新細明體,serif;">試驗體系é¸æ“‡ä¹‹ç†ç”±ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;"> 10.</span><span style="font-family: 新細明體,serif;">試驗體系之特性æ述，例如生物之å稱ã€æ•¸é‡ã€é«”é‡ç¯„åœã€å¹´é½¡ã€æ€§åˆ¥ã€ä¾›æ‡‰ä¾†æºã€å“種ã€å“ç³»åŠå…¶ä»–有關資料。</span> </p><p style="margin: 5.4pt 0cm 0pt 53.65pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">11.</span><span style="font-family: 新細明體,serif;">試驗體系之è˜åˆ¥æ³•ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 56.25pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">12.</span><span style="font-family: 新細明體,serif;">用於動物試驗éŽç¨‹ä¸ä¹‹æº¶åŠ‘ã€ä¹³åŒ–劑ã€é£¼æ–™ã€é£²æ°´ç‰ä¹‹æ•˜è¿°æˆ–鑑別。若已知上述物質ä¸å«æœ‰å½±éŸ¿è©¦é©—çµæžœä¹‹æ±¡æŸ“ç‰©è³ªï¼Œå‰‡é ˆæ˜Žå®šè©²æ±¡æŸ“ç‰©è³ªä¹‹å®¹è¨±ç¯„åœã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 36.8pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">13.</span><span style="font-family: 新細明體,serif;">投予途徑åŠé¸æ“‡è©²é€”徑之ç†ç”±ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 37.25pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">14.</span><span style="font-family: 新細明體,serif;">投予劑é‡ã€æ–¹æ³•åŠé »çŽ‡ã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">15.</span><span style="font-family: 新細明體,serif;">統計方法之敘述。</span> </p><p style="margin: 5.4pt 0cm 0pt 49.75pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">16.</span><span style="font-family: 新細明體,serif;">試驗機構</span><span style="font-family: 新細明體,serif;">管ç†éšŽå±¤</span><span style="font-family: times new roman,serif;"> (</span><span style="font-family: 新細明體,serif;">å«è©¦é©—委託者</span><span style="font-family: times new roman,serif;">)</span><span style="font-family: 新細明體,serif;">之èªå¯æ—¥æœŸèˆ‡è©¦é©—主æŒäººä¹‹ç°½ååŠç°½è¨»æ—¥æœŸã€‚</span> </p><p style="margin: 5.4pt 0cm 0pt 37.55pt; text-autospace: ideograph-numeric; punctuation-wrap: simple;" class="paragraph3"><span style="font-family: times new roman,serif;">17.</span><span style="font-family: 新細明體,serif;">需ä¿å˜ç´€éŒ„èˆ‡è³‡æ–™ä¹‹é …ç›®ã€‚</span> </p><p style="margin: 1.5pt 0cm 0pt 61.1pt; punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ï¼ˆäºŒï¼‰ç¶“æ ¸å‡†ä¹‹è¨ˆç•«æ›¸éœ€ä½œä»»ä½•ä¿®è¨‚æˆ–è®Šæ›´æ™‚ï¼Œå‡æ‡‰ç¶“試驗主æŒäººæ ¸å‡†ç°½ååŠç°½è¨»æ—¥æœŸï¼Œä¸”éœ€è¨»æ˜Žå…¶ä¿®è¨‚åŽŸå› ä¸¦èˆ‡è©¦é©—è¨ˆç•«æ›¸ä¿å˜ä¹‹ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二ã€è©¦é©—之執行</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）任何試驗å‡æ‡‰ä¾æ“šè©¦é©—計畫書åŠæœ‰é—œä¹‹æ¨™æº–æ“作程åºåŸ·è¡Œï¼Œä¸¦äºˆä»¥è¿½è¹¤ç®¡åˆ¶ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）æ¯ä¸€è©¦é©—å‡æ‡‰æœ‰ä¸€æ˜Žç¢ºçš„標示，試驗éŽç¨‹ä¸æ‰€ä½¿ç”¨è©¦è—¥ã€æº¶æ¶²åŠæ¨™æœ¬ç‰æ‡‰äºˆæ˜Žç¢ºä¹‹æ¨™ç¤ºã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">（三）標本應以é©ç•¶æ–¹æ³•æ¨™ç¤ºè©¦é©—種類ã€è©¦é©—體系之編號åŠæŽ¡é›†æ—¥æœŸã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）解剖å–得標本之肉眼觀察應予以記錄，以便執行組織病ç†å¸æª¢æŸ¥ä¹‹äººå“¡åƒè€ƒã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 24: ;"><span style="font-family: 新細明體,serif;">（五）試驗所得到數據之記錄åŠè®Šæ›´ï¼Œæ‡‰éµå¾ªä¸‹åˆ—å„äº‹é …ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">1.<span style="font-family: 新細明體,serif;">試驗éŽç¨‹ä¸ç”¢ç”Ÿä¹‹æ•¸æ“šï¼Œå‡æ‡‰ä»¥ä¸å¯å¡—銷之方法直接ã€è¿…速ã€æ¸…æ™°ã€æ£ç¢ºåœ°äºˆä»¥è¨˜éŒ„，並簽ååŠç°½è¨»æ—¥æœŸã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">2.<span style="font-family: 新細明體,serif;">è‡ªå‹•æ•¸æ“šæ”¶é›†ç³»çµ±ç”¢ç”Ÿä¹‹æ•¸æ“šï¼Œæ–¼è¼¸å…¥æ™‚æ‡‰ç”±è² è²¬éµå…¥è€…予以確èªç°½ååŠç°½è¨»æ—¥æœŸã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 5.4pt 61.1pt; punctuation-wrap: simple;">3.<span style="font-family: 新細明體,serif;">任何資料ã€æ•¸æ“šæ–¼è®Šæ›´æ™‚亦應ä¿ç•™å…¶åŽŸå§‹æ•¸æ“šï¼Œä¸”è¨»æ˜Žè®Šæ›´åŽŸå› ã€æ—¥æœŸåŠç¢ºèªè€…ç°½åã€‚è‡ªå‹•æ•¸æ“šæ”¶é›†ç³»çµ±ç”¢ç”Ÿä¹‹æ•¸æ“šï¼Œéœ€è®Šæ›´æ™‚ï¼Œæ‡‰è¨»æ˜Žè®Šæ›´åŽŸå› åŠéµå…¥è€…予以確èªç°½ååŠç°½è¨»æ—¥æœŸã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（å…）試驗進行ä¸æœ‰ä»»ä½•ç•°å¸¸æˆ–éžé 期之ç¾è±¡æ™‚，åƒèˆ‡è©¦é©—人員應迅速å‘試驗主æŒäººå ±å‘Šä¸¦è©³ç´°è¨˜éŒ„之。</span> </p><p style="punctuation-wrap: simple; 61: ;"> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">ç¬¬å…«ç« </span> <span style="font-family: 新細明體,serif;">ç´€éŒ„èˆ‡å ±å‘Š</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">一ã€æœ€çµ‚è©¦é©—å ±å‘Š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）æ¯ä¸€è©¦é©—終了時å‡æ‡‰ä¾è©¦é©—è¨ˆç•«æ›¸æ’°å¯«æœ€çµ‚è©¦é©—å ±å‘Šï¼Œå…§å®¹è‡³å°‘éœ€åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">1.<span style="font-family: 新細明體,serif;">試驗å稱ã€æ€§è³ªåŠç›®çš„。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">2.<span style="font-family: 新細明體,serif;">試驗機構單ä½å稱åŠåœ°å€ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">3.<span style="font-family: 新細明體,serif;">試驗之開始åŠå®Œæˆæ—¥æœŸã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 36: ;">4.<span style="font-family: 新細明體,serif;">試驗方法</span> (<span style="font-family: 新細明體,serif;">å«è§€å¯Ÿã€æ¸¬é‡ã€æ¸¬è©¦åŠåˆ†æžä¹‹å½¢å¼ã€é »çŽ‡åŠæ–¹æ³•</span>)<span style="font-family: 新細明體,serif;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">5.<span style="font-family: 新細明體,serif;">å–樣åŠè©¦é©—éŽç¨‹ä¸æ‰€ç”¢ç”Ÿæ•¸æ“šä¹‹å®Œæ•´ç´€éŒ„，包括自動è¨å‚™è¼¸å‡ºä¹‹åŽŸå§‹è³‡æ–™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">6.<span style="font-family: 新細明體,serif;">å°ç…§åŠè©¦é©—物質之å稱ã€ç·¨è™Ÿæˆ–代碼ã€æ‰¹è™Ÿã€åŠ›åƒ¹ã€ç´”度åŠçµ„æˆæˆ–其他é©ç•¶ä¹‹ç‰¹æ€§æ述以確èªè©²ç‰ç‰©è³ªã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">7.<span style="font-family: 新細明體,serif;">試驗物質åŠå°ç…§ç‰©è³ªæ–¼æ—¢å®šä¹‹æŠ•äºˆæ¢ä»¶ä¸‹ä¹‹å®‰å®šæ€§ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">8.<span style="font-family: 新細明體,serif;">試驗體系之特性æ述，例如生物之å稱ã€æ•¸é‡ã€æ€§åˆ¥ã€é«”é‡ç¯„åœã€ä¾›æ‡‰ä¾†æºã€å“種ã€åŠå…¶è˜åˆ¥ç¨‹åºã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 36: ;">9.<span style="font-family: 新細明體,serif;">投予劑é‡ã€é€”徑ã€é »çŽ‡åŠæŠ•äºˆæœŸé–“之記載。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">10.<span style="font-family: 新細明體,serif;">試驗主æŒäººåŠåƒèˆ‡è©¦é©—人員姓å。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 48: ;">11.<span style="font-family: 新細明體,serif;">分æžæ•¸æ“šæ‰€ç”¨ä¹‹çµ±è¨ˆæ–¹æ³•ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 48: ;">12.<span style="font-family: 新細明體,serif;">å¯èƒ½å½±éŸ¿æ•¸æ“šå“質åŠè©¦é©—å®Œæ•´æ€§ä¹‹å› ç´ ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;">13.<span style="font-family: 新細明體,serif;">試驗數據之é‹ç®—，分æžåŠå…¶å°Žå‡ºä¹‹çµè«–åŠè©¦é©—çµæžœä¹‹è©•ä¼°åˆ¤å®šèˆ‡æ‘˜è¦</span>(<span style="font-family: 新細明體,serif;">包括åƒèˆ‡è©¦é©—之主è¦å°ˆæ¥äººå“¡ç°½ååŠç°½è¨»æ—¥æœŸçš„å€‹åˆ¥å ±å‘Š</span>)<span style="font-family: 新細明體,serif;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 36: ;">14.<span style="font-family: 新細明體,serif;">標本ã€åŽŸå§‹æ•¸æ“šåŠæœ€çµ‚è©¦é©—å ±å‘Šä¹‹å„²å˜å ´æ‰€åŠæœŸé™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 23: ;">15.<span style="font-family: 新細明體,serif;">åŽŸå§‹è©¦é©—è¨ˆç•«æ›¸ä¹‹ä»»ä½•è®Šæ›´äº‹é …ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 0cm 5.4pt 36.65pt; punctuation-wrap: simple;">16.<span style="font-family: 新細明體,serif;">å“質ä¿è‰å–®ä½ä¾æœ¬è¦ç¯„ç¬¬äºŒç« è¦å®šä½œæˆä¹‹å ±å‘Šã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）試驗主æŒäººæ‡‰å…·çµç¢ºèªæ•¸æ“šä¹‹çœŸå¯¦æ€§åŠè©¦é©—程åºå‡ä¾æœ¬è¦ç¯„è¦å®šåŸ·è¡Œï¼Œä¸¦æ–¼æœ€çµ‚è©¦é©—å ±å‘Šç°½å。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">ï¼ˆä¸‰ï¼‰æœ€çµ‚è©¦é©—å ±å‘Šä¹‹è£œå……æˆ–ä¿®æ£æ‡‰ç”±è©¦é©—主æŒäººä¾ä¸€å®šç¨‹åºä¿®è¨‚ä¹‹ï¼Œä¸”æ–¼è©²å ±å‘Šä¸æ¸…楚顯示其為增補或修æ£éƒ¨ä»½ï¼Œä¸”載明其ç†ç”±ï¼Œä¸¦ç”±ä¿®è¨‚者簽ååŠç°½è¨»æ—¥æœŸå¾Œç”±è©¦é©—主æŒäººç¢ºèªä¹‹ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">二ã€ç´€éŒ„åŠå ±å‘Šä¹‹å„²å˜èˆ‡è¿½æº¯</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗產生之所有原始數據ã€æ¨™æœ¬</span>(<span style="font-family: 新細明體,serif;">致çªè®Šæ€§è©¦é©—åŠè¡€æ¶²ã€å°¿ç³žã€ç”Ÿç‰©é«”液之標本除外</span>)<span style="font-family: 新細明體,serif;">ã€ç´€éŒ„文書ã€è©¦é©—è¨ˆç•«æ›¸å’Œæœ€çµ‚è©¦é©—å ±å‘Šæ‡‰å»ºæª”ä¸¦äºˆä¿å˜ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（二）所有原始數據ã€æ¨™æœ¬ã€ç´€éŒ„文書ã€è©¦é©—計畫書ã€ä¸é–“åŠæœ€çµ‚è©¦é©—å ±å‘Šå‡æ‡‰ä¾åºå˜æª”且利於追溯。其儲å˜ç‹€æ³æ‡‰ä»¥é¿å…變質為原則，且ä¿å˜å ´æ‰€æ‡‰æœ‰é™ä½Žè‡³æœ€å°æ害之è¨è¨ˆï¼›è©¦é©—機構亦å¯å§”託檔案ä¿ç®¡æ©Ÿæ§‹æ供其é©ç•¶ä¿å˜å ´æ‰€ã€‚è‹¥æ¨™æœ¬æˆ–åŽŸå§‹æ•¸æ“šèˆ‡æœ€çµ‚è©¦é©—å ±å‘Šåˆ†é–‹å»ºæª”ä¿å˜æ™‚ï¼Œæœ€çµ‚è©¦é©—å ±å‘Šä¹‹æª”æ¡ˆæ‡‰äºˆè©³ç¢ºè¨˜éŒ„ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）紀錄åŠå ±å‘Šä¹‹å„²å˜å ´æ‰€æ‡‰æœ‰ç‰¹å®šäººå“¡è² 責管ç†ä¸”éžç¶“授權ä¸å¯é€²å…¥ã€‚進出檔案室之物å“應予記錄。</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">ï¼ˆå››ï¼‰å› è©¦é©—è¦å®šå¿…é ˆå„²å˜ä¹‹ç‰©è³ªåŠå…¶æœ‰é—œè³‡æ–™æ‡‰ä¾åºç·¨ç´¢ä»¥åˆ©è¿½æº¯ï¼Œä¾‹å¦‚以試驗å稱ã€è©¦é©—物質ã€è©¦é©—日期ã€è©¦é©—體系åŠè©¦é©—本質ç‰ç‚ºç´¢å¼•ã€‚</span> </p><p style="punctuation-wrap: simple;"><span style="font-family: 新細明體,serif;">三ã€ç´€éŒ„åŠå ±å‘Šä¹‹ä¿å˜æœŸé™</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（一）試驗產生之所有原始數據ã€æ¨™æœ¬ã€ç´€éŒ„文書ã€æ¨™æº–æ“作程åºåŠå…¶åˆ¶è¨‚æ·ç¨‹ã€è©¦é©—è¨ˆç•«æ›¸å’Œæœ€çµ‚è©¦é©—å ±å‘Šç‰ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹è—¥ç‰©æŸ¥é©—登記者，ä¿å˜è‡³æ ¸å‡†ä¸Šå¸‚後至少五年；其未用於申請藥物查驗登記者亦應ä¿å˜è‡³è©¦é©—完æˆæˆ–終æ¢å¾Œè‡³å°‘二年。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 48: ;"><span> </span><span style="font-family: 新細明體,serif;">（二）除å‰æ¬¾è¦å®šå¤–，溼性標本</span>(<span style="font-family: 新細明體,serif;">致çªè®Šæ€§è©¦é©—åŠ</span> <span style="font-family: 新細明體,serif;">血液ã€å°¿ç³žã€ç”Ÿç‰©é«”液得到之標本除外</span>)<span style="font-family: 新細明體,serif;">ã€è©¦é©—物質或å°ç…§ç‰©è³ªæ¨£å“åŠç¶“特別處ç†ä¹‹ç‰©è³ªï¼Œä¿å˜éŽç¨‹æ˜“顯著變質者，應ä¿å˜è‡³è©²ç‰©è³ªå¯è©•ä¼°ä¹‹æœ€å¾ŒæœŸé™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（三）å“質ä¿è‰å–®ä½ä¹‹ä¸»è¨ˆç•«é€²åº¦è¡¨ã€ç¨½æŸ¥ç´€éŒ„åŠè² 責稽查之試驗計畫書影本å‡æ‡‰ä¾åºæ¸æª”，並ä¾æœ¬ç« ç¬¬ä¸‰é …ç¬¬ä¸€æ¬¾ä¹‹è¦å®šä¿å˜æ–¼å“質ä¿è‰å–®ä½ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（四）所使用儀器之檢查ã€ä¿é¤ŠåŠæ ¡æ£ç´€éŒ„，應ä¾æœ¬ç« ç¬¬ä¸‰é …ç¬¬ä¸€æ¬¾ä¹‹è¦å®šä¿å˜ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（五）ä¾æ“šæœ¬è¦ç¯„ç¬¬äºŒç« ä¹‹è¦å®šæœ‰é—œåƒèˆ‡è©¦é©—</span><span> </span><span style="font-family: 新細明體,serif;">人員之è·è²¬ã€è¨“ç·´éŽç¨‹åŠå¸ç¶“æ·èƒŒæ™¯ç‰è³‡æ–™æ‡‰ä¾æœ¬ç« ç¬¬ä¸‰é …ç¬¬ä¸€æ¬¾ä¹‹è¦å®šä¿å˜ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（å…ï¼‰æœ¬é …ä¹‹ç´€éŒ„æ–‡æ›¸å¾—ä»¥åŽŸå§‹ç´€éŒ„æ–‡æ›¸ã€ç›¸ç‰‡ã€é¡¯å¾®å½±ç‰‡ã€é›»å紀錄或其他精確產生之原始紀錄文書之真實複å°æœ¬ä¿å˜ä¹‹ã€‚</span> </p><p style="punctuation-wrap: simple; 61: ;"><span style="font-family: 新細明體,serif;">（七）若試驗機構或委託檔案ä¿ç®¡æ©Ÿæ§‹çµæŸç‡Ÿé‹æ™‚ï¼Œæœ¬é …æ‰€è¿°ä¹‹æ‰€æœ‰åŽŸå§‹æ•¸æ“šã€ç´€éŒ„文書ã€åŠç›¸é—œè³‡æ–™æª”案應轉移繼任試驗機構；若無法定繼任者時，則轉移試驗委託者指定之檔案室。</span> </p>2013-12-04
查驗登記類,指示藥å“審查基準,驅蟲劑行政解釋指示藥å“審查基準-驅蟲劑詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4508&type=0
查驗登記類,指示藥å“審查基準,指示藥å“審查基準-一般皮膚外用劑行政解釋指示藥å“審查基準-一般皮膚外用劑<p style="text-align: center;"><span style="font-family: 標楷體; font-size: 16pt;">一般皮膚外用劑</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">I</span><span style="font-family: 標楷體; font-size: 14pt;">ã€é©ç”¨ç¯„åœ</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">A</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å‡¡çš®è†šå¤–用製劑，載明有抗èŒã€å±€éƒ¨æ¶ˆæ¯’ã€æ»…è¨ã€æŠ—發炎ã€æ¢ç™¢ã€æ¢ç—›ã€ç·©è§£çš®è†šåˆºæ¿€ã€åŽ»è§’質ã€åŽ»ç–£æˆ–治療é 皮屑ã€è‰²ç´ 變化ã€å°‹å¸¸æ€§ç—¤ç˜¡åŠå…¶ä»–宣稱有療效的皮膚外用製劑å‡é©ç”¨æœ¬åŸºæº–。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">B</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å‡¡å«æœ‰ç”Ÿè—¥æˆ–ä¸è—¥ä¹‹è£½åŠ‘ä¸é©ç”¨æœ¬åŸºæº–。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">II</span><span style="font-family: 標楷體; font-size: 14pt;">ã€æœ‰æ•ˆæˆåˆ†</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">(A)</span><span style="font-family: 標楷體; font-size: 10pt;">有效æˆåˆ†ä¹‹ç¨®é¡ž</span> </p><table style="margin: auto auto auto 45.35pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <thead> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 35.3pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;" colspan="2"> <p style="text-align: center; line-height: 15pt; margin: 3pt 5.65pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">主æˆåˆ†</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">最高å«é‡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">é©æ‡‰ç—‡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">用法用é‡</span> </p> </td> </tr> </thead> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">抗</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">生</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">ç´ </span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">A1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Bacitracin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">500unit/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救ã€é 防åŠæ¸›ç·©çš®è†šåˆ€å‚·ã€åˆ®å‚·ã€ç‡™å‚·ä¹‹æ„ŸæŸ“</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Polymycin B</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt;"><span style="font-size: 10pt;">10,000unit/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救ã€é 防åŠæ¸›ç·©çš®è†šåˆ€å‚·ã€åˆ®å‚·ã€ç‡™å‚·ä¹‹æ„ŸæŸ“</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Neomycin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3.5mg/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救ã€é 防åŠæ¸›ç·©çš®è†šåˆ€å‚·ã€åˆ®å‚·ã€ç‡™å‚·ä¹‹æ„ŸæŸ“</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">A2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Erythromycin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 1.4pt 0pt;"><span style="font-size: 10pt;">1% </span><span style="font-family: 標楷體; font-size: 10pt;">軟è†</span><span style="font-size: 10pt;"><br /> <span style="letter-spacing: -0.2pt;">20mg/ml</span></span><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 10pt;">æ´—</span><span style="font-family: 標楷體; font-size: 10pt;">劑</span><span style="font-size: 10pt;"><br /> 2% w/v</span><span style="font-family: 標楷體; font-size: 10pt;">溶液</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療尋常性痤瘡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Tetracycline Hydrochloride</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">30mg/g</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">急救ã€é 防åŠæ¸›ç·©çš®è†šåˆ€å‚·ã€åˆ®å‚·ã€ç‡™å‚·ä¹‹æ„ŸæŸ“</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2-4</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">抗</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">é»´</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">èŒ</span><span style="font-size: 10pt;"><br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">B1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Clotrimazole</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1% w/w</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴èŒæ„ŸæŸ“，如：足癬（香港腳）ã€è‚¡ç™¬ã€æ±—æ–‘</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部，兒童ä¸å®œä½¿ç”¨</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Ketoconazole</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1% </span><span style="font-family: 標楷體; font-size: 10pt;">洗髮精</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">æ¸›å°‘å› é»´èŒæ„ŸæŸ“所引起之é 皮屑治療之輔助劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">/</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">週，</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次間隔至少三天，使用時間ä¸è¶…éŽå››é€±</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">Miconazole Nitrat</span><span style="font-size: 10pt;">e</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴èŒæ„ŸæŸ“，如：足癬（香港腳）ã€è‚¡ç™¬ã€æ±—æ–‘</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">一天</span><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">B2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Undecylenic Acid and Derivatives</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 1.4pt 0pt;"><span style="font-size: 10pt;">25% of undecylenic acid</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴èŒæ„ŸæŸ“，如：足癬（香港腳）ã€è‚¡ç™¬</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">一天</span><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">B3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Tolnaftate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">治療皮膚表淺性黴èŒæ„ŸæŸ“，如：足癬（香港腳）ã€è‚¡ç™¬ã€æ±—æ–‘</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">一天</span><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">æ»…</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">è¨</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">C</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Phenothrin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.2% w/w</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療é è¨ã€é™°è¨</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">塗於乾燥毛髮之整個患部，使自然乾燥後</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">å°æ™‚æ´—æ·¨å†æ²–洗，並用細齒梳梳髮去掉è¨åµï¼Œå¿…è¦æ™‚</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">7-9</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">天後å¯é‡è¦†ä½¿ç”¨</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">å±€</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">部</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">消</span><span style="font-size: 10pt;"><br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">毒</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">D</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Chlorhexidine Gluconate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1.25% v/v<span style="text-decoration: underline;"></span></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">一般外用消毒劑，å¯ç•¶ä½œåˆæ¥å‚·å£è™•ç†</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="letter-spacing: -0.4pt; font-size: 10pt;">Hydrogen Peroxid</span><span style="font-size: 10pt;">e</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1.5% w/w<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">å‚·å£æ¶ˆæ¯’</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">以棉çƒæ²¾ä¹‹å¡—於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3% w/w<br /> Solution</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">å‚·å£æ¶ˆæ¯’</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">以棉çƒæ²¾ä¹‹å¡—於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Povidone-Iodine</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1% </span><span style="font-family: 標楷體; font-size: 10pt;">有效碘</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">å‚·å£æ¶ˆæ¯’</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">以棉çƒæ²¾ä¹‹å¡—於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="12"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">抗</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">發</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="12"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">E</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Betamethasone Dipropionate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.02%<br /> Lotion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Betamethasone Valerate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.10%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Fluocinolone Acetonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Hydrocortisone Butyrate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.20%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Hydrocortisone Valerate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.10%<br /> Ointment</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Triamcinolone Acetonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.10%<br /> Lotion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Betamethasone Valerate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Lotion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Desonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Fluocinolone Acetonide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.01%<br /> Soultion</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Dexamethasone <span style="letter-spacing: -0.2pt;">Sodium phosphat</span>e</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.05%<br /> Cream</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Hydrocortisone Acetate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="letter-spacing: -0.5pt; font-size: 10pt;">Methylprednisolon</span><span style="font-size: 10pt;">e Acetate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.25%<br /> Ointment</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 10pt;">濕疹或皮膚</span><span style="font-family: 標楷體; font-size: 10pt;">ç‚Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 69.9pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; height: 69.9pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">æ¢</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">癢</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">åŠ</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">å±€</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">部</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">麻</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">醉</span><span style="font-size: 10pt;"><br /> </span><span style="font-family: 標楷體; font-size: 10pt;">劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">F1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Diphenhydramine Hydrochloride</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">暫時緩解皮膚æ”癢</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3-4</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 69.9pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">F2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Dibucaine</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">昆蟲咬傷或皮膚刺激所引起之疼痛åŠæ”癢</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; height: 69.9pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">3-4</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">å…¶</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">ä»–</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">G</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Urea</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">10%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">去角質</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Zinc Oxide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">10%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">緩解皮膚刺激åŠå°¿å¸ƒç–¹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">需è¦æ™‚使用，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">H</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Benzoyl Peroxide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">10%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療尋常性痤瘡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Capsaicin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">0.025%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">暫時緩解局部疼痛</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">ä¸è¶…éŽ</span><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Hydroquinone</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">減輕黑斑ã€é›€æ–‘æˆ–å…¶ä»–è‰²ç´ æ²‰è‘—</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 2.85pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">早晚å„å¡—æ•·</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">次</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 17.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-family: 標楷體; font-size: 10pt;">å…¶</span><span style="font-size: 10pt;"><br /> <br /> <br /> <br /> <br /> <br /> <br /> <br /> </span><span style="font-family: 標楷體; font-size: 10pt;">ä»–</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">H</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 1.4pt 0pt 5.65pt;"><span style="font-size: 10pt;">Selenium Sulfide<br /> <span style="letter-spacing: -0.8pt;">(</span></span><span style="letter-spacing: -0.8pt; font-family: 標楷體; font-size: 10pt;">ï¼</span><span style="letter-spacing: -0.8pt; font-size: 10pt;">Selenium Disulfied</span><span style="font-size: 10pt;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">é 皮屑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">一般使用方法：å‰äºŒæ˜ŸæœŸï¼Œæ¯é€±</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，後æ¯æ˜ŸæœŸ</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次或二星期</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，塗於患部。</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Pyrithione Zinc</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">é 皮屑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">一般使用方法：å‰äºŒæ˜ŸæœŸï¼Œæ¯é€±</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">2</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，後æ¯æ˜ŸæœŸ</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次或二星期</span><span style="letter-spacing: -0.4pt; font-size: 10pt;">1</span><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 10pt;">次，塗於患部。</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 15pt; margin: 1pt 0cm;"><span style="font-size: 10pt;">I</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 96pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">Salicylic Acid</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">2%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">去角質</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 78pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">17%</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-family: 標楷體; font-size: 10pt;">治療疣</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 79.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 15pt; margin: 0cm 5.65pt 0pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">次</span><span style="font-size: 10pt;">/</span><span style="font-family: 標楷體; font-size: 10pt;">天，塗於患部</span> </p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 10.2pt 0pt 54.6pt;"><span style="font-size: 10pt;">(B)</span><span style="font-family: 標楷體; font-size: 10pt;">複åˆé…æ–¹</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æŠ—ç”Ÿç´ é¡žï¼š</span><span style="font-size: 10pt;">A1</span><span style="font-family: 標楷體; font-size: 10pt;">ä¸è¶…éŽ</span><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">種。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">A2</span><span style="font-family: 標楷體; font-size: 10pt;">é ˆå–®ç¨å˜åœ¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä»»æ„æŠ—ç”Ÿç´ ï¼ˆ</span><span style="font-size: 10pt;">A1</span><span style="font-family: 標楷體; font-size: 10pt;">）＋抗發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）åªèƒ½å„å«</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å…¶ä»–類之（</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）å¯èˆ‡ä»»ä½•ç¨®é¡žé…åˆã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">ã€</span><span style="font-size: 10pt;">C</span><span style="font-family: 標楷體; font-size: 10pt;">（滅è¨ï¼‰ã€</span><span style="font-size: 10pt;">D</span><span style="font-family: 標楷體; font-size: 10pt;">ï¼ˆå±€éƒ¨æŠ—æ„ŸæŸ“åŠ‘ï¼‰é ˆå–®ç¨å˜åœ¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">5</span><span style="font-family: 標楷體; font-size: 10pt;">ã€</span><span style="font-size: 10pt;">Steroid</span><span style="font-family: 標楷體; font-size: 10pt;">åªèƒ½å«</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種，æ¢ç™¢åŠ‘åŠå±€éƒ¨éº»é†‰åŠ‘å¯å«</span><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">種。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">6</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å…¶ä»–類之（</span><span style="font-size: 10pt;">I</span><span style="font-family: 標楷體; font-size: 10pt;">）å¯èˆ‡ï¼ˆ</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€æŠ—發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€æŠ—é»´èŒåŠ‘（</span><span style="font-size: 10pt;">B</span><span style="font-family: 標楷體; font-size: 10pt;">）å„</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種é…åˆã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">7</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æŠ—ç”Ÿç´ ï¼ˆ</span><span style="font-size: 10pt;">A1</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種＋抗發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種＋其他類之（</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）å¯é…åˆã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">8</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æŠ—發炎劑（</span><span style="font-size: 10pt;">E</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">種＋æ¢ç™¢åŠ‘åŠå±€éƒ¨éº»é†‰åŠ‘（</span><span style="font-size: 10pt;">F</span><span style="font-family: 標楷體; font-size: 10pt;">）å¯å«</span><span style="font-size: 10pt;">1-2</span><span style="font-family: 標楷體; font-size: 10pt;">種＋其他類之（</span><span style="font-size: 10pt;">G</span><span style="font-family: 標楷體; font-size: 10pt;">）å¯é…åˆã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">III</span><span style="font-family: 標楷體; font-size: 14pt;">ã€åŠ‘åž‹</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">A</span><span style="font-family: 標楷體; font-size: 10pt;">ã€åŒ…括：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">ä¹³è†ï¼ˆ</span><span style="font-size: 10pt;">Cream</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€è»Ÿè†ï¼ˆ</span><span style="font-size: 10pt;">Ointment</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€å‡è† （</span><span style="font-size: 10pt;">Gel</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€æ´—劑（</span><span style="font-size: 10pt;">Lotion</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€æº¶æ¶²ï¼ˆ</span><span style="font-size: 10pt;">Solution</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€è²¼å¸ƒï¼ˆ</span><span style="font-size: 10pt;">Patch</span><span style="font-family: 標楷體; font-size: 10pt;">）ã€ç²‰åŠ‘（</span><span style="font-size: 10pt;">Powder</span><span style="font-family: 標楷體; font-size: 10pt;">）。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">B</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å¦‚在æˆåˆ†è¡¨ä¸åˆ—有劑型者，åªèƒ½ä»¥è¡¨ä¸ä¹‹åŠ‘åž‹å˜åœ¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">IV</span><span style="font-family: 標楷體; font-size: 14pt;">ã€å‰¯ä½œç”¨</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">æŠ—ç”Ÿç´ ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€éŽæ•æ€§çš®è†šç‚Žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ç¹¼ç™¼æ€§æ„ŸæŸ“。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€</span><span style="font-size: 10pt;">Neomycin</span><span style="font-family: 標楷體; font-size: 10pt;">：耳åŠè…Žæ¯’性。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">抗黴èŒåŠ‘：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å±€éƒ¨çš®è†šåˆºæ¿€åŠç¼ç†±æ„Ÿã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€éŽæ•æ€§çš®è†šç‚Žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ç´…ã€è…«ã€æ°´æ³¡ã€è„«çš®ã€æ”癢ç‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Phenothrin</span><span style="font-family: 標楷體; font-size: 10pt;">：å¶æœ‰éŽæ•å應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Selenium</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å±€éƒ¨åˆºæ¿€æ„Ÿã€è„«é«®ã€é 髮褪色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é é«®ã€é 皮會有出油或乾澀之ç¾è±¡ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Chlorhexidine</span><span style="font-family: 標楷體; font-size: 10pt;">：刺激感ã€çš®è†šç‚Žã€éŽæ•æ€§å應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Pyrithione Zinc</span><span style="font-family: 標楷體; font-size: 10pt;">：å¶æœ‰æŽ¥è§¸æ€§çš®è†šç‚Žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">類固醇：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 112.6pt;"><span style="font-size: 10pt;">(A)</span><span style="font-family: 標楷體; font-size: 10pt;">局部性：æ”癢ã€åˆºç—›ã€ç´…æ–‘ã€çš®è†šæ„ŸæŸ“ã€æ¯›å›Šç‚Žã€é’春痘ã€çš®è†šæ¿•è»Ÿã€ç¹¼ç™¼æ€§æ„ŸæŸ“ã€å¤šæ¯›ç—‡ã€çš®è†šèŽç¸®ã€ç—±åã€æ¯›ç´°ç®¡æ“´å¼µã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 112.6pt;"><span style="font-size: 10pt;">(B)</span><span style="font-family: 標楷體; font-size: 10pt;">全身性：庫欣å¼ç—‡å€™ç¾¤ï¼ˆ</span><span style="font-size: 10pt;">Cushing's syndrome</span><span style="font-family: 標楷體; font-size: 10pt;">，如滿月臉ã€é«”é‡å¢žåŠ ã€ç–²å€¦ã€é«˜è¡€å£“ã€å¤šæ¯›ç—‡ã€æœˆç¶“異常ã€äººæ ¼ç•°å¸¸ã€æ°´è…«ã€å¤šå°¿ã€å¤šæ¸´ç‰ï¼‰ã€ç¹¼ç™¼æ€§è…Žä¸Šè…ºåŠŸèƒ½ä¸è¶³ï¼ˆ</span><span style="font-size: 10pt;">secondary adrenal insufficiency</span><span style="font-family: 標楷體; font-size: 10pt;">，如疲倦ã€ç„¡åŠ›ã€å™å¿ƒå˜”åã€é£Ÿæ…¾ä¸æŒ¯ã€é«”é‡æ¸›è¼•ã€ä½Žè¡€å£“ã€è…¹ç—›ã€ä¾¿ç§˜æˆ–腹瀉ç‰ï¼‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Dibucaine</span><span style="font-family: 標楷體; font-size: 10pt;">：局部ç¼ç†±ã€åˆºç—›ã€å¶æœ‰éŽæ•æ€§å應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Benzoyl Peroxide</span><span style="font-family: 標楷體; font-size: 10pt;">：éŽæ•æ€§çš®è†šç‚Žï¼ŒéŽåº¦çš„皮膚乾燥，脫皮ã€åˆºç—›ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Salicylic Acid</span><span style="font-family: 標楷體; font-size: 10pt;">：紅斑ã€æ”癢ã€åˆºç—›æ„Ÿã€æ°´æ¥Šé…¸å應（耳鳴ã€æšˆçœ©ã€å™å¿ƒã€å˜”åç‰ï¼‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Capsaicin</span><span style="font-family: 標楷體; font-size: 10pt;">：皮膚ç¼ç†±æ„Ÿã€åˆºç—›ã€ç´…æ–‘ã€å—†é¼»ã€åˆºæ¿€æ€§å’³å—½ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Hydroquinone</span><span style="font-family: 標楷體; font-size: 10pt;">：局部紅斑ã€åˆºç—›ã€éŽæ•æ€§çš®è†šç‚Žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">V</span><span style="font-family: 標楷體; font-size: 14pt;">ã€æ³¨æ„äº‹é …ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é ˆç½®æ–¼å°å©æŽ¥è§¸ä¸åˆ°ä¹‹è™•ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é¿å…陽光直射，宜ä¿å˜æ–¼é™°æ¶¼ä¹‹è™•ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é™¤éžè—¥å¸«ã€è—¥åŠ‘生或醫師指示，兒童ã€å•å©¦åŠæŽˆä¹³å©¦ä¸å»ºè°è‡ªè¡Œä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å‹¿è¶…éŽå»ºè°åŠ‘é‡ï¼Œè‹¥æœ‰å‰¯ä½œç”¨ç”¢ç”Ÿï¼Œæ‡‰ç«‹å³åœè—¥å°±é†«ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">5</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é™¤éžè—¥å¸«ã€è—¥åŠ‘生或醫師指示，本製劑é™æ–¼çš®è†šå¤–用ä¸å¾—å…§æœï¼Œæˆ–使用於眼ç›å…§ï¼Œäº¦ä¸å¾—施於眼ç›å››å‘¨æˆ–é»è†œã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">6</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é™¤éžæœ‰è—¥å¸«ã€è—¥åŠ‘生或醫師指示，本製劑勿使用於大é¢ç©ä¹‹é«”表或皮膚深部感染。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">7</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä½¿ç”¨å¾Œè‡ªè¦ºç‹€æ³æœªæ”¹å–„或更惡化，應立å³åœè—¥ä¸¦å°±é†«ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">8</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é™¤éžè—¥å¸«ã€è—¥åŠ‘生或醫師指示，使用皮膚外用藥後請勿覆蓋，以å…å¢žåŠ å‰¯ä½œç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">9</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å¡—抹皮膚外用藥後應徹底洗淨雙手後，å†æˆ´éš±å½¢çœ¼é¡ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">10</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æ·±éƒ¨çš®è†šçµ„織感染請就醫治療。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 62.35pt;"><span style="font-size: 10pt;">11</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é»´èŒæ²»ç™‚至少二星期，使用æ¤è—¥é ˆå®Œæˆå…¨ç¨‹ç™‚程。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 67.85pt;"><span style="font-size: 10pt;">12</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä¸€èˆ¬é»´èŒæ²»ç™‚一星期症狀會改善，股癬和體癬經二星期，足癬經四星期治療症狀若沒有改善應åœè—¥ç«‹å³å°±é†«ï¼Œå³ä½¿è‹¥ç—‡ç‹€æœ‰æ”¹å–„åœè—¥å¾Œè‹¥ç—…情複發應åœè—¥ç«‹å³å°±é†«ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 67.85pt;"><span style="font-size: 10pt;">13</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é™¤éžè—¥å¸«ã€è—¥åŠ‘生或醫師指示，類固醇抗發炎劑ä¸å¯é€£çºŒä½¿ç”¨è¶…éŽäºŒæ˜ŸæœŸã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 67.85pt;"><span style="font-size: 10pt;">14</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä½¿ç”¨</span><span style="font-size: 10pt;"> Benzoyl Peroxide </span><span style="font-family: 標楷體; font-size: 10pt;">é¿å…與其他皮膚刺激原（如陽光）接觸，塗抹部ä½æ‡‰é¿å…陽光æ›æ›¬ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 14pt;">VI</span><span style="font-family: 標楷體; font-size: 14pt;">ã€è¦èªž</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">æŠ—ç”Ÿç´ ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é•·æœŸä½¿ç”¨æœ‰å¯èƒ½å¼•èµ·ç¹¼ç™¼æ€§æ„ŸæŸ“。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æœƒä½¿è¡£ç‰©æŸ“色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">抗黴èŒåŠ‘：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">局部消毒劑：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Chlorhexidine</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä½¿ç”¨å‰æ‡‰ä¾ä»¿å–®è¦å®šç¨€é‡‹ï¼Œä»¥å…ç¼ç‡’皮膚。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é¿å…接觸外耳é“ï¼Œå°¤å…¶è€³è†œç ´è£‚æ™‚é€²å…¥ä¸è€³ï¼Œæœ‰é€ æˆè€³è¾ä¹‹è™žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Povidone Iodine</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ç¢˜éŽæ•è€…ä¸èƒ½ä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æœ‰å…¨èº«æ€§å¸æ”¶ä¹‹å¯èƒ½æ€§ï¼Œå› æ¤å覆使用新生兒å¯èƒ½å‡ºç¾ç”²ç‹€è…ºåŠŸèƒ½ä½Žä¸‹ï¼Œå•å©¦åŠå…¶èƒŽå…’åŠæŽˆä¹³å©¦æœ‰é€ æˆç”²ç‹€è…ºè…«åŠç”²ç‹€è…ºåŠŸèƒ½ä½Žä¸‹ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æœƒä½¿çš®è†šæˆ–衣物染色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">類固醇：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°å©é•·æœŸä½¿ç”¨è¼ƒæ˜“引起庫欣æ°ç—‡å€™ç¾¤åŠè…Žä¸Šè…ºåŠŸèƒ½éšœç¤™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ç™¬é¡žæˆ–其他皮膚感染症，應使用抗感染劑，單ç¨ä½¿ç”¨é¡žå›ºé†‡æœƒä½¿ç—…情惡化。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">ã€è‡‰éƒ¨ã€è…‹éƒ¨åŠé¼ 蹊部，若長期使用類固醇容易出ç¾å±€éƒ¨çš®è†šèŽç¸®ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">5</span><span style="font-family: 標楷體; font-size: 10pt;">ã€çš®è†šçš„é»´èŒæ„ŸæŸ“有時ä¸æ˜“與其他皮膚炎å€åˆ†ï¼Œèª¤ç”¨é¡žå›ºé†‡æœƒä½¿ç—…æƒ…æƒ¡åŒ–ä¸¦é€ æˆæ—¥å¾Œè¨ºæ–·åŠæ²»ç™‚之困難。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 10pt;">其他類：</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Selenium</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€çš®è†šé 皮有急性發炎時勿使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å¯èƒ½å‚·åŠç 寶，使用å‰å…ˆé™¤åŽ»ã€æ²»ç™‚後充分沖洗。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä¸æ‡‰é•·æœŸä½¿ç”¨ï¼Œé•·æœŸä½¿ç”¨æœƒè„«é«®ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Diphenhydramine HCl</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é€£çºŒä½¿ç”¨è¶…éŽä¸‰æ˜ŸæœŸæ™‚æœ‰å¢žåŠ éŽæ•æ€§æŽ¥è§¸æ€§çš®è†šç‚Žä¹‹è™žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Dibucaine</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä¸å¾—大é‡ä½¿ç”¨ï¼Œä»¥é¿å…全身性å¸æ”¶ï¼Œæ›¾æœ‰è‡´æ»å ±å‘Šã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Benzoyl Peroxide</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä¸è¦è§¸ç¢°çœ¼çš®ã€å”‡éƒ¨é»è†œåŠç™¼ç‚Žçš„皮膚。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ç‚ºä¸€ç¨®æ°§åŒ–劑會使é 髮褪色ã€ä½¿è¡£ç‰©æŸ“色。</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Salicylic acid</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å¤§ç¯„åœåŠé•·æœŸä½¿ç”¨æœƒé€ æˆæ°´æ¥Šé…¸æ•ˆæ‡‰ï¼ˆè€³é³´ã€æšˆçœ©ã€å™å¿ƒã€å˜”åç‰ï¼‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">3</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é¿å…觸碰衣物ã€å¡‘è† å“ã€æœ¨æã€é‡‘屬。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">4</span><span style="font-family: 標楷體; font-size: 10pt;">ã€ä¸è¦è§¸ç¢°çœ¼éƒ¨ã€è‡‰éƒ¨ã€é™°éƒ¨ã€é»è†œã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Hydroquinone</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€æœ‰å±€éƒ¨çš®è†šéŽæ•ä¹‹å±éšªï¼Œç¬¬ä¸€æ¬¡ä½¿ç”¨æ‡‰ä»¥å°é‡é–‹å§‹ï¼Œè§€å¯Ÿ</span><span style="font-size: 10pt;">24</span><span style="font-family: 標楷體; font-size: 10pt;">å°æ™‚有無ä¸è‰¯å應，若出ç¾æ°´æ³¡ã€çš®è†šæ”癢ã€ç´…ã€è…«æ‡‰åœæ¢ä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-size: 10pt;">Pyrithione Zinc</span><span style="font-family: 標楷體; font-size: 10pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">1</span><span style="font-family: 標楷體; font-size: 10pt;">ã€å°è—¥ç‰©å„æˆåˆ†éŽæ•è€…ä¸å¾—使用。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 12pt 0pt 72.65pt;"><span style="font-size: 10pt;">2</span><span style="font-family: 標楷體; font-size: 10pt;">ã€é çš®æˆ–çš®è†šæœ‰ç ´çš®æˆ–ç™¼ç‚Žè€…è«‹å‹¿ä½¿ç”¨ã€‚</span> </p>2013-12-04
查驗登記類,指示藥å“審查基準,胃腸製劑行政解釋指示藥å“審查基準-胃腸製劑詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4510&type=0
查驗登記類,指示藥å“審查基準,眼用製劑行政解釋指示藥å“審查基準-眼用製劑<div style="layout-grid: 16.3pt none;" class="WordSection1"><p style="text-justify: distribute-all-lines; text-align: justify; margin: 0cm 5cm 30pt;"><span style="font-family: 標楷體; font-size: 28pt;">眼用製劑</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">Iã€</span><span style="font-family: 標楷體; font-size: 18pt;">é©ç”¨ç¯„åœ</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">凡是<b>施用於眼ç›</b>æ²»ç™‚çœ¼éƒ¨ç–¾ç—…ï¼ŒåŒ…æ‹¬ï¼šå› è¼•å¾®çœ¼éƒ¨åˆºæ¿€æ‰€å¼•èµ·ä¹‹ä¸é©æˆ–眼ç›ç´…ã€çœ¼ç›ç–²å‹žã€<b>眼ç›ç™¢</b>ï¼Œå› çœ¼ç›ä¹¾æ¾€æ‰€å¼•èµ·ç¼ç†±æ„Ÿèˆ‡åˆºæ¿€æ„Ÿ<b>或用於沖洗眼部</b>的藥劑，å‡é©ç”¨æœ¬åŸºæº–。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">隱型眼é¡è—¥æ°´ï¼Œä¸é©ç”¨æœ¬åŸºæº–。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 12pt 41.95pt;"><span style="font-size: 18pt;">IIã€</span><span style="font-family: 標楷體; font-size: 18pt;">有效æˆåˆ†</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">有效æˆåˆ†ä¹‹ç¨®é¡žåŠå«é‡ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">本基準å¯é…åˆä¹‹æœ‰æ•ˆæˆåˆ†ï¼Œè¨˜è¼‰æ–¼è¡¨ä¸€ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><span style="font-family: 標楷體; font-size: 14pt;">表一ä¸ï¼Œé™¤</span><span style="font-size: 14pt;">G</span><span style="font-family: 標楷體; font-size: 14pt;">欄外，è¦å®šå„å“é …å¯é…åˆä¹‹æœ€é«˜å«é‡ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">表一ä¸ï¼Œè¦å®šå„欄之é©æ‡‰ç—‡ã€‚</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 6pt 72pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一ã€æœ‰æ•ˆæˆåˆ†ç¨®é¡ž</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 3pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">欄 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">é … </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 42.55pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">有效æˆåˆ† </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">最高å«é‡(%)</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 22.7pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">é©æ‡‰ç—‡ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="12"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">A</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Ephedrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span>0.123<br /> (</span><span style="font-family: 標楷體;">單一濃度</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="12"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">æš«æ™‚ç·©è§£å› è¼•å¾®çœ¼éƒ¨åˆºæ¿€æ‰€å¼•èµ·ä¹‹ä¸é©ã€æˆ–眼ç›ç´…</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Naphazoline hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b>0.01</b> - 0.03</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Phenylephrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.08 - 0.20</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Tetrahydrozoline hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.01 - 0.05</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Ephedrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Naphazoline hydrochloride </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.003</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Phenylephrine hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Tetrahydrozoline hydrochloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.05</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Epinephrine</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.003</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt; padding-top: 1pt;"><b><span>Epinephrine hydrochloride <sup>*</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 1.4pt; padding-top: 1pt;"><b><span>0.003<br /> <span style="letter-spacing: -0.2pt;">(as Epinephrine</span>)</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Naphazoline nitrate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.003</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 0cm 1pt 5.65pt; padding-top: 1pt;"><b><span style="letter-spacing: -0.1pt;">dl-Methylephedrine hydrochlorid</span></b><b>e</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">B</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Neostigmine methylsulfate</b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.005</b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt;"> </p> </td> </tr> </tbody></table><p style="page-break-before: always; line-height: 20pt; margin: 0cm 0cm 6pt 72pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一ã€æœ‰æ•ˆæˆåˆ†ç¨®é¡žï¼ˆçºŒï¼‰</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 3pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">欄 </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">é … </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 42.55pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">有效æˆåˆ† </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">最高å«é‡(%)</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 22.7pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">é©æ‡‰ç—‡ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="9"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">C</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b><span style="font-family: 標楷體;">ε</span></b><b>-Aminocaproic acid</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>5</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="9"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">æš«æ™‚ç·©è§£å› è¼•å¾®çœ¼éƒ¨åˆºæ¿€æ‰€å¼•èµ·ä¹‹ä¸é©</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Allantoin</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="2"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Berberine hydrochloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.025</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Berberine sulfate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.025</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Sodium azulene sulfonate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.02</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">5</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Dipotassium glycyrrhizinate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.25</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="2"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">6</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Zinc sulfate</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">0.25</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Zinc lactate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.25</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 0.5pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">7</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Lysozyme chloride</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.5 (</b><b><span style="font-family: 標楷體;">力價</span></b><b>)</b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 55.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 55.1pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; height: 55.1pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 1.4pt; padding-top: 1pt;"><span style="font-size: 14pt;">D</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; height: 55.1pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 55.1pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Diphenhydramine hydrochloride</b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; height: 55.1pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.05</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; height: 55.1pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">眼ç›ç™¢</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 55.15pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 55.15pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 55.15pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Chlorpheniramine maleate</b></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; height: 55.15pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.03</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="10"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">E</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Sodium flavin adenine dinuleotide</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">0.05</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="10"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">眼ç›ç–²å‹ž</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">Cyanocobalamin</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;">0.02</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="2"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">3</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Retinol acetate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b><span>50,000units/ 100ml</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Retinol palmitate</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">4</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Pyridoxine hydrochloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Pyridoxal phosphate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" rowspan="3"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">5</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Panthenol</b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Calcium pantothenate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Sodium pantothenate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">6</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Tocopherol Acetate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.05</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">F</span></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="3"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>L-Potassium aspartate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>1</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 1pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">眼ç›ç–²å‹ž</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>L-Magnesium aspartate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>L-Potassium and magnesium aspartate (equal mixture)</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>2</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 0cm 1pt 5.65pt; padding-top: 1pt;"><b>Taurine (Aminoethylsulfonic acid)</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>1</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-size: 14pt;">3</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>Sodium chondroitin sulfate</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 1pt 5.65pt; padding-top: 1pt;"><b>0.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">G</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Potassium chloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">沖洗眼部</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Calcium chloride</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;">Sodium chloride</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium bicarbonate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium carbonate</b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> </tbody></table><p style="page-break-before: always; line-height: 20pt; margin: 0cm 0cm 6pt 72pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一ã€æœ‰æ•ˆæˆåˆ†ç¨®é¡žï¼ˆçºŒï¼‰</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 3pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">欄 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 0cm 1.4pt 0pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">é … </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 42.55pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">有效æˆåˆ† </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">最高å«é‡(%)</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 22.7pt; padding-top: 1pt;"><span style="font-family: 標楷體; font-size: 14pt;">é©æ‡‰ç—‡ </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">G</span></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium carbonate, dried</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">沖洗眼部</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Magnesium sulfate</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium phosphate, dibasic</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Sodium phosphate, monobasic</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt;"><b>Potassium phosphate, monobasic</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><b><span style="font-family: 標楷體;">ï¼</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">H</span></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; margin: 0cm 1.4pt 0pt;"><span style="font-size: 14pt;">1</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 28.9pt;"><span>(a)<span style="font: 7pt times new roman;"> </span></span><span>Cellulose der.<br /> Carboxymethylcellose sodium<br /> Hydroxyethyl cellulose<br /> Hydroxypropyl methylcellose<br /> Methylcellulose</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 0.2 - 2.5<br /> 0.2 - 2.5<br /> 0.2 - 2.5<br /> 0.2 - 2.5</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 95.5pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1pt 5.65pt;"><span style="font-family: 標楷體; font-size: 14pt;">æš«æ™‚ç·©è§£å› çœ¼ç›ä¹¾æ¾€æ‰€å¼•èµ·ç¼ç†±æ„Ÿèˆ‡åˆºæ¿€æ„Ÿ</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 20.4pt;"><span>(b) </span>Dextran 70</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.1</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 20.4pt;"><span>(c) </span>Gelatin</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.01</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; margin: 1pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 29.45pt;"><span>(d)<span style="font: 7pt times new roman;"> </span></span><span>Polyols liquid<br /> Glycerin<br /> Polyethylene glycol 300<br /> Polyethylene glycol 400<br /> Polysorbate 80<br /> Propylene glycol</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 0.2 – 1.0<br /> 0.2 – 1.0<br /> 0.2 – 1.0<br /> 0.2 – 1.0<br /> 0.2 – 1.0</span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 24.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 24.55pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 24.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 20.4pt;"><span>(e) </span>Polyvinyl alcohol</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; height: 24.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.1 – 4.0</p> </td> </tr> <tr style="page-break-inside: avoid; height: 24.6pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; height: 24.6pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; height: 24.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 18.1pt;"><span>(f)</span> Povidone </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; height: 24.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;">0.1 – 2.0</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 20.85pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; margin: 2pt 1.4pt; padding-top: 1pt;"><span style="font-size: 14pt;">2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 28.9pt;"><span>(a)<span style="font: 7pt times new roman;"> </span></span><span>Lanolin Preparations<br /> Anhydrous lanolin<br /> Lanolin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 1 – 10<br /> 1 – 10</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 72pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="border-bottom: windowtext 0.75pt solid; padding-bottom: 1pt; margin: 1pt 0cm; padding-top: 1pt;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 182.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1pt 5.65pt 1pt 29.45pt;"><span>(b)<span style="font: 7pt times new roman;"> </span></span><span>Oleaginous Ingredients<br /> Light mineral oil<br /> Mineral oil<br /> Paraffin<br /> Petrolatum<br /> White ointment<br /> White petrolatum<br /> White wax<br /> Yellow wax</span></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90.45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 5.65pt;"><span><br /> 50<br /> 50<br /> 5<br /> 100<br /> 100<br /> 100<br /> 5<br /> 5</span></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 3pt 0cm 12pt 72pt; layout-grid-mode: char;"><b><span style="font-size: 14pt;">*</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å¯ä½¿ç”¨å„國藥典收載之</span></b><b><span style="font-size: 14pt;">Epinephrine Solution</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">替代之。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 21pt 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">é…åˆè¦å‰‡ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">）之é…åˆè¦å‰‡ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 111.7pt;"><span style="font-size: 14pt;">1ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†åŠå¯é…åˆæˆåˆ†ï¼ˆè¦‹è¡¨äºŒï¼‰ï¼š</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …æ‰€å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚一般眼用製劑（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之é…æ–¹ä¸ï¼Œéœ€å«ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¯é…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ä¹‹</span></b><b><span style="font-size: 14pt;">Zinc sulfate</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，或</span></b><b><span style="font-size: 14pt;">H</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …æ‰€å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">å„å¿…é ˆé…åˆæˆåˆ†å¯å–®æ–¹ä½¿ç”¨ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3ã€</span><span style="font-family: 標楷體; font-size: 14pt;">ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†ï¼‹</span><span style="font-size: 14pt;">Zinc sulfate</span><span style="font-family: 標楷體; font-size: 14pt;">，複方é…åˆä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 111.7pt;"><span style="font-size: 14pt;">4ã€</span><span style="font-family: 標楷體; font-size: 14pt;">ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†ï¼‹</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">é …ä¹‹ä¸€ç¨®æœ‰æ•ˆæˆåˆ†ï¼Œè¤‡æ–¹é…åˆä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 111.7pt;"><span style="font-size: 14pt;">5ã€</span><span style="font-family: 標楷體; font-size: 14pt;">ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†ï¼‹</span><span style="font-size: 14pt;">Zinc sulfate</span><span style="font-family: 標楷體; font-size: 14pt;">＋</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">é …ä¹‹ä¸€ç¨®æœ‰æ•ˆæˆåˆ†ï¼Œè¤‡æ–¹é…åˆä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><b><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之é…åˆè¦å‰‡ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 111.7pt;"><span style="font-size: 14pt;">1ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†åŠå¯é…åˆæˆåˆ†ï¼ˆè¦‹è¡¨äºŒï¼‰ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼Œ</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼Œæˆ–</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …æ‰€å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之é…æ–¹ä¸ï¼Œè‡³å°‘需å«ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¯é…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">4</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼Œæˆ–</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …æ‰€å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之é…æ–¹ä¸ï¼Œé™¤ä¸Šé …</span></b><b><span style="font-size: 14pt;"> (a) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†å¯ç›¸äº’é…åˆä½¿ç”¨å¤–，亦å¯èˆ‡ä¸Šé …</span></b><b><span style="font-size: 14pt;"> (b) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å¯é…åˆæˆåˆ†ï¼Œè¤‡æ–¹é…åˆä½¿ç”¨ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">以下å„欄，僅å¯å„é…åˆä¸€ç¨®æœ‰æ•ˆæˆåˆ†ä½¿ç”¨ï¼š</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼Œæˆ–</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 111.7pt;"><span style="font-size: 14pt;">4ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">以下å„欄，最多å¯å„é…åˆä¸‰ç¨®æœ‰æ•ˆæˆåˆ†ä½¿ç”¨ï¼Œä½†å„欄æ¯ä¸€é …ä¸åƒ…å¯ä½¿ç”¨ä¸€ç¨®æœ‰æ•ˆæˆåˆ†ï¼š</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄ã€</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 111.7pt;"><span style="font-size: 14pt;">1ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ï¼‰å¿…é ˆé…åˆæˆåˆ†åŠå¯é…åˆæˆåˆ†ï¼ˆè¦‹è¡¨äºŒï¼‰ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼Œæˆ–</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）之é…æ–¹ä¸ï¼Œè‡³å°‘需å«ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†ã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¯é…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼Œæˆ–</span></b><b><span style="font-size: 14pt;">H</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …</span></b><b><span style="font-size: 14pt;"> (a)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ã€</span></b><b><span style="font-size: 14pt;">(e)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ã€</span></b><b><span style="font-size: 14pt;">(f) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">所å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ï¼‰ï¼Œé™¤ä¸Šé …</span></b><b><span style="font-size: 14pt;"> (a) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†å¯ç›¸äº’é…åˆä½¿ç”¨å¤–，亦å¯èˆ‡ä¸Šé …</span></b><b><span style="font-size: 14pt;">(b) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å¯é…åˆæˆåˆ†ï¼Œè¤‡æ–¹é…åˆä½¿ç”¨ï¼›å¦ï¼Œäº¦å¯ä»¥åƒ…å«</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所å«ä¹‹æœ‰æ•ˆæˆåˆ†ç‚ºå¿…é ˆé…åˆæˆåˆ†ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3ã€</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span><span style="font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">），以</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">é …ä¹‹äºŒè‡³ä¸‰ç¨®æœ‰æ•ˆæˆåˆ†ï¼Œä»»æ„複方é…åˆä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 112.8pt;"><span style="font-size: 14pt;">4ã€</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span><span style="font-size: 14pt;">3</span><span style="font-family: 標楷體; font-size: 14pt;">），以</span><span style="font-size: 14pt;">H</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">é …äºŒç¨®æˆ–äºŒç¨®ä»¥ä¸Šä¹‹æœ‰æ•ˆæˆåˆ†ï¼Œä»»æ„複方é…åˆä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 6pt 89.6pt;"><span style="font-size: 14pt;">(D)</span><b><span style="font-family: 標楷體; font-size: 14pt;">洗眼劑：</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 111.7pt;"><span style="font-size: 14pt;">1ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†åŠå¯é…åˆæˆåˆ†ï¼ˆè¦‹è¡¨äºŒï¼‰ï¼š</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 3pt 126.45pt;"><span style="font-size: 14pt;">(a)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，或</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚洗眼劑之é…æ–¹ä¸ï¼Œè‡³å°‘需å«ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†ã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 126.45pt;"><span style="font-size: 14pt;">(b)</span><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">å¯é…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€ä¸</span></b><b><span style="letter-spacing: -0.2pt; font-size: 14pt;">E</span></b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">欄，或</span></b><b><span style="letter-spacing: -0.2pt; font-size: 14pt;">F</span></b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">欄所å«ä¹‹æœ‰æ•ˆæˆåˆ†</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">2ã€</span><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，僅å¯é…åˆä¸€ç¨®æœ‰æ•ˆæˆåˆ†ä½¿ç”¨ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">3ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">以下å„欄，最多å¯å„é…åˆä¸‰ç¨®æœ‰æ•ˆæˆåˆ†ä½¿ç”¨ï¼Œä½†å„欄æ¯ä¸€é …ä¸åƒ…å¯ä½¿ç”¨ä¸€ç¨®æœ‰æ•ˆæˆåˆ†ï¼š</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 111.7pt;"><span style="font-size: 14pt;">4ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">以</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所å«ä¹‹æœ‰æ•ˆæˆåˆ†ç‚ºå¿…é ˆé…åˆæˆåˆ†ä¹‹æ´—眼劑：除</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所å«ä¹‹æœ‰æ•ˆæˆåˆ†å¯ç›¸äº’é…åˆä½¿ç”¨å¤–，亦å¯èˆ‡ä¸Šé …</span></b><b><span style="font-size: 14pt;"> (b) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å¯é…åˆæˆåˆ†ï¼Œè¤‡æ–¹é…åˆä½¿ç”¨ã€‚å…¶é©æ‡‰ç—‡éœ€æ¨™ç¤ºç‚ºæ²–洗眼部。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.7pt;"><span style="font-size: 14pt;">5ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">以</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄所å«ä¹‹æœ‰æ•ˆæˆåˆ†ç‚ºå¿…é ˆé…åˆæˆåˆ†ä¹‹æ´—眼劑：å¯å«ä¸€ç¨®ä»¥ä¸Šå¿…é ˆé…åˆæˆåˆ†é…åˆã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 21pt 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><span style="font-family: 標楷體; font-size: 14pt;">有效æˆåˆ†ä¹‹é…åˆé‡ï¼ˆè¦‹è¡¨ä¸‰ï¼‰ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">å„有效æˆåˆ†ä¹‹é…åˆé‡ï¼Œå‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—之最高å«é‡ã€‚<b>洗眼劑若å«</b></span><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄åŠ</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄ä¸ä¹‹æœ‰æ•ˆæˆåˆ†ï¼Œå…¶å„有效æˆåˆ†ä¹‹æœ€é«˜å«é‡ç‚ºå…¶è¡¨ä¸€ä¸æœ€é«˜å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄（無機鹽類）之é…åˆé‡ä¾æ·šæ¶²ä¹‹æ€§ç‹€è€Œå®šï¼Œä¸åšå«é‡ä¹‹è¦å®šã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><b><span style="font-family: 標楷體; font-size: 14pt;">表一ä¸</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄ã€</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄，若é…åˆåŒæ¬„ä¸äºŒç¨®æˆ–二種以上有效æˆåˆ†æ™‚，其æ¯ä¸€æœ‰æ•ˆæˆåˆ†çš„é…åˆæ¿ƒåº¦é™¤ä»¥æœ€é«˜å«é‡æ‰€å¾—數值的總和，ä¸å¯å¤§æ–¼</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。但洗眼劑的有效æˆåˆ†çš„é…åˆæ¿ƒåº¦é™¤ä»¥æœ€é«˜å«é‡æ‰€å¾—數值的總和，ä¸å¯å¤§æ–¼</span></b><b><span style="font-size: 14pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">）ä¸ï¼Œ</span><span style="font-size: 14pt;">A</span><span style="font-family: 標楷體; font-size: 14pt;">欄</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">é …åƒ…åˆ—å–®ä¸€æ¿ƒåº¦ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(D)</span><b><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑（</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）ä¸ï¼Œè‹¥å«ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†æ™‚，則æ¤æœ‰æ•ˆæˆåˆ†çš„最低å«é‡æ‡‰ç‚ºè¡¨ä¸€æœ€é«˜å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。若å«äºŒç¨®æˆ–äºŒç¨®ä»¥ä¸Šå¿…é ˆé…åˆæˆåˆ†æ™‚，則å„有效æˆåˆ†çš„最低å«é‡ç‚ºè¡¨ä¸€æœ€é«˜å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(E)</span><b><span style="font-family: 標楷體; font-size: 14pt;">人工淚液（</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）ä¸ï¼Œ</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄有效æˆåˆ†ä¹‹æœ€ä½Žå«é‡æ‡‰ç‚ºè¡¨ä¸€æœ€é«˜å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">；若é…åˆ</span></b><b><span style="font-size: 14pt;">H</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ä¹‹</span></b><b><span style="font-size: 14pt;"> (e)Polyvinyl alcohol</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ã€</span></b><b><span style="font-size: 14pt;">(f)Povidone </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之有效æˆåˆ†ï¼Œå‰‡</span></b><b><span style="font-size: 14pt;"> (e) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">åŠ</span></b><b><span style="font-size: 14pt;"> (f) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之最低å«é‡ï¼Œåˆ†åˆ¥ç‚º</span></b><b><span style="font-size: 14pt;">0.2% </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å’Œ</span></b><b><span style="font-size: 14pt;">0.25%</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。人工淚液之</span></b><b><span style="font-size: 14pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">值為</span></b><b><span style="font-size: 14pt;">5.5 - 8.0</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，滲é€å£“比為</span></b><b><span style="font-size: 14pt;">0.85 - 1.55</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（å°ç”Ÿç†é£Ÿé¹½æ°´æ»²é€å£“比）。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(F)</span><b><span style="font-family: 標楷體; font-size: 14pt;">洗眼劑ä¸ï¼Œè‹¥é…åˆè¡¨ä¸€</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄有效æˆåˆ†ï¼Œå‰‡å…¶æœ€ä½Žå«é‡ç‚ºæœ¬ç¯€</span></b><b><span style="font-size: 14pt;"> (A) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">所定最高å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（å³è¡¨ä¸€æœ€é«˜å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/50</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）。若é…åˆè¡¨ä¸€</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄或</span></b><b><span style="font-size: 14pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄的有效æˆåˆ†ï¼Œå‰‡å…¶æœ€ä½Žå«é‡ç‚ºæœ¬ç¯€</span></b><b><span style="font-size: 14pt;"> (A) </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">所定最高å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（å³è¡¨ä¸€æœ€é«˜å«é‡</span></b><b><span style="font-size: 14pt;">1/100</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）。洗眼劑的</span></b><b><span style="font-size: 14pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">值為</span></b><b><span style="font-size: 14pt;">5.5 - 8.0</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，滲é€å£“比為</span></b><b><span style="font-size: 14pt;">0.60 - 1.55</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（å°ç”Ÿç†é£Ÿé¹½æ°´æ»²é€æ¯”）。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 9pt 89.6pt;"><span style="font-size: 14pt;">(G)</span><b><span style="font-family: 標楷體; font-size: 14pt;">如無其他è¦å®šï¼Œè‹¥é…åˆè¡¨ä¸€ä¸çš„</span></b><b><span style="font-size: 14pt;">E</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">4</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼Œæˆ–</span></b><b><span style="font-size: 14pt;"> F</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;"> 2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …æ‰€è¼‰çš„æœ‰æ•ˆæˆåˆ†æ™‚，其有效æˆåˆ†çš„最低å«é‡ç‚ºè¡¨ä¸€ä¸æœ€é«˜å«é‡çš„</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 21pt 24pt 89.6pt;"><span style="font-size: 14pt;">(H)</span><b><span style="font-family: 標楷體; font-size: 14pt;">以</span></b><b><span style="font-size: 14pt;">G</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄（無機鹽類）所製æˆçš„製劑亦å¯ç”¨æ–¼äººå·¥æ·šæ¶²åŠæ´—眼劑，其å«é‡ä»¥ç‰©æ€§å€¼è¦ç¯„之：</span></b><b><span style="font-size: 14pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">值為其ä¸å¿ƒå€¼</span></b><b><span style="font-size: 14pt;"> ± 1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，滲é€å£“比為其ä¸å¿ƒå€¼</span></b><b><span style="font-size: 14pt;"> ± 0.2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">IIIã€</span><span style="font-family: 標楷體; font-size: 18pt;">劑型</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 41.95pt;"><span style="font-family: 標楷體; font-size: 14pt;">é™æ–¼<b>點眼è†åŠ‘</b>ã€<b>眼用å‡è† 劑</b>ã€<b>點眼液劑</b>ã€<b>眼用洗劑</b>ã€<b>點眼懸液劑</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">IVã€</span><span style="font-family: 標楷體; font-size: 18pt;">é©æ‡‰ç—‡</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 41.95pt;"><span style="font-family: 標楷體; font-size: 14pt;">複方眼用製劑其é©æ‡‰ç—‡ä¾é…åˆæˆåˆ†è€Œç•°ï¼Œå¦‚未é…åˆä¹‹é¡žåˆ¥çš„有效æˆåˆ†ä¸å¾—記載其類別之é©æ‡‰ç—‡ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">Vã€</span><span style="font-family: 標楷體; font-size: 18pt;">用法ã€ç”¨é‡</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">一般眼用製劑：<b>一天</b></span><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">至</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次</span></b><span style="font-family: 標楷體; font-size: 14pt;">，æ¯æ¬¡</span><span style="font-size: 14pt;">1</span><span style="font-family: 標楷體; font-size: 14pt;">至</span><span style="font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">滴。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">人工淚液：需è¦æ™‚使用，<b>æ¯æ¬¡</b></span><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">至</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æ»´</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><b><span style="font-family: 標楷體; font-size: 14pt;">洗眼劑：一天</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">至</span></b><b><span style="font-size: 14pt;">6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æ¬¡ï¼Œå¿…é ˆæ¸…æ¥šæŒ‡æ˜Žæ¯æ¬¡ç”¨é‡ã€‚會附上洗眼輔助器，如洗眼用æ¯ï¼Œä¸¦æ¸…楚註明使用é‡ã€‚æ¯æ¬¡ä½¿ç”¨å‰ï¼Œå°‡æ´—眼用æ¯å¿«é€Ÿä»¥æ°´æ¿•æ½¤ï¼Œé¿å…污染洗眼用æ¯çš„æ¯ç·£èˆ‡æ¯å…§é¢ã€‚å°‡æ¯åè£ä¸€æ¬¡ä½¿ç”¨é‡ä¸”拿近欲處ç†çš„眼部，壓緊以å…液體æµå‡ºï¼Œå°‡é ç¨å‘後仰，打開眼瞼且轉動眼çƒä½¿æ´—çœ¼æ¶²èƒ½å¤ å……åˆ†æ¸…æ´—åˆ°çœ¼éƒ¨ï¼Œåœ¨ä½¿ç”¨å¾Œç”¨ä¹¾æ·¨çš„æ°´æ´—æ·¨æ¯å。如用細管注射器，需è¦æ™‚çŒæ´—眼部，利用瓶上的壓力控制溶液æµå‡ºçš„速度</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">VIã€</span><span style="font-family: 標楷體; font-size: 18pt;">注æ„äº‹é …</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><b><span style="font-family: 標楷體; font-size: 14pt;">為防æ¢å…’童誤食請妥善ä¿ç®¡ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><span style="font-family: 標楷體; font-size: 14pt;">é¿å…陽光直射，宜ä¿å˜æ–¼é™°æ¶¼ä¹‹è™•ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><span style="font-family: 標楷體; font-size: 14pt;">使用å‰ï¼Œè«‹æ´—淨雙手。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(å››)</span><b><span style="font-family: 標楷體; font-size: 14pt;">è«‹ä¾ç…§è—¥å“標示使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(五)</span><b><span style="font-family: 標楷體; font-size: 14pt;">éŽæœŸçœ¼è—¥æ°´ï¼Œè«‹å‹¿ä½¿ç”¨ã€‚瓶è£ä¹‹çœ¼è—¥æ°´ï¼Œé–‹ç“¶</span></b><b><span style="font-size: 14pt;">30</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">天後請勿繼續使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(å…)</span><b><span style="font-family: 標楷體; font-size: 14pt;">單劑é‡åŒ…è£ï¼Œé ˆä¸€æ¬¡ä½¿ç”¨å®Œï¼Œæœªä½¿ç”¨å®Œä¹‹æº¶æ¶²è«‹å‹¿ç¹¼çºŒä½¿ç”¨ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; page-break-before: always; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(七)</span><span style="font-family: 標楷體; font-size: 14pt;">藥液混æ¿ã€è®Šè‰²æˆ–出ç¾ç•°ç‰©æ™‚請丟棄。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(å…«)</span><b><span style="font-family: 標楷體; font-size: 14pt;">為é¿å…污染藥å“，</span></b><span style="font-family: 標楷體; font-size: 14pt;">使用時勿碰觸藥瓶瓶å£ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(ä¹)</span><span style="font-family: 標楷體; font-size: 14pt;">使用兩種<b>眼藥水</b>時，請隔開<b>至少</b></span><b><span style="font-size: 14pt;">5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">分é˜å¾Œ</span></b><span style="font-family: 標楷體; font-size: 14pt;">點藥。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(å)</span><span style="font-family: 標楷體; font-size: 14pt;">使用兩種眼藥時，請先使用藥水å†ç”¨è—¥è†ï¼›<b>並請隔開至少</b></span><b><span style="font-size: 14pt;">10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">分é˜å¾Œé»žè—¥</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 24pt 70.85pt;"><span style="font-family: 標楷體; font-size: 14pt;">(å一)</span><b><span style="font-family: 標楷體; font-size: 14pt;">使用眼藥è†æ™‚å¯èƒ½æœ‰è¦–線模糊之ç¾è±¡ç”¢ç”Ÿï¼Œæ•…建è°åœ¨ç¡å‰ä½¿ç”¨è¼ƒé©å®œã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 41.95pt;"><span style="font-size: 18pt;">VIIã€</span><span style="font-family: 標楷體; font-size: 18pt;">è¦èªž</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(一)</span><span style="font-family: 標楷體; font-size: 14pt;">以下情æ³æ‡‰åœè—¥ç«‹å³å°±é†«ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 89.6pt;"><span style="font-size: 14pt;">(A)</span><span style="font-family: 標楷體; font-size: 14pt;">連續使用三天（或</span><span style="font-size: 14pt;">72</span><span style="font-family: 標楷體; font-size: 14pt;">å°æ™‚）症狀未解除。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 9pt 89.6pt;"><span style="font-size: 14pt;">(B)</span><b><span style="font-family: 標楷體; font-size: 14pt;">使用後產生</span></b><span style="font-family: 標楷體; font-size: 14pt;">眼ç›åŠ‡ç—›ã€è¦–力模糊或眼ç›<b>æŒçºŒ</b>發紅ã€è…«ã€ç†±ã€åˆºæ¿€æ„Ÿã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 89.6pt;"><span style="font-size: 14pt;">(C)</span><span style="font-family: 標楷體; font-size: 14pt;">發生éŽæ•å應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 89.6pt;"><span style="font-size: 14pt;">(D)</span><span style="font-family: 標楷體; font-size: 14pt;">é’光眼（</span><span style="font-size: 14pt;">Glaucoma</span><span style="font-family: 標楷體; font-size: 14pt;">）患者。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(二)</span><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 14pt;">å°çœ¼ç”¨è£½åŠ‘之主è¦æˆåˆ†ã€é˜²è…劑或其他賦形劑éŽæ•è€…，ä¸æŽ¨è–¦ä½¿ç”¨</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(三)</span><span style="font-family: 標楷體; font-size: 14pt;">æ£åœ¨æŽ¥å—醫師治療或醫師處方眼藥之患者，<b>ä¸æ‡‰è‡ªè¡Œè³¼è²·ä½¿ç”¨</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(å››)</span><b><span style="font-family: 標楷體; font-size: 14pt;">éŽåº¦ä½¿ç”¨è¡€ç®¡æ”¶ç¸®åŠ‘æœƒå¢žåŠ çœ¼ç›ç´…腫。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(五)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å«æœ‰æ±žåŒ–åˆç‰©ç•¶é˜²è…劑者：è¦æ¨™ç¤ºæ‰€å«æ±žçš„å稱åŠå«é‡ï¼ŒåŠæ¤åŒ–åˆç‰©çš„作用為防è…劑。並註明：若å°å«æ±žåŒ–åˆç‰©ï¼ˆæˆ–汞本身）éŽæ•è€…，或使用數週後產生接觸性眼瞼炎或角çµè†œç‚Žï¼Œå‰‡ä¸è¦ä½¿ç”¨æ¤é¡žè£½åŠ‘。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(å…)</span><b><span style="font-family: 標楷體; font-size: 14pt;">é’光眼患者，除éžç¶“醫師指示，å¦å‰‡ä¸è¦ä½¿ç”¨å«è¡€ç®¡æ”¶ç¸®æˆåˆ†ä¹‹è£½åŠ‘。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 70.9pt;"><span style="font-family: 標楷體; font-size: 14pt;">(七)</span><b><span style="font-family: 標楷體; font-size: 14pt;">å«æœ‰</span></b><b><span style="font-size: 14pt;">Lysozyme HCl </span></b><b><span style="font-family: 標楷體; font-size: 14pt;">的製劑較易引起éŽæ•ï¼Œéœ€éµå¾žè—¥å¸«ã€è—¥åŠ‘生或醫師指示使用。</span></b><b> </b></p></div><span style="font-family: times new roman,serif; font-size: 14pt;"><br style="page-break-before: always;" clear="all" /></span><p style="line-height: 20pt; margin: 0cm 0cm 6pt;"><span style="font-family: 標楷體; font-size: 14pt;">表二ã€é…åˆè¦å‰‡</span> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 199pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 1pt 14.2pt 0pt 5cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">製劑å</span> </p> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 0cm 127.6pt 1pt 14.2pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">有效æˆåˆ†</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 127.3pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">一般眼用製劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 191.05pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">人工淚液</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 127.35pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">洗眼劑</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 1pt 1cm;"><span style="layout-grid-mode: line; font-size: 9pt;"> </span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">2</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">1</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">1</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">2</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">A</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Vasoconstrictors</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（四種æˆåˆ†ï¼‰</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅å¯å«ä¸€ç¨®æˆåˆ†</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Vasoconstrictors</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（八種æˆåˆ†ï¼‰</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">B</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Neostigmine methyl sulfate </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 0cm;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">C</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">ε</span><span style="layout-grid-mode: line; font-size: 9pt;">-Aminocaproic acid </span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">至多å«ä¸‰ç¨®æˆåˆ†ï¼Œå„é …ä¸åƒ…å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Allantoin </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Berberines</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種æˆåˆ†ï¼‰</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">4</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Sodium azulene sulfonate </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">5</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Dipotassium glycyrrhetinate </span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">6</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Zinc sulfate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Zinc lactate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">7</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Lysozyme hydrochloride</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">D</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Antihistamines</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種æˆåˆ†ï¼‰</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">E</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Sod. Flavin adenine dinucleotide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">至多å«ä¸‰ç¨®æˆåˆ†ï¼Œå„é …ä¸åƒ…å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Cyancobalamin</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Retinols</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種æˆåˆ†ï¼‰</span> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.15pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">4</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Pyridoxine hydrochloride</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; height: 10.15pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.1pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; height: 10.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Pyridoxal phosphate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">5</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Pantothenates</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（三種æˆåˆ†ï¼‰</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">6</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Tocopherol acetate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">F</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Aspartates</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（三種æˆåˆ†ï¼‰</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">至多å«ä¸‰ç¨®æˆåˆ†ï¼Œå„é …ä¸åƒ…å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Taurine</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（</span><span style="layout-grid-mode: line; font-size: 9pt;">Aminoethyl sulfonic acid</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">3</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Sodium chondroitin sulfate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">G</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">Inorganic salts</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（å種æˆåˆ†ï¼‰</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 0cm;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24.75pt; padding-right: 0cm; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="8"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">H</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(a)Cellulose derivatives</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（四種æˆåˆ†ï¼‰</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">與一般眼用製劑（</span><span style="layout-grid-mode: line; font-size: 9pt;">1</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）é…åˆæ™‚，僅å¯å«ä¸€ç¨®æˆåˆ†</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(b)Dextran</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(c)Gelatin</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(d)Polyos liquid</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（五種æˆåˆ†ï¼‰</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(e)Polyvinyl alcohol</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—‹</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(f)Povidone</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 24pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 2.85pt;"><span style="layout-grid-mode: line; font-size: 9pt;">2</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(a)Lanolin preparations</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">（二種æˆåˆ†ï¼‰</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 0cm;"><b><span style="layout-grid-mode: line; color: black; font-size: 9pt;">×</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 0cm;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 0cm 1pt 5.65pt;"><span style="layout-grid-mode: line; font-size: 9pt;">(b)<span style="letter-spacing: -0.2pt;">Oleaginous ingredients</span></span><span style="layout-grid-mode: line; letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">（八種æˆåˆ†</span><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 199pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.6pt; margin: 1pt 2cm;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 4.25pt;"> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.6pt; margin: 1pt 4.25pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 4.25pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">å¯å«äºŒè‡³ä¸‰</span> <span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">種æˆåˆ†</span> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;"><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">å¯å«äºŒç¨®æˆ–二種以上æˆåˆ†</span> </p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.65pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.6pt; margin: 1pt 4.25pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63.7pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;"><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">僅å¯å«</span></b><b><span style="layout-grid-mode: line; font-size: 9pt;">G</span></b><b><span style="layout-grid-mode: line; font-family: 標楷體; font-size: 9pt;">欄æˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 85.4pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.6pt; margin: 1pt 4.25pt;"> </p> </td> </tr> </tbody></table></div><p style="margin: 0cm 0cm 3pt;"><span style="font-family: 標楷體; font-size: 8pt;">â—Žï¼šå¿…é ˆé…åˆæˆåˆ†</span><span style="font-size: 8pt;"> </span><span style="font-family: 標楷體; font-size: 8pt;">○：å¯é…åˆæˆåˆ†</span><span style="font-size: 8pt;"> </span><span style="layout-grid-mode: line; color: black; font-size: 8pt;">×</span><span style="font-family: 標楷體; font-size: 8pt;">：ä¸å¯é…åˆæˆåˆ†</span><span style="font-size: 8pt;"><br style="page-break-before: always;" clear="all" /></span><span style="font-family: 標楷體; font-size: 14pt;">表三ã€é…åˆä¿‚數</span> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 152.05pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;" colspan="3"> <h1 style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1cm;"><span style="font-family: 標楷體; font-size: 9pt; font-weight: normal;">製劑</span> </h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><span style="font-family: 標楷體; font-size: 9pt;">一般眼用製劑（</span><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">一般眼用製劑（</span></b><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">人工淚液（</span></b><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">洗眼劑（</span></b><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">）</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><span style="font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 152.05pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3" colspan="3"> <h1 style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.1pt; page-break-after: auto; margin: 1.5pt 1cm;"><span style="font-family: 標楷體; font-size: 9pt; font-weight: normal;">有效æˆåˆ†</span> </h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt; font-weight: normal;">å„個æˆåˆ†</span> </h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 150pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">å„個æˆåˆ†</span> </h1> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">åŒæ¬„ä¸å«äºŒç¨®ä»¥ä¸Šæˆåˆ†çš„é…åˆä¿‚數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">å„個æˆåˆ†</span> </h1> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">åŒæ¬„ä¸å«äºŒç¨®ä»¥ä¸Šæˆåˆ†çš„é…åˆä¿‚數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <h1 style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">å„個æˆåˆ†</span> </h1> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">åŒæ¬„ä¸å«äºŒç¨®ä»¥ä¸Šæˆåˆ†çš„é…åˆä¿‚數</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">å¿…é ˆé…åˆ</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">æˆåˆ†</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">（一種）</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">å¯é…åˆ</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">æˆåˆ†</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">（一種）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">å¿…é ˆé…åˆæˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><b><span style="font-family: 標楷體; font-size: 9pt;">å¯é…åˆæˆåˆ†</span></b><b><span style="font-size: 9pt;"><br /> (</span></b><b><span style="letter-spacing: -0.3pt; font-family: 標楷體; font-size: 9pt;">æˆåˆ†æ•¸ä¸æ‹˜</span></b><b><span style="font-size: 9pt;">)</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">å«ä¸€ç¨®</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">å«äºŒç¨®ä»¥ä¸Š</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">A<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Vasoconstrictors</span></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">從表一</span> </p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">僅å¯å«ä¸€ç¨®</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Vasoconstrictors</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">僅å¯å«ä¸€ç¨®</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">B<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Neositigmine methyl sulfate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">C<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: symbol; font-size: 9pt;">½</span><span style="font-size: 9pt;"><br /> 7</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Anti-inflammatory astringents</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">Zinc sulfate</span></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/50</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 8.5pt 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">至多å«</span></b><b><span style="font-size: 9pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">種æˆåˆ†ï¼Œå„é …ä¸åƒ…å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">D<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Antihistamines</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/50</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">僅å¯å«ä¸€ç¨®</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">E<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Sodium flavin adenine dinucleotide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" rowspan="3" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><s style="text-line-through: double;"> </s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 8.5pt 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">至多å«</span></b><b><span style="font-size: 9pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">種æˆåˆ†ï¼Œå„é …ä¸åƒ…å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Cyanocobalamin</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Retinols</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">4</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Pyridoxine hydrochloride<br /> Pyridoxal phosphate</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">5</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Pantothenatos</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">6</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Tocopherol acetate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">F<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Aspartates</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" rowspan="3" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom: windowtext 2.25pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/2</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 2.25pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"><b><span style="font-size: 9pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 8.5pt 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">2/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">至多å«</span></b><b><span style="font-size: 9pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">種æˆåˆ†ï¼Œå„é …ä¸åƒ…å¯å«ä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Aminoethyl sulfonic acid</span></p> </td> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 2.25pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0.85pt;"><b><span style="font-size: 9pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;"><br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="font-size: 9pt;">1/100</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Sodium chondroitin sulfate</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">G<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Inorganic salts</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">ç„¡è¨å®šå«é‡</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 2.25pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 2.25pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">ç„¡è¨å®šå«é‡</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1.4pt;"><b><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 9pt;">以</span></b><b><span style="letter-spacing: -0.4pt; font-size: 9pt;">G</span></b><b><span style="letter-spacing: -0.4pt; font-family: 標楷體; font-size: 9pt;">欄所製æˆä¹‹äºº</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">å·¥<span style="letter-spacing: -0.4pt;">淚液åŠæ´—眼劑其å«</span>é‡<span style="letter-spacing: -0.4pt;">以物性質è¦ç¯„之</span></span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">H<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Hydroxyethyl cellulose, etc.</span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">從表一</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧≧</span></b><b><span style="font-size: 9pt;">1/10</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 0.55pt 1.5pt 1.4pt;"><b><span style="letter-spacing: -0.7pt; font-family: 標楷體; font-size: 9pt;">ç„¡è¨å®šå«</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">é‡</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">人工淚液（</span><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">）之é…åˆé‡å¾žè¡¨ä¸€</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 0cm;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Lanolin preparation<br /> Oleaginous ingredients</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">人工淚液（</span><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">）之é…åˆé‡å¾žè¡¨ä¸€</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 152.05pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 9.1pt; margin: 1.5pt 1cm;"><span style="font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 99.95pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 200pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">：</span></b><b><span style="font-size: 9pt;">5.5 - 8.0<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">滲é€å£“比：</span></b><b><span style="font-size: 9pt;">0.85 - 1.55<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">（å°ç”Ÿç†é£Ÿé¹½æ°´ï¼‰</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 100pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><b><span style="font-size: 9pt;">pH</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">：</span></b><b><span style="font-size: 9pt;">5.5 - 8.0<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">滲é€å£“比：</span></b><b><span style="font-size: 9pt;">0.60 - 1.55<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">（å°ç”Ÿç†é£Ÿé¹½æ°´ï¼‰</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid; height: 6.7pt;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 116.6pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 49.95pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><s style="text-line-through: double;"><span style="font-size: 9pt; text-decoration: none;"> </span></s></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 81.6pt; padding-right: 0cm; height: 6.7pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 14.2pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 21.25pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 116.55pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Note 1</span><span style="font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 5.65pt;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 100pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" colspan="2"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">：該製劑ä¸ä¸å¯é…åˆ</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 150pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" colspan="3"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">：沒有é…åˆè¦å‰‡</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-align: right; line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-size: 9pt;">Note 2</span><span style="font-family: 標楷體; font-size: 9pt;">）</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 50pt; padding-right: 0cm; padding-top: 0cm;border: windowtext 2.25pt solid;"> <p style="text-align: center; line-height: 9.1pt; margin: 1.5pt 2.85pt;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 131.6pt; padding-right: 0cm; padding-top: 0cm;border-color: #f0f0f0;" colspan="2"> <p style="line-height: 9.1pt; margin: 1.5pt 2.85pt;"><span style="font-family: 標楷體; font-size: 9pt;">ï¼šç·šæ¡†ç‚ºå¿…é ˆé…åˆæˆåˆ†</span> </p> </td> </tr> </tbody></table></div><p style="line-height: 0.7pt;"><s style="text-line-through: double;"><span style="font-size: 8pt; text-decoration: none;"> </span></s></p>2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=2719&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=2728&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=5762&type=0
查驗登記類,指示藥å“審查基準,解熱鎮痛劑行政解釋指示藥å“審查基準-解熱鎮痛劑<div style="layout-grid: 18pt none;" class="WordSection1"><p style="text-align: center; margin: 0cm 0cm 36pt;"><span style="font-family: 標楷體; font-size: 28pt;">解熱鎮痛劑</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">壹ã€é©ç”¨ç¯„åœ</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">凡內æœæˆ–è‚›é–€æ “åŠ‘æŠ•äºˆï¼Œä»¥è§£ç†±éŽ®ç—›ç‚ºç›®çš„ä¹‹è£½åŠ‘ï¼Œå‡é©ç”¨æœ¬åŸºæº–。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt;"><span> </span><span style="font-family: 標楷體; font-size: 20pt;">è²³ã€æœ‰æ•ˆæˆåˆ†</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 78.25pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">一ã€</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">有效æˆåˆ†ä¹‹ç¨®é¡žåŠå«é‡ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.15pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(一)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">本基準å¯é…åˆä¹‹æœ‰æ•ˆæˆåˆ†ï¼Œè¨˜è¼‰æ–¼è¡¨ä¸€ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.15pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(二)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">表一è¦å®š</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄åŠ</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄ä¸ï¼Œå„有效æˆåˆ†ä¹‹</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ã€‚å…¶ä¸ï¼Œ</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄å¯äºŒçµ„擇一使用。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 111.15pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(三)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">表一è¦å®š</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄ä¸å„有效æˆåˆ†ä¸€æ—¥é…åˆé‡ä¹‹ä¸Šä¸‹é™ï¼ŒåŠ</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄å„有效æˆåˆ†ä¹‹ä¸€æ—¥æœ€å¤§é…åˆé‡ã€‚</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 6pt 36pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一ã€æœ‰æ•ˆæˆåˆ†ä¹‹ç¨®é¡ž</span> </p><table style="margin: auto auto auto 37.4pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="600"> <tbody> <tr style="page-break-inside: avoid; height: 25.15pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; height: 25.15pt; padding-top: 0cm;border: windowtext 1pt solid;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">有</span> <span style="font-family: 標楷體;">效</span> <span style="font-family: 標楷體;">æˆ</span> <span style="font-family: 標楷體;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center;">1<span style="font-family: 標楷體;">次最大é…åˆé‡</span> </p> <p style="text-align: center;"><b><span style="font-size: 11pt;">(</span></b><b><span style="font-family: 標楷體; font-size: 11pt;">最大單ä½å«é‡</span></b><b><span style="font-size: 11pt;">)</span></b><b> </b><b><sup><span style="font-size: 11pt;">*1</span></sup></b> (mg)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; height: 25.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">一日最大é…åˆé‡</span> (mg)</p> </td> </tr> <tr style="page-break-inside: avoid; height: 25.1pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第一組</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第二組</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第一組</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; height: 25.1pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-family: 標楷體; font-size: 11pt;">第二組</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center;">A</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Acetaminophen</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">325</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">1000</span></b></p> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">(500)<sup> *1</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">1600</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">4000</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center;">2</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Aspirin</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">500</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">1000</span></b></p> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">(500)<sup> *1</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">1600</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">4000</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;">3</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">Ethenzamide</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">500</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">—</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">1500</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">—</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Salicylamide</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">325</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">—</span></b> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">1600</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 51.75pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">—</span></b> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;">B</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="2"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">Caffeine</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">120</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><span style="font-size: 11pt;">300</span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">Caffeine Anhydrous</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">120</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center; line-height: 13pt; margin: 2pt 0cm;"><b><span style="font-size: 11pt;">300</span></b></p> </td> </tr> <tr style="height: 66.8pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 450pt; padding-right: 1.4pt; height: 66.8pt; padding-top: 0cm;border-color: #f0f0f0;" colspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2pt 0cm 6pt;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 450pt; padding-right: 1.4pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" colspan="8"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2pt 0cm 6pt;"><span style="font-family: 標楷體; font-size: 14pt;">表一ã€æœ‰æ•ˆæˆåˆ†ä¹‹ç¨®é¡žï¼ˆçºŒï¼‰</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="border-bottom: windowtext 0.75pt solid; text-align: center; padding-bottom: 1pt; margin: 3pt 1.4pt; padding-top: 1pt;"><span style="font-family: 標楷體;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; margin: 3pt 1.4pt; padding-top: 1pt;"><span style="font-family: 標楷體;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; margin: 3pt 2cm;"><span style="font-family: 標楷體;">有</span> <span style="font-family: 標楷體;">效</span> <span style="font-family: 標楷體;">æˆ</span> <span style="font-family: 標楷體;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; margin: 3pt 5.65pt; padding-top: 1pt;"><span style="font-family: 標楷體;">一日é…åˆé‡</span>(mg)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-align: center;"><b>C</b></p> <p style="text-align: center;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><b>1</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">Vitamin B<sub>1</sub></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">1.8-30</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 1.4pt 0.5pt 0cm; layout-grid-mode: char;"><b><span style="font-family: 標楷體;">有效æˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 187.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Bisbentiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Bisibutiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Cetotiamine hydrochloride</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Cycotiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Dibenzoyl thiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.6pt; font-size: 11pt;">Dibenzoyl thiamine hydrochloride</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Fursultiamine hydrochloride</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Octotiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Prosultiamine</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Thiamine hydrochloride<br /> (Vitamin B<sub>1</sub>)</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Thiamine mononitrate</span></b></p> <p style="margin: 0cm 1.4pt 0.5pt 7.55pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Thiamine dicetylsulfate</span></b></p> <p><b><span style="font-size: 11pt;">Thiamine disulfide</span></b> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><b>2</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">Vitamin B<sub>2</sub></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">2.25-10</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 0cm 1.4pt 0.5pt 0cm; layout-grid-mode: char;"><b><span style="font-family: 標楷體;">有效æˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 187.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Riboflavin (Vitamin B<sub>2</sub>)</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Riboflavin butyrate</span></b></p> <p style="margin: 1.5pt 0cm 1.5pt 7.6pt;"><b><span style="font-size: 11pt;">Riboflavin sodium phosphate</span></b> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">Vitamin C</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b><span style="font-size: 11pt;">82.5-500</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="margin: 1.5pt 0cm;"><b><span style="font-family: 標楷體;">有效æˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 187.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Ascorbic acid (Vitamin C)</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">L-Ascorbyl palmitate</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">L-Ascorbyl stearate</span></b></p> <p style="text-justify: inter-ideograph; text-align: justify; margin: 1.5pt 1.4pt 1.5pt 7.6pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Calcium ascorbate</span></b></p> <p style="margin: 1.5pt 0cm 1.5pt 7.6pt;"><b><span style="font-size: 11pt;">Sodium ascorbate</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="4"> <p style="text-align: center; margin: 1.5pt 0cm;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">欄</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">é …</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-align: center;"><span style="font-family: 標楷體;">有效æˆåˆ†</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 207pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-align: center; margin: 3pt 0cm;"><span style="font-family: 標楷體;">一日最大é…åˆé‡</span><span>(g)<b><sup>*2</sup></b></span></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 1.4pt;"><span style="font-family: 標楷體;">浸</span> <span style="font-family: 標楷體;">è†</span><sup><span><br /> </span></sup><span style="letter-spacing: -0.7pt; font-size: 9pt;">(</span><span style="letter-spacing: -0.7pt; font-family: 標楷體; font-size: 9pt;">原生藥æ›ç®—é‡</span><span style="letter-spacing: -0.7pt; font-size: 9pt;">)</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1pt 1.4pt;"><span style="font-family: 標楷體;">粉</span> <span style="font-family: 標楷體;">末</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="4"> <p style="text-align: center;"><b>D</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18.7pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="4"> <p style="text-align: center;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Glycyrrhizae radix </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">甘è‰</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">1.5</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Cinnamomi cortex </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">æ¡‚çš®</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">1</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Zingiberis rhizoma </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">生薑</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">3</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">1</span></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 205.6pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="margin: 1.5pt 5.65pt; layout-grid-mode: char;"><b><span style="font-size: 11pt;">Paeoniae radix </span></b><b><span style="font-family: 標楷體; font-size: 11pt;">èŠè—¥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 103.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; margin: 1.5pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 11pt;">2</span></b></p> </td> </tr> </tbody></table><p style="line-height: 20pt; margin: 3pt 0cm 3pt 63pt;"><span style="font-size: 14pt;">*1. </span><b><span style="font-family: 標楷體; font-size: 14pt;">最大單ä½å«é‡ï¼šç‚ºé™åˆ¶éŒ 劑ã€è† 囊ã€æ “劑ã€æ•£åŠ‘</span></b><b><span style="font-size: 14pt;">……</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ç‰ä¹‹æ¯è£½åŠ‘å–®ä½ï¼ˆä¾‹å¦‚：æ¯éŒ ã€æ¯é¡†ã€æ¯åŒ…</span></b><b><span style="font-size: 14pt;">……</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）ä¸æœ‰æ•ˆæˆåˆ†ä¹‹æœ€é«˜å«é‡ã€‚</span></b> </p><p style="line-height: 20pt; margin: 3pt 0cm 18pt 62.85pt;"><span style="font-size: 14pt;">*2. </span><b><span style="font-family: 標楷體; font-size: 14pt;">åŒä¸€æˆåˆ†ä¹‹æµ¸è†èˆ‡ç²‰æœ«ä¸å¯åŒæ™‚使用。浸è†ä¹‹ä¸€æ—¥æœ€å¤§é…åˆé‡ä¿‚以原生藥經抽æ製æˆæµ¸è†æ‰€ç”¨çš„原生藥é‡è¡¨ç¤ºä¹‹ã€‚</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 12pt;"><span style="font-family: 標楷體; font-size: 14pt;">二ã€é…åˆè¦å‰‡ï¼ˆè¦‹è¡¨äºŒï¼‰ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 72.05pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">ï¼ˆä¸€ï¼‰å¿…é ˆé…åˆæˆåˆ†ï¼š</span></b><b> </b></p><ol> <li>ç¬¬ä¸€çµ„è£½åŠ‘ä¹‹å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€A欄ä¸ä¹‹å„有效æˆåˆ†ã€‚é…æ–¹ä¸è‡³å°‘需å«ä¸€ç¨®ï¼Œæœ€å¤šå¯åŒæ™‚é…åˆä¸‰ç¨®å¿…é ˆé…åˆæˆåˆ†ã€‚ <ol> <li>ç¬¬äºŒçµ„è£½åŠ‘ä¹‹å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€A欄1é …åŠ2é …ä¸ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚é…æ–¹ä¸è‡³å°‘需å«ä¸€ç¨®ï¼Œæœ€å¤šå¯åŒæ™‚é…åˆäºŒç¨®å¿…é ˆé…åˆæˆåˆ†ã€‚</li> </ol> </li></ol><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 72.05pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">（二）å¯é…åˆæˆåˆ†ï¼š</span></b><b> </b></p><ol> <li>指表一B欄ã€C欄åŠD欄ä¸ä¹‹æœ‰æ•ˆæˆåˆ†ï¼Œå¯èˆ‡Aæ¬„å¿…é ˆé…åˆæˆåˆ†è¤‡æ–¹é…åˆä½¿ç”¨ã€‚若第二組製劑é…åˆD欄æˆåˆ†æ™‚ï¼Œé ˆæª¢é™„å大先進國ä¸ä¸€åœ‹ä»¥ä¸ŠæŽ¡ç”¨ä¹‹è™•æ–¹ä¾æ“šã€‚</li> <li>B欄ä¸è‡³å¤šå¯é…åˆä¸€ç¨®æˆåˆ†ã€‚</li></ol><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 72.05pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">（三）製劑ä¸å«ç”Ÿè—¥æˆåˆ†è€…（表一</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄），應åšç”Ÿè—¥æˆåˆ†ä¹‹å®šæ€§è©¦é©—ï¼›å°æ–¼è—¥å…¸ç‰å…¬å®šæ›¸æ‰€æ”¶è¼‰ä¹‹ç”Ÿè—¥æœ‰æŒ‡æ¨™æˆåˆ†å®šé‡è€…，應åšå®šé‡è©¦é©—。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 14pt;">三ã€æœ‰æ•ˆæˆåˆ†ä¹‹é…åˆé‡ï¼ˆè¦‹è¡¨äºŒï¼‰</span></b><span style="font-family: 標楷體; font-size: 14pt;">：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 63pt;"><b><span style="font-family: 標楷體; font-size: 16pt;">(一)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄æˆåˆ†ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">å„有效æˆåˆ†ä¹‹</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ï¼Œä¾è¡¨ä¸€è©²è£½åŠ‘é…åˆçµ„別之è¦å®šã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">å„有效æˆåˆ†ä¹‹æ¯æ¬¡æœ€é«˜é…åˆåŠ‘é‡åŠæ¯æ—¥æœ€é«˜åŠ‘é‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—之</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ã€‚</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">第二組</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">製劑ä¸å«</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">或</span></b><b><span style="font-size: 14pt;">Aspirin</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">時，æ¯è£½åŠ‘å–®ä½æœ€é«˜å«é‡ä¸å¾—超éŽè¡¨ä¸€æœ€å¤§å–®ä½å«é‡ä¹‹è¦å®šã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 48pt 89.9pt; layout-grid-mode: char;"><span style="font-size: 16pt;">3ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">åŒæ¬„ä¸é…åˆä¸€ç¨®æœ‰æ•ˆæˆåˆ†æ™‚，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該é…åˆæˆåˆ†ä¹‹é…åˆä¿‚數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">åŠ</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">4ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">第一組製劑：åŒæ¬„ä¸é…åˆäºŒç¨®æˆ–三種有效æˆåˆ†æ™‚，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該欄之é…åˆä¿‚數應介於</span></b><b><span style="font-size: 14pt;">38/30</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">åŠ</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間，且該欄å„é…åˆæˆåˆ†æ¯æ—¥åŠ‘é‡ä¹‹é…åˆä¿‚數下é™ä¸å¾—å°æ–¼</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 89.9pt; layout-grid-mode: char;"><span style="font-size: 16pt;">5ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">第二組製劑：åŒæ¬„ä¸é…åˆäºŒç¨®æœ‰æ•ˆæˆåˆ†æ™‚，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該欄之é…åˆä¿‚數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">åŠ</span></b><b><span style="font-size: 14pt;">1/2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間，且該欄å„é…åˆæˆåˆ†æ¯æ—¥åŠ‘é‡ä¹‹é…åˆä¿‚數下é™ä¸å¾—å°æ–¼</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><span style="font-size: 16pt;">6ã€</span><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">n</span></sub></b></p> </div> </td> </tr> </tbody></table><b><span style="font-family: 標楷體; font-size: 14pt;">é…åˆä¿‚數ï¼</span></b><b><span style="font-size: 14pt;">Σ</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="font-size: 14pt;">X<sub>i</sub> / mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">ï¼</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>1</sub> / mX<sub>1</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>2</sub> / mX<sub>2</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+……+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>n</sub> / mX<sub>n</sub></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 90pt;"><b><span style="font-size: 14pt;">X<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：å„欄é…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之æ¯æ—¥åŠ‘é‡</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 90pt;"><b><span style="font-size: 14pt;">mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：å„欄é…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大é…åˆé‡ï¼ˆç¬¬ä¸€ã€äºŒçµ„製劑應分別採用其è¦å®šä¹‹ä¸€æ—¥æœ€å¤§é…åˆé‡ï¼‰</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 89.85pt;"><b><span style="font-size: 14pt;">n</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：å„欄之é…åˆæˆåˆ†æ•¸</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 62.95pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 16pt;">(二)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é…æ–¹ä¸å«è¡¨ä¸€</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄æˆåˆ†ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">å„有效æˆåˆ†ä¹‹æ¯æ¬¡æœ€é«˜é…åˆåŠ‘é‡åŠæ¯æ—¥æœ€é«˜åŠ‘é‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—之</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">é…æ–¹ä¸å«</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄有效æˆåˆ†æ™‚，該欄之é…åˆä¿‚數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">åŠ</span></b><b><span style="font-size: 14pt;">1/5</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 105.95pt;"><span style="font-size: 16pt;">3ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">é…åˆä¿‚數ï¼</span></b><b><span style="font-size: 14pt;">X / mX</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 89.85pt;"><b><span style="font-size: 14pt;">X</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄ä¸ï¼Œé…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">x</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之æ¯æ—¥åŠ‘é‡</span></b><b><span style="font-size: 14pt;"><br />mX</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄ä¸ï¼Œé…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">x</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大é…åˆé‡</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 63pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 16pt;">(三)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é…æ–¹ä¸å«è¡¨ä¸€</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄æˆåˆ†ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1ã€</span><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄å„é…åˆæˆåˆ†ä¸€æ—¥é…åˆé‡ä¹‹ä¸Šä¸‹é™ä¾è¡¨ä¸€ä¹‹è¦å®šã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 72pt 89.9pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2ã€</span><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …åŠ</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ä¸é…åˆäºŒç¨®æˆ–二種以上æˆåˆ†æ™‚ï¼Œè©²é …ä¹‹é…åˆä¿‚數ä¸å¯å¤§æ–¼</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。å³è©²é …å„é…åˆæˆåˆ†ä¹‹æ¯æ—¥åŠ‘é‡é™¤ä»¥è©²æˆåˆ†ä¹‹ä¸€æ—¥æœ€å¤§é…åˆé‡ï¼Œæ‰€å¾—數值的總和ä¸å¯å¤§æ–¼</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><span style="font-size: 16pt;">3ã€</span><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">n</span></sub></b></p> </div> </td> </tr> </tbody></table><b><span style="font-family: 標楷體; font-size: 14pt;">é…åˆä¿‚數ï¼</span></b><b><span style="font-size: 14pt;">Σ</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="font-size: 14pt;">X<sub>i</sub> / mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="font-size: 14pt;"><br /></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">ï¼</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>1</sub> / mX<sub>1</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>2</sub> / mX<sub>2</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+……+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>n</sub> / mX<sub>n</sub></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">X<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄é…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之æ¯æ—¥åŠ‘é‡</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄é…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大é…åˆé‡</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 108pt; layout-grid-mode: char;"><b><span style="font-size: 14pt;">n</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄之é…åˆæˆåˆ†æ•¸</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 63pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 16pt;">(å››)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é…æ–¹ä¸å«è¡¨ä¸€</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄æˆåˆ†ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">1ã€</span><b><span style="font-family: 標楷體; font-size: 14pt;">åŒæ¬„ä¸é…åˆä¸€ç¨®æˆåˆ†æ™‚，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">該欄之é…åˆä¿‚數應介於</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">åŠ</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之間</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 9pt 90pt; layout-grid-mode: char;"><span style="font-size: 16pt;">2ã€</span> <span style="z-index: 251659264; position: absolute; left: 0pt;"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div style="padding-bottom: 0pt; padding-left: 0pt; padding-right: 0pt; padding-top: 0pt;" class="shape"> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">n</span></sub></b></p> </div> </td> </tr> </tbody></table></span><b><span style="font-family: 標楷體; font-size: 14pt;">åŒæ¬„ä¸é…åˆäºŒç¨®æˆ–二種以上æˆåˆ†æ™‚，該é…åˆæˆåˆ†ä¹‹é…åˆä¿‚數ä¸å¯å¤§æ–¼</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">，</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">且該欄å„é…åˆæˆåˆ†æ¯æ—¥åŠ‘é‡ä¹‹é…åˆä¿‚數下é™ä¸å¾—å°æ–¼</span></b><b><span style="font-size: 14pt;">1/10</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><span style="font-size: 16pt;">3ã€</span> <span style="z-index: 251658240; position: absolute; left: 0pt;"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div style="padding-bottom: 0pt; padding-left: 0pt; padding-right: 0pt; padding-top: 0pt;" class="shape"> <p style="text-align: center;"><b><sub><span style="font-size: 14pt;">i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table></span><b><span style="font-family: 標楷體; font-size: 14pt;">é…åˆä¿‚數ï¼</span></b><b><span style="font-size: 14pt;">Σ</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="font-size: 14pt;">X<sub>i</sub> / mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 6pt 153pt;"><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">ï¼</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>1</sub> / mX<sub>1</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>2</sub> / mX<sub>2</sub></span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">+……+</span></b><b><span style="letter-spacing: -1.6pt; font-family: 標楷體; font-size: 14pt;">（</span></b><b><span style="letter-spacing: -1.6pt; font-size: 14pt;">X<sub>n</sub> / mX<sub>n</sub></span></b><b><span style="letter-spacing: -1.3pt; font-family: 標楷體; font-size: 14pt;">）</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">X<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄é…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之æ¯æ—¥åŠ‘é‡</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 3pt 135pt;"><b><span style="font-size: 14pt;">mX<sub>i</sub></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄é…åˆæˆåˆ†</span></b><b><span style="font-size: 14pt;">i</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">之一日最大é…åˆé‡</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 30pt 108pt; layout-grid-mode: char;"><b><span style="font-size: 14pt;">n</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">：</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄之é…åˆæˆåˆ†æ•¸</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">åƒã€åŠ‘åž‹</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 5.65pt 18pt 59.3pt;"><span style="font-family: 標楷體; font-size: 14pt;">一ã€é™æ–¼éŒ 劑ã€<b>è†œè¡£éŒ ã€ç³–è¡£éŒ </b>ã€è† 囊劑ã€<b>è»Ÿè† å›ŠåŠ‘ã€å…§æœ</b>液劑ã€<b>懸液劑</b>ã€ç³–漿劑ã€æ•£åŠ‘ã€<b>溶液用粉劑ã€ç³–漿用粉劑ã€å…§æœ</b>顆粒劑ã€<b>糖漿用</b>顆粒劑ã€<b>細粒劑</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 5.65pt 18pt 59.1pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">二ã€å…§æœæ¶²åŠ‘（å«ç³–漿劑）æˆäºº</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">次用é‡é ˆ</span></b><b><span style="font-size: 14pt;">5mL</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">以上，零售最大單ä½åŒ…è£ä¸å¾—超éŽä¸‰æ—¥ç”¨é‡ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 5.65pt 18pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">三ã€å«</span></b><b><span style="font-size: 14pt;">Salicylates</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">水楊酸類產å“å¯ç‚ºè…¸æº¶åŠ‘型。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 78pt 67.5pt;"><span style="font-family: 標楷體; font-size: 14pt;">å››ã€<b>å«</b></span><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ã€</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …æˆ–</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …</span></b><b><span style="font-size: 14pt;">Salicylamide</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ä¹‹å–®æ–¹è£½åŠ‘å¾—æœ‰æ “åŠ‘</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">肆ã€é©æ‡‰ç—‡</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 30pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">退燒ã€æ¢ç—›ï¼ˆç·©è§£é ç—›ã€ç‰™ç—›ã€å’½å–‰ç—›ã€é—œç¯€ç—›ã€ç¥žç¶“ç—›ã€è‚Œè‚‰é…¸ç—›ã€æœˆç¶“痛）。</span></b><b> </b></p><h1 style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">ä¼ã€ç”¨æ³•ç”¨é‡</span> </h1><p style="line-height: 20pt; margin: 0cm 0cm 18pt 59.2pt;"><span style="font-family: 標楷體; font-size: 14pt;">一ã€<b>第一組製劑：發燒</b>或需è¦æ™‚æœç”¨ï¼Œè‹¥ç—‡ç‹€æŒçºŒï¼Œå‰‡æ¯</span><span style="font-size: 14pt;">4~6</span><span style="font-family: 標楷體; font-size: 14pt;">å°æ™‚å¯é‡è¤‡æœç”¨<b>。æ¯</b></span><b><span style="font-size: 14pt;">24</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å°æ™‚å…§ä¸å¯è¶…éŽ</span></b><b>â—‹</b><b><span style="font-family: 標楷體; font-size: 14pt;">次。</span></b><b><s> </s></b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 59.2pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">二ã€ç¬¬äºŒçµ„製劑：發燒或需è¦æ™‚æœç”¨ï¼Œè‹¥ç—‡ç‹€æŒçºŒï¼Œå‰‡æ¯</span></b><b><span style="font-size: 14pt;">4~6</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å°æ™‚å¯é‡è¤‡æœç”¨ï¼Œæ¯æ¬¡</span></b><b>â—‹</b><b><span style="font-size: 14pt;">~</span></b><b>â—‹</b><b><span style="font-family: 標楷體; font-size: 14pt;">éŒ ï¼ˆæˆ–é¡†ã€åŒ…</span></b><b><span style="font-size: 14pt;">……</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">），åˆæ¬¡æ‡‰ä½¿ç”¨æœ€å°å»ºè°åŠ‘é‡ï¼Œå†è¦–症狀增減用é‡ã€‚æ¯</span></b><b><span style="font-size: 14pt;">24</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å°æ™‚å…§ä¸å¯è¶…éŽ</span></b><b>â—‹</b><b><span style="font-family: 標楷體; font-size: 14pt;">次。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 59.2pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">三ã€å«</span></b><b><span style="font-size: 14pt;">Salicylates</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">水楊酸類產å“ï¼Œé ˆè¨˜è¼‰ã€Œé£¯å¾ŒåŠå°æ™‚å…§æœç”¨ç‚ºå®œã€</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 36pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">å››ã€è…¸æº¶è£½åŠ‘應整粒åžæœï¼Œä¸å¾—å‰åŠæˆ–嚼碎。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 45.1pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">五ã€æ “劑ä¸å¾—å‰åŠä½¿ç”¨</span></b><b><span style="font-family: 標楷體; font-size: 11pt;">。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 6pt 36pt;"><span style="font-family: 標楷體; font-size: 14pt;">å…ã€å¹´é½¡åˆ†é…係數：</span> </p><p style="line-height: 20pt; margin: 0cm 5.65pt 30pt 72pt;"><span style="font-size: 14pt;">12</span><span style="font-family: 標楷體; font-size: 14pt;">æ²ä»¥ä¸Šï¼Œé©ç”¨æˆäººåŠ‘é‡ã€‚</span><span style="font-size: 14pt;"><br />6</span><span style="font-family: 標楷體; font-size: 14pt;">æ²ä»¥ä¸Šæœªæ»¿</span><span style="font-size: 14pt;">12</span><span style="font-family: 標楷體; font-size: 14pt;">æ²ï¼Œé©ç”¨æˆäººåŠ‘é‡ä¹‹</span><span style="font-size: 14pt;">1/2</span><span style="font-family: 標楷體; font-size: 14pt;">。</span><span style="font-size: 14pt;"><br />3</span><span style="font-family: 標楷體; font-size: 14pt;">æ²ä»¥ä¸Šæœªæ»¿</span> <span style="font-size: 14pt;">6</span><span style="font-family: 標楷體; font-size: 14pt;">æ²ï¼Œé©ç”¨æˆäººåŠ‘é‡ä¹‹</span><span style="font-size: 14pt;">1/4</span><span style="font-family: 標楷體; font-size: 14pt;">。</span><span style="font-size: 14pt;"><br />3</span><span style="font-family: 標楷體; font-size: 14pt;">æ²ä»¥ä¸‹ä¹‹å¬°å¹¼å…’，<b>請洽醫師診治，ä¸å®œè‡ªè¡Œä½¿ç”¨</b>。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt;"><span style="font-family: 標楷體; font-size: 20pt;">陸ã€æ³¨æ„äº‹é …</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><span style="font-size: 16pt;">一ã€<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; font-size: 14pt;">為防æ¢å…’童誤食請妥善ä¿ç®¡</span></b><span style="font-family: 標楷體; font-size: 14pt;">。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><span style="font-size: 16pt;">二ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 14pt;">é¿å…陽光直射，宜ä¿å˜æ–¼é™°æ¶¼ä¹‹è™•ã€‚</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 62.95pt;"><span style="font-size: 16pt;">三ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 14pt;">除éž<b>有醫師藥師藥劑生</b>指示，å•å©¦åŠæŽˆä¹³å©¦ä¸å»ºè°è‡ªè¡Œä½¿ç”¨ã€‚</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><b><span style="font-size: 16pt;">四〠</span></b><span style="font-family: 標楷體; font-size: 14pt;">勿超éŽå»ºè°åŠ‘é‡ï¼Œ<b>若有ä¸é©æƒ…æ³ç”¢ç”Ÿï¼Œ</b>應<b>åœæ¢ä½¿ç”¨ä¸¦è«‹æ•™é†«å¸«è—¥å¸«è—¥åŠ‘生</b>。</span><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 62.95pt;"><span style="font-size: 16pt;">五ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 14pt;">懸液劑使用å‰é ˆæŒ¯æ–å‡å‹»ï¼Œä¸¦ä½¿ç”¨å» 商所附é‡å™¨é‡å–è—¥é‡ã€‚</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><b><span style="font-size: 16pt;">å…〠</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æ “åŠ‘é™ä½¿ç”¨æ–¼è‚›é–€ï¼Œè‹¥è—¥åŠ‘éŽè»Ÿæ™‚，請置於低溫待較硬後å†ä½¿ç”¨ã€‚</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 30pt 62.95pt;"><b><span style="font-size: 16pt;">七〠</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ä¸å¾—ä½µæœå«é…’精飲料。</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 16pt;"><span style="font-family: 標楷體; font-size: 20pt;">柒ã€è¦èªž</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><span style="font-size: 14pt;">一ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 14pt;">æœç”¨å¾Œï¼Œè‹¥æœ‰ç™¼ç–¹ã€ç™¼ç´…ã€å™å¿ƒã€å˜”åã€é£Ÿæ…¾ä¸æŒ¯ã€é 暈ã€è€³é³´ç‰ç—‡ç‹€æ™‚，應åœè—¥ä¸¦å°±é†«ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 24pt;"><span style="font-size: 14pt;">二ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 14pt;">除éž<b>有醫師藥師藥劑生</b>指示，請éµå¾ªä¸‹åˆ—情æ³æœç”¨ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 81pt;"><span style="font-size: 14pt;">(一)<span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt;">3</span><span style="font-family: 標楷體; font-size: 14pt;">æ²ä»¥ä¸‹ä¸å»ºè°è‡ªè¡Œä½¿ç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 81pt;"><span style="font-size: 14pt;">(二)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 14pt;">æ›¾ç¶“å› è—¥ç‰©å¼•èµ·éŽæ•ç—‡ç‹€è€…ä¸å¾—使用。</span> </p><p style="line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><b><span style="font-size: 14pt;">三ã€<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æœç”¨æœ¬é¡žè£½åŠ‘三天後，發燒ã€ç–¼ç—›ç—‡ç‹€æœªè¦‹æ”¹å–„，應åœè—¥å°±é†«ã€‚</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><b><span style="font-size: 14pt;">å››ã€<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æˆäººä¸å¾—連續æœç”¨æœ¬é¡žè£½åŠ‘超éŽ</span></b><b><span style="font-size: 14pt;">7</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">天，å°å©ä¸å¾—超éŽ</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">天，視情形需è¦ï¼Œç¹¼çºŒæœç”¨æœ¬é¡žè£½åŠ‘å‰ï¼Œè«‹æ´½é†«å¸«ã€‚</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 10pt 62.95pt;"><b><span style="font-size: 14pt;">五ã€<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å«</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘ï¼Œå¢žåˆ—ä¸‹è¿°è¦èªžï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 16pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">é…’ç²¾è¦èªžï¼šè‹¥æ¯æ—¥å–三æ¯æˆ–更多之酒精性飲料，請詢å•é†«å¸«æ˜¯å¦èƒ½æœç”¨æœ¬è—¥ï¼Œå› 為</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å¯èƒ½é€ æˆè‚æ害。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 62.95pt;"><b><span style="font-size: 14pt;">å…ã€<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å«</span></b><b><span style="font-size: 14pt;">Acetaminophen</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（表一</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼‰é…åˆå…¶ä»–解熱鎮痛æˆåˆ†ï¼ˆè¡¨ä¸€</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …åŠ</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘ï¼Œå¢žåˆ—ä¸‹è¿°è¦èªžï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 48pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">é…’ç²¾è¦èªžï¼šè‹¥æ¯æ—¥å–三æ¯æˆ–更多之酒精性飲料，請詢å•é†«å¸«æ˜¯å¦èƒ½æœç”¨æœ¬è—¥ï¼Œå› 為ã€ç”¢å“æˆåˆ†ã€‘å¯èƒ½é€ æˆè‚æ害åŠèƒƒå‡ºè¡€ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 63pt;"><b><span style="font-size: 14pt;">七ã€<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å«æ°´æ¥Šé…¸é¡žï¼ˆè¡¨ä¸€</span></b><b><span style="font-size: 14pt;">A</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄</span></b><b><span style="font-size: 14pt;">2</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …åŠ</span></b><b><span style="font-size: 14pt;">3</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘ï¼Œå¢žåˆ—ä¸‹è¿°è¦èªžï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">本藥å«ã€æˆåˆ†å稱】，應注æ„ä¸‹åˆ—äº‹é …ï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 89.9pt;"><b><span style="font-size: 14pt;">(一)<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">é…’ç²¾è¦èªžï¼šè‹¥æ¯æ—¥å–三æ¯æˆ–更多之酒精性飲料，請詢å•é†«å¸«æ˜¯å¦èƒ½æœç”¨æœ¬è—¥ï¼Œå› 為ã€ç”¢å“æˆåˆ†ã€‘å¯èƒ½é€ æˆèƒƒå‡ºè¡€ã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 90pt;"><b><span style="font-size: 14pt;">(二)<span style="font: 7pt times new roman;"> </span></span></b><span style="letter-spacing: -0.3pt; font-family: 標楷體; font-size: 14pt;">除éž<b>有醫師藥師藥劑生</b>指示，</span><span style="font-family: 標楷體; font-size: 14pt;">è«‹éµå¾ªä¸‹åˆ—情æ³æœç”¨<b><span style="letter-spacing: -0.1pt;">：</span></b></span><b> </b></p><ol> <li><span style="font-family: 標楷體; font-size: 14pt;">本藥ä¸å¾—使用於</span><b><span style="font-size: 14pt;">12</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æ²ä»¥ä¸‹</span></b><span style="font-family: 標楷體; font-size: 14pt;">å…’ç«¥<b>，亦ä¸å¾—使用於æˆäºº</b>之水痘或æµè¡Œæ€§æ„Ÿå†’ç—‡ç‹€ä¹‹è§£é™¤ã€‚å› å…¶å¯èƒ½èˆ‡ä¸€ç¨®ç½•è¦‹è€Œåš´é‡ä¹‹ç–¾ç—…</span><span style="font-size: 14pt;">─</span><span style="font-family: 標楷體; font-size: 14pt;">é›·æ°ç—‡å€™ç¾¤ï¼ˆ</span><span style="font-size: 14pt;">Reye's Syndrome</span><span style="font-family: 標楷體; font-size: 14pt;">）有相關性。</span> </li> <li><span style="font-family: 標楷體; font-size: 14pt;">曾有消化性潰ç˜æˆ–使用抗å‡è¡€åŠ‘之患者，ä¸å¾—æœç”¨æœ¬è—¥ã€‚</span> </li></ol><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 90pt;"><span style="font-size: 14pt;">(三)<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; font-size: 14pt;">è ¶è±†ç—‡ï¼ˆ</span></b><b><span style="font-size: 14pt;">6-</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">磷酸葡è„糖脫氫酶缺ä¹ç—‡ï¼Œ</span></b><b><span style="font-size: 14pt;">Glucose-6-Phosphate Dehydrogenase Deficiency</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">）患者，ä¸å¾—æœç”¨æœ¬è—¥ã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 90pt;"><span style="font-size: 14pt;">(å››)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; font-size: 14pt;">å¯èƒ½å¼•èµ·èƒƒè…¸ä¸é©ã€èƒƒè…¸å‡ºè¡€ã€çš®è†šå‡ºç–¹ã€å‡ºè¡€å‚¾å‘ã€<b>氣喘</b>ã€è€³é³´ç‰ä¸é©ç—‡ç‹€ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 63pt;"><b><span style="font-size: 14pt;">å…«ã€<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 標楷體; font-size: 14pt;">å«å’–å•¡å› æˆåˆ†ï¼ˆè¡¨ä¸€</span></b><b><span style="font-size: 14pt;">B</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æ¬„ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 18pt 62.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">本藥å«å’–å•¡å› é¡žæˆåˆ†ï¼Œæ‡‰é™åˆ¶å†æœç”¨å«å’–å•¡å› è—¥å“ã€é£²æ–™ï¼ˆå¦‚：茶ã€å’–å•¡ã€å¯æ¨‚ç‰ï¼‰ï¼ŒéŽå¤šçš„å’–å•¡å› æœƒå¼•èµ·ç¥žç¶“ç·Šå¼µï¼Œèˆˆå¥®èˆ‡å¤±çœ ï¼Œä¸”å¸¸æœƒå¼•èµ·å¿ƒæéŽé€Ÿã€‚</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 66.4pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">ä¹ã€å«ç”˜è‰ï¼ˆè¡¨ä¸€</span></b><b><span style="font-size: 14pt;">D</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">欄）一日é…åˆé‡è¶…éŽ</span></b><b><span style="font-size: 14pt;">1 g</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">（或浸è†ä¹‹åŽŸç”Ÿè—¥æ›ç®—é‡ç‚º</span></b><b><span style="font-size: 14pt;">1 g</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">ä»¥ä¸Šï¼‰ä¹‹æœ¬é¡žè£½åŠ‘ï¼ŒåŠ å…¥ä¸‹è¿°è¦èªžï¼š</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 0cm 0cm 12pt 63pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">本藥å«ã€æˆåˆ†å稱】，應注æ„ä¸‹åˆ—äº‹é …ï¼š</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 12pt 94.5pt;"><b><span style="font-size: 14pt;">(</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">一</span></b><b><span style="font-size: 14pt;">)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">除éžæœ‰é†«å¸«è—¥å¸«è—¥åŠ‘生指示，高齡者與有嚴é‡è…¹ç—›ã€å™å¿ƒã€å˜”åã€æ°´è…«ç—‡ç‹€åŠé«˜è¡€å£“ã€å¿ƒè‡ŸåŠŸèƒ½éšœç¤™ã€è…Žè‡ŸåŠŸèƒ½éšœç¤™ä¹‹ç—…患請勿æœç”¨æœ¬è—¥ã€‚</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 94.4pt;"><b><span style="font-size: 14pt;">(</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">二</span></b><b><span style="font-size: 14pt;">)</span></b><b><span style="font-family: 標楷體; font-size: 14pt;">æœç”¨ä¸ç™¼ç¾æœ‰å°¿é‡æ¸›å°‘ã€é¢éƒ¨æˆ–手足浮腫ã€çœ¼çš®æ²‰é‡ã€æ‰‹éƒ¨åƒµç¡¬ï¼Œè¡€å£“å‡é«˜ã€é ç—›ç‰ç¾è±¡ï¼Œæ‡‰ç«‹å³åœè—¥å°±é†«ã€‚</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 12pt 26.95pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">åã€æ “åŠ‘ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span></b><b> </b></p><p style="line-height: 20pt; margin: 0cm 0cm 18pt 94.4pt;"><b><span style="font-family: 標楷體; font-size: 14pt;">æœƒé€ æˆç›´è…¸åˆºæ¿€æ„Ÿã€è…¹éƒ¨ä¸é©ï¼Œè…¹ç€‰è€…ä¸å®œä½¿ç”¨ã€‚</span></b><b> </b></p></div><b><span style="font-family: times new roman,serif; font-size: 14pt;"><br style="page-break-before: always;" clear="all" /></span></b><p><b><span style="font-family: 標楷體;">表二ã€é…åˆè¦å‰‡ã€é…åˆä¿‚數</span></b><b> </b></p><table style="margin: auto auto auto 0.75pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="972"> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt double; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 99pt; padding-right: 0cm; border-right-color: #f0f0f0; border-top: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3" colspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 17pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">有效æˆåˆ†</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 189pt; padding-right: 0cm; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 42.55pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">第一組製劑</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 171pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 42.55pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">第二組製劑</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt solid; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 3cm; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">備註</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">é…åˆè¦å‰‡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">åŒé¡žæˆ</span><span style="font-family: 標楷體; font-size: 9pt;">分</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">é…åˆä¸€</span><span style="font-family: 標楷體; font-size: 9pt;">種</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 108pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 0cm; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">åŒé¡žæˆåˆ†</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">至少é…åˆäºŒç¨®</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">é…åˆè¦å‰‡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">åŒé¡žæˆ</span><span style="font-family: 標楷體; font-size: 9pt;">分</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">é…åˆä¸€</span><span style="font-family: 標楷體; font-size: 9pt;">種</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 90pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 0cm; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">åŒé¡žæˆåˆ†</span><span style="font-size: 9pt;"><br /> </span><span style="font-family: 標楷體; font-size: 9pt;">至少é…åˆäºŒç¨®</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">é…åˆä¿‚</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">é…åˆä¿‚</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 0.55pt;"><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">å„æˆåˆ†ä¸€</span><span style="font-family: 標楷體; font-size: 9pt;">æ—¥</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">é…åˆé‡ä¸‹</span><span style="font-family: 標楷體; font-size: 9pt;">é™</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">é…åˆä¿‚</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.1pt; font-family: 標楷體; font-size: 9pt;">é…åˆä¿‚</span><span style="font-family: 標楷體; font-size: 9pt;">數</span> </p> </td> <td style="border-bottom: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 0.55pt;"><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">å„æˆåˆ†ä¸€</span><span style="font-family: 標楷體; font-size: 9pt;">æ—¥</span><span style="font-size: 9pt;"><br /> </span><span style="letter-spacing: -1.4pt; font-family: 標楷體; font-size: 9pt;">é…åˆé‡ä¸‹</span><span style="font-family: 標楷體; font-size: 9pt;">é™</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><span style="font-size: 9pt;">A<br /> </span><span style="font-family: 標楷體; font-size: 9pt;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt double; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><span style="font-size: 9pt;">1</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt double; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -2pt; font-size: 9pt;">1</span><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">38/30</span></b><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" rowspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span> <span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/2</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1.5pt double; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 2.85pt 0.5pt 11.9pt; layout-grid-mode: char;"><span style="font-family: wingdings; font-size: 11pt;">l </span><span style="font-family: 標楷體; font-size: 9pt;">至少需å«ä¸€ç¨®</span><b> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 2.85pt 0.5pt 11.9pt; layout-grid-mode: char;"><span style="font-family: wingdings; font-size: 11pt;">l </span><span style="font-family: 標楷體; font-size: 9pt;">第一組製劑最多å¯é…åˆä¸‰ç¨®æˆåˆ†</span><b> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 0cm 2.85pt 1pt 11.9pt; layout-grid-mode: char;"><span style="font-family: wingdings; font-size: 11pt;">l </span><span style="font-family: 標楷體; font-size: 9pt;">第二組製劑最多å¯é…åˆäºŒç¨®æˆåˆ†</span><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt double; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><span style="font-size: 9pt;">2</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt double; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><span style="font-size: 9pt;">3</span><span style="font-family: 標楷體; font-size: 9pt;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 9pt;">â—Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><span style="font-size: 9pt;">×</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">B<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" colspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">å’–å•¡å› </span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt double; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.2pt; font-size: 9pt;">1/5</span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 0cm 2.85pt 1pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">最多é…åˆä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 0cm; layout-grid-mode: char;"><b><span style="font-size: 9pt;">C</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -1pt; font-family: 標楷體; font-size: 9pt;">é …</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">Vitamin B<sub>1</sub></span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 1pt 2.85pt 0.5pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">“</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b><span style="font-size: 9pt;">”</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">：從表一一日é…åˆé‡ä¸Šä¸‹é™ä¹‹è¦å®š</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-size: 9pt;">2</span></b><b><span style="letter-spacing: -1pt; font-family: 標楷體; font-size: 9pt;">é …</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">Vitamin B<sub>2</sub></span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-size: 9pt;">3</span></b><b><span style="letter-spacing: -1pt; font-family: 標楷體; font-size: 9pt;">é …</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">Vitamin C</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="font-size: 9pt;">1</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="font-family: 標楷體; font-size: 9pt;">從表一</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1.5pt solid; border-left: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 18pt; padding-right: 0cm; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">D<br /> </span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 81pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 5.65pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">生藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0 </span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 63pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 27pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt; layout-grid-mode: char;"><b><span style="font-size: 9pt;">â—‹</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 54pt; padding-right: 0cm; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: distribute-all-lines; text-align: justify; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b><b><span style="letter-spacing: -0.5pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0 </span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 1.4pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1</span></b><b><span style="letter-spacing: -2.2pt; font-family: 標楷體; font-size: 9pt;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 45pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-align: center; line-height: 11.4pt; margin: 1pt 2.85pt;"><b><span style="letter-spacing: -0.5pt; font-size: 9pt;">1/1</span></b><b><span style="font-size: 9pt;">0</span></b></p> </td> <td style="border-bottom: windowtext 1.5pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 0cm; width: 270pt; padding-right: 0cm; border-left-color: #f0f0f0; border-right: windowtext 1.5pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 11.4pt; margin: 0cm 2.85pt 1pt; layout-grid-mode: char;"><b><span style="font-family: 標楷體; font-size: 9pt;">第二組製劑é…åˆ</span></b><b><span style="font-size: 9pt;">F</span></b><b><span style="font-family: 標楷體; font-size: 9pt;">欄æˆåˆ†æ™‚ï¼Œé ˆæª¢é™„å大先進國ä¸ä¸€åœ‹ä»¥ä¸ŠæŽ¡ç”¨ä¹‹è™•æ–¹ä¾æ“š</span></b><b> </b></p> </td> </tr> </tbody></table><p style="line-height: 11.5pt; margin: 3pt 0cm 0pt; layout-grid-mode: char;"><span style="font-family: 標楷體; font-size: 11pt;">â—Ž</span><span style="font-family: 標楷體; font-size: 11pt;">ï¼šå¿…é ˆé…åˆæˆåˆ†</span><span style="font-size: 11pt;"> â—‹</span><span style="font-family: 標楷體; font-size: 11pt;">：å¯é…åˆæˆåˆ†</span> </p>2013-12-04
查驗登記類,指示藥å“審查基準,綜åˆæ„Ÿå†’藥行政解釋指示藥å“審查基準-綜åˆæ„Ÿå†’劑詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4511&type=0
查驗登記類,指示藥å“審查基準,綜åˆæ„Ÿå†’è—¥,抗éŽæ•åŠ‘行政解釋指示藥å“審查基準-綜åˆæ„Ÿå†’劑åŠæŠ—éŽæ•åŠ‘詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4512&type=0
查驗登記類,指示藥å“審查基準,瀉藥行政解釋指示藥å“審查基準-瀉劑<p style="text-align: center;"><span style="font-family: 新細明體,serif; font-size: 14pt;">瀉</span> <span style="font-family: 新細明體,serif; font-size: 14pt;">　劑</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">壹ã€é©ç”¨ç¯„åœ</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><span style="font-family: 新細明體,serif;">一ã€å‡¡ç”¨ä»¥<b>軟便或</b>緩解便祕為目的<b>之</b>å…§æœ<b>製</b>劑<b>æˆ–æ “åŠ‘</b>，å‡é©ç”¨æœ¬åŸºæº–。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">二ã€åƒ…以本基準所列之</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …ï¼ˆ</span>c</b><b><span style="font-family: 新細明體,serif;">）ã€</span>C</b><b><span style="font-family: 新細明體,serif;">欄åŠ</span>D</b><b><span style="font-family: 新細明體,serif;">欄生藥æˆåˆ†ç‚ºè£½åŠ‘者，ä¸é©ç”¨æœ¬åŸºæº–。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">è²³ã€æœ‰æ•ˆæˆåˆ†</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">一ã€æœ‰æ•ˆæˆåˆ†ä¹‹ç¨®é¡žåŠå«é‡ï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 62: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">一</span>) </b><b><span style="font-family: 新細明體,serif;">本基準å¯é…åˆä¹‹æœ‰æ•ˆæˆåˆ†ï¼Œè¨˜è¼‰æ–¼è¡¨ä¸€ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 98: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">二</span>) </b><b><span style="font-family: 新細明體,serif;">表一è¦å®š</span>A</b><b><span style="font-family: 新細明體,serif;">欄ä¸å„有效æˆåˆ†ä¹‹</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ï¼›</span>B</b><b><span style="font-family: 新細明體,serif;">欄å„有效æˆåˆ†ä¹‹</span>1</b><b><span style="font-family: 新細明體,serif;">次é…åˆé‡ä¸Šä¸‹é™åŠä¸€æ—¥æœ€å¤§é…åˆé‡ï¼›</span>C</b><b><span style="font-family: 新細明體,serif;">欄åŠ</span>D</b><b><span style="font-family: 新細明體,serif;">欄ä¸å„有效æˆåˆ†ä¹‹ä¸€æ—¥æœ€å¤§é…åˆé‡ã€‚</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><span style="font-family: 新細明體,serif;">表一ã€æœ‰æ•ˆæˆåˆ†ä¹‹ç¨®é¡ž</span> </p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0" width="600"> <tbody> <tr style="page-break-inside: avoid; height: 31.15pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 31.15pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é …</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> <span style="font-family: 新細明體,serif;">效</span> <span style="font-family: 新細明體,serif;">æˆ</span> <span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; height: 31.15pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span>A<b> </b></span></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>a</b><b><span style="font-family: 新細明體,serif;">）</span></b>Bisacodyl</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.015</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.015</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>b</b><b><span style="font-family: 新細明體,serif;">）</span><span>Sennosides<sup> *2</sup></span></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.024</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.024</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> <span style="font-family: 新細明體,serif;">效</span> <span style="font-family: 新細明體,serif;">æˆ</span> <span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸è†</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; -0: ;">(<span style="font-family: 新細明體,serif;">原生藥æ›ç®—é‡</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸è†</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">(<span style="font-family: 新細明體,serif;">原生藥æ›ç®—é‡</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>c</b><b><span style="font-family: 新細明體,serif;">）生藥</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Aloe </b><b><span style="font-family: 新細明體,serif;">蘆薈</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.38</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.38</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 17.65pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Cascara Sagrada </b><b><span style="font-family: 新細明體,serif;">ç¾Žé¼ æŽ</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; height: 17.65pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 23.75pt;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 23.75pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: windowtext; padding-left: 1.4pt; width: 18pt; layout-flow: vertical-ideographic; padding-right: 1.4pt; border-top-width: 1pt; height: 23.75pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" valign="bottom"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; height: 23.75pt; padding-top: 0cm;border-color: #f0f0f0;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 36.25pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 450pt; padding-right: 1.4pt; height: 36.25pt; border-right-color: #f0f0f0; border-left-color: #f0f0f0; padding-top: 0cm;" valign="bottom" colspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">表一ã€æœ‰æ•ˆæˆåˆ†ä¹‹ç¨®é¡žï¼ˆçºŒï¼‰</span><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é …</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> <span style="font-family: 新細明體,serif;">效</span> <span style="font-family: 新細明體,serif;">æˆ</span> <span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span><sup>*1</sup> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸è†</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">(<span style="font-family: 新細明體,serif;">原生藥æ›ç®—é‡</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸è†</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">(<span style="font-family: 新細明體,serif;">原生藥æ›ç®—é‡</span>)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span> </p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="13"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">A</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="7"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">（</span>c</b><b><span style="font-family: 新細明體,serif;">）生藥</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Frangula Bark </b><b><span style="font-family: 新細明體,serif;">æé¼ æŽçš®</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Pharbitidis Semen </b><b><span style="font-family: 新細明體,serif;">牽牛å</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.1</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Rhei Rhizoma </b><b><span style="font-family: 新細明體,serif;">大黃</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>4</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Rosae Fructus </b><b><span style="font-family: 新細明體,serif;">營實</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.7</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.67</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>5</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Sennae Folium </b><b><span style="font-family: 新細明體,serif;">番瀉葉</span> </b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>6</b></p> </td> <td style="border-bottom: windowtext 1pt dotted; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Sennae Fructus </b><b><span style="font-family: 新細明體,serif;">番瀉果</span> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 63.8pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 67.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt dotted; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">―</span> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é …</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> <span style="font-family: 新細明體,serif;">效</span> <span style="font-family: 新細明體,serif;">æˆ</span> <span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Magnesium hydroxide</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">0.5</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2.1</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Magnesium oxide</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">0.5</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">3</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Calcium polycarbophil</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">6</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span>Psyllium <b>Husk<sup>*3</sup></b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">3.4</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">10</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">4</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 3: ;"><span>Docusate sodium (Dioctyl sodium sulfosuccinate; DSS)<b></b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span>0.2<br /> <b>(0.12)<sup>*4</sup></b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">0.2</p> </td> </tr> <tr style="page-break-inside: avoid; height: 18pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 18pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é …</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> <span style="font-family: 新細明體,serif;">效</span> <span style="font-family: 新細明體,serif;">æˆ</span> <span style="font-family: 新細明體,serif;">分</span> </p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">1<span style="font-family: 新細明體,serif;">次</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; height: 18pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt 0cm; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é…åˆé‡</span>(g)</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">B</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">1</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Bisacodyl</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b>0.005</b><b><span style="font-family: 新細明體,serif;">ï¼</span></b>0.01</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;">0.01</p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">2</p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">Glycerin</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b><b><span style="font-family: 新細明體,serif;">ï¼</span></b>3</p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;">3</p> </td> </tr> <tr style="page-break-inside: avoid; height: 23.3pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 23.3pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">欄</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 23.3pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">é …</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; height: 23.3pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有</span> <span style="font-family: 新細明體,serif;">效</span> <span style="font-family: 新細明體,serif;">æˆ</span> <span style="font-family: 新細明體,serif;">分</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 243.8pt; padding-right: 1.4pt; height: 23.3pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="4"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一日最大é…åˆé‡</span><span>(g)<sup> *1</sup><b></b></span></p> </td> </tr> <tr style="page-break-inside: avoid; height: 4.2pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; height: 4.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">浸è†</span> </p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（原生藥æ›ç®—é‡ï¼‰</span><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; height: 4.2pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">粉末</span><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <h1 style="line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: times new roman,serif; font-size: 11pt;">C</span></b></h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Glycyrrhizae Radix </b><b><span style="font-family: 新細明體,serif;">甘è‰</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Moutan Cortex </b><b><span style="font-family: 新細明體,serif;">牡丹皮</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>4</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.3</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Smilacis Rhizoma </b><b><span style="font-family: 新細明體,serif;">土茯苓</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <h1 style="line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: times new roman,serif; font-size: 11pt;">D</span></b></h1> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="5"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Cinnamomi Cortex </b><b><span style="font-family: 新細明體,serif;">æ¡‚çš®</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Coptidis Rhizoma </b><b><span style="font-family: 新細明體,serif;">黃連</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Foeniculi Fructus </b><b><span style="font-family: 新細明體,serif;">å°èŒ´é¦™</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.5</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Magnoliae Cortex </b><b><span style="font-family: 新細明體,serif;">厚朴</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2.5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>0.75</b></p> </td> </tr> <tr style="page-break-inside: avoid;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 170.2pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Scutellariae Radix </b><b><span style="font-family: 新細明體,serif;">黃苓</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 122.3pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 121.5pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1.5</b></p> </td> </tr> </tbody></table></div><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span> </span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 74: ;"><b>*1. </b><b><span style="font-family: 新細明體,serif;">åŒä¸€æˆåˆ†ä¹‹æµ¸è†èˆ‡ç²‰æœ«ä¸å¯åŒæ™‚使用。浸è†ï¼ˆæˆ–粉末）欄內若無</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡è¦å®šæ™‚，則該æˆåˆ†ä¸å¾—以浸è†ï¼ˆæˆ–粉末）é…åˆä½¿ç”¨ã€‚浸è†ä¹‹</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ä¿‚以原生藥經抽æ製æˆæµ¸è†æ‰€ç”¨çš„原生藥é‡è¡¨ç¤ºä¹‹ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b>*2. Sennosides</b><b><span style="font-family: 新細明體,serif;">所定之</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ï¼Œä»¥å…¶æ‰€å«ä¹‹</span>Sennoside A</b><b><span style="font-family: 新細明體,serif;">ã€</span>Sennoside B</b><b><span style="font-family: 新細明體,serif;">或</span>Sennoside A</b><b><span style="font-family: 新細明體,serif;">＆</span>B</b><b><span style="font-family: 新細明體,serif;">定é‡ä¹‹ï¼ˆä¸å«é¹½åŸºï¼‰ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 73: ;"><b>*3. Psyllium Husk</b><b><span style="font-family: 新細明體,serif;">：包括</span><i>Plantago ovata </i>[Blond Psyllium</b><b><span style="font-family: 新細明體,serif;">或</span>Indian Psyllium</b><b><span style="font-family: 新細明體,serif;">或</span>Ispaghula]</b><b><span style="font-family: 新細明體,serif;">ã€</span><i>Plantago psyllium</i></b><b><span style="font-family: 新細明體,serif;">åŠ</span><i>Plantago indica</i><span> (<i>Plantago arenaria) </i>[ Spanish or French Psyllium (Fam. Plantaginaceae)]</span></b><b><span style="font-family: 新細明體,serif;">的種皮。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 73: ;"><b>*4. </b><b><span style="font-family: 新細明體,serif;">å…§æœè£½åŠ‘åŒæ™‚é…åˆ</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>4</b><b><span style="font-family: 新細明體,serif;">é …</span>Docusate sodium (Dioctyl sodium sulfosuccinate; DSS)</b><b><span style="font-family: 新細明體,serif;">åŠ</span>A</b><b><span style="font-family: 新細明體,serif;">欄其他有效æˆåˆ†ä¸”用法用é‡ç‚ºä¸€æ—¥</span>1</b><b><span style="font-family: 新細明體,serif;">次時，計算該欄é…åˆä¿‚數åŠ</span>Docusate sodium</b><b><span style="font-family: 新細明體,serif;">æ¯æ—¥æœ€é«˜åŠ‘é‡ä¹‹ä¸‹é™æ‰€ä½¿ç”¨ä¹‹</span>Docusate sodium 1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡ä»¥</span>0.12 g</b><b><span style="font-family: 新細明體,serif;">為準。</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">二ã€é…åˆè¦å‰‡ï¼ˆè¦‹è¡¨äºŒï¼‰</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 40: ;"><b><span> (</span></b><b><span style="font-family: 新細明體,serif;">一</span>) </b><b><span style="font-family: 新細明體,serif;">å…§æœè£½åŠ‘：</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">ã€å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …ã€</span>2</b><b><span style="font-family: 新細明體,serif;">é …ã€</span>3</b><b><span style="font-family: 新細明體,serif;">é …åŠ</span>4</b><b><span style="font-family: 新細明體,serif;">é …ä¸æ‰€å«ä¹‹æœ‰æ•ˆæˆåˆ†ï¼›é…æ–¹ä¸è‡³å°‘需å«ä¸€ç¨®å¿…é ˆé…åˆæˆåˆ†ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">ã€å¯é…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€</span>C</b><b><span style="font-family: 新細明體,serif;">欄åŠ</span>D</b><b><span style="font-family: 新細明體,serif;">欄ä¸æ‰€å«ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>3</b><b><span style="font-family: 新細明體,serif;">ã€é™¤å¦æœ‰è¦å®šå¤–，上述</span>1</b><b><span style="font-family: 新細明體,serif;">ä¹‹å¿…é ˆé…åˆæˆåˆ†å¯ç›¸äº’é…åˆä½¿ç”¨ï¼Œäº¦å¯èˆ‡ä¸Šè¿°</span>2</b><b><span style="font-family: 新細明體,serif;">之å¯é…åˆæˆåˆ†è¤‡æ–¹é…åˆä½¿ç”¨ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>4</b><b><span style="font-family: 新細明體,serif;">ã€è¡¨ä¸€</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>3</b><b><span style="font-family: 新細明體,serif;">é …ä¹‹</span>Calcium polycarbophil</b><b><span style="font-family: 新細明體,serif;">é™ç‚ºå–®æ–¹è£½åŠ‘。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>5</b><b><span style="font-family: 新細明體,serif;">ã€</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …æœ‰æ•ˆæˆåˆ†ä¸ï¼Œ</span>Sennae Folium(</b><b><span style="font-family: 新細明體,serif;">番瀉葉</span>)</b><b><span style="font-family: 新細明體,serif;">或</span>Sennae Fructus(</b><b><span style="font-family: 新細明體,serif;">番瀉果</span>) </b><b><span style="font-family: 新細明體,serif;">ä¸å¯èˆ‡</span>Sennosides</b><b><span style="font-family: 新細明體,serif;">åŒæ™‚é…åˆä½¿ç”¨ï¼Œä½†</span>Sennae Folium(</b><b><span style="font-family: 新細明體,serif;">番瀉葉</span>)</b><b><span style="font-family: 新細明體,serif;">與</span>Sennae Fructus(</b><b><span style="font-family: 新細明體,serif;">番瀉果</span>) </b><b><span style="font-family: 新細明體,serif;">å¯åŒæ™‚é…åˆä½¿ç”¨ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>6</b><b><span style="font-family: 新細明體,serif;">ã€å¿…é ˆé…åˆæˆåˆ†ä¸ï¼Œ</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …æœ€å¤šå¯åŒæ™‚é…åˆå››ç¨®æœ‰æ•ˆæˆåˆ†ï¼›</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">é …ã€</span>3</b><b><span style="font-family: 新細明體,serif;">é …åŠ</span>4</b><b><span style="font-family: 新細明體,serif;">é …ä¸å„é …æœ€å¤šå¯é…åˆä¸€ç¨®æœ‰æ•ˆæˆåˆ†ã€‚ä½†æ‰€æœ‰çš„å¿…é ˆé…åˆæˆåˆ†æœ€å¤šåªå¯åŒæ™‚é…åˆå››ç¨®ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>7</b><b><span style="font-family: 新細明體,serif;">ã€å¯é…åˆæˆåˆ†ä¸ï¼Œ</span>C</b><b><span style="font-family: 新細明體,serif;">欄最多å¯åŒæ™‚é…åˆä¸‰ç¨®æœ‰æ•ˆæˆåˆ†ï¼›</span>D</b><b><span style="font-family: 新細明體,serif;">欄最多å¯åŒæ™‚é…åˆå››ç¨®æœ‰æ•ˆæˆåˆ†ã€‚但所有的å¯é…åˆæˆåˆ†æœ€å¤šåªå¯åŒæ™‚é…åˆäº”種。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 116: ;"><b>8</b><b><span style="font-family: 新細明體,serif;">ã€è£½åŠ‘ä¸å«ç”Ÿè—¥æˆåˆ†è€…（表一</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …ï¼ˆ</span>c</b><b><span style="font-family: 新細明體,serif;">）ã€</span>C</b><b><span style="font-family: 新細明體,serif;">欄åŠ</span>D</b><b><span style="font-family: 新細明體,serif;">欄），應åšç”Ÿè—¥æˆåˆ†ä¹‹å®šæ€§è©¦é©—ï¼›å°æ–¼è—¥å…¸ç‰å…¬å®šæ›¸æ‰€æ”¶è¼‰ä¹‹ç”Ÿè—¥æœ‰æŒ‡æ¨™æˆåˆ†å®šé‡è€…，應åšå®šé‡è©¦é©—。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 54pt: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">二</span>) </b><b><span style="font-family: 新細明體,serif;">æ “åŠ‘ï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">ã€å¿…é ˆé…åˆæˆåˆ†ï¼šæŒ‡è¡¨ä¸€</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …åŠ</span>2</b><b><span style="font-family: 新細明體,serif;">é …ä¸ä¹‹æœ‰æ•ˆæˆåˆ†ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">ã€é™ç‚ºå–®æ–¹è£½åŠ‘。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span> </span></b><b><span style="font-family: 新細明體,serif;">表二ã€é…åˆè¦å‰‡åŠé…åˆä¿‚數</span> </b></p><div style="text-align: center;"><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid; height: 24.5pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 112.5pt; padding-right: 1.4pt; height: 24.5pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="2" colspan="4"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 7.65pt 0pt 0cm; layout-grid-mode: char;"><b><span> </span></b><b><span style="font-family: 新細明體,serif;">製</span> <span> </span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span> </span></b><b><span style="font-family: 新細明體,serif;">有</span> </b><b><span style="font-family: 新細明體,serif;">效</span> </b><b><span style="font-family: 新細明體,serif;">æˆ</span> </b><b><span style="font-family: 新細明體,serif;">分</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.5pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">é…åˆè¦å‰‡</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">åŒæ¬„æˆåˆ†</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">é…åˆä¸€ç¨®</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 109.7pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">åŒæ¬„æˆåˆ†</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">至少é…åˆäºŒç¨®</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 133.3pt; padding-right: 1.4pt; height: 24.5pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å‚™</span><span> </span></b><b><span style="font-family: 新細明體,serif;">註</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 33pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å…§æœ</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">製劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">æ “åŠ‘</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">é…åˆä¿‚數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">é…åˆä¿‚數</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-family: 新細明體,serif;">å„æˆåˆ†æ¯æ—¥</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -1pt; font-family: 新細明體,serif;">最高劑é‡ä¹‹ä¸‹é™</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>A</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">é …</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 54pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">刺激性瀉藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>(a)</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">â—Ž</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>×</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/2</b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/2</b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt;"><b><span style="letter-spacing: -0.7pt; font-family: 標楷體; font-size: 11pt;">最多å¯é…åˆå››ç¨®æˆåˆ†</span></b><b> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 43.3pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="6"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>A</b><b><span style="font-family: 新細明體,serif;">欄æˆåˆ†æœ€å¤šå¯åŒæ™‚é…åˆå››ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.75pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>(b)</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 10.75pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>(c)</b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 10.75pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/10</b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">é …</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">鹽類瀉藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt;"><b><span style="font-family: 標楷體; font-size: 11pt;">最多é…åˆä¸€ç¨®æˆåˆ†</span></b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>3</b><b><span style="font-family: 新細明體,serif;">é …</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">膨脹性瀉藥</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.5pt; font-family: 新細明體,serif;">最多é…åˆä¸€ç¨®æˆåˆ†ï¼›</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.6pt;">Calcium polycarbophil</span></b><b><span style="font-family: 新細明體,serif;">é™ç‚ºå–®æ–¹è£½åŠ‘</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>4</b><b><span style="font-family: 新細明體,serif;">é …</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">溼潤性瀉藥</span></b><b> </b></p> </td> <td style="border-bottom-color: #f0f0f0; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">最多é…åˆä¸€ç¨®æˆåˆ†</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 20pt; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>B</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">é …</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">刺激性瀉藥</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Bisacodyl</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>×</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">â—Ž</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">從表一</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b></b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 133.3pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">é™ç‚ºå–®æ–¹è£½åŠ‘</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 20pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 22.5pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">é …</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 72pt; padding-right: 1.4pt; height: 20pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">高滲é€å£“瀉藥</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>Glycerin</b><b> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 33pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 33pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>C</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 94.5pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">輔助緩和</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">瀉下æˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>×</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/10</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">≧</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1/10</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.7pt; font-family: 新細明體,serif;">最多å¯é…åˆä¸‰ç¨®æˆåˆ†</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 43.3pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" rowspan="2"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 1: ;"><b>C</b><b><span style="font-family: 新細明體,serif;">欄åŠ</span>D</b><b><span style="font-family: 新細明體,serif;">欄æˆåˆ†æœ€å¤šå¯åŒæ™‚é…åˆäº”種æˆåˆ†</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 33pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 18pt; padding-right: 1.4pt; height: 33pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>D</b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; -1: ;"><b><span style="font-family: 新細明體,serif;">欄</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 94.5pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="3"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 5.65pt 0pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å¥èƒƒæˆåˆ†</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 29.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">â—‹</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 28.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>×</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 56.8pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>1</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/5</b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 45pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>2</b><b><span style="font-family: 新細明體,serif;">≧≧</span>1/5</b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 64.7pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">ç„¡è¨å®š</span></b><b> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 90pt; padding-right: 1.4pt; height: 33pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="letter-spacing: -0.7pt; font-family: 新細明體,serif;">最多å¯é…åˆå››ç¨®æˆåˆ†</span> </b></p> </td> </tr> </tbody></table></div><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span> </span></b><b><span style="font-family: 新細明體,serif;">â—Žï¼šå¿…é ˆé…åˆæˆåˆ†ã€€ã€€â—‹ï¼šå¯é…åˆæˆåˆ†ã€€ã€€</span>×</b><b><span style="font-family: 新細明體,serif;">：ä¸å¯é…åˆæˆåˆ†</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 31: ;"><b><span style="font-family: 新細明體,serif;">三ã€æœ‰æ•ˆæˆåˆ†ä¹‹é…åˆé‡ï¼ˆè¦‹è¡¨äºŒï¼‰</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 62: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">一</span>) </b><b><span style="font-family: 新細明體,serif;">å…§æœè£½åŠ‘</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 98: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">ã€è¡¨ä¸€</span>A</b><b><span style="font-family: 新細明體,serif;">欄æˆåˆ†ï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）å„有效æˆåˆ†ä¹‹æ¯æ¬¡æœ€é«˜é…åˆåŠ‘é‡åŠæ¯æ—¥æœ€é«˜åŠ‘é‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—之</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡åŠä¸€æ—¥æœ€å¤§é…åˆé‡ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）åŒæ¬„ä¸é…åˆä¸€ç¨®æœ‰æ•ˆæˆåˆ†æ™‚，該é…åˆæˆåˆ†ä¹‹é…åˆä¿‚數應介於</span>1</b><b><span style="font-family: 新細明體,serif;">åŠ</span>1/2</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 148: ;"><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）åŒæ¬„ä¸é…åˆäºŒç¨®æˆ–二種以上有效æˆåˆ†æ™‚，該欄之é…åˆä¿‚數應介於</span>2</b><b><span style="font-family: 新細明體,serif;">åŠ</span>1/2</b><b><span style="font-family: 新細明體,serif;">之間，且é…åˆæˆåˆ†ä¸å«</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …ï¼ˆ</span>a</b><b><span style="font-family: 新細明體,serif;">）ã€ï¼ˆ</span>b</b><b><span style="font-family: 新細明體,serif;">）åŠ</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">é …ã€</span>3</b><b><span style="font-family: 新細明體,serif;">é …ã€</span>4</b><b><span style="font-family: 新細明體,serif;">é …æ™‚ï¼Œè©²é …å„é…åˆæˆåˆ†æ¯æ—¥æœ€é«˜åŠ‘é‡ä¹‹é…åˆä¿‚數下é™ä¸å¾—å°æ–¼</span>1/5</b><b><span style="font-family: 新細明體,serif;">，若é…åˆæˆåˆ†ä¸å«</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …ï¼ˆ</span>c</b><b><span style="font-family: 新細明體,serif;">ï¼‰æ™‚ï¼Œè©²é …å„é…åˆæˆåˆ†æ¯æ—¥æœ€é«˜åŠ‘é‡ä¹‹é…åˆä¿‚數下é™ä¸å¾—å°æ–¼</span>1/10</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">ã€é…æ–¹ä¸å«è¡¨ä¸€</span>C</b><b><span style="font-family: 新細明體,serif;">欄æˆåˆ†ï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）å„有效æˆåˆ†ä¹‹æ¯æ—¥æœ€é«˜åŠ‘é‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—之一日最大é…åˆé‡ï¼›é…åˆ</span>C</b><b><span style="font-family: 新細明體,serif;">欄時，å„有效æˆåˆ†æ¯æ¬¡æœ€é«˜é…åˆåŠ‘é‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—一日最大é…åˆé‡ä¹‹</span>1/3</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 148: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）åŒæ¬„ä¸é…åˆä¸€ç¨®æœ‰æ•ˆæˆåˆ†æ™‚，該æˆåˆ†ä¹‹é…åˆä¿‚數應介於</span>1</b><b><span style="font-family: 新細明體,serif;">åŠ</span>1/10</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）åŒæ¬„ä¸é…åˆäºŒç¨®æˆ–二種以上有效æˆåˆ†æ™‚，該欄之é…åˆä¿‚數ä¸å¯å¤§æ–¼</span>2</b><b><span style="font-family: 新細明體,serif;">，且該欄å„é…åˆæˆåˆ†æ¯æ—¥æœ€é«˜åŠ‘é‡ä¹‹é…åˆä¿‚數下é™ä¸å¾—å°æ–¼</span>1/10</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>3</b><b><span style="font-family: 新細明體,serif;">ã€é…æ–¹ä¸å«è¡¨ä¸€</span>D</b><b><span style="font-family: 新細明體,serif;">欄æˆåˆ†ï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）å„有效æˆåˆ†ä¹‹æ¯æ—¥æœ€é«˜åŠ‘é‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—之一日最大é…åˆé‡ï¼›é…åˆ</span>D</b><b><span style="font-family: 新細明體,serif;">欄時，å„有效æˆåˆ†æ¯æ¬¡æœ€é«˜é…åˆåŠ‘é‡ä¸å¾—超éŽè¡¨ä¸€æ‰€åˆ—一日最大é…åˆé‡ä¹‹</span>1/3</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）åŒæ¬„ä¸é…åˆä¸€ç¨®æœ‰æ•ˆæˆåˆ†æ™‚，該æˆåˆ†ä¹‹é…åˆä¿‚數應介於</span>1</b><b><span style="font-family: 新細明體,serif;">åŠ</span>1/5</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 144pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）åŒæ¬„ä¸é…åˆäºŒç¨®æˆ–二種以上有效æˆåˆ†æ™‚，該欄之é…åˆä¿‚數應介於</span>2</b><b><span style="font-family: 新細明體,serif;">åŠ</span>1/5</b><b><span style="font-family: 新細明體,serif;">之間。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 4cm: ;"><b>4</b><b><span style="font-family: 新細明體,serif;">ã€</span>A</b><b><span style="font-family: 新細明體,serif;">欄å„æˆåˆ†é…åˆä¿‚數之計算方å¼ï¼Œä¾ç”¨æ³•ç”¨é‡ä¹‹ä¸åŒæœ‰ä»¥ä¸‹ä¸‰ç¨®è¨ˆç®—æ–¹å¼ï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 153pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>1</b><b><span style="font-family: 新細明體,serif;">）一日</span>1</b><b><span style="font-family: 新細明體,serif;">次之用法：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">所é…åˆæˆåˆ†ä¹‹æ¯æ—¥æœ€é«˜åŠ‘é‡ï¼Œé™¤ä»¥è©²æˆåˆ†</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 153pt: ;"><b><span style="font-family: 新細明體,serif;">（</span>2</b><b><span style="font-family: 新細明體,serif;">）一日</span>1~2</b><b><span style="font-family: 新細明體,serif;">次之用法：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">所é…åˆæˆåˆ†ä¹‹æ¯æ—¥æœ€é«˜åŠ‘é‡ï¼Œé™¤ä»¥è©²æˆåˆ†</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡ä¹˜ä»¥</span>2</b><b><span style="font-family: 新細明體,serif;">所得數值或該æˆåˆ†ä¹‹ä¸€æ—¥æœ€å¤§é…åˆé‡ï¼Œæ“‡å…©è€…ä¸æ•¸å€¼è¼ƒå°è€…。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 153pt: ;"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><b><sub><span style="font-size: 14pt;"> i = 1</span></sub></b></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><b><sub><span style="font-size: 14pt;"> <span style="letter-spacing: -1pt;"> </span>n</span></sub></b></p> </div> </td> </tr> </tbody></table><b><span style="font-family: 新細明體,serif;">（</span>3</b><b><span style="font-family: 新細明體,serif;">）一日</span>1~3</b><b><span style="font-family: 新細明體,serif;">次之用法：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">所é…åˆæˆåˆ†ä¹‹æ¯æ—¥æœ€é«˜åŠ‘é‡ï¼Œé™¤ä»¥è©²æˆåˆ†ä¸€æ—¥æœ€å¤§é…åˆé‡ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 175: ;"><b><span style="font-family: 新細明體,serif;">é…åˆä¿‚數</span> =</b><b><span style="font-family: 新細明體,serif;">Σ</span><span>(X<sub>i</sub> / mX<sub>i</sub>)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b><span style="letter-spacing: -1pt;">= (X<sub>1</sub> / mX<sub>1</sub>) + (X<sub>2</sub> / mX<sub>2</sub>) +……+ (X<sub>n</sub> / mX<sub>n</sub>)</span></b></p><table style="margin: auto auto auto 145.4pt; border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>X<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å„欄é…åˆæˆåˆ†</span>i</b><b><span style="font-family: 新細明體,serif;">之æ¯æ—¥æœ€é«˜åŠ‘é‡</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>mX<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å„欄é…åˆæˆåˆ†</span>i</b><b><span style="font-family: 新細明體,serif;">之一日最大é…åˆé‡</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 19: ;"><b><span style="font-family: 新細明體,serif;">（或</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡ã€</span>1</b><b><span style="font-family: 新細明體,serif;">次最大é…åˆé‡ä¹˜ä»¥</span>2</b><b><span style="font-family: 新細明體,serif;">，視用法用é‡è€Œå®šï¼‰</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>n</b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å„欄之é…åˆæˆåˆ†æ•¸</span> </b></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 114: ;"><b>5</b><b><span style="font-family: 新細明體,serif;">ã€</span>k</b><b><span style="font-family: 新細明體,serif;">值（æ¯æ—¥åŠ‘é‡ç¯„åœï¼‰ä¹‹è¨ˆç®—：</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">å› æ‡‰ç€‰åŠ‘ä¹‹ç”¨æ³•ç”¨é‡ä¸åŒï¼Œéœ€åŠ å…¥</span>k</b><b><span style="font-family: 新細明體,serif;">值之計算，以確èªå…¶æ¯æ—¥æœ€é«˜åŠæœ€ä½ŽåŠ‘é‡ç¯„åœæ˜¯å¦é©ç•¶ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 197: ;"><b>k =</b><b><span style="font-family: 新細明體,serif;">é…åˆæˆåˆ†ä¹‹æ¯æ—¥æœ€é«˜åŠ‘é‡</span> / </b><b><span style="font-family: 新細明體,serif;">é…åˆæˆåˆ†ä¹‹</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 197: ;"><b><span style="font-family: 新細明體,serif;">æ¯æ—¥æœ€ä½ŽåŠ‘é‡</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>k</b><b><span style="font-family: 新細明體,serif;">值之å…許範åœç‚º</span>1</b><b><span style="font-family: 新細明體,serif;">＜</span>k</b><b><span style="font-family: 新細明體,serif;">≦</span>4 </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 99pt: ;"><b>6</b><b><span style="font-family: 新細明體,serif;">ã€</span>C</b><b><span style="font-family: 新細明體,serif;">欄åŠ</span>D</b><b><span style="font-family: 新細明體,serif;">欄å„æˆåˆ†é…åˆä¿‚數之計算方å¼ï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 175: ;"><b><span style="font-family: 新細明體,serif;">é…åˆä¿‚數</span> =</b><b><span style="font-family: 新細明體,serif;">Σ</span><span>(X<sub>i</sub> / mX<sub>i</sub>)</span></b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b><span style="letter-spacing: -1pt;">= (X<sub>1</sub> / mX<sub>1</sub>) + (X<sub>2</sub> / mX<sub>2</sub>) +……+ (X<sub>n</sub> / mX<sub>n</sub>)</span></b></p><table style="margin: auto auto auto 145.4pt; border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>X<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å„欄é…åˆæˆåˆ†</span>i</b><b><span style="font-family: 新細明體,serif;">之æ¯æ—¥æœ€é«˜åŠ‘é‡</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span>mX<sub>i</sub></span></b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å„欄é…åˆæˆåˆ†</span>i</b><b><span style="font-family: 新細明體,serif;">之一日最大é…åˆé‡</span> </b></p> </td> </tr> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 49.5pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b>n</b><b><span style="font-family: 新細明體,serif;">：</span> </b></p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 275.25pt; padding-right: 1.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å„欄之é…åˆæˆåˆ†æ•¸</span> </b></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 62: ;"><b><span> (</span></b><b><span style="font-family: 新細明體,serif;">二</span>) </b><b><span style="font-family: 新細明體,serif;">æ “åŠ‘</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 126pt: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">ã€è¡¨ä¸€</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …åŠ</span>2</b><b><span style="font-family: 新細明體,serif;">é …å„æˆåˆ†ä¹‹</span>1</b><b><span style="font-family: 新細明體,serif;">次é…åˆé‡ä¸Šä¸‹é™åŠä¸€æ—¥æœ€å¤§é…åˆé‡ä¾è¡¨ä¸€ä¹‹è¦å®šã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 98: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">ã€ç„¡éœ€è¨ˆç®—é…åˆä¿‚數åŠ</span>k</b><b><span style="font-family: 新細明體,serif;">值。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">åƒã€åŠ‘åž‹</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><span style="font-family: 新細明體,serif;">一ã€é™æ–¼éŒ 劑ã€<b>è†œè¡£éŒ ã€ç³–è¡£éŒ ã€</b>è† å›ŠåŠ‘ã€<b>è»Ÿè† å›ŠåŠ‘</b>ã€ä¸¸åŠ‘<b>ã€å…§æœ</b>液劑ã€æ•£åŠ‘ã€<b>å…§æœ</b>顆粒劑ã€<b>細粒劑</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">二ã€å…§æœæ¶²åŠ‘é™ä½¿ç”¨æ–¼</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">é …é¹½é¡žç€‰è—¥æˆåˆ†ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">三ã€å«</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …ï¼ˆ</span>a</b><b><span style="font-family: 新細明體,serif;">）</span>Bisacodyl</b><b><span style="font-family: 新細明體,serif;">之內æœè£½åŠ‘é™ç‚ºè…¸æº¶åŠ‘型。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b><span style="font-family: 新細明體,serif;">å››ã€å«</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …</span></b>Bisacodyl<b><span style="font-family: 新細明體,serif;">åŠ</span>B</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">é …</span></b>Glycerin<span style="font-family: 新細明體,serif;">å¾—æœ‰æ “åŠ‘ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">肆ã€é©æ‡‰ç—‡</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 36pt: ;"><b><span style="font-family: 新細明體,serif;">軟便。若é…åˆæˆåˆ†ä¸å«</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …åˆºæ¿€æ€§ç€‰è—¥æˆåˆ†ï¼Œé©æ‡‰ç—‡å¯ç‚º</span></b><span style="font-family: 新細明體,serif;">緩解便祕</span><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">ä¼ã€ç”¨æ³•ç”¨é‡</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">一ã€å„製劑用法用é‡ä¹‹æ¨™ç¤ºè«‹åƒè€ƒè¡¨ä¸‰ã€‚å…¶ä¸ï¼Œå…§æœè£½åŠ‘訂定用法用é‡æ™‚需è¦å®šæ¯æ¬¡ä½¿ç”¨åŠ‘é‡ä¹‹ä¸Šä¸‹é™ç¯„åœ</span>(</b><b><span style="font-family: 新細明體,serif;">如</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">â—‹</span>)</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p><p style="line-height: 16pt; layout-grid-mode: char; 72pt: ;"><span style="font-family: 標楷體; font-size: 11pt;">二ã€å¹´é½¡åˆ†é…係數： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b>12</b><b><span style="font-family: 新細明體,serif;">æ²ä»¥ä¸Šï¼Œé©ç”¨æˆäººåŠ‘é‡ã€‚</span><span><br />6</span></b><b><span style="font-family: 新細明體,serif;">æ²ä»¥ä¸Šæœªæ»¿</span>12</b><b><span style="font-family: 新細明體,serif;">æ²ï¼Œé©ç”¨æˆäººåŠ‘é‡ä¹‹</span>1/2</b><b><span style="font-family: 新細明體,serif;">。</span><span><br />3</span></b><b><span style="font-family: 新細明體,serif;">æ²ä»¥ä¸Šæœªæ»¿</span>6</b><b><span style="font-family: 新細明體,serif;">æ²ï¼Œé©ç”¨æˆäººåŠ‘é‡ä¹‹</span>1/4</b><b><span style="font-family: 新細明體,serif;">。</span><span><br /></span></b><b><span style="font-family: 新細明體,serif;">未滿</span>3</b><b><span style="font-family: 新細明體,serif;">æ²ä¹‹å¬°å¹¼å…’，請洽醫師診治，ä¸å®œè‡ªè¡Œä½¿ç”¨ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b><span style="font-family: 新細明體,serif;">三ã€è‹¥è£½åŠ‘ä¸å«</span>A</b><b><span style="font-family: 新細明體,serif;">欄</span>3</b><b><span style="font-family: 新細明體,serif;">é …</span></b><span style="font-family: 新細明體,serif;">膨脹性瀉藥<b>æˆåˆ†ï¼Œ</b>æ¯æ¬¡æœç”¨è‡³å°‘é ˆèˆ‡</span><span>240 m<b>l</b></span><span style="font-family: 新細明體,serif;">水一起æœç”¨ã€‚</span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 45: ;"><b><span style="font-family: 新細明體,serif;">å››ã€è…¸æº¶è£½åŠ‘應整粒åžæœï¼Œä¸å¾—å‰åŠæˆ–嚼碎。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 45: ;"><b><span style="font-family: 新細明體,serif;">五ã€æ “劑ä¸å¾—å‰åŠä½¿ç”¨ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 24: ;"><b><span style="font-family: 新細明體,serif;">表三ã€ç”¨æ³•ç”¨é‡</span> </b></p><table style="margin: auto auto auto 24pt; border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr style="page-break-inside: avoid;"> <td style="border-bottom-color: #f0f0f0; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.4pt; padding-right: 1.4pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">製</span><span> </span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 405pt; padding-right: 1.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">用</span> </b><b><span style="font-family: 新細明體,serif;">法</span> </b><b><span style="font-family: 新細明體,serif;">用</span> </b><b><span style="font-family: 新細明體,serif;">é‡</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 109.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 1.4pt; width: 58.4pt; padding-right: 1.4pt; height: 109.55pt; padding-top: 0cm;border: windowtext 1pt solid;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 3.5pt 0pt 3.3pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">å…§</span><span> </span></b><b><span style="font-family: 新細明體,serif;">æœ</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 3.5pt 0pt 3.3pt; layout-grid-mode: char;"><b></b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 3.5pt 0pt 3.3pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">製</span><span> </span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 405pt; padding-right: 1.4pt; height: 109.55pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 3.4pt; layout-grid-mode: char;"><b>(a) </b><b><span style="font-family: 新細明體,serif;">一日</span>1</b><b><span style="font-family: 新細明體,serif;">次，</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">○，於ç¡å‰ï¼ˆæˆ–空腹時）æœç”¨ã€‚</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 21.1pt; layout-grid-mode: char;"><b>(b) </b><b><span style="font-family: 新細明體,serif;">一日</span>1~2</b><b><span style="font-family: 新細明體,serif;">次，</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">○，一日以</span>2</b><b><span style="font-family: 新細明體,serif;">次為é™ï¼Œæ–¼æ—©æ™šï¼ˆæˆ–æœç”¨é–“éš”é ˆ</span>4</b><b><span style="font-family: 新細明體,serif;">å°æ™‚以上），空腹時</span>(</b><b><span style="font-family: 新細明體,serif;">或隨é¤</span>)</b><b><span style="font-family: 新細明體,serif;">æœç”¨ã€‚</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 21.1pt; layout-grid-mode: char;"><b>(c) </b><b><span style="font-family: 新細明體,serif;">一日</span>1~3</b><b><span style="font-family: 新細明體,serif;">次，</span>1</b><b><span style="font-family: 新細明體,serif;">次○</span>~</b><b><span style="font-family: 新細明體,serif;">○，一日以</span>3</b><b><span style="font-family: 新細明體,serif;">次為é™ï¼Œæœç”¨é–“éš”é ˆ</span>4</b><b><span style="font-family: 新細明體,serif;">å°æ™‚以上，於飯å‰</span>(</b><b><span style="font-family: 新細明體,serif;">或隨é¤</span>)</b><b><span style="font-family: 新細明體,serif;">æœç”¨ã€‚</span> </b></p> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm 2.85pt 0pt 3.4pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">以上三種用法，å‡é ˆåŠ 註</span> "</b><b><span style="font-family: 新細明體,serif;">åˆæ¬¡æ‡‰ä½¿ç”¨æœ€å°åŠ‘é‡ï¼Œå†è¦–通便情æ³å¢žæ¸›ç”¨é‡</span>"</b><b><span style="font-family: 新細明體,serif;">。</span> </b></p> </td> </tr> <tr style="page-break-inside: avoid; height: 24.8pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 58.4pt; padding-right: 1.4pt; height: 24.8pt; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 2: ;"><b><span style="font-family: 新細明體,serif;">æ “</span><span> </span></b><b><span style="font-family: 新細明體,serif;">劑</span> </b></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 405pt; padding-right: 1.4pt; height: 24.8pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;"> <p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 3: ;"><b>1</b><b><span style="font-family: 新細明體,serif;">次使用</span>1</b><b><span style="font-family: 新細明體,serif;">個。（未見效果時，得å†ä½¿ç”¨</span>1</b><b><span style="font-family: 新細明體,serif;">個。）</span><sup>*5</sup> </b></p> </td> </tr> </tbody></table><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 22: ;"><b>*5. </b><b><span style="font-family: 新細明體,serif;">請標明æ¯æ—¥å¯ä½¿ç”¨å€‹æ•¸ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">陸ã€æ³¨æ„äº‹é …</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 37: ;"><b><span style="font-family: 新細明體,serif;">一ã€ç‚ºé˜²æ¢å…’童誤食請妥善ä¿ç®¡ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 37: ;"><span style="font-family: 新細明體,serif;">二ã€é¿å…陽光直射，宜ä¿å˜æ–¼é™°æ¶¼ä¹‹è™•ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 68: ;"><span style="font-family: 新細明體,serif;">三ã€é™¤éž<b>有醫師藥師藥劑生</b>指示，å•å©¦åŠæŽˆä¹³å©¦ä¸å»ºè°è‡ªè¡Œä½¿ç”¨ã€‚</span> </p><p style="line-height: 16pt;"><span style="font-family: 全真楷書; font-size: 11pt;">å››ã€å‹¿è¶…éŽå»ºè°åŠ‘é‡ï¼Œ<b>若有ä¸é©æƒ…æ³ç”¢ç”Ÿï¼Œ</b>應<b>åœæ¢ä½¿ç”¨ä¸¦è«‹æ•™é†«å¸«è—¥å¸«è—¥åŠ‘生</b>。</span><b> </b></p><p style="line-height: 16pt;"><span style="font-family: 全真楷書; font-size: 11pt;">五ã€æ¶²åŠ‘使用å‰é ˆæŒ¯æ–å‡å‹»ï¼Œä¸¦ä½¿ç”¨å» 商所附é‡å™¨é‡å–è—¥é‡ã€‚</span> </p><p style="line-height: 16pt;"><b><span style="font-family: 全真楷書; font-size: 11pt;">å…ã€æ “劑é™ä½¿ç”¨æ–¼è‚›é–€ï¼Œè‹¥è—¥åŠ‘éŽè»Ÿæ™‚，請置於低溫待較硬後å†ä½¿ç”¨ã€‚</span></b><b> </b></p><p style="line-height: 16pt;"><b><span style="font-family: 全真楷書; font-size: 11pt;">七ã€æ “劑使用時，應待便æ„強度æŒçºŒå¾Œå†è¡ŒæŽ’便。若使用後立å³æŽ’便，å¯èƒ½å°‡æœ¬è—¥å®Œå…¨æŽ’空而導致失效。</span></b><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 63pt: ;"><span style="font-family: 新細明體,serif;">å…«ã€ç€‰åŠ‘ä¸æ‡‰é•·æœŸä½¿ç”¨ï¼Œä¸€æ—¦æŽ’便æ£å¸¸ï¼Œå³æ‡‰åœè—¥ã€‚除éž<b>有醫師藥師藥劑生</b>指示，ä¸å¾—連續使用一星期以上，應儘é‡ä»¥å«çº–ç¶é£²é£Ÿï¼Œå……分æ”å–水分åŠé‹å‹•ä¾†æ”¹å–„便祕。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">柒ã€è¦èªž</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 70: ;"><b><span>一ã€<span style="font: 7pt times new roman;"> </span></span></b><b><span style="font-family: 新細明體,serif;">除éžæœ‰é†«å¸«è—¥å¸«è—¥åŠ‘生指示，ä¸å¾—併用其他瀉劑。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">二ã€é™¤éžæœ‰é†«å¸«è—¥å¸«è—¥åŠ‘ç”ŸæŒ‡ç¤ºï¼Œæ›¾ç¶“å› æœ¬é¡žè—¥ç‰©å¼•èµ·éŽæ•ç—‡ç‹€è€…ä¸å¾—使用。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">三ã€å…§æœè£½åŠ‘使用期間，若有å™å¿ƒã€å˜”åã€åš´é‡è…¹ç—›æˆ–發疹ç‰éŽæ•ç—‡ç‹€æ™‚，應åœæ¢ä½¿ç”¨ä¸¦è«‹æ•™é†«å¸«è—¥å¸«è—¥åŠ‘生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><span style="font-family: 新細明體,serif;">å››ã€è‹¥æœ‰è¡€ä¾¿åŠè‡ªç™¼æ€§<b>è…¸é“</b>出血狀æ³ï¼Œæ‡‰<b>ç«‹å³åœè—¥</b>就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">五ã€ä½¿</span></b><span style="font-family: 新細明體,serif;">用一星期後無效者，應<b>ç«‹å³åœè—¥</b>就醫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">å…ã€ä½¿ç”¨æœŸé–“會有腹瀉發生，若腹瀉æŒçºŒä¸æ¢æˆ–åŠ åŠ‡çš„æƒ…æ³ä¸‹ï¼Œæ‡‰åœæ¢ä½¿ç”¨ä¸¦è«‹æ•™é†«å¸«è—¥å¸«è—¥åŠ‘生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 70: ;"><b><span style="font-family: 新細明體,serif;">七ã€</span></b><span style="font-family: 新細明體,serif;">除éž<b>有醫師藥師藥劑生</b>指示<b>，未滿</b></span><b>3</b><span style="font-family: 新細明體,serif;">æ²<b>之嬰幼兒</b>ä¸å¾—使用<b>。</b></span><b> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 70pt: ;"><b><span style="font-family: 新細明體,serif;">å…«ã€å«</span></b><span style="font-family: 新細明體,serif;">刺激性瀉藥<b>æˆåˆ†ï¼ˆè¡¨ä¸€</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …åŠ</span>B </b><b><span style="font-family: 新細明體,serif;">欄</span>1</b><b><span style="font-family: 新細明體,serif;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">ç¦æ¢ç”¨æ–¼èƒƒè…¸é“阻塞ã€è…¹ç—›ã€å˜”åã€å™å¿ƒä¹‹æ‚£è€…。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">é•·æœŸä½¿ç”¨æœƒé€ æˆé›»è§£è³ªä¸å¹³è¡¡èˆ‡æ°´åˆ†ç¼ºä¹ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">三</span>)<b><span style="font-family: 新細明體,serif;">å«</span> Bisacodyl</b><b><span style="font-family: 新細明體,serif;">之內æœè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b><span style="font-family: 新細明體,serif;">å«</span> </b>Bisacodyl<b><span style="font-family: 新細明體,serif;">之腸溶製</span></b><span style="font-family: 新細明體,serif;">åŠ‘é ˆæ•´ç²’åžæœï¼Œä¸å¾—咬碎<b>或磨粉</b>，且使用藥å‰å¾Œä¸€å°æ™‚ä¸å¾—使用制酸劑或牛乳。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;">(<span style="font-family: 新細明體,serif;">å››</span>)<b><span style="font-family: 新細明體,serif;">å«</span>Senna</b><b><span style="font-family: 新細明體,serif;">é¡žä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span></b> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;">1<span style="font-family: 新細明體,serif;">ã€</span>Senna<span style="font-family: 新細明體,serif;">類會使酸性尿呈黃ã€æ£•è‰²ï¼Œé¹¼æ€§å°¿å‘ˆç²‰ç´…或紫紅色；且會使çµè…¸<b>é»</b>膜變黑。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 117pt: ;"><b>2</b><b><span style="font-family: 新細明體,serif;">ã€æœ¬è—¥å«</span>Senna</b><b><span style="font-family: 新細明體,serif;">é¡žæˆåˆ†ï¼Œè‹¥æœ‰çš®è†šç´…ã€çš®è†šç™¢ç‰éŽæ•ç—‡ç‹€æ™‚，應åœæ¢ä½¿ç”¨ä¸¦è«‹æ•™é†«å¸«è—¥å¸«è—¥åŠ‘生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">五</span>)</b><b><span style="font-family: 新細明體,serif;">å«è˜†è–ˆä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b><span style="font-family: 新細明體,serif;">大é‡ä½¿ç”¨å«è˜†è–ˆä¹‹è£½åŠ‘，會引起骨盆腔內之臟器充血，å•å©¦ã€ç¶“期ä¸å©¦å¥³åŠè…Žç‚Žã€ç—”瘡之患者應留æ„。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">å…</span>)</b><b><span style="font-family: 新細明體,serif;">å«å¤§é»ƒä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b><span style="font-family: 新細明體,serif;">本藥å«å¤§é»ƒæˆåˆ†ï¼Œè‹¥æœ‰çš®è†šç´…ã€çš®è†šç™¢ç‰éŽæ•ç—‡ç‹€æ™‚，應åœæ¢ä½¿ç”¨ä¸¦è«‹æ•™é†«å¸«è—¥å¸«è—¥åŠ‘生。</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 67: ;"><b><span style="font-family: 新細明體,serif;">ä¹ã€å«</span></b><span style="font-family: 新細明體,serif;">鹽類瀉藥<b>æˆåˆ†ï¼ˆè¡¨ä¸€</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90pt: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">ç¦æ¢ç”¨æ–¼èƒƒè…¸é“阻塞ã€è…¹ç—›ã€å˜”åã€å™å¿ƒä¹‹æ‚£è€…。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">é•·æœŸä½¿ç”¨æœƒé€ æˆé›»è§£è³ªä¸å¹³è¡¡èˆ‡æ°´åˆ†ç¼ºä¹ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 89: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">三</span>)</b><b><span style="font-family: 新細明體,serif;">除éžæœ‰é†«å¸«è—¥å¸«è—¥åŠ‘生指示，腎臟功能障礙之病患請勿æœç”¨æœ¬è—¥ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm -10.2pt 0pt 67.5pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">åã€å«</span></b><span style="font-family: 新細明體,serif;">膨脹性瀉藥<b>æˆåˆ†ï¼ˆè¡¨ä¸€</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span> 3</b><b><span style="font-family: 新細明體,serif;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">ç¦æ¢ç”¨æ–¼èƒƒè…¸é“阻塞ã€è…¹ç—›ã€å˜”åã€å™å¿ƒã€è…¸é“æ½°ç˜ã€ç‹¹çª„或粘é»ä¹‹æ‚£è€…。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">需</span>12<span style="font-family: 新細明體,serif;">å°æ™‚至三天æ‰æœƒç™¼ç”Ÿä½œç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">三</span>)<span style="font-family: 新細明體,serif;">ä¸é©ç”¨æ–¼é ˆé™åˆ¶æ°´ä»½ä¹‹æ‚£è€…。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 85: ;">(<span style="font-family: 新細明體,serif;">å››</span>)<span style="font-family: 新細明體,serif;">ä½¿ç”¨æ™‚é ˆä¾æŒ‡ç¤ºåŠ <b>足é‡</b>æ°´æœç”¨ï¼Œ<b>å¦å‰‡æ˜“</b>引起胸痛ã€å˜”åã€å£æ°´éŽå¤šã€å®¹æ˜“嗆到<b>ç‰é£Ÿé“阻塞之症狀或徵候</b>ï¼Œé ˆ<b>åœæ¢ä½¿ç”¨ä¸¦è«‹æ•™é†«å¸«è—¥å¸«è—¥åŠ‘生</b>。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; margin: 0cm -10.2pt 0pt 67.5pt; layout-grid-mode: char;"><b><span style="font-family: 新細明體,serif;">åã€å«</span></b><span style="font-family: 新細明體,serif;">溼潤性瀉藥<b>æˆåˆ†ï¼ˆè¡¨ä¸€</b></span><b>A</b><b><span style="font-family: 新細明體,serif;">欄</span>4</b><b><span style="font-family: 新細明體,serif;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90pt: ;">(<span style="font-family: 新細明體,serif;">一</span>)<span style="font-family: 新細明體,serif;">ç¦æ¢ç”¨æ–¼èƒƒè…¸é“阻塞ã€è…¹ç—›ã€å˜”åã€å™å¿ƒã€è…¸é“æ½°ç˜ã€ç‹¹çª„或粘é»ä¹‹æ‚£è€…。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90pt: ;">(<span style="font-family: 新細明體,serif;">二</span>)<span style="font-family: 新細明體,serif;">溼潤性瀉<b>è—¥æˆåˆ†</b>，ä¸å¯èˆ‡ç¤¦ç‰©æ²¹åˆç”¨ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90: ;">(<span style="font-family: 新細明體,serif;">三</span>)<span style="font-family: 新細明體,serif;">é•·æœŸä½¿ç”¨æœƒé€ æˆé›»è§£è³ªä¸å¹³è¡¡èˆ‡æ°´åˆ†ç¼ºä¹ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 72pt: ;"><b><span style="font-family: 新細明體,serif;">å一ã€å«</span></b><span style="font-family: 新細明體,serif;">高滲é€å£“瀉藥<b>æˆåˆ†ï¼ˆè¡¨ä¸€</b></span><b>B</b><b><span style="font-family: 新細明體,serif;">欄</span>2</b><b><span style="font-family: 新細明體,serif;">é …ï¼‰ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 90: ;"><span style="font-family: 新細明體,serif;">ç¦æ¢ç”¨æ–¼èƒƒè…¸é“阻塞ã€è…¹ç—›ã€å˜”åã€å™å¿ƒä¹‹æ‚£è€…。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 76: ;"><b><span style="font-family: 新細明體,serif;">å二ã€å«ç”˜è‰ï¼ˆè¡¨ä¸€</span>C</b><b><span style="font-family: 新細明體,serif;">欄）一日é…åˆé‡è¶…éŽ</span>1 g</b><b><span style="font-family: 新細明體,serif;">（或浸è†ä¹‹åŽŸç”Ÿè—¥æ›ç®—é‡ç‚º</span>1 g</b><b><span style="font-family: 新細明體,serif;">ä»¥ä¸Šï¼‰ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">一</span>)</b><b><span style="font-family: 新細明體,serif;">除éžæœ‰é†«å¸«è—¥å¸«è—¥åŠ‘生指示，高齡者與有嚴é‡è…¹ç—›ã€å™å¿ƒã€å˜”åã€æ°´è…«ç—‡ç‹€åŠé«˜è¡€å£“ã€å¿ƒè‡ŸåŠŸèƒ½éšœç¤™ã€è…Žè‡ŸåŠŸèƒ½éšœç¤™ä¹‹ç—…患請勿æœç”¨æœ¬è—¥ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><b>(</b><b><span style="font-family: 新細明體,serif;">二</span>)</b><b><span style="font-family: 新細明體,serif;">æœç”¨ä¸ç™¼ç¾æœ‰å°¿é‡æ¸›å°‘ã€é¢éƒ¨æˆ–手足浮腫ã€çœ¼çš®æ²‰é‡ã€æ‰‹éƒ¨åƒµç¡¬ï¼Œè¡€å£“å‡é«˜ã€é ç—›ç‰ç¾è±¡ï¼Œæ‡‰ç«‹å³åœè—¥å°±é†«ã€‚</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 35: ;"><b><span style="font-family: 新細明體,serif;">å三ã€æ “åŠ‘ä¹‹æœ¬é¡žè£½åŠ‘åŠ å…¥ä¸‹è¿°è¦èªžï¼š</span> </b></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16pt; layout-grid-mode: char; 94: ;"><span style="font-family: 新細明體,serif;">æœƒé€ æˆç›´è…¸åˆºæ¿€æ„Ÿ<b>ã€è…¹éƒ¨ä¸é©ã€‚</b></span> </p>2013-12-04
查驗登記類,指示藥å“審查基準,鎮咳祛痰劑行政解釋指示藥å“審查基準鎮-咳祛痰劑詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4513&type=0
查驗登記類,指示藥å“審查基準,鎮暈劑行政解釋指示藥å“審查基準-鎮暈劑詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4514&type=0
臨床試驗類,ç ”ç©¶ç”¨äººé«”æª¢é«”æŽ¡é›†èˆ‡ä½¿ç”¨æ³¨æ„äº‹é …è¡Œæ”¿è§£é‡‹ç ”ç©¶ç”¨äººé«”æª¢é«”æŽ¡é›†èˆ‡ä½¿ç”¨æ³¨æ„äº‹é …<p style="text-align: center;"><b><span style="font-family: 標楷體; color: #333333; font-size: 14pt;">ç ”ç©¶ç”¨äººé«”æª¢é«”æŽ¡é›†èˆ‡ä½¿ç”¨æ³¨æ„äº‹é … </span></b></p><p style="text-align: center;"> </p><p><span style="font-family: 標楷體;">一ã€ç‚ºç¢ºä¿ç ”究用檢體之æ£ç•¶æŽ¡é›†åŠä½¿ç”¨ï¼Œä¿éšœæª¢é«”æ供者之權益，並促 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">進科å¸ä¹‹æ£ç•¶ç™¼å±•ï¼Œç‰¹è¨‚定本注æ„äº‹é …ã€‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æŽ¡é›†æª¢é«”ä¾›ç ”ç©¶ä½¿ç”¨ï¼Œé™¤ä¾æ³•ä»¤è¦å®šå¤–，ä¾æœ¬æ³¨æ„äº‹é …ç‚ºä¹‹ã€‚ </span></p><p><span style="font-family: 標楷體;">二ã€æœ¬æ³¨æ„äº‹é …ç”¨è©žå®šç¾©å¦‚ä¸‹ï¼š </span></p><p><span style="font-family: 標楷體;">（一）檢體：指與人體分離之細胞ã€çµ„ç¹”ã€å™¨å®˜ã€é«”液或其è¡ç”Ÿç‰©è³ªï¼ˆå« </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">éºå‚³ç‰©è³ªï¼‰ï¼ŒåŒ…括剩餘檢體ã€æŽ¡é›†è‡ªèƒŽå…’或å±é«”之檢體。 </span></p><p><span style="font-family: 標楷體;">（二）檢體æ供者：指接å—檢體採集之人。 </span></p><p><span style="font-family: 標楷體;">（三）檢體使用者：指直接使用檢體ã€æŒ‡ç¤ºä»–人使用檢體或ä¾èˆ‡æª¢é«”æä¾› </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">者間之契約ç‰ç‰¹å®šé—œä¿‚而得使用檢體之人或機構。 </span></p><p><span style="font-family: 標楷體;">（四）檢體ä¿ç®¡è€…：指ä¿å˜æª¢é«”之人或機構。 </span></p><p><span style="font-family: 標楷體;">（五）編碼：以數å—或英文å—æ¯ç‰ä»£ç¢¼ï¼Œå–代檢體æ供者姓åã€èº«ä»½è‰å— </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">號ã€ç—…æ·è™Ÿç‰å¯ä¾›è¾¨è˜å€‹äººè³‡è¨Šä¹‹ä½œæ¥æ–¹å¼ã€‚ </span></p><p><span style="font-family: 標楷體;">（å…）去連çµï¼šæ–¼æª¢é«”編碼後，將代碼與檢體æ供者å¯ä¾›è¾¨è˜å€‹äººè³‡è¨Šä¹‹ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å°ç…§è³‡æ–™å®Œå…¨æ°¸ä¹…消除之作æ¥æ–¹å¼ã€‚ </span></p><p><span style="font-family: 標楷體;">（七）剩餘檢體：係指病ç†æª¢é©—ã€é†«äº‹æª¢é©—æˆ–ç ”ç©¶å‰©é¤˜ä¹‹æª¢é«”ã€‚ </span></p><p><span style="font-family: 標楷體;">三ã€æŽ¡é›†èˆ‡ä½¿ç”¨æª¢é«”應先æå…·ç ”ç©¶è¨ˆç•«æ›¸ï¼Œä¸¦ç¶“äººé«”è©¦é©—å§”å“¡æœƒæˆ–å…¶ä»–é¡ž </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">似之倫ç†å§”員會（以下簡稱倫ç†å§”å“¡æœƒï¼‰å¯©æ ¸åŒæ„，始得為之。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ä»¥å‰©é¤˜æª¢é«”é€²è¡Œç ”ç©¶ï¼Œæ‡‰æ–¼ä½¿ç”¨å‰æå…·ç ”ç©¶è¨ˆç•«é€å€«ç†å§”å“¡æœƒå¯©æ ¸ã€‚ </span></p><p><span style="font-family: 標楷體;">å››ã€æª¢é«”之採集與使用ä¸å¾—é•èƒŒé†«å¸å€«ç†ï¼Œä¸¦æ‡‰æ³¨æ„防制å°äººé¡žã€ç‰¹å®šæ— </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">群åŠç”Ÿæ…‹ç’°å¢ƒä¹‹å±å®³ã€‚ </span></p><p><span style="font-family: 標楷體;">五ã€æŽ¡é›†æª¢é«”ä¾›ç ”ç©¶ä½¿ç”¨ï¼Œé™¤æ³•å¾‹æœ‰è¦å®šè€…外，應告知檢體æ供者下列事 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">é …ï¼Œä¸¦å–å¾—å…¶åŒæ„： </span></p><p><span style="font-family: 標楷體;">（一）檢體採集之目的åŠå…¶å¯èƒ½ä½¿ç”¨ç¯„åœèˆ‡ä½¿ç”¨æœŸé–“。 </span></p><p><span style="font-family: 標楷體;">（二）檢體採集之方法ã€ç¨®é¡žã€æ•¸é‡åŠæŽ¡é›†éƒ¨ä½ã€‚ </span></p><p><span style="font-family: 標楷體;">（三）檢體採集å¯èƒ½ç™¼ç”Ÿä¹‹ä½µç™¼ç—‡èˆ‡å±éšªã€‚ </span></p><p><span style="font-family: 標楷體;">（四）檢體æ供者之權益與檢體使用者ã€ä¿ç®¡è€…之義務。 </span></p><p><span style="font-family: 標楷體;">ï¼ˆäº”ï¼‰ç ”ç©¶ä¹‹é‡è¦æ€§ã€‚ </span></p><p><span style="font-family: 標楷體;">（å…）被é¸ç‚ºåƒèˆ‡è€…çš„åŽŸå› ã€‚ </span></p><p><span style="font-family: 標楷體;">（七）é æœŸä¹‹ç ”ç©¶æˆæžœã€‚ </span></p><p><span style="font-family: 標楷體;">（八）åˆç†ç¯„åœå…§å¯é 見之風險或ä¸ä¾¿ã€‚ </span></p><p><span style="font-family: 標楷體;">（ä¹ï¼‰ä¿éšœæª¢é«”æ供者個人隱ç§çš„機制。 </span></p><p><span style="font-family: 標楷體;">（å）檢體æ供者得拒絕åƒèˆ‡ç ”ç©¶ï¼Œä¸¦å¾—éš¨æ™‚é€€å‡ºç ”ç©¶ï¼ŒåŠå…¶é€€å‡ºä¹‹ç¨‹åº </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">。檢體æ供者之拒絕或退出，ä¸å½±éŸ¿å…¶æ‡‰æœ‰ä¹‹é†«ç™‚照顧。 </span></p><p><span style="font-family: 標楷體;">（åä¸€ï¼‰ç ”ç©¶æª¢é«”æ‰€å¾—è³‡è¨Šå°æª¢é«”æ供者åŠå…¶è¦ªå±¬æˆ–æ—群å¯èƒ½é€ æˆçš„影響 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: 標楷體;">（å二）檢體ä¿ç®¡è€…與檢體使用者。 </span></p><p><span style="font-family: 標楷體;">（å三）檢體是å¦æœ‰æä¾›ã€è®“與或授權國內或國外之他人使用檢體之情形 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: 標楷體;">（å四）剩餘檢體之處ç†æƒ…形。 </span></p><p><span style="font-family: 標楷體;">（åäº”ï¼‰ç ”ç©¶ç¶“è²»ä¾†æºåŠæ‰€æœ‰åƒèˆ‡ç ”究之機構。 </span></p><p><span style="font-family: 標楷體;">（åå…）其他ä¾å„ç ”ç©¶è¨ˆç•«ä¹‹éœ€è¦ï¼Œèˆ‡æª¢é«”採集ã€ç—…æ·æª¢é–±ã€è¿½è¹¤æª¢æŸ¥æª¢ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">驗或病情資訊相關之é‡è¦äº‹é …。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ä»¥å‰©é¤˜æª¢é«”ä¾›ç ”ç©¶ä½¿ç”¨ï¼Œé™¤å‰é …第二款åŠç¬¬ä¸‰æ¬¾å¤–ï¼Œå…¶é¤˜å‘ŠçŸ¥äº‹é …ä» </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應告知檢體æ供者，å–å¾—åŒæ„。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å‰äºŒé …告知與åŒæ„應以書é¢ç‚ºä¹‹ï¼Œä¸¦è¼”以å£é 告知，務使檢體æ供者 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">明çžå…¶å…§å®¹ã€‚ </span></p><p><span style="font-family: 標楷體;">å…ã€æŽ¡é›†èƒŽå…’之檢體，需經其æ¯è¦ªåŒæ„。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">檢體æ供者為未滿七æ²ä¹‹æœªæˆå¹´äººï¼Œç”±å…¶æ³•å®šä»£ç†äººä»£ç‚ºåŒæ„；滿七 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ²ä»¥ä¸Šä¹‹æœªæˆå¹´äººï¼Œæ‡‰ç”±æ³•å®šä»£ç†äººèˆ‡æª¢é«”æ供者共åŒåŒæ„；檢體æ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">供者為無æ„æ€èƒ½åŠ›è€…，由法定代ç†äººä»£ç‚ºåŒæ„，無法定代ç†äººæ™‚，由 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">最近親屬代為åŒæ„ï¼›å±é«”檢體之æ供應得其最近親屬或本人生å‰ä¹‹æ›¸ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">é¢åŒæ„。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å‰é …最近親屬範åœå¦‚下： </span></p><p><span style="font-family: 標楷體;">（一）é…å¶ã€‚ </span></p><p><span style="font-family: 標楷體;">（二）æˆå¹´ä¹‹ç›´ç³»è¡€è¦ªå‘親屬。 </span></p><p><span style="font-family: 標楷體;">（三）父æ¯ã€‚ </span></p><p><span style="font-family: 標楷體;">（四）兄弟姊妹。 </span></p><p><span style="font-family: 標楷體;">（五）祖父æ¯ã€‚ </span></p><p><span style="font-family: 標楷體;">（å…）曾祖父æ¯æˆ–三親ç‰æ—系血親。 </span></p><p><span style="font-family: 標楷體;">（七）一親ç‰ç›´ç³»å§»è¦ªã€‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">最近親屬書é¢åŒæ„得以一人行之；最近親屬æ„見ä¸ä¸€è‡´æ™‚，ä¾å‰é …å„ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ¬¾å…ˆå¾Œå®šå…¶é †åºã€‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å‰é …åŒä¸€é †åºä¹‹äººï¼Œä»¥è¦ªç‰è¿‘者為先，親ç‰åŒè€…，以åŒå±…親屬為先， </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç„¡åŒå±…親屬者，以年長者為先。 </span></p><p><span style="font-family: 標楷體;">七ã€æŽ¡é›†èˆ‡ä½¿ç”¨æª¢é«”å¯èƒ½è¡ç”Ÿå…¶ä»–如商æ¥åˆ©ç›Šç‰æ¬Šç›Šæ™‚，檢體使用者應告 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">知檢體æ供者並為必è¦ä¹‹æ›¸é¢ç´„定。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å‰é …檢體採集自胎兒ã€å±é«”ã€æœªæˆå¹´äººæˆ–ç„¡æ„æ€èƒ½åŠ›è€…時，檢體使用 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">者應告知å‰é»žè¦å®šå¾—為åŒæ„之人，並為必è¦ä¹‹æ›¸é¢ç´„定。 </span></p><p><span style="font-family: 標楷體;">å…«ã€ç•¶ç ”究æˆæžœå¯åˆç†é 期å°å¯è¾¨è˜ä¹‹æª¢é«”æ供者個人å¥åº·æœ‰é‡å¤§å½±éŸ¿æ™‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">，檢體使用者經倫ç†å§”å“¡æœƒå¯©æ ¸ï¼Œä¸”æª¢é«”æ供者é¸æ“‡çŸ¥æ‚‰æ™‚，檢體使 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">用者應告知並å”助æ供必è¦ä¹‹ç›¸é—œè«®è©¢ã€‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å‰é …之倫ç†å§”員會審查，應考é‡æª¢é«”æ供者å¥åº·å±å®³çš„程度，與é 防 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŠæ²»ç™‚æˆæœ¬æ•ˆç›Šç‰å› ç´ ã€‚ </span></p><p><span style="font-family: 標楷體;">ä¹ã€æª¢é«”使用者應在檢體æ供者所åŒæ„或ä¾æ³•å¾—使用之範åœå…§ä½¿ç”¨æª¢é«”。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">使用檢體如逾越å‰é …範åœï¼Œæ‡‰ä¾ç¬¬ä¸‰é»žã€ç¬¬äº”點åŠç¬¬ä¸ƒé»žè¦å®šè¾¦ç†å¯© </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">查åŠå‘ŠçŸ¥ç¨‹åºã€‚ </span></p><p><span style="font-family: 標楷體;">åã€é™¤æ³•å¾‹æœ‰è¦å®šè€…外，檢體æ供者得拒絕接å—採集ã€çµ‚æ¢æª¢é«”ä½¿ç”¨ä¹‹åŒ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ„或變更所åŒæ„之使用範åœã€‚但檢體與個人資料已去連çµè€…ä¸åœ¨æ¤é™ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">檢體æ供者拒絕檢體之採集或使用，應ä¸å½±éŸ¿å…¶é†«ç™‚或個人之權益。 </span></p><p><span style="font-family: 標楷體;">å一ã€æª¢é«”ä¿ç®¡è€…或檢體使用者應妥善ä¿å˜åŠç®¡ç†æª¢é«”。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">檢體使用完畢或檢體æ供者終æ¢æª¢é«”使用之åŒæ„時，應確實銷毀檢 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">體，éžç¶“檢體æ供者事å‰ä¹‹æ›¸é¢åŒæ„，ä¸å¾—繼續ä¿å˜ã€‚但檢體已去 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">連çµè€…ä¸åœ¨æ¤é™ã€‚ </span></p><p><span style="font-family: 標楷體;">å二ã€æª¢é«”ä¿ç®¡è€…與檢體使用者應尊é‡ä¸¦ä¿è·æª¢é«”æä¾›è€…ä¹‹äººæ ¼æ¬Šã€‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å°æ–¼å› 檢體採集ã€ä¿å˜ã€ä½¿ç”¨æ‰€çŸ¥æ‚‰ä¹‹æª¢é«”æ供者秘密ã€éš±ç§æˆ–個 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">人資料，ä¸å¾—ç„¡æ•…æ´©æ¼ã€‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">檢體ä¿å˜åŠè™•ç†éŽç¨‹æ‡‰ä»¥ç·¨ç¢¼ã€åŽ»é€£çµæˆ–其他匿åæ–¹å¼ç‚ºä¹‹ã€‚ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">檢體使用者將檢體所得資訊æ供予第三人或公開其資料時，應以無 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">從è˜åˆ¥æª¢é«”æ供者個人資料之方å¼è™•ç†ã€‚ </span></p><p><span style="font-family: 標楷體;">å三ã€éžç¶“倫ç†å§”員會之審查，確ä¿æª¢é«”æ供者åŠæˆ‘國民眾之權益åŠå®‰å…¨ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">，檢體ä¸æ‡‰è®“與或授權國外使用。 </span></p><p><span style="font-family: 標楷體;">åå››ã€å…·ä¸‹åˆ—情形之一者，得ä¸å—第五點與第七點è¦å®šä¹‹é™åˆ¶ï¼Œä½†æ‡‰ä¾ç¬¬ </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">三點è¦å®šç¶“倫ç†å§”員會審查通éŽå¾Œï¼Œå§‹å¾—為之： </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">（一）難以辨èªæª¢é«”æ供者身分。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ï¼ˆäºŒï¼‰å› ç„¡æ³•è¿½è¹¤æˆ–è¯çµ¡ç‰åŽŸå› ，難以é‡æ–°å–得檢體æ供者åŒæ„。 </span></p><p><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">（三）本注æ„äº‹é …ä¿®æ£é ’è¡Œå‰ï¼Œå·²å¯å…¬é–‹å–得之檢體。 </span></p><p><span style="font-family: 標楷體;">å五ã€ä¾æœ¬æ³¨æ„äº‹é …æŽ¡é›†ä¹‹æª¢é«”ä½¿ç”¨æ–¼æ•™å¸æ™‚，準用第å二點之è¦å®šã€‚ </span></p>2013-12-04
其他類,æ血者å¥åº·æ¨™æº–法è¦å‘½ä»¤æ血者å¥åº·æ¨™æº–<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本標準ä¾è¡€æ¶²è£½åŠ‘æ¢ä¾‹ç¬¬åå››æ¢ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æè¡€è€…é ˆç¬¦åˆä¸‹åˆ—æ¢ä»¶ï¼Œå§‹å¾—æ血：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€</span> <span style="font-family: 新細明體,serif;">年齡：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å七æ²ä»¥ä¸Šï¼Œå…å五æ²ä»¥ä¸‹ï¼Œä¸€èˆ¬å¥åº·æƒ…æ³è‰¯å¥½ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">未滿å七æ²è€…，應視體能狀æ³ï¼Œä¸¦ç¶“法定代ç†äººä¹‹åŒæ„，始得æ血。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">逾å…å五æ²è€…，除應å¥åº·æƒ…æ³è‰¯å¥½å¤–，並應å–得醫師之åŒæ„，始得æ血。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é«”é‡ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">女性應四å五公斤以上，男性應五å公斤以上。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ分離術血å°æ¿ã€åˆ†é›¢è¡“白血çƒåŠåˆ†é›¢è¡“血漿者，應五å公斤以上。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é«”溫：å£æº«ä¸è¶…éŽæ”æ°ä¸‰ä¸ƒï¼Žäº”度。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¡€å£“：收縮壓ä¹â—‹ï½žä¸€å…○毫米汞柱，舒張壓五○～ä¹äº”毫米汞柱，如兩者之è·é›¢ä½Žæ–¼ä¸‰â—‹æˆ–高於ä¹â—‹æ¯«ç±³æ±žæŸ±ï¼Œé ˆç¶“醫師許å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è¡€æ¶²æª¢æŸ¥ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡€ç´…ç´ ï¼šç”·æ€§å三公克％以上</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">使用硫酸銅法時血液比é‡ä¸€â€§â—‹äº”å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。女性å二公克％以上</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">使用硫酸銅法時血液比é‡ä¸€â€§â—‹äº”二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡€å°æ¿ï¼šæè¡€å°æ¿è€…，其血å°æ¿æ•¸ç›®æ‡‰åœ¨</span><span style="font-family: calibri;"> 15</span><span style="font-family: 新細明體,serif;">×</span><span style="font-family: calibri;">10,000</span><span style="font-family: 新細明體,serif;">ï¼</span><span style="font-family: calibri;">mm3 </span><span style="font-family: 新細明體,serif;">以上。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">白血çƒï¼šæ白血çƒè€…，其絕å°é¡†ç²’çƒæ•¸ç›®æ‡‰åœ¨</span><span style="font-family: calibri;"> 3,000</span><span style="font-family: 新細明體,serif;">ï¼</span><span style="font-family: calibri;">mm3 </span><span style="font-family: 新細明體,serif;">以上。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血漿總蛋白：æ血漿者，應於首次æ血暨æ¯éš”åŠå¹´åŠ 驗血漿總蛋白é‡ï¼Œå…¶è¡€æ¼¿ç¸½è›‹ç™½æ‡‰åœ¨</span><span style="font-family: calibri;"> 6g/d1 </span><span style="font-family: 新細明體,serif;">以上。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血者æ¯æ¬¡ä¹‹æè¡€é‡åŠæ血間隔如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ¯æ¬¡æ血以二五○毫å‡ç‚ºåŽŸå‰‡ï¼Œä½†é«”é‡å…○公斤以上者，æ¯æ¬¡æ血得為五○○毫å‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ¯æ¬¡æ血二五○毫å‡è€…，其æ血間隔應為二個月以上；æ¯æ¬¡æ血五○○毫å‡è€…，其æ血間隔應為三個月以上。但男性年æè¡€é‡æ‡‰åœ¨ä¸€ã€äº”○○毫å‡ä»¥å…§ï¼›å¥³æ€§å¹´æè¡€é‡æ‡‰åœ¨ä¸€ã€â—‹â—‹â—‹æ¯«å‡ä»¥å…§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ分離術血å°æ¿ã€åˆ†é›¢è¡“白血çƒæˆ–分離術血漿者，æ¯æ¬¡ä¹‹é–“隔為二星期以上。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ分離術血漿é‡æ¯æ¬¡ä»¥äº”○○毫å‡ç‚ºé™ï¼Œå…¶å…¨å¹´æ血漿é‡ä¸å¾—超éŽå二公å‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血者有下列情形之一者，應暫緩æ血：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å©¦å¥³æ‡·å•ä¸æˆ–產後</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«æµç”¢å¾Œ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å…個月以內者。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¤§æ‰‹è¡“未滿一年或一年內曾接å—輸血者。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å››æ˜ŸæœŸå…§æ›¾æŽ¥ç¨®éº»ç–¹ã€å¾·åœ‹éº»ç–¹ã€è…®è…ºç‚ŽåŠå°å…’麻痺</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å£æœ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ç‰æ´»æ€§æ¸›æ¯’疫苗者。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å…個月內曾罹患è‚炎或密切接觸è‚炎病患者。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç¾æ‚£æ¢…毒ã€æ´»å‹•æ€§çµæ ¸ç—…ã€ç³–å°¿ç—…ã€å¿ƒè‡Ÿç—…ã€æ¶ˆåŒ–é“æ½°ç˜å‡ºè¡€ã€é«˜è¡€å£“ã€è…Žè‡Ÿç—…ã€å“®å–˜ã€æ„Ÿå†’ã€æ€¥æ€§æ„ŸæŸ“ã€å‚³æŸ“ç—…ã€éŽæ•ç—…症者。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è‡ªç˜§ç–¾ç–«å€å›žåœ‹ä¸€å¹´å…§æˆ–曾在三年內罹患瘧疾者。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æ›¾åœ¨ä¸ƒå二å°æ™‚內拔牙者。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æ›¾åœ¨äº”天內æœç”¨å«</span><span style="font-family: calibri;"> Aspirin</span><span style="font-family: 新細明體,serif;">ã€é¡žè—¥ç‰©æˆ–其他å¯æŠ‘制血å°æ¿åŠŸèƒ½ä¹‹è—¥ç‰©è€…，ä¸å¾—æè¡€å°æ¿ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€</span><span style="font-family: calibri;">B </span><span style="font-family: 新細明體,serif;">åž‹è‚炎表é¢æŠ—原檢查呈陽性å應者。</span> </p><p><span style="font-family: 新細明體,serif;">åã€</span><span style="font-family: calibri;">C </span><span style="font-family: 新細明體,serif;">åž‹è‚炎病毒抗體檢查呈陽性å應者。</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€æ°‘國å…åä¹å¹´è‡³å…«å五年間曾在英國輸血或曾至英國旅éŠæˆ–居留時間åˆè¨ˆè¶…éŽä¸‰å€‹æœˆè€…，或民國å…åä¹å¹´ä»¥å¾Œæ›¾æ–¼æ洲旅éŠæˆ–居留時間åˆè¨ˆè¶…éŽäº”年者。</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€ç¶“é€šå ±ç‚ºåš´é‡æ€¥æ€§å‘¼å¸é“症候群疑似或å¯èƒ½ç—…例，於治療痊癒後，未逾三個月內者。</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€æ›¾èˆ‡åš´é‡æ€¥æ€§å‘¼å¸é“症候群疑似或å¯èƒ½ç—…例密切接觸，於最後接觸日起一個月內者。</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€è‡ªæœ‰åœ°å€æ€§å‚³æ’åš´é‡æ€¥æ€§å‘¼å¸é“症候群之地å€å›žåœ‹å¾Œä¸€å€‹æœˆå…§è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€è‡ªè¥¿å°¼ç¾…病毒æµè¡Œå€é›¢å¢ƒæ—¥èµ·ä¸€å€‹æœˆå…§è€…。</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€æ‡·ç–‘自己感染愛滋病毒者或二年內曾與å¯èƒ½æ„ŸæŸ“愛滋病毒者發生性行為者。</span> </p><p><span style="font-family: 新細明體,serif;">å七ã€ä¸€å¹´å…§æ›¾å¾žäº‹å±éšªæ€§è¡Œç‚ºæˆ–曾罹患性病</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">梅毒ã€æ·‹ç—…ã€æŠ«è¡£èŒã€ç”Ÿæ®–器皰疹ã€è»Ÿæ€§ä¸‹ç–³ã€å°–åž‹æ¿•ç–£ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">者。</span> </p><p><span style="font-family: 新細明體,serif;">åå…«ã€ä¸€å¹´å…§æ›¾åˆºé’者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血者有下列情形之一者，永ä¸å¾—æ血：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ›¾æ‚£æƒ¡æ€§è…«ç˜¤ã€ç™½è¡€ç—…或其他經醫師èªç‚ºæ°¸ä¹…ä¸å¾—æ血者。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ›¾æœ‰å‡ºè¡€ä¸æ¢ã€æŠ½ç—™æˆ–æ˜è¿·ä¹‹ç—…å²è€…。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ›¾æœ‰å¸æ¯’或慢性酒精ä¸æ¯’者。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€éœè„ˆæ³¨å°„藥物æˆç™®è€…ã€ç”·æ€§é–“性行為者åŠé•·æœŸä½¿ç”¨è¡€æ¶²è£½åŠ‘者。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ›¾ç‚º</span><span style="font-family: calibri;"> AIDS </span><span style="font-family: 新細明體,serif;">患者。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ„›æ»‹ç—…毒第一型åŠç¬¬äºŒåž‹</span><span style="font-family: calibri;"> (HIV-I</span><span style="font-family: 新細明體,serif;">ï¼</span><span style="font-family: calibri;">HIV-II)</span><span style="font-family: 新細明體,serif;">ã€æŠ—體檢查經確èªå‘ˆé™½æ€§å應者。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€äººé¡žå—œ</span><span style="font-family: calibri;"> T</span><span style="font-family: 新細明體,serif;">ã€æ·‹å·´çƒç—…毒第一型</span><span style="font-family: calibri;"> (HTLV-I) </span><span style="font-family: 新細明體,serif;">抗體檢查經確èªå‘ˆé™½æ€§å應者。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æ›¾ç½¹æ‚£åº«è³ˆæ°ç—…者</span><span style="font-family: calibri;"> (CJD)</span><span style="font-family: 新細明體,serif;">ã€æ›¾æ³¨å°„人類腦下垂體生長è·çˆ¾è’™è€…ã€æ›¾æ³¨å°„äººé¡žè…¦ä¸‹åž‚é«”è¦ªç”Ÿæ®–è…ºç´ </span><span style="font-family: calibri;"> (human pituitary gonadotropins) </span><span style="font-family: 新細明體,serif;">者ã€æ›¾æ³¨å°„ç‰›èƒ°å³¶ç´ ç‰ç”Ÿç‰©è£½åŠ‘者ã€æ›¾æŽ¥å—硬腦膜移æ¤è€…或家æ—ä¸æœ‰åº«è³ˆæ°ç—…</span><span style="font-family: calibri;"> (CJD) </span><span style="font-family: 新細明體,serif;">患者。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ›¾å¾žäº‹æ€§å·¥ä½œè€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ血機構å°æ血者實施å¥åº·ç¯©æª¢ä¹‹é …目如附表。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本標準自發布日施行。</span> </p>2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6067&type=0
查驗登記類,æ ¸é†«æ”¾å°„æ€§è—¥å“å¯©æŸ¥åŸºæº–è¡Œæ”¿è§£é‡‹æ ¸é†«æ”¾å°„æ€§è—¥å“審查基準<pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬ä¸€ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">通論</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">為確ä¿ä¸Šå¸‚æ ¸é†«æ”¾å°„æ€§è—¥å“çš„å“質ã€å®‰å…¨æ€§åŠæœ‰æ•ˆæ€§ï¼Œä¸¦ä½¿æŸ¥é©—登記檢é€</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">資料時有所ä¾æ“šï¼Œç‰¹è¨‚å®šã€Œæ ¸é†«æ”¾å°„æ€§è—¥å“審查基準ã€ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æœ¬åŸºæº–æ‰€ç¨±ã€Œæ ¸é†«æ”¾å°„æ€§è—¥å“ã€ä¿‚指符åˆè—¥äº‹æ³•ç¬¬å…æ¢ä¹‹è—¥å“定義，</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">以具有放射活度之物質使用於人體內，經體內分佈之後，å¯è¢«ç”¨ä¾†è¨º</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ–·ã€ç›£æ¸¬ã€æ²»ç™‚或緩解疾病ç‰å…·é†«ç™‚效能之藥å“或生物製劑。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“應符åˆè—¥äº‹æ³•åŠç›¸é—œè¦ç¯„之管ç†ï¼Œå¦‚：優良藥å“è£½é€ </span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¦ç¯„ã€è—¥å“優良臨床試驗è¦ç¯„ã€è—¥å“éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„ã€è—¥å“</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">éžè‡¨åºŠè©¦é©—安全性è¦ç¯„ç‰ã€‚有關放射性物質之輸出入ã€é‹é€ã€è™•ç†åŠ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">貯å˜ï¼Œæ‡‰ç¬¦åˆåœ‹å…§ç›¸é—œä¸»ç®¡æ©Ÿé—œç®¡ç†æ³•è¦ã€‚å«æœ‰æ”¾å°„性物質的生物製</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">劑，則並應符åˆç”Ÿç‰©è£½åŠ‘相關法è¦çš„è¦æ±‚。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“於查驗登記所檢附的å„é …è³‡æ–™ï¼Œæ‡‰ç”±åˆä¹Žç›¸é—œåŸºæº–çš„</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">試驗ç²å¾—，或åƒè€ƒå·²ç™¼è¡¨çš„æ–‡ç»ï¼ŒåŠç”±æ¨¡å¼æŽ¨ä¼°åŠæ•¸æ“šåˆ†æžç‰å…¶ä»–æ–¹</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å¼è€Œç²å¾—。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å››</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ä¸€èˆ¬è¨ºæ–·ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“之安全性評估，å¯è€ƒæ…®å…¶ä¸åŒæ–¼ä¸€èˆ¬åŒ–å¸</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">醫藥å“之毒性試驗，但å°è©²è—¥å“輻射劑é‡</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (radiation dosimetry)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ä»æ‡‰ä½œé©ç•¶è©•ä¼°ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">五</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“å“質與安定性的評估è¦é …，包括：藥å“類屬ã€è—¥å“技</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">術檔案åŠè—¥å“å®‰å®šæ€§è©¦é©—å ±å‘Šï¼Œå¦é ˆæª¢é™„國外採用è‰æ˜Žæˆ–處方ä¾æ“šç‰</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">相關資料。</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">åƒè€ƒæœ¬åŸºæº–ç¬¬äºŒç« </span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å…</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¨ºæ–·ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“çš„éžè‡¨åºŠæ¯’ç†å®‰å…¨æ€§è©¦é©—，應ä¾æ‰€å®£ç¨±çš„è—¥å“</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">安全性分級來進行。</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">åƒè€ƒæœ¬åŸºæº–ç¬¬ä¸‰ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">七</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“的臨床安全性與有效性，雖然並ä¸å®Œå…¨æ˜¯é‡å°æŸä¸€ç¨®</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">或æŸä¸€é¡žç‰¹å®šçš„疾病，但是ä»æ‡‰é‡å°æ‰€å®£ç¨±é©æ‡‰ç—‡ï¼Œæä¾›æ£ç¢ºåŠæœ‰æ•ˆ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">之臨床試驗資料。</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">åƒè€ƒæœ¬åŸºæº–ç¬¬å››ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å…«</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">申請查驗登記應檢é€ä¹‹æ–‡ä»¶è³‡æ–™è«‹åƒè€ƒé™„表，並ä¾è³‡æ–™åˆ†é¡žè£è¨‚æˆå†Š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬äºŒç« </span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“之å“質與安定性</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“之å“質與安定性資料包括：藥å“類屬ã€è—¥å“技術檔案ã€è—¥</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å“å®‰å®šæ€§è©¦é©—å ±å‘Šã€åœ‹å¤–採用è‰æ˜Žç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è—¥å“類屬：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">醫用放射性åŒä½ç´ 發生器：係指放射性åŒä½ç´ æ¯æ ¸ç¨®èˆ‡åæ ¸ç¨®ç¶“ä¸€</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">定分離æ¥é©Ÿå¾Œï¼Œæ–¹å¯æ供放射性åæ ¸ç¨®é€²è¡Œæ ¸é†«æ”¾å°„æ€§è—¥å“之調劑</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">或標è˜ï¼Œå¦‚：</span><span style="font-family: times new roman,serif; font-size: 11pt;">99mTc </span><span style="font-family: 標楷體; font-size: 11pt;">放射性åŒä½ç´ 發生器。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">標è˜å‰é©…劑：係指製備後，å³å¯æä¾›æ”¾å°„æ€§æ ¸ç¨®é€²è¡Œæ ¸é†«æ”¾å°„æ€§è—¥</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å“之調劑或標è˜ï¼Œå¦‚：</span><span style="font-family: times new roman,serif; font-size: 11pt;">111InCl3 </span><span style="font-family: 標楷體; font-size: 11pt;">標è˜å‰é©…劑。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">放射性å³ç”¨è£½åŠ‘：係指已製備好å¯ç«‹å³ä½¿ç”¨ä¹‹æ ¸é†«æ”¾å°„性藥å“，如</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">：</span><span style="font-family: times new roman,serif; font-size: 11pt;">201TlCl </span><span style="font-family: 標楷體; font-size: 11pt;">å¿ƒè‡Ÿé€ å½±åŠ‘ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å››</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">éžæ”¾å°„性å³ç”¨å¥—組：係指該æˆå“經放射性åŒä½ç´ 之標è˜åŠæ™‚調劑後</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ï¼Œæ–¹ç‚ºæ ¸é†«æ”¾å°„æ€§è—¥å“，如：</span><span style="font-family: times new roman,serif; font-size: 11pt;">MDP </span><span style="font-family: 標楷體; font-size: 11pt;">éª¨éª¼é€ å½±åŠ‘ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">五</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">å…¶ä»–é¡žæ ¸é†«æ”¾å°„æ€§è—¥å“。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è—¥å“技術檔案：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">èµ·æºã€ç™¼ç¾ä¹‹ç¶“éŽæˆ–åœ‹å¤–ä½¿ç”¨æƒ…å½¢ï¼šä¿‚æŒ‡æ ¸é†«æ”¾å°„æ€§è—¥å“çš„ç ”ç©¶èƒŒ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">景ã€åƒè€ƒæ–‡ç»ã€ä½¿ç”¨æƒ…å½¢åŠèˆ‡å…¶ä»–è—¥å“之比較ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">物ç†åŠåŒ–å¸æ€§è³ªã€æª¢é©—方法åŠè¦æ ¼ï¼šä¿‚指該醫放射性藥å“所使用æˆ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">份之物ç†åŒ–å¸çš„性狀ã€æª¢é©—è¦æ ¼æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">包括原料åŠæˆ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å“</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">ç‰è³‡æ–™ã€‚åŒæ™‚應å°æ‰€ä½¿ç”¨çš„放射性åŒä½ç´ ï¼Œè¨»æ˜Žæ ¸ç¨®å稱ã€æ ¸</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">種純度ã€æ ¸ç¨®èƒ½èœã€æ¯”放射活度ç‰ï¼›ä¸¦å°æ‰€ä½¿ç”¨çš„放射性åŒä½ç´ 標</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è˜åŒ–åˆç‰©ï¼Œè¨»æ˜Žä¾›æ‡‰è€…ã€åˆæˆæ–¹æ³•ã€æ¨™è˜æ–¹æ³•ã€ç´”度ã€æ¨™è˜ä½ç½®åŠ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">經時安定性ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">與所附æˆå“檢驗æˆç¸¾æ›¸åŒæ‰¹è™Ÿä¹‹å®Œæ•´æ‰¹æ¬¡ç´€éŒ„ï¼Œæˆ–è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å››</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">申請無èŒè£½åŠ‘查驗登記，應檢附無èŒè£½åŠ‘æ»…èŒåŠç„¡èŒå……填確效之書</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">é¢ä½œæ¥ç¨‹åºåŠå ±å‘Šè³‡æ–™ã€‚</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">ä¾æœ¬ç½²</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 84.4.29 </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥å—第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 8402349</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 0 </span><span style="font-family: 標楷體; font-size: 11pt;">號公告</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è—¥å“安定性試驗書é¢ä½œæ¥ç¨‹åºåŠå…¶æª¢é©—å ±å‘Šï¼š</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">åƒè€ƒæœ¬ç½²</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 75.6.13</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥å—第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 597181 </span><span style="font-family: 標楷體; font-size: 11pt;">號公告，或</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87.7.22 </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥å—第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87041838 </span><span style="font-family: 標楷體; font-size: 11pt;">å…¬</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å‘Š</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“之藥å“å®‰å®šæ€§è©¦é©—å ±å‘Šï¼Œä¸€èˆ¬é ˆåŒ…æ‹¬è©²è—¥å“之三批</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">次經時安定性åŠæœ‰æ•ˆæœŸé™çš„評估數據。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">若為çŸåŠè¡°æœŸæ ¸ç¨®</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">如：æ£å放射製劑</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">çš„æ ¸é†«æ”¾å°„æ€§è—¥å“，其安</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å®šæ€§è©¦é©—å ±å‘Šï¼Œæ‡‰ä»¥å…·ç§‘å¸æ„義並能åˆç†é¡¯ç¤ºè—¥å“å“質為å‡å‹»ç©©å®š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">之評估試驗å–代。亦å¯ä¾æ“šè©²è—¥å“製備系統的線上管制紀錄</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (on</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> line control records) </span><span style="font-family: 標楷體; font-size: 11pt;">åŠ ä»¥åˆ†æžç¢ºèªã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å››</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">國外採用è‰æ˜Žï¼š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¼¸å…¥æ ¸é†«æ”¾å°„æ€§è—¥å“應ä¾æœ¬ç½²</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87.3.13 </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥å—第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 87010820 </span><span style="font-family: 標楷體; font-size: 11pt;">號公</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å‘Šè¦å®šï¼Œæª¢é™„國外採用è‰æ˜Žã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬ä¸‰ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¨ºæ–·ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“之毒ç†èˆ‡å®‰å…¨æ€§</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“之毒ç†åŠå®‰å…¨æ€§è³‡æ–™ï¼Œæ‡‰èƒ½ä½œç‚ºæ±ºå®šä½¿ç”¨åŠ‘é‡åŠå®‰å…¨æ€§åˆ†</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">級之åƒè€ƒã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¨ºæ–·ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“ä¾å…¶çµ„æˆæˆåˆ†åŠä½¿ç”¨åŠ‘é‡çš„安全性分為三級：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬ä¸€ç´šæ ¸é†«æ”¾å°„æ€§è—¥å“：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 1 </span><span style="font-family: 標楷體; font-size: 11pt;">è©²æ ¸é†«æ”¾å°„æ€§è—¥å“的組æˆæˆåˆ†ç‚ºä¸€èˆ¬åŒ–å¸ç‰©è³ªï¼Œä¸”其放射活度僅</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">é™æ–¼ç¤ºè¹¤åŠ‘é‡ï¼Œä¸è¶³ä»¥å¼•èµ·ä»»ä½•æ˜Žé¡¯çš„è—¥ç†å應。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 2 </span><span style="font-family: 標楷體; font-size: 11pt;">該類藥å“的劑é‡ç¯„åœè©¦é©—</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (dosing ranging study) </span><span style="font-family: 標楷體; font-size: 11pt;">，一般å¯ä»¥</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å…除；其輻射劑é‡ç¯„åœä¸‹é™å¯ç”±æ•¸å¸æˆ–物ç†çš„模å¼æŽ¨ä¼°ï¼Œä¸Šé™å‰‡</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">以生物體å¯æŽ¥å—之輻射劑é‡ç‚ºä¾æ“šã€‚通常ä¸é ˆè¨»æ˜Žæœ€å¤§è€å—劑é‡</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬äºŒç´šæ ¸é†«æ”¾å°„æ€§è—¥å“：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 1 </span><span style="font-family: 標楷體; font-size: 11pt;">è©²æ ¸é†«æ”¾å°„æ€§è—¥å“之放射活度僅é™æ–¼ç¤ºè¹¤åŠ‘é‡ï¼Œä½†å› 其組æˆæˆåˆ†</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å«æœ‰ç”Ÿç‰©ç‰©è³ªï¼Œä»æœ‰å¯èƒ½å¼•èµ·éŽæ•æˆ–其他å…ç–«å應，故應進行å…</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç–«å¸åæ‡‰çš„ç ”ç©¶èˆ‡è©•ä¼°ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 2 </span><span style="font-family: 標楷體; font-size: 11pt;">該類藥å“å› ç‚ºå¯èƒ½å…·æŠ—原å應，所以應以具最高放射活度劑é‡</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> the highest radioactive dose) </span><span style="font-family: 標楷體; font-size: 11pt;">之最低蛋白質劑é‡</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (the low-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> est protein dose) </span><span style="font-family: 標楷體; font-size: 11pt;">，為é©ç•¶ä½¿ç”¨åŠ‘é‡ï¼Œé€šå¸¸ä¹Ÿä¸é ˆè¨»æ˜Žæœ€å¤§è€</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å—劑é‡ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬ä¸‰ç´šæ ¸é†«æ”¾å°„æ€§è—¥å“：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 1 </span><span style="font-family: 標楷體; font-size: 11pt;">ç•¶æ ¸é†«æ”¾å°„æ€§è—¥å“之使用劑é‡è¶³ä»¥ç”¢ç”Ÿè—¥ç†å應時，應é‡å°è©²è—¥</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å“之特殊活性所å¯èƒ½ç”¢ç”Ÿä¹‹å±éšªé€²è¡Œå®‰å…¨æ€§è©•ä¼°ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 2 </span><span style="font-family: 標楷體; font-size: 11pt;">該類藥å“以å¯è¡¨ç¾å‡ºè‡¨åºŠå¯è§€å¯Ÿä¹‹è—¥ç†å應的劑é‡ç‚ºæœ€é«˜åŠ‘é‡ï¼Œ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">而以能產生令人滿æ„影效果的劑é‡ç‚ºæœ€ä½ŽåŠ‘é‡ã€‚在第一階段臨床</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">試驗ä¸ï¼Œé ˆä»¥ä¸€å®šæ•¸ç›®çš„病人進行廣泛的安全性評估。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">劑é‡æ±ºå®šçš„原則：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">é€šå¸¸è¨ºæ–·ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“的劑é‡ï¼Œæ‡‰è©²ä»¥ç—…人所接å—的放射活度</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">與輻射劑é‡ä¾†ä¼°è¨ˆï¼Œè€Œä¸æ˜¯ç”±è—¥å“所產生的藥ç†æˆ–ä¸è‰¯å應的劑é‡</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">來決定。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">è¦ä¼°è¨ˆè¨ºæ–·ç”¨æ ¸é†«æ”¾å°„性藥å“的劑é‡ï¼Œæ‡‰æ ¹æ“šè‡³å°‘一種動物åŠä¸€å®š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">數é‡çš„人體試驗所è’集到的生體分佈性資料來推估。è·æ¥ä¸Šå®¹è¨±çš„</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">最大暴露劑é‡ï¼Œä¸¦ä¸é©å®œç”¨ä¾†å»ºç«‹è¨ºæ–·ç”¨æ ¸é†«æ”¾å°„性藥å“的輻射劑</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">é‡çš„指標。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ¯’æ€§è©¦é©—ï¼šè¨ºæ–·ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“çš„éžè‡¨åºŠå®‰å…¨æ€§è©•ä¼°ï¼Œä¸€èˆ¬ä¸é ˆé€²</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¡Œé‡è¦†åŠ‘é‡æ¯’性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">如：慢性毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">ã€ç”Ÿæ®–毒性試驗åŠè‡´ç™Œæ€§</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">æˆ–è‡´åŸºå› è®Šç•°æ€§è©¦é©—</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。å°æ–¼ç¬¬ä¸‰ç´šçš„診斷用放射性藥å“</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">，å¯èƒ½ä»éœ€é€²è¡Œå–®ä¸€åŠ‘é‡æ¯’性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">急性毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬å››ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“之臨床安全性與有效性</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“的臨床安全性與有效性，雖然並ä¸å®Œå…¨æ˜¯é‡å°æŸä¸€ç¨®æˆ–æŸ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">一類特定的疾病，但是ä»æ‡‰é‡å°æ‰€å®£ç¨±é©æ‡‰ç—‡ï¼Œæä¾›æ£ç¢ºåŠæœ‰æ•ˆä¹‹è‡¨åºŠè©¦</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">驗資料，以評估該藥å“的臨床安全與有效性。其檢附之資料應包括：é©æ‡‰</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">症類屬ã€è‡¨åºŠè³‡æ–™æˆ–推估模å¼</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (model approach) </span><span style="font-family: 標楷體; font-size: 11pt;">ã€ä¸è‰¯å應ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">é©æ‡‰ç—‡é¡žå±¬ï¼š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為器官或組織定ä½ä¹‹è©•ä¼°ï¼šä¸»è¦åœ¨æ供器官或組織定ä½åŠæ¨™ç¤ºä¹‹</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">評估，åŒæ™‚å°å…¶å¤–觀æ£å¸¸èˆ‡å¦äº¦å¯æ供評估資料，如：定ä½è…¸é“或</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">血管所在ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為器官ã€èº«é«”系統功能或生化特性之評估：申請者應æä¾›æ£å¸¸äºº</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">的生ç†å€¼åŠå¯æŽ¥å—çš„ä¿¡è³´å€é–“，以作為該藥å“用於診斷或治療時，</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å¯ä¾›åˆ¤æ–·çš„定性或定é‡ä¸Šåƒè€ƒæ•¸æ“šã€‚如：心臟射出分率ã€å¿ƒè‚Œå£æ´»</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">動情æ³ã€å¤§è…¦è¡€æµçŒæ³¨ã€è‘¡è„糖代è¬èˆ‡ç‰¹å®šå—體功能評估ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為疾病或特定器官專一性之評估：主è¦åœ¨ä»¥è—¥å“çš„æ•æ„Ÿåº¦ã€å°ˆä¸€</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">性å°ç–¾ç—…或特定器官進行åµæ¸¬è©•ä¼°ï¼Œå¦‚ï¼šå–®æ ªæŠ—é«”åµæ¸¬ç‰¹å®šè…«ç˜¤æˆ–</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">以標è˜ç´°èƒž</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (labeled cell) </span><span style="font-family: 標楷體; font-size: 11pt;">æ–¹å¼åµæ¸¬æ„ŸæŸ“æˆ–æ “å¡žèˆ‡å¦ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å››</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">作為決定醫療處置åŠå…¶çµæžœå½±éŸ¿ä¹‹è©•ä¼°ï¼šä¸»è¦åœ¨æ供資訊以決定å°</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç—…æ‚£ä¹‹é†«ç™‚è™•ç½®ï¼Œå¦‚ï¼šå† ç‹€å‹•è„ˆç–¾ç—…è¡“å¾Œè©•ä¼°ã€ç–¾ç—…復發後å¯å¦é€²</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¡Œå†åˆ‡é™¤æ‰‹è¡“ã€çµ„ç¹”å˜æ´»åŠ›ã€ç—…人é 後åŠä»‹å…¥æ€§æ²»ç™‚æˆæ•ˆ</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (inter-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> ventional outcome) </span><span style="font-family: 標楷體; font-size: 11pt;">之評估ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">臨床資料或推估模å¼ï¼š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">除了傳統上å°ä»¥ç‰¹å®šç–¾ç—…作為é©æ‡‰ç—‡çš„臨床試驗方法以外，å°æ–¼ä¸æ˜¯</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">é‡å°ç‰¹å®šç–¾ç—…çš„æ ¸é†«æ”¾å°„æ€§è—¥å“ï¼Œå¾—ä»¥ä¸‹åˆ—è‡¨åºŠç ”ç©¶çš„æ¨¡å¼æŽ¨ä¼°</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (m-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> odel approach) </span><span style="font-family: 標楷體; font-size: 11pt;">進行評估：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">疾病發展éŽç¨‹çš„推估模å¼ï¼šé€™é¡žè‡¨åºŠè©¦é©—主è¦æ˜¯é‡å°æŸäº›å…·æœ‰å…±é€š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">病程之éžç‰¹å®šç–¾ç—…來進行評估，以決定該類藥å“之é©æ‡‰ç—‡ã€‚例如：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">器官å£é‹å‹•çš„改變或解剖å¸ä¹‹ç•°å¸¸ç‰ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">多é‡å°è¦æ¨¡åˆ†çµ„的推估模å¼ï¼šé€™é¡žè‡¨åºŠè©¦é©—è¨è¨ˆå¯å…ˆå°‡åƒèˆ‡è‡¨åºŠè©¦</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">é©—çš„ç—…äººåŠ ä»¥åˆ†çµ„ï¼Œä¾‹å¦‚ï¼šä¾ç–¾ç—…來分組，但å°æ¯ä¸€åˆ†çµ„çš„å—試病</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">患數目ä»é ˆäº‹å…ˆè€ƒé‡ï¼Œä»¥ç¬¦åˆçµ±è¨ˆå¸çš„需求。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ä¸è‰¯å應：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">æ ¸é†«æ”¾å°„æ€§è—¥å“çš„ä¸è‰¯å應，å¯èƒ½æ˜¯ç”±æ–¼ç—…人潛在的疾病ã€ç„¦æ…®ç‰</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">心ç†å› ç´ æˆ–æ˜¯æ”¾å°„æ€§é€ å½±éŽç¨‹æœ¬èº«æ‰€å¼•èµ·ã€‚æ¤æ™‚å¯æ–¼å„種藥å“的回</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">溯性病æ·è³‡æ–™ä¸ï¼Œå°æ–¼æŸç¨®ç‰¹å®šæ¨¡å¼çš„用藥程åº</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (modality) </span><span style="font-family: 標楷體; font-size: 11pt;">，è’</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">集ä¸è‰¯å應的型å¼å’Œç™¼ç”Ÿé »çŽ‡ç‰è¨˜éŒ„，æ¤æœ‰åŠ©æ–¼äº†è§£è©²é …è—¥å“çš„ä¸</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">良å應。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">è¨ºæ–·ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“çš„ä¸è‰¯å應有å¯èƒ½æ˜¯å“本身所引起，æ¤æ™‚也</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å¯ä½¿ç”¨å®‰æ…°åŠ‘</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">如：ä¸å¸¶æ”¾å°„性活度的該å“</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">來進行安全性評估。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">安慰劑所產生的ä¸è‰¯å應也å¯ç”¨ä¾†å»ºç«‹è©²æ”¾å°„性藥å“的安全性資料</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ï¼Œä¸¦æ‡‰åŠ è¨»æ–¼è©²ç”¢å“的標籤ã€ä»¿å–®ä¹‹ä¸Šã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å››</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç•¶æ²’æœ‰ä»»ä½•å·²ä¸Šå¸‚çš„æ ¸é†«æ”¾å°„æ€§è—¥å“å¯èˆ‡è©²è—¥æ¯”較時，å¯ä»¥é‡å°å…¶æ‰€</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">宣稱的é©æ‡‰ç—‡ï¼Œä»¥å¦ä¸€ç¨®å·²å»ºç«‹å®‰å…¨æ€§åŠæœ‰æ•ˆæ€§çš„診斷方å¼æˆ–臨床資</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">料來評估，如：外科手術之觀察或組織病ç†å¸è³‡æ–™ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">ç¬¬äº”ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“之特殊考é‡</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å¤§éƒ¨ä»½æ–¼ç¬¬äºŒç« ã€ç¬¬ä¸‰ç« åŠç¬¬å››ç« 列舉之基準è¦é …，皆é©ç”¨æ–¼æ²»ç™‚ç”¨æ ¸é†«</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">放射性藥å“。下列å„點係é‡å°æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“查驗登記時，所需注</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">æ„之特殊考é‡</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">åƒè€ƒæœ¬ç½²</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 88.5.14 </span><span style="font-family: 標楷體; font-size: 11pt;">衛署藥å—第</span><span style="font-family: times new roman,serif; font-size: 11pt;"> 88027704 </span><span style="font-family: 標楷體; font-size: 11pt;">號公告</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">éžè‡¨åºŠè³‡æ–™ï¼š</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">輻射劑é‡ä¹‹å‹•ç‰©é«”內分佈試驗ã€æœ¬è©¦é©—ä¹ƒç‚ºæ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">åˆæ¥è¨ˆç®—輻射劑é‡ä¹‹åŸºç¤Žã€‚å› ç‚ºå°åŒä¸€æ ¸é†«æ”¾å°„性藥å“而言，診斷</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">劑é‡èˆ‡æ²»ç™‚劑é‡æ‰€é€ æˆä¹‹ç”Ÿç‰©é«”分佈å¯èƒ½ä¸åŒï¼Œæ•…輻射劑é‡ä¹‹å‹•ç‰©</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">體內分佈試驗，應在ä¸åŒä¹‹è¼»å°„劑é‡ä¹‹é€²è¡Œã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">動物毒性試驗：由於治療所需藥å“之輻射劑é‡ï¼Œä¸€èˆ¬æ¯”診斷所需劑</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">é‡é«˜ï¼Œæ‰€ä»¥å°æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“，應以較廣泛之動物毒性試驗</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">進行評估</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">è«‹åƒç…§ã€Œè—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„ã€ç¬¬äº”ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">。在æŸ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">些狀æ³ä¸ï¼Œå¯èƒ½éœ€è¦é€²è¡Œé‡è¦†åŠ‘é‡æ¯’性試驗。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">輻射生物毒性試驗</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (radiobiologic toxicity study) </span><span style="font-family: 標楷體; font-size: 11pt;">：輻射生物</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">毒性之評估，應用兩種ä¸åŒç¨®é¡žå‹•ç‰©</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">è«‹åƒç…§ã€Œè—¥å“éžè‡¨åºŠè©¦é©—安</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">全性è¦ç¯„ã€ç¬¬äº”ç« </span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">，使用足供療效之輻射劑é‡ç¯„åœä¹‹æ²»ç™‚ç”¨æ ¸é†«</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">放射性藥å“之後，以決定該藥å“之輻射效應</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (radiobiology effe-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> ct) </span><span style="font-family: 標楷體; font-size: 11pt;">。å°æ–¼æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“ï¼Œé ˆé€²è¡Œé•·æœŸè¿½ç¸±è©¦é©—ï¼Œæ–¹å¯é©</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">當評估輻射效應。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å››</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">若有é©ç•¶å‹•ç‰©æ¨¡å¼å¯ä»¥é€²è¡Œè©¦é©—ï¼Œå‰‡æ‡‰æ–¼æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“進</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">行臨床試驗å‰ï¼Œä»¥è©²å‹•ç‰©æ¨¡å¼ç¢ºèªè—¥å“å¯èƒ½ç™‚效。請åƒç…§ã€Œè—¥å“éž</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">臨床試驗安全性è¦ç¯„ã€ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">臨床資料：</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">一</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“之臨床資料，應é‡å°è©²è—¥å“所稱之é©æ‡‰ç—‡æ</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">供臨床效益評估，並說明å¯èƒ½ç”¢ç”Ÿçš„風險åŠé©ç•¶ä¹‹è‡¨åºŠè™•ç½®ç‰ã€‚臨</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">åºŠè©•ä¼°çš„é …ç›®åŒ…æ‹¬ï¼šè—¥å“之血液清除率ã€æŽ’泄ã€å™¨å®˜åˆ†ä½ˆç‰æ•¸æ“šã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å¦éª¨é«“分佈之評估亦特別é‡è¦ï¼Œå› 其輻射劑é‡æœ€ä¸»è¦ä¹‹é™åˆ¶ç‚ºå°éª¨</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">髓之毒性。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">二</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“之臨床使用劑é‡ï¼Œæ‡‰ä»¥è¼»å°„劑é‡å¸è¨ˆç®—，以</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">能產生療效之最低輻射劑é‡ç‚ºèµ·å§‹åŠ‘é‡ï¼Œä¸¦ä»¥ä¸æœƒç”¢ç”Ÿç—…人無法接</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">å—毒性作用</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (disabling toxicity) </span><span style="font-family: 標楷體; font-size: 11pt;">之輻射劑é‡ç‚ºæœ€é«˜åŠ‘é‡ã€‚</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">三</span><span style="font-family: times new roman,serif; font-size: 11pt;">) </span><span style="font-family: 標楷體; font-size: 11pt;">æ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“之ä¸è‰¯åæ‡‰ï¼šæ²»ç™‚ç”¨æ ¸é†«æ”¾å°„æ€§è—¥å“應視需</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">è¦é•·æœŸè¿½è¹¤ä½¿ç”¨æ‚£è€…之後期ä¸è‰¯å應åŠå…¶æ²»ç™‚效果。</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">åƒè€ƒæ–‡ç»</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 1 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1990). </span><span style="font-family: 標楷體; font-size: 11pt;">「優良藥å“è£½é€ æ¨™æº–ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 2 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1994). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥事法åŠå…¶æ–½è¡Œç´°å‰‡ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 3 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1996). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥å“優良臨床試驗è¦ç¯„ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 4 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1997). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥å“è‡¨åºŠè©¦é©—ç”³è«‹é ˆçŸ¥ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 5 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥å“éžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 6 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 7 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—基準åŠç›¸</span> </pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> </span><span style="font-family: 標楷體; font-size: 11pt;">關資料ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 8 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1998). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥å“安定性試驗基準ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 9 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1999). </span><span style="font-family: 標楷體; font-size: 11pt;">「藥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 10 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1999). </span><span style="font-family: 標楷體; font-size: 11pt;">「輸入藥å“查驗登記審查準則ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 11 </span><span style="font-family: 標楷體; font-size: 11pt;">行政院衛生署</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (1999). </span><span style="font-family: 標楷體; font-size: 11pt;">ã€Œæ ¸é†«æ”¾å°„æ€§è—¥å“臨床試驗基準ã€</span><span style="font-family: times new roman,serif; font-size: 11pt;"> (</span><span style="font-family: 標楷體; font-size: 11pt;">å°åŒ—</span><span style="font-family: times new roman,serif; font-size: 11pt;">)</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 12 Guidelines for the Clinical Evaluation of Radiopharmaceutical</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> Drugs. CDER, FDA, USA; Oct. 1981</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 13 Proposal by Council on Radionuclides and Radiopharmaceuticals</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> for a Regulation Governing Evaluation and Approval of Diagnos-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> tic Radiopharmaceuticals. FDA, USA; Jan. 1998</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 14 Extending the Scope of Directives 65/65/EEC and 75/319/EEC and</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> Laying down Additional Provisions for Radiopharmaceuticals.</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> Official Journal of the European Communities; May 1989</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> 15 Japan Pharmaceutical Reference. Japan Medical Products Inter-</span></pre><pre><span style="font-family: times new roman,serif; font-size: 11pt;"> national Trade Association; 1996</span></pre>2013-12-04
臨床試驗類,è—¥å“臨床試驗基準,æ ¸é†«æ”¾å°„æ€§è—¥å“è‡¨åºŠè©¦é©—åŸºæº–è¡Œæ”¿è§£é‡‹æ ¸é†«æ”¾å°„æ€§è—¥å“臨床試驗基準詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=230&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4515&type=0
化å¸è£½é€ 管制類,國內藥å“委託檢驗實施è¦é»žè¡Œæ”¿è§£é‡‹åœ‹å…§è—¥å“委託檢驗實施è¦é»ž<pre style="text-align: center;"><b><span style="font-family: 細明體;">國內藥å“委託檢驗實施è¦é»ž </span></b></pre><pre style="text-align: center;"><span style="font-family: 細明體; font-size: 11pt;"> </span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">一 本藥å“委託檢驗實施è¦é»ž (以下簡稱本è¦é»ž) ，ä¾è—¥å“å„ªè‰¯è£½é€ è¦ç¯„ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">ç¬¬å»¿äºŒé»žç¬¬äº”é …è¦å®šè¨‚定。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">二 行政院衛生署 (以下簡稱本署) ，為促進生物科技製藥產æ¥ä¹‹æ•´é«”發 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">展，並é…åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之實施，åŠè€ƒé‡è—¥å» æ¥å‹™åˆ†å·¥ä¹‹éœ€æ±‚， </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">乃å°è—¥å“之委託檢驗予以è¦ç¯„。在ä¸å½±éŸ¿å§”託者ã€å—託者åŠæ¶ˆè²»è€…é–“ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">之權益，並é¿å…å› ä¸ç•¶ä¹‹ä½œæ¥æˆ–æª¢é©—è€Œé€ æˆçˆåŸ·ï¼Œç‰¹è¨‚定本è¦é»žã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">三 è—¥å“之委託檢驗應ä¾æœ¬è¦é»žåŠå…¶ä»–相關法令之è¦å®šã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">å›› 凡æŒæœ‰è—¥å“許å¯è‰æ–¼æœ‰æ•ˆæœŸé™å…§ä¹‹è—¥å•†ï¼Œæˆ–新申請藥å“查驗登記之藥 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">商，å‡å¯ä¾æ“šæœ¬è¦é»žç”³è«‹å§”託檢驗。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">五 å—è¨—æª¢é©—è€…é ˆç‚ºåœ‹å…§ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„å„階段之 cGMP 「ç¾è¡Œè—¥ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">å“å„ªè‰¯è£½é€ è¦ç¯„ (current Good Manufacturing Practices，簡稱cG</span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> MP) </span><span style="font-size: 11pt;">ã€è—¥å» ，或符åˆå„ªè‰¯å¯¦é©—室æ“作è¦ç¯„ (Good Laboratory Pract-</span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> ices</span><span style="font-size: 11pt;">，簡稱GLP) 精神之國內å¸è¡“ã€ç ”究åŠæª¢é©—機構ç‰ç›¸é—œå–®ä½ï¼Œå§‹ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">得接å—委託檢驗。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">特殊情æ³å¯å°ˆæ¡ˆç”³è«‹ã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">å… å§”è¨—æª¢é©—è€…æ‡‰è¨‚å®šè©²å§”è¨—æª¢é©—ç¯„åœä¹‹ç›¸é—œäº‹é …，委託者åŠå—託者應訂 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">定作æ¥è¨ˆç•«æ›¸ã€æ¨™æº–作æ¥ç¨‹åº (å«æŽ¡æ¨£æ–¹æ³•ã€æ¨£æœ¬ä¿å˜æ–¹æ³•ã€é‹é€ç§» </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">交æ¢ä»¶ç‰) ，俾便å—託者ä¾åˆç´„è¦å®šåŸ·è¡Œä½œæ¥ã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">七 委託檢驗之範åœåŒ…括：技術層é¢ä¹‹ç ”究發展ã€è£½ç¨‹ä¸ä¹‹ç®¡åˆ¶ä½œæ¥åŠåŽŸ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">物料ã€åŠè£½å“或產å“之å“質管制ã€å®‰å®šæ€§è©¦é©—ç‰é …目。 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">å…« 委託檢驗應由委託者先行覓妥å—託檢驗單ä½ï¼Œç”±å§”託者填具申請書， </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">檢附雙方簽訂之委託檢驗作æ¥è¨ˆç•«æ›¸ã€æ¨™æº–作æ¥ç¨‹åºç‰ç›¸é—œæ–‡ä»¶ï¼Œå‘ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">本署藥物食å“æª¢é©—å±€å ±å‚™ã€‚è—¥ç‰©é£Ÿå“檢驗局未於二個月內回復者，應 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">視åŒæ ¸å‚™ã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">藥物食å“檢驗局得視實際需è¦å°å—託者進行ç¾å ´æŸ¥æ ¸ã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">ä¹ å—託檢驗單ä½ä¹‹ä½œæ¥ï¼Œæ‡‰ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„ä¸å“質管制之è¦å®šï¼Œ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">並å°æª¢é©—çµæžœä¹‹æº–ç¢ºæ€§è² è²¬ã€‚å…¶å„相關紀錄應由委託者åŠå—託檢驗者 </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">ä¾è—¥å“å„ªè‰¯è£½é€ è¦ç¯„第四å八點åŠç¬¬äº”å點è¦å®šäºˆä»¥ä¿å˜ã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">一○ ç¶“æ ¸å‚™ä¹‹å§”è¨—æª¢é©—ï¼Œå§”è¨—è€…æ‡‰æª¢é™„ä¾æª¢é©—所需二å€ä»¥ä¸Šæ•¸é‡ä¹‹æª¢é«” </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">，é€å—託者檢驗，其驗餘完整包è£ä¹‹æª¢é«”，由å—託者å°ç·˜å¾Œï¼Œäº¤ç”± </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">委託者自行ä¿å˜ã€‚ </span></span></pre><pre><span style="font-family: 細明體;"><span style="font-size: 11pt;"> </span><span style="font-size: 11pt;">一一 ç¶“æ ¸å‡†å§”è¨—æª¢é©—ä¹‹è—¥å“，除法律å¦æœ‰è¦å®šå¤–，其產å“責任應由委託 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化å¸è£½é€ 管制類,指導手冊,ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„-清潔確效作æ¥æŒ‡å°Žæ‰‹å†Šè¡Œæ”¿è§£é‡‹ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„-清潔確效作æ¥æŒ‡å°Žæ‰‹å†Š<p><span style="font-family: 新細明體,serif;">ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„</span><span style="font-family: calibri;">-</span><span style="font-family: 新細明體,serif;">清潔確效作æ¥æŒ‡å°Žæ‰‹å†Š</span> </p><p><span style="font-family: 新細明體,serif;">壹ã€å‰è¨€</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">本手冊主è¦åƒè€ƒåŠ 拿大</span><span style="font-family: calibri;">Cleaning validation guidelines-Therapeutic products programme</span><span style="font-family: 新細明體,serif;">，åŠç¾Žåœ‹</span><span style="font-family: calibri;">FDA Guide to inspections validation of cleaning processes </span><span style="font-family: 新細明體,serif;">兩份資料，並åƒé…Œåœ‹å…§ç›¸é—œè³‡æ–™æ‰€åˆ¶è¨‚。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å°æ–¼è¨å‚™ä½¿ç”¨å‰å¿…é ˆæ˜¯æ¸…æ½”çš„è¦å®šï¼Œæ˜¯çœ¾æ‰€çš†çŸ¥ä¹‹äº‹ï¼Œå…¶ä¸»è¦ç›®çš„是é¿å…è—¥å“的污染與羼雜ã€ä¸é©ç•¶çš„清潔åŠè¨å‚™ç¶è·ï¼Œæˆ–塵埃控制系統ä¸è‰¯è€Œé€ æˆæ±¡æŸ“。尤其是éžç›¤å°¼è¥¿æž—與盤尼西林藥å“的交互污染，或藥å“與類固醇ã€ç´°èƒžæ¯’劑或è·çˆ¾è’™çš„交互污染。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">例如，在美國</span><span style="font-family: calibri;">1988</span><span style="font-family: 新細明體,serif;">å¹´</span><span style="font-family: calibri;">Cholestyramine Resin USP</span><span style="font-family: 新細明體,serif;">的容器é‡è¤‡ä½¿ç”¨ï¼Œç–‘ä¼¼å› æ¸…æ½”åŠæª¢é©—ä¸ç¢ºå¯¦ï¼Œå¼•èµ·äº¤å‰æ±¡æŸ“而致產å“回收。å¦å¤–æ–¼</span><span style="font-family: calibri;">1992</span><span style="font-family: 新細明體,serif;">å¹´ï¼Œè£½é€ å» å•†æ‰€æ出的清潔確效，åªè‰æ˜Žæ²’有上一製程的殘留化åˆç‰©ï¼Œä½†å¾žæ´—滌水的薄層層æžæ³•ä¸ï¼Œç™¼ç¾æœ‰ä¸Šä¸€è£½ç¨‹å應ä¸çš„副產物和分解物。æ¤äºŒæ¡ˆä¾‹ï¼Œç‚ºæ¸…æ½”ä¸æ°ç•¶çš„å…©å€‹æ¡ˆä¾‹ï¼Œå› æ¤å¯è¦‹æ¸…潔確效之必è¦æ€§ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">本手冊是å°æ–¼æ¸…潔確效，有關的å•é¡Œèˆ‡ä¸»é¡Œæ出一些指引，而並éžæ³•å®šè¦æ±‚。清潔確效應與其它確效一樣，ä¸åªä¸€ç¨®æ–¹æ³•ï¼Œå¦‚æžœä¾ç…§é©ç•¶ç§‘å¸æ–¹æ³•ï¼Œæ出建è°ä¸¦åšæˆè‰æ˜Žæ–‡ä»¶ï¼Œäº¦å¯æŽ¥å—。使用æ¤æ‰‹å†Šæ™‚å¦è«‹åƒé–±è—¥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–ç¬¬äºŒç·¨ç¬¬äºŒç« ä¹‹ç›¸é—œè¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">è²³ã€ç¯„åœ</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">本手冊是é‡å°ä½¿ç”¨æ–¼è£½åŠ‘，åŠåŽŸæ–™è—¥ï¼ˆå«ç”Ÿç‰©è£½åŠ‘之有效æˆåˆ†ï¼‰ä¹‹è£½é€ è¨å‚™ï¼Œè¨‚出與清潔確效相關原則，與先å‰ç”¢å“之污染物的移除，有關之清潔的確效ã€æ´—滌劑的殘留物，以åŠæ½›åœ¨å¾®ç”Ÿç‰©æ±¡æŸ“物的管制ç‰ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">åƒã€åŽŸå‰‡</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€æ¸…潔確效的目標，是è¦ç¢ºèªæ¸…潔程åºå°ç”¢å“殘留物ã€åˆ†è§£ç”¢ç‰©ã€é˜²è…劑ã€è³¦å½¢åŠ‘åŠ</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或清潔劑之移除的有效性，藉使例行階段ä¸çš„分æžç›£æ¸¬ï¼Œå¯ä»¥æ¸›è‡³æœ€å°‘。æ¤å¤–，我們還需è¦ç¢ºä¿ä¸æœƒèˆ‡æœ‰æ•ˆæˆåˆ†äº¤äº’污染有關的å±éšªæ€§ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€æ¸…潔程åºå¿…é ˆè¦åš´æ ¼éµå¾ªç¢ºæ•ˆéŽçš„方法。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€å°æ‰€æœ‰è£½ç¨‹ä¸èˆ‡ç”¢å“接觸的è¨å‚™æ‡‰ç ”訂出é©ç•¶çš„清潔æ¥é©Ÿã€‚å°ç”¢å“å¯èƒ½æ±¡æŸ“到的間接接觸的零件，如墊圈ã€æ··åˆæ©Ÿè»¸ã€çƒ˜ç®±ä¹‹é¢¨æ‰‡ï¼ŒåŠåŠ 熱的元件ç‰ï¼Œäº¦æ‡‰è€ƒé‡åˆ°å…¶æ¸…潔之æ¥é©Ÿã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€å°æ–¼ç”Ÿç‰©æ€§è—¥ç‰©ï¼Œç”±æ–¼å®ƒå€‘固有的特徵（蛋白質本質上是é»æ€§çš„）ã€æ³¨å°„劑的純度è¦æ±‚ã€è¨å‚™çš„複雜性以åŠéœ€å¾…清除之廣泛物質，所以，相關的製程è¨å‚™æ¸…潔確效方法，也è¦æœ‰æ‰€è¦æ±‚。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">五ã€å°æ–¼éžå¸¸ç›¸ä¼¼çš„產å“與製程，其清潔程åºä¸éœ€è¦åŽ»åšå€‹åˆ¥çš„確效，å¯ä¾å…¶å…±é€šæ€§ã€è¨å‚™èˆ‡è¡¨é¢ç©ã€æˆ–者是涉åŠæ‰€æœ‰èˆ‡ç”¢å“相接觸之è¨å‚™çš„環境去åšå‡ºæ±ºå®šã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å°æ–¼ç›¸ä¼¼çš„產å“和相似的製程的清潔æ¥é©Ÿï¼Œå¯ä»¥é¸æ“‡å…·ä»£è¡¨æ€§çš„方法，如ä¾æ“šç”¢å“的相似物ç†æ€§ã€é…方組æˆã€æ¶ˆè²»è€…之使用的方å¼èˆ‡ä½¿ç”¨é‡ã€å…ˆå‰è£½é€ 之其它產å“的特性，以åŠï¼Œèˆ‡å…ˆå‰è£½é€ 之產å“相比較的批é‡ç‰ï¼Œéƒ½æ˜¯è‰æ˜Žä¸€ç¨®ç¢ºæ•ˆè¨ˆç•«ä¹‹é—œéµå› ç´ ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">é¸æ“‡æœ€å·®æƒ…æ³çš„組åˆï¼ŒåŠå…¶ç›¸é—œåŸºæº–來實施確效作æ¥ï¼Œä¸€èˆ¬èªç‚ºæ˜¯å¯ä»¥æŽ¥å—的。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å°æ–¼ç”Ÿç‰©è£½åŠ‘，籃狀試驗法將åªåœ¨å‡å®šå…¶æ‰€æ¶‰åŠçš„是相åŒç”¢å“之少數情æ³ï¼Œæ‰å¯ä»¥è¢«æŽ¥å—（例如，在åŒç¨®é¡žä¸”ä»¥ç›¸è¿‘ç´°èƒžåŸ¹é¤Šæ¶²åŸ¹é¤Šé½§é½’é¡žç´°èƒžæ ªä¸ï¼Œä»¥è¡¨ç¾å‡ºé‡çµ„蛋白質時，相åŒè¨è¨ˆï¼Œä½†æœ‰ä¸åŒå®¹é‡ä¹‹ç™¼é…µæ§½çš„清潔）。在疫苗的情æ³ï¼Œç±ƒç‹€è©¦é©—法被視為是å¯ä»¥æŽ¥å—的。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">肆ã€æ¸…æ½”éŽç¨‹çš„確效</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€èˆ‡ç”¢å“相接觸的è¨å‚™ï¼Œå¿…é ˆè¦å°ˆç”¨æ–¼ä¸€ç¨®ç”¢å“，如è¦å…±ç”¨è¨å‚™ï¼Œå¿…é ˆè¦æœ‰ä¸€å¥—經éŽç¢ºæ•ˆçš„清潔程åºæ‰å¯ï¼Œé€™æ˜¯ä¸€å€‹åŸºæœ¬çš„概念。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€åœ¨å¤šç¨®ç”¢å“共用的è¨å‚™ä¸Šï¼Œæ¸…潔方法確效所投入的æˆæœ¬ï¼Œæ‡‰è©²èˆ‡æŠŠæ¤è¨å‚™æ°¸ä¹…專用於一種產å“çš„è²»ç”¨ï¼ŒåŠ ä»¥è©•ä¼°æ¯”è¼ƒã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€è¨å‚™æ¸…潔確效，å¯ä»¥åœ¨è£½ç¨‹é–‹ç™¼è‡¨åºŠç”¨è—¥å¯¦éš›ç”Ÿç”¢éšŽæ®µåŒæ™‚åŸ·è¡Œã€‚ç¢ºæ•ˆå·¥ä½œå¿…é ˆæŒçºŒé€²è¡Œï¼Œä¸€ç›´åˆ°å®Œæˆé‡ç”¢ç‚ºæ¢ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€æ¸¬è©¦åˆ°æ¸…潔為æ¢çš„觀念，å¯ä»¥ç”¨æ–¼æ¸…æ½”ç ”ç©¶ï¼Œä½†æ˜¯é€šå¸¸è¢«èªç‚ºæ˜¯ç„¡æ³•æŽ¥å—的。這種觀念是包å«æœ‰æ¸…æ½”ã€å–æ¨£èˆ‡æ¸¬è©¦çš„é †åºä¹‹é‡è¤‡å¯¦æ–½ï¼Œä¸€ç›´åˆ°é”æˆå¯æŽ¥å—çš„é™é‡ç‚ºæ¢ã€‚å°æ–¼å·²ç¢ºæ•ˆéŽä¹‹æ¸…潔程åºçš„系統或è¨å‚™ï¼Œé€™ç¨®å†å–樣的實施是ä¸å¾—使用的。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">五ã€åœ¨ç ”究時若當所è¦æ¸…除的物質是具有毒性或者是å±éšªæ€§æ™‚，å¯è€ƒæ…®ä»¥æ¨¡æ“¬é€™ç¨®ç‰©è³ªä¹‹ç‰©ç†åŒ–å¸æ€§è³ªçš„產å“，å–代這類物質進行測試。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å…ã€ä¾†è‡ªä¸åŒä¾›æ‡‰å•†çš„原料，必需考慮å¯èƒ½æœƒæœ‰ä¸åŒçš„物ç†æ€§è³ªåŠé›œè³ªçµ„åˆã€‚當è¨è¨ˆå…¶æ¸…潔程åºæ™‚ï¼Œé€™æ¨£çš„å·®ç•°å¿…é ˆè¦åŠ ä»¥è€ƒæ…®ï¼Œå› ç‚ºé€™äº›ç‰©è³ªå¯èƒ½æœƒè¡¨ç¾ä¸åŒã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">七ã€æ‰€æœ‰ç›¸é—œçš„åƒæ•¸éƒ½å¿…é ˆè¦åŠ ä»¥æŸ¥æ ¸ï¼Œä»¥ç¢ºä¿é€™å€‹çµ‚將被é‹ä½œçš„清潔éŽç¨‹ï¼Œæ˜¯å·²ç¶“確效éŽçš„ã€‚å› æ¤ï¼Œå¦‚果為é”æˆæ¸…潔而其關éµæº«åº¦æœ‰æ‰€éœ€è¦æ™‚ï¼Œé‚£å°±å¿…é ˆåŠ ä»¥ç¢ºèªã€‚æ‰€æ·»åŠ ä¹‹ä»»ä½•åŒ–å¸è—¥åŠ‘ï¼Œéƒ½å¿…é ˆè¦å°å…¶é¡žåž‹åŠå…¶æ·»åŠ çš„é‡åŠ 以確èªã€‚清潔劑的濃度與沖洗液的容é‡åŠé€Ÿåº¦ï¼Œåœ¨åˆé©æ™‚ï¼Œä¹Ÿå¿…é ˆè¦åŠ 以評估。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å…«ã€å¦‚果使用自動化的程åºï¼ˆå°±åœ°æ¸…æ½”ï¼‰æ™‚ï¼Œå¿…é ˆè¦è€ƒæ…®ä½¿ç”¨é©ç•¶çš„感應器，去監測其關éµç®¡åˆ¶ç«™åŠå…¶åƒæ•¸ä»¥åŠè¦å ±é»žï¼Œä»¥ç¢ºä¿æ¸…æ½”éŽç¨‹æ˜¯è¢«åš´æ ¼ç®¡åˆ¶çš„。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ¸…æ½”éŽç¨‹çš„ç¢ºæ•ˆï¼Œå¿…é ˆè¦ä»¥æœ€å·®ç‹€æ³ç‚ºåŸºç¤Žï¼Œå®ƒåŒ…å«æœ‰ï¼š</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（一）ã€æ¸…æ½”éŽç¨‹çš„挑戰，以顯ç¾å‡ºæŒ‘戰用的污染物，å¯ä»¥æœ‰é©ç•¶çš„é‡è¢«å›žæ”¶ï¼Œæˆ–是展示出å°æ•¸æ€§çš„移除，以確ä¿æ¸…æ½”éŽç¨‹ï¼Œç¢ºå¯¦æ˜¯æŠŠæ±¡æŸ“物移除到所è¦æ±‚的殘留é‡ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（二）ã€ä½¿ç”¨æ¸›ä½Žçš„清潔åƒæ•¸ï¼Œè«¸å¦‚åŠ éŽé‡ä¹‹æ±¡æŸ“物ã€è¨å‚™è¡¨é¢ä¹‹éŽä»½ä¹¾ç‡¥ã€æ¸…潔劑之最低濃度åŠ</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或清潔劑的最çŸæŽ¥è§¸æ™‚é–“ç‰ä¹‹ä½¿ç”¨ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">åã€æ¸…潔程åºå¿…é ˆé€£çºŒåŸ·è¡Œä¸‰æ¬¡ï¼Œä¸¦èƒ½é”é 期效果，以è‰æ˜Žé€™å€‹æ¸…潔方法是經éŽç¢ºæ•ˆã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ä¼ã€è¨å‚™èˆ‡äººå“¡</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€æ‰€æœ‰è£½ç¨‹æ“作è¨å‚™ä¹‹è¨è¨ˆï¼Œæ‡‰è€ƒæ…®æ˜“於清潔åŠä¾¿æ–¼ç›®è¦–檢查，且儘å¯èƒ½æŽ¡ç”¨éžå應性æ質之平滑的表é¢æ‰€è£½æˆã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€å°è¨å‚™æœ‰åŠè‡ªå‹•æˆ–全自動化就地清潔系統時，宜使用無çƒé–¥çš„衛生管路，若有採用éžè¡›ç”Ÿæ€§çƒé–¥æ™‚ï¼Œå…¶æ¸…æ½”æ‡‰æ›´åŠ å¼·ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€å¦‚使用就地清潔系統，特別是採用éžè¡›ç”Ÿæ€§çƒé–¥æ™‚，æ“ä½œå“¡å¿…é ˆæ³¨æ„並了解清潔困難度，並接å—æ¤ç³»çµ±åŠé–¥çš„清潔訓練ã€åŒæ™‚å¿…é ˆè©•ä¼°æ“作員，是å¦æœ‰è³‡æ ¼æ“作æ¤æ¸…潔程åºã€‚ç¢ºæ•ˆæ–‡ä»¶å¿…é ˆç‰¹åˆ¥æŒ‡å‡ºï¼Œæ¤é¡žç³»çµ±çš„清潔確效。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€åœ¨æœ‰ç‰½æ¶‰åˆ°ç®¡è·¯è½‰æŽ¥çš„大系統ä¸ï¼Œå¿…需有æµç¨‹åœ–清楚標示閥門ä½ç½®ï¼Œä»¥ä¾¿æ“作員進行清潔工作，åŒæ™‚å¯é¿å…錯誤的清潔作æ¥ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">五ã€æª¢æŸ¥é‡è¦çµ„件，åŒæ™‚æŒ‡å‡ºè£½é€ çµæŸï¼Œè‡³æ¯ä¸€æ¸…æ½”æ¥é©Ÿçš„時間。å°æ–¼è»Ÿ</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">ä¹³è†ã€æ‡¸æµ®æ¶²ã€åŽŸæ–™è—¥çš„æ“ä½œï¼Œå› æ®˜ç•™ç‰©çš„ä¹¾å‡…ï¼Œæœƒå½±éŸ¿æ¸…æ½”éŽç¨‹æ•ˆçŽ‡ï¼Œé€™äº›å› 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ä»¥ä¹¾ç‡¥ï¼Œä»¥åŠè¨å‚™åœ¨æ¸…潔作æ¥ä¹‹å¾Œï¼Œä¸è«–任何情æ³ï¼Œéƒ½ä¸å¾—容許有ä¸å‹•çš„æ°´ä¿ç•™åœ¨è¨å‚™ä¸Šã€‚è¨å‚™ä½¿ç”¨å¾Œï¼Œåˆ°æ¸…潔開始å‰ä¹‹é–“éš”æ™‚é–“ï¼Œä¹Ÿå¿…é ˆè¦åŠ 以建立。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€ç¶“ç”±è¨å‚™ä¹‹é©ç•¶æ¸…潔與儲è—ä»¥æŽ§åˆ¶ç”Ÿç‰©è² è·èŒï¼Œå°ç¢ºä¿åœ¨å¾Œä¾†çš„æ»…èŒæˆ–消毒éŽç¨‹ï¼Œä»¥é”æˆæ‰€éœ€ä¹‹ç„¡èŒæ€§çš„ä¿è‰ï¼Œæ˜¯å¾ˆé‡è¦çš„。從熱原在無èŒæ“作ä¸ä¹‹ç®¡åˆ¶çš„立足點來看，這也是特別é‡è¦ï¼Œå› 為è¨å‚™çš„æ»…èŒéŽç¨‹ï¼Œå¯èƒ½ç„¡æ³•é©ç•¶åœ°é”æˆç†±åŽŸä¹‹é¡¯è‘—去活化或者是移除。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">柒ã€æ–‡ä»¶ç®¡ç†</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€è©³ç´°çš„清潔程åºï¼Œæ‡‰å½™é›†æ–¼æ¨™æº–作æ¥ç¨‹åºä¸ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€æ¸…æ½”ç¢ºæ•ˆè¨ˆç•«æ›¸ï¼Œå¿…é ˆè¦æ•˜è¿°ï¼Œä½¿ç”¨æ–¼ç¢ºæ•ˆæ¸…æ½”éŽç¨‹çš„程åºã€‚除了一般性所應è‰æ˜Žè³‡è¨Šå¤–ï¼Œå®ƒé‚„å¿…é ˆåŒ…å«ä»¥ä¸‹çš„資訊：所使用è¨å‚™çš„æ述；生產終了與清潔程åºé–‹å§‹ä¹‹é–“的間隔時間；å°æ¯ä¸€ç¨®ç”¢å“ã€æ¯ä¸€å€‹è£½é€ 系統或æ¯ä¸€ä»¶è¨å‚™ï¼Œæ‰€è¦ä½¿ç”¨çš„清潔程åºå–樣方法；包å«æœ€ä½Žæª¢æ¸¬æ¿ƒåº¦ï¼Œèˆ‡æœ€ä½Žå®šé‡æ¿ƒåº¦ç‰åˆ†æžæ–¹æ³•ï¼›åˆæ ¼æ¨™æº–åŠå…¶ç†è«–基礎，以åŠå†ç¢ºæ•ˆçš„時機ç‰ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€åŸ·è¡Œå„種清潔æ¥é©Ÿæˆ–程åºæ‰€éœ€è¦æ–‡ä»¶æ†‘è‰çš„數é‡ï¼Œå¯è¦–其系統的複雜性，與清潔éŽç¨‹è€Œæœ‰æ‰€ä¸åŒã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€ç•¶éœ€è¦è¼ƒç‚ºè¤‡é›œçš„清潔程åºæ™‚，把關éµçš„清潔æ¥é©Ÿï¼Œä¾‹å¦‚，æŸäº›åŽŸæ–™è—¥çš„åˆæˆéŽç¨‹ï¼Œåšæˆæ–‡ä»¶æ˜¯å¿…é ˆçš„ã€‚æ¤ç‰¹å®šæ–‡ä»¶ï¼Œå°šé ˆåŒ…括關於清潔者ã€åŸ·è¡Œçš„時機，以åŠæ¤è¨å‚™æ“作å‰æ‰¹ä¹‹ç”¢å“ç‰è³‡è¨Šã€‚惟å°æ–¼è¼ƒå–®ç´”的清潔æ“作，åªè¦æœ‰å…¶æ‰€åŸ·è¡ŒéŽä¹‹å…¨é¢æ¸…æ½”éŽç¨‹çš„文件憑è‰ï¼Œå¯èƒ½å°±è¶³å¤ 了。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">五ã€å…¶å®ƒçš„å› ç´ ï¼Œå¦‚æ·æ¬¡æ¸…æ½”çš„ç›¸é—œè³‡æ–™éœ€åŠ è¨»è§£ï¼Œæ¸…æ½”å¾Œçš„æ®˜ç•™é‡åŠæ¸¬è©¦çµæžœçš„變異性，也會影響所需文書的é‡ã€‚例如，已被確èªçš„清潔程åºï¼Œåœ¨æ¸…潔後檢測到ä¸åŒçš„殘留é‡ï¼Œå¿…é ˆé€²è¡Œé©ç•¶çš„評估；以建立程åºå’Œæ“作者執行的有效性；當æ“作者的表ç¾è¢«èªç‚ºæ˜¯ä¸€å€‹å•é¡Œæ™‚，需è¦æ›´é€²ä¸€æ¥çš„指引和訓練。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">æŒã€åˆ†æžæ–¹æ³•</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€æª¢æ¸¬æ®˜ç•™ç‰©æˆ–污染物所使用的分æžæ–¹æ³•ï¼Œå°æ–¼æ‰€è¦åŸ·è¡Œå«é‡æ¸¬å®šçš„物質，例如，產å“殘留物ã€æ¸…潔劑殘留物åŠ</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">æˆ–å…§æ¯’ç´ å¿…é ˆæ˜¯å°ˆä¸€çš„ï¼Œè€Œä¸”ï¼Œå¿…é ˆè¦åœ¨å¯¦æ–½æ¸…æ½”ç¢ºæ•ˆç ”ç©¶ä¹‹å‰ï¼Œå°±åšå¥½åˆ†æžæ–¹æ³•ç¢ºæ•ˆã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€åˆ†æžæ–¹æ³•çš„專一性與éˆæ•åº¦å¿…é ˆè¦ç¢ºç«‹ã€‚如果污染物或污染物的殘留é‡ç„¡æ³•è¢«æª¢æ¸¬å‡ºï¼Œå®ƒä¸¦éžæ„謂清潔之後就沒有殘留的污染物å˜åœ¨ã€‚它åªæ˜¯æš—示出污染物的é‡ï¼Œæ˜¯ä½Žæ–¼åˆ†æžæ–¹æ³•çš„éˆæ•åº¦æˆ–檢測é™é‡è€Œå·²ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€åœ¨ç”Ÿç‰©æ€§è—¥ç‰©çš„情æ³ï¼Œä½¿ç”¨ç”¢å“專一性的å«é‡æ¸¬å®šæ–¹æ³•ï¼Œå¯èƒ½æ˜¯ä¸é©ç•¶çš„，例如，å…疫分æžæ³•ï¼ŒåŽ»ç›£æ¸¬ç”Ÿç‰©è£½åŠ‘ä¹‹æ»¯ç•™ã€‚å› ç‚ºä¸€å€‹é™°æ€§å應，並ä¸ä»£è¡¨å…¶è›‹ç™½è³ªå«é‡æˆ–殘留é‡ä½Žæ–¼ç®¡ç†å€¼ï¼Œè€Œå¯èƒ½æ˜¯è›‹ç™½è³ªçš„抗原決定基之變性的çµæžœæ‰€è‡´ã€‚å°æ–¼è›‹ç™½è³ªæ®˜ç•™é‡ä¹‹æª¢æ¸¬ï¼Œé™¤äº†ç¸½æœ‰æ©Ÿç¢³ä¹‹æª¢æ¸¬æ³•å¤–，也å¯ä»¥åŠ 測產å“專一性的å«é‡æ¸¬å®šæ³•ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€æ±¡æŸ“物的分æžæ–¹æ³•èˆ‡å›žæ”¶ç™¾åˆ†çŽ‡ï¼Œå¿…é ˆè¦èˆ‡æ‰€ä½¿ç”¨çš„å–æ¨£æ–¹æ³•ä¸€ä½µç ”ç©¶ã€‚é€™æ˜¯è¦é¡¯ç¤ºæ±¡æŸ“物，å¯ä»¥å¾žè¨å‚™è¡¨é¢è¢«å›žæ”¶ï¼Œä¸¦ä¸”，顯示出回收率以åŠå›žæ”¶çš„一致性。在å¯ä»¥ä»¥æª¢å“çµæžœç‚ºåŸºç¤ŽåŽ»åšä»»ä½•çµè«–之å‰ï¼Œé€™æ˜¯éœ€è¦å…ˆåšåˆ°çš„。陰性å應也å¯èƒ½æœƒæ˜¯ä¸è‰¯çš„å–樣技術所導致的。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">玖ã€å–樣ã€æ´—滌ã€æ´—滌檢å“與清潔劑</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€æœ‰å…©ç¨®å–樣的類型，被èªç‚ºæ˜¯å¯ä»¥æŽ¥å—的，亦å³ï¼Œç›´æŽ¥è¡¨é¢å–樣法（擦æ‹æ³•ï¼‰åŠé–“接å–樣法（使用洗滌液去å–樣）。通常，這兩種方法的併用是最令人滿æ„的，特別是在，è¨å‚™ä¹‹é…件的å¯æŽ¥è¿‘性，會妨礙直接表é¢å–樣時。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€ç›´æŽ¥è¡¨é¢å–樣法</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（一）ã€æœ€å›°é›£æ¸…潔而且å¯ä»¥åˆç†åœ°æŽ¥è¿‘或進入的å€åŸŸï¼Œæ˜¯å¯ä»¥ç”¨è¡¨é¢å–樣法去評估，以確èªåœ¨æ¯ä¸€å·²çŸ¥è¡¨é¢ç©ä¸Šä¹‹æ±¡æŸ“物的殘留é‡ã€‚æ¤å¤–，乾涸的或是ä¸æº¶æ€§çš„殘留物，å¯ç”¨ç‰©ç†æ€§çš„移除法å–樣之。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（二）ã€æ‰€è¦ä½¿ç”¨æ–¼å–樣的æ料與å–樣媒介質，其é©ç”¨æ€§å¿…é ˆè¦åŠ 以確定。準確地回收一個檢å“的能力，很å¯èƒ½æœƒå—到å–樣æ料之é¸æ“‡æ‰€å½±éŸ¿ã€‚確ä¿å–樣媒介質與溶媒（用於從媒介質上抽å–被分æžç‰©ï¼‰ç‚ºä»¤äººæ»¿æ„，而且是å¯ä»¥å¾ˆå®¹æ˜“使用，是很é‡è¦çš„。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€é–“接å–樣法</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（一）ã€å°å¤§é¢ç©æŽ¡æ¨£ï¼Œå’Œä¸èƒ½æŽ¥è¿‘的系統，或ä¸èƒ½è¢«ä¾‹è¡Œæ‹†è§£çš„è¨å‚™ï¼Œæ´—滌å–樣法是å¯ç”¨çš„。ä¸éŽï¼Œå¿…é ˆè¦è€ƒæ…®åˆ°æ®˜ç•™ç‰©æˆ–污染物，å¯èƒ½æ˜¯ä¸æº¶æ€§ï¼Œæˆ–是å¯èƒ½è¢«ç‰©ç†æ€§å°é–‰æ–¼è¨å‚™ä¹‹ä¸çš„事實。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（二）ã€ç•¶æ´—滌å–樣法，被用於確效清潔éŽç¨‹æ™‚ï¼Œå¿…é ˆè¦åšåˆ°æ±¡æŸ“物或殘留物，在é©åˆ‡æº¶åª’ä¸çš„直接é‡æ¸¬ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€ä¸€æ—¦æ¸…æ½”éŽç¨‹å·²ç¶“åšå¥½ç¢ºæ•ˆï¼Œå‰‡é–“接測試法，例如，導電度法，å°æŸäº›ä¾‹è¡Œç›£æ¸¬å¯èƒ½å…·æœ‰æŸäº›åƒ¹å€¼ã€‚é€™åœ¨åŽŸæ–™è—¥å» å°¤å…¶å¸¸è¦‹ã€‚å應器與離心機，åŠé€£æŽ¥å¤§åž‹è¨å‚™ä¹‹é–“的管線之å–樣，åªèƒ½ä½¿ç”¨æ´—滌å–樣法去å–樣。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚果是使用空白物法，進行確效清潔éŽç¨‹æ™‚ï¼Œå› å¯èƒ½æœŸå¾…會å‡å‹»åœ°åˆ†æ•£åœ¨æ•´å€‹ç³»çµ±ä¸ï¼Œæˆ–是被從è¨å‚™è¡¨é¢å‡å‹»åœ°æ‘©æ“¦å‡ºä¾†ï¼Œé‚£æ˜¯å¾ˆé›£æ出ä¿è‰çš„，所以原則上ä¸æŽ¨è–¦æ¤æ–¹æ³•ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å…ã€é™¤äº†åˆ†æžæ–¹æ³•ä»¥å¤–，使用目視檢查法，以確ä¿æ¸…æ½”éŽç¨‹æ˜¯å¯æŽ¥å—的，也是很é‡è¦çš„。如是åŒä¸€ç”¢å“間的批與批間，或原料藥生產éŽç¨‹ä¸ï¼Œä¸åŒæ‰¹è€ŒåŒä¸€ä¸é–“物的ä¸åŒæ‰¹ä¹‹æ¸…潔程åºï¼Œæ¤ç¨®æ¸…潔程åºä¸éœ€ç¢ºæ•ˆï¼Œè¨å‚™åªè¦ç¬¦åˆ“目視檢查”çš„è¦æ±‚å³å¯ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">七ã€ç•¶æ¸…潔劑使用在清潔éŽç¨‹ä¸æ™‚ï¼Œä½¿ç”¨è€…å¿…é ˆè¦çžè§£å…¶çµ„æˆæˆåˆ†ï¼Œè€Œä¸”ï¼Œå®ƒå€‘çš„ç§»é™¤ï¼Œä¹Ÿå¿…é ˆè¦åŠ 以確èªã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å…«ã€åœ¨æ¸…æ½”éŽç¨‹ä¸ä½¿ç”¨çš„æ¸…æ½”åŠ‘ï¼Œå¿…é ˆæ˜¯è¦å¾ˆå®¹æ˜“被移除的。在清潔之後，清潔劑殘留物的å¯æŽ¥å—é™é‡ï¼Œå¿…é ˆè¦åŠ 以界定。當確效清潔程åºæ™‚，清潔劑之分解的å¯èƒ½æ€§ï¼Œä¹Ÿæ˜¯å¿…é ˆåŠ ä»¥è€ƒæ…®çš„ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ä¹ã€èˆ‡ç„¡èŒç”¢å“相接觸之è¨å‚™ï¼Œå…¶æ¸…潔程åºä¹‹æœ€å¾Œæ´—æ»Œä¸Šï¼Œå¿…é ˆä½¿ç”¨æ³¨å°„ç”¨æ°´å†æ¸…洗。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">åã€èˆ‡éžç„¡èŒç”¢å“相接觸之è¨å‚™ï¼Œå…¶æ¸…潔程åºä¹‹æœ€å¾Œæ´—æ»Œä¸Šï¼Œå¿…é ˆä½¿ç”¨ç´”æ·¨æ°´å†æ¸…洗。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">由於ä¸åŒç¨‹åº¦ä¹‹æœ‰æ©Ÿèˆ‡ç„¡æ©Ÿæ®˜ç•™ç‰©ï¼Œä»¥åŠæ°¯çš„å˜åœ¨ï¼Œæ‰€ä»¥è‡ªä¾†æ°´ï¼Œä¸å¾—使用與產å“相接觸之生產è¨å‚™çš„任何清潔程åºçš„最後洗滌上。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">拾ã€ç”¢å“殘留é™é‡çš„訂定</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€è£½é€ å» å°ç”¢å“殘留物é¸æ“‡é™é‡çš„ç†è«–åŸºç¤Žï¼Œå¿…é ˆè¦åˆä¹Žé‚輯，並且è¦ä»¥å…¶æ‰€æ¶‰åŠçš„物質，åŠå…¶æ²»ç™‚劑é‡ç‚ºåŸºç¤Žã€‚æ¤é™é‡å¿…é ˆæ˜¯å¯è¡Œã€å¯é”æˆï¼Œè€Œä¸”是å¯ç¢ºèªçš„。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">二ã€åœ¨å»ºç«‹ç”¢å“殘留é™é‡æ™‚，åªæŠŠç„¦é»žæ”¾åœ¨ä¸»è¦å應物，å¯èƒ½æ˜¯ä¸åˆé©çš„ï¼Œå› ç‚ºå‰¯ç”¢ç‰©</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">化å¸è®Šç•°ï¼ˆæ´»æ€§åˆ†è§£ç‰©ï¼‰ï¼Œå¯èƒ½æœƒæ›´å›°é›£åŽ»ç§»é™¤ã€‚除化å¸æ¸¬è©¦ä¹‹å¤–，薄層層æžæ³•çš„篩é¸ï¼Œåœ¨æŸäº›æƒ…æ³ä¸å¯èƒ½é‚„是需è¦çš„。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">三ã€æ®˜ç•™é™é‡çš„訂定，至少å¯è€ƒé‡ä¸‹åˆ—æ–¹å¼ï¼š</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（一）ã€æ‰€æœ‰ç”¢å“之專一性清潔確效。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（二）ã€å°‡ç”¢å“分群åŠé¸æ“‡æœ€å·®ç‹€æ³ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（三）ã€åšå±éšªæ—群之分類，例如，éžå¸¸æ˜“溶的產å“ã€æ•ˆåƒ¹ç›¸ä¼¼ã€é«˜æ¯’性或難檢測者。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（四）ã€è¨å®šé™é‡æ–¼ä¸å®¹è¨±è¶…éŽæ®˜ç•™çš„æŸä¸€æ¯”率值。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（五）ã€ä¸åŒåŠ‘型有ä¸åŒå®‰å…¨å› å。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å››ã€ç”¢å“殘留物管ç†æ¨™æº–çš„è¨å®šï¼Œä¾ä¸‹åˆ—ä¸‰é …æ¨™æº–ä¸æœ€ç‚ºåš´æ ¼è€…來è¨å®šï¼š</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（一）ã€ä»»ä½•ç”¢å“出ç¾åœ¨éš¨å¾Œç”¢å“之最大æ¯æ—¥åŠ‘é‡çš„é‡ï¼Œä¸å¾—大於該產å“æ£å¸¸æ²»ç™‚æ¯æ—¥æœ€å°åŠ‘é‡çš„</span><span style="font-family: calibri;">0.1</span><span style="font-family: 新細明體,serif;">％。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（二）ã€ä»»ä½•ç”¢å“出ç¾åœ¨å¦ä¸€ç”¢å“ä¸çš„é‡ï¼Œä¸å¾—大於</span><span style="font-family: calibri;">10ppm</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（三）ã€åœ¨æ¸…潔程åºåŸ·è¡Œä¹‹å¾Œï¼Œæ²’有目視å¯è¦‹çš„殘留物在è¨å‚™ä¸Šã€‚å¤–åŠ ç ”ç©¶æ³•å¿…é ˆè¦æ¸¬å®šå…¶æœ€å…·æ´»æ€§æˆåˆ†ï¼Œå¯ä»¥ç”±ç›®è¦–法檢測出的濃度。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å°æ–¼æŸäº›éŽæ•æ€§è—¥ç‰©ï¼Œå¦‚é’é»´ç´ é¡žã€é å¢åèŒç´ 類，或是強效性類固醇與細胞毒劑，其é™é‡å¿…é ˆè¦æ¯”å¯ä»¥ç²å¾—之最佳分æžæ–¹æ³•çš„檢測é™é‡ç‚ºä½Žã€‚實際上，這å¯èƒ½æ„謂，å°é€™äº›ç”¢å“是è¦ä½¿ç”¨å°ˆç”¨çš„å ´æ‰€åŽ»è£½é€ ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">附註：æŸäº›é™é‡ï¼ŒåŒ…括：分æžæª¢æ¸¬é‡ä¾‹å¦‚</span><span style="font-family: calibri;">10ppm</span><span style="font-family: 新細明體,serif;">；生物活性é‡ä¾‹å¦‚æ£å¸¸æ²»ç™‚劑é‡çš„</span><span style="font-family: calibri;">1/1000</span><span style="font-family: 新細明體,serif;">；以åŠæ„Ÿå®˜é‡ä¾‹å¦‚沒有目視å¯è¦‹æ®˜ç•™ç‰©ç‰ï¼Œéƒ½å·²ç‚ºå·¥æ¥ç•Œçš„代表在文ç»ä¸Šæˆ–在發表會上æ出。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ç’°ä¿ç½²èˆ‡æ¯’ç†å¸å®¶å»ºè°ï¼Œä¸€ç¨®æ¯’性物質的一個å¯æŽ¥å—çš„é‡ï¼Œå¯ä»¥æ˜¯ä¸è¶…éŽæ¯’性劑é‡çš„</span><span style="font-family: calibri;">1/1000</span><span style="font-family: 新細明體,serif;">（ä¸åŒåŠ‘型有ä¸åŒçš„安全係數），或是在已知最æ•æ„Ÿçš„動物體系ä¸ï¼Œå·²çŸ¥ä¸æœƒé¡¯ç¾å‡ºä»»ä½•æœ‰å®³çš„生物效應，例如，無效應之é‡çš„</span><span style="font-family: calibri;">1/100</span><span style="font-family: 新細明體,serif;">至</span><span style="font-family: calibri;">1/1000</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">拾壹ã€çµè«–</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">æ¸…æ½”ç¢ºæ•ˆè¨ˆç•«å¿…é ˆè¦ä¾æ“šï¼Œè©³ç›¡çš„清潔程åºã€å„ªè‰¯çš„訓練計畫ã€ç¢ºæ•ˆè¨ˆç•«æ›¸ã€ç¢ºæ•ˆå¥½çš„化å¸èˆ‡å¾®ç”Ÿç‰©å¸çš„分æžæ–¹æ³•ã€è®Šæ›´ç®¡åˆ¶è¨ˆç•«ã€æœ€çµ‚å ±å‘Šï¼Œä»¥åŠç¢ºä¿ä¾å¾žæ€§æ‰€è¦æ±‚çš„ä»»ä½•ç¨½æ ¸ç‚ºåŸºç¤Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è‹±åè©žå°ç…§</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ä¸å‹•çš„æ°´</span> </p><p><span style="font-family: calibri;">Stagnant water</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å¯æŽ¥è¿‘性</span> </p><p><span style="font-family: calibri;">Accessibility</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å¤–åŠ ç ”ç©¶æ³•</span> </p><p><span style="font-family: calibri;">Spiking study</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">抗原決定基</span> </p><p><span style="font-family: calibri;">Epitope</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">ä¾å¾žæ€§</span> </p><p><span style="font-family: calibri;">Compliance</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">注射用水</span> </p><p><span style="font-family: calibri;">Water for injection</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">物ç†æ€§å°é–‰</span> </p><p><span style="font-family: calibri;">Physically occluded</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">空白物法</span> </p><p><span style="font-family: calibri;">Placebo method</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">é’é»´ç´ é¡ž</span> </p><p><span style="font-family: calibri;">Penicillins</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">éžå應性æ質</span> </p><p><span style="font-family: calibri;">Non-reactive material</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">洗滌劑</span> </p><p><span style="font-family: calibri;">Cleaning agent</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">純淨水</span> </p><p><span style="font-family: calibri;">Purified water</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">清潔劑</span> </p><p><span style="font-family: calibri;">Detergent</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">細胞毒劑</span> </p><p><span style="font-family: calibri;">Cytotoxic</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">最低定é‡æ¿ƒåº¦</span> </p><p><span style="font-family: calibri;">Limit of quantitation</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">最低檢測濃度</span> </p><p><span style="font-family: calibri;">Limit of detection</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">最差狀æ³</span> </p><p><span style="font-family: calibri;">Worst-case scenario</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">媒介質</span> </p><p><span style="font-family: calibri;">Medium</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">就地清潔</span> </p><p><span style="font-family: calibri;">Clean-in place</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">減低的清潔åƒæ•¸</span> </p><p><span style="font-family: calibri;">Reduced cleaning parameter</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">測試到清潔為æ¢</span> </p><p><span style="font-family: calibri;">Test until clean</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">無效應</span> </p><p><span style="font-family: calibri;">No effect</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">è·çˆ¾è’™</span> </p><p><span style="font-family: calibri;">Hormone</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">間隔時間</span> </p><p><span style="font-family: calibri;">Time frame</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">å°æ•¸æ€§çš„移除</span> </p><p><span style="font-family: calibri;">Log removal</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">滯留</span> </p><p><span style="font-family: calibri;">Carry over</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">盤尼西林</span> </p><p><span style="font-family: calibri;">Penicillin</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">é å¢åèŒç´ é¡ž</span> </p><p><span style="font-family: calibri;">Cephalosporins</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">薄層層æžæ³•</span> </p><p><span style="font-family: calibri;">Thin layer chromatography</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">籃狀試驗法</span> </p><p><span style="font-family: calibri;">Bracketing</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">雜質組åˆ</span> </p><p><span style="font-family: calibri;">Impurity profile</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">類固醇</span> </p><p><span style="font-family: calibri;">Steroid</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">è¦å ±é»ž</span> </p><p><span style="font-family: calibri;">Alarm point</span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">英ä¸åè©žå°ç…§</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Accessibility</span></p><p><span style="font-family: 新細明體,serif;">å¯æŽ¥è¿‘性</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Alarm point</span></p><p><span style="font-family: 新細明體,serif;">è¦å ±é»ž</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Bracketing</span></p><p><span style="font-family: 新細明體,serif;">籃狀試驗法</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Carry over</span></p><p><span style="font-family: 新細明體,serif;">滯留</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Cephalosporins</span></p><p><span style="font-family: 新細明體,serif;">é å¢åèŒç´ é¡ž</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Clean-in place</span></p><p><span style="font-family: 新細明體,serif;">就地清潔</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Cleaning agent</span></p><p><span style="font-family: 新細明體,serif;">洗滌劑</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Compliance</span></p><p><span style="font-family: 新細明體,serif;">ä¾å¾žæ€§</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Cytotoxic</span></p><p><span style="font-family: 新細明體,serif;">細胞毒劑</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Detergent</span></p><p><span style="font-family: 新細明體,serif;">清潔劑</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Epitope</span></p><p><span style="font-family: 新細明體,serif;">抗原決定基</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Hormone</span></p><p><span style="font-family: 新細明體,serif;">è·çˆ¾è’™</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Impurity profile</span></p><p><span style="font-family: 新細明體,serif;">雜質組åˆ</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Limit of detection</span></p><p><span style="font-family: 新細明體,serif;">最低檢測濃度</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Limit of quantitation</span></p><p><span style="font-family: 新細明體,serif;">最低定é‡æ¿ƒåº¦</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Log removal</span></p><p><span style="font-family: 新細明體,serif;">å°æ•¸æ€§çš„移除</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Medium</span></p><p><span style="font-family: 新細明體,serif;">媒介質</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">No effect</span></p><p><span style="font-family: 新細明體,serif;">無效應</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Non-reactive material</span></p><p><span style="font-family: 新細明體,serif;">éžå應性æ質</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Penicillin</span></p><p><span style="font-family: 新細明體,serif;">盤尼西林</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Penicillins</span></p><p><span style="font-family: 新細明體,serif;">é’é»´ç´ é¡ž</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Physically occluded</span></p><p><span style="font-family: 新細明體,serif;">物ç†æ€§å°é–‰</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Placebo method</span></p><p><span style="font-family: 新細明體,serif;">空白物法</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Purified water</span></p><p><span style="font-family: 新細明體,serif;">純淨水</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Reduced cleaning parameter</span></p><p><span style="font-family: 新細明體,serif;">減低的清潔åƒæ•¸</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Spiking study</span></p><p><span style="font-family: 新細明體,serif;">å¤–åŠ ç ”ç©¶æ³•</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Stagnant water</span></p><p><span style="font-family: 新細明體,serif;">ä¸å‹•çš„æ°´</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Steroid</span></p><p><span style="font-family: 新細明體,serif;">類固醇</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Test until clean</span></p><p><span style="font-family: 新細明體,serif;">測試到清潔為æ¢</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Thin layer chromatography</span></p><p><span style="font-family: 新細明體,serif;">薄層層æžæ³•</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Time frame</span></p><p><span style="font-family: 新細明體,serif;">間隔時間</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Water for injection</span></p><p><span style="font-family: 新細明體,serif;">注射用水</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">Worst-case scenario</span></p><p><span style="font-family: 新細明體,serif;">最差狀æ³</span> </p><p><span style="font-family: calibri;"> </span></p>2013-12-04
藥政管ç†é¡ž,藥事法行政解釋公告å«serrapeptaseæˆåˆ†å†è©•ä¼°æœªç²é€šéŽç›¸é—œäº‹å®œè©³å¦‚附件2013-12-16
化å¸è£½é€ 管制類,指導手冊,ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„-電腦化系統確效指導手冊行政解釋ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„-電腦化系統確效指導手冊詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4520&type=0
化å¸è£½é€ 管制類,指導手冊,ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„-製程確效作æ¥æŒ‡å°Žæ‰‹å†Šè¡Œæ”¿è§£é‡‹ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„-製程確效作æ¥æŒ‡å°Žæ‰‹å†Šè©³å¦‚附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4521&type=0
化å¸è£½é€ 管制類,指導手冊,最終滅èŒä½œæ¥æŒ‡å°Žæ‰‹å†Šè¡Œæ”¿è§£é‡‹æœ€çµ‚æ»…èŒä½œæ¥æŒ‡å°Žæ‰‹å†Šè©³å¦‚附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4522&type=0
臨床試驗類,è—¥å“臨床試驗基準,æ¤ç‰©æŠ½å–新藥臨床試驗基準行政解釋æ¤ç‰©è—¥æ–°è—¥è‡¨åºŠè©¦é©—基準詳如附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4523&type=0
化å¸è£½é€ 管制類,指導手冊,ç„¡èŒæ“作作æ¥æŒ‡å°Žæ‰‹å†Šè¡Œæ”¿è§£é‡‹ç„¡èŒæ“作作æ¥æŒ‡å°Žæ‰‹å†Šè©³å¦‚附件2013-12-04https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4524&type=0
臨床試驗類,藥動å¸è©¦é©—基準,腎功能ä¸å…¨ç—…患的藥動å¸è©¦é©—基準行政解釋腎功能ä¸å…¨ç—…患之藥動å¸è©¦é©—基準詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4546&type=0
臨床試驗類,è—¥å“臨床試驗基準,感染症治療藥å“臨床試驗基準行政解釋感染症治療藥å“臨床試驗基準詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4547&type=0
查驗登記類,æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記療效åŠå®‰å…¨æ€§ä¹‹è€ƒé‡é‡é»žè¡Œæ”¿è§£é‡‹æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記療效åŠå®‰å…¨æ€§ä¹‹è€ƒé‡é‡é»žè©³å¦‚附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4548&type=0
查驗登記類,æ–°åž‹æµæ„Ÿç–«è‹—查驗登記指引行政解釋新型æµæ„Ÿç–«è‹—查驗登記指引詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4549&type=0
查驗登記類,新藥查驗登記精簡審查程åºè¡Œæ”¿è§£é‡‹æ–°è—¥æŸ¥é©—登記精簡審查程åºè©³å¦‚附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4550&type=0
查驗登記類,新藥查驗登記優先審查機制行政解釋新藥查驗登記優先審查機制詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4551&type=0
化å¸è£½é€ 管制類,指導手冊,æ»…èŒéŽç¨‹ç¢ºæ•ˆæŒ‡å°Žæ‰‹å†Šè¡Œæ”¿è§£é‡‹æ»…èŒéŽç¨‹ç¢ºæ•ˆæŒ‡å°Žæ‰‹å†Š<p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">「滅èŒéŽç¨‹ç¢ºæ•ˆæŒ‡å°Žæ‰‹å†Šã€</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ç›®</span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">錄</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">ç¬¬ä¸€ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å‰è¨€ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 1</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">ç¬¬äºŒç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">最終蒸氣滅èŒéŽç¨‹ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 1</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">一ã€è£½ç¨‹åŠæˆå“資炓．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 2</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">二ã€æ»…èŒéŽç¨‹çš„ç†±ç ”ç©¶ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 3</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">三ã€æ»…èŒæ•ˆæžœçš„ç ”ç©¶ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 4</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å››ã€ç’°å¢ƒå¾®ç”Ÿç‰©çš„管制．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 6</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">五ã€å®¹å™¨ã€å°è“‹èˆ‡åŒ…è£çš„密å°å®Œæ•´æ€§ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 6</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å…ã€ç´°èŒå…§æ¯’ç´ è©¦é©—æ–¹æ³•ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 7</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">七ã€ç„¡èŒè©¦é©—åŠæ”¾è¡Œè¦æ ¼ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 7</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">ç¬¬ä¸‰ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">其他的最終滅èŒéŽç¨‹ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 7</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">一ã€ç’°æ°§ä¹™çƒ¯ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;"> 8</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">二ã€æ”¾å°„線．．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;"> 9</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">ç¬¬å››ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ç„¡èŒå……填．．．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">10</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">一ã€å» 房與è¨æ–½ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">10</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">二ã€è£½ç¨‹æ¦‚說．．．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">11</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">三ã€å®¹å™¨ã€å°è“‹ã€è¨å‚™åŠåŽŸæ–™çš„æ»…èŒèˆ‡åŽ»ç†±åŽŸï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">12</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å››ã€åŸ¹é¤ŠåŸºå……填試驗．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">13</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">五ã€åŸ¹é¤ŠåŸºå……填試驗失敗時有關æˆå“的處置．．．．．．．．．</span><span style="font-size: 10pt;">14</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å…ã€ç’°å¢ƒå¾®ç”Ÿç‰©çš„管制．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">14</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">七ã€å®¹å™¨ã€å°è“‹èˆ‡åŒ…è£çš„密å°å®Œæ•´æ€§ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">15</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å…«ã€ç´°èŒå…§æ¯’ç´ è©¦é©—æ–¹æ³•ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">16</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¹ã€ç„¡èŒè©¦é©—åŠæ”¾è¡Œè¦æ ¼ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">16</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">ç¬¬äº”ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">微生物管制與å“質ç¶è·ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">16</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">一ã€å®¹å™¨èˆ‡å°è“‹çµ„åˆçš„密å°æ€§ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">16</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">二ã€é˜²è…劑的效果．．．．．．．．．．．．．．．．．．．．</span><span style="font-size: 10pt;">17</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">三ã€ç†±åŽŸæˆ–ç´°èŒå…§æ¯’ç´ è©¦é©—ï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Žï¼Ž</span><span style="font-size: 10pt;">17</span></p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">一</span> <span style="font-family: 標楷體; font-size: 10pt;">ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å‰</span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">言</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¾æ“šå„ªè‰¯è—¥å“è£½é€ æ¨™æº–è¦å®šï¼Œç‚ºé¿å…ç„¡èŒç”¢å“å—到微生物的污染，應訂有書é¢ä½œæ¥ç¨‹</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">åºä¸¦ç¢ºå¯¦éµå®ˆã€‚這些作æ¥ç¨‹åºæ‡‰åŒ…括所有滅èŒéŽç¨‹çš„確效。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒéŽç¨‹ç¢ºæ•ˆæ˜¯æ ¹æ“šä¸€ç³»åˆ—的實驗計劃書åŠå¯¦é©—çµæžœä¾†ç¢ºèªæ»…èŒéŽç¨‹çš„有效性，其çµ</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">果應顯示æ¤æ»…èŒéŽç¨‹åŠç›¸é—œçš„管制åŠæ“作標準å¯ä»¥ç”¨ä¾†é‡è¦†è£½é€ 出符åˆç„¡èŒå“質的藥å“。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¸è«–è—¥å» æ˜¯ä½¿ç”¨æœ€çµ‚æ»…èŒ</span><span style="font-size: 10pt;"> (TERMINAL STERILIZATION) </span><span style="font-family: 標楷體; font-size: 10pt;">或是無èŒæ“作方å¼</span> </p><p><span style="font-size: 10pt;">(ASEPTIC OPERATIONS) </span><span style="font-family: 標楷體; font-size: 10pt;">ä¾†è£½é€ ç„¡èŒç”¢å“ï¼Œå…¶è£½é€ éŽç¨‹å‡æ‡‰æä¾›é©ç•¶çš„確效資料。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒéŽç¨‹çš„確效å¯ä»¥ç”¨é©ç•¶ä¹‹åª’介物代替，ä¸éœ€ä¸€å®šè¦ç”¨å¯¦éš›çš„產å“試驗三批來判定。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒéŽç¨‹ç¢ºæ•ˆä¹‹ç‹€æ³åŠæ¢ä»¶æ‡‰èˆ‡æ£å¼ç”Ÿç”¢æ™‚一樣，如æ¤å–得之數據æ‰èƒ½ä»£è¡¨ä¸¦è‰æ˜Žå¯¦</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">際產å“之無èŒæ€§ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">本滅èŒéŽç¨‹ç¢ºæ•ˆæŒ‡å°Žæ‰‹å†Šï¼ˆä»¥ä¸‹ç°¡ç¨±æœ¬æ‰‹å†Šï¼‰ï¼Œç›®çš„在於æ供無èŒè—¥å“在無èŒç¢ºæ•ˆéŽ</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">程之範åœèˆ‡è¦æ±‚，作為æ¥è€…è£½é€ ç„¡èŒè£½åŠ‘執行無èŒç¢ºæ•ˆä¹‹åƒè€ƒã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">二</span> <span style="font-family: 標楷體; font-size: 10pt;">ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">最終蒸氣滅èŒéŽç¨‹</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一ã€è£½ç¨‹åŠæˆå“資料</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">æˆå“åŠå®¹å™¨å°è“‹çµ„åˆç³»çµ±ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明需滅èŒçš„æˆå“åŠå®¹å™¨å°è“‹çµ„åˆ</span><span style="font-size: 10pt;">,</span><span style="font-family: 標楷體; font-size: 10pt;">如大å°ã€å……å¡«é‡æˆ–包è£ã€‚</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒéŽç¨‹ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明被滅èŒç‰©åŒ…括藥å“於最終容器å°è“‹çµ„åˆå…§ã€ä»¥åŠåŽŸæ–™è—¥ã€åŠè£½å“åŠç›¸é—œç‰©å“</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ç‰æ‰€ä½¿ç”¨çš„æ»…èŒéŽç¨‹ã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">æ出è‰æ˜Žæ»…èŒéŽç¨‹æ•ˆæžœçš„資料åŠæ•¸æ“šï¼ˆåƒè¦‹ç¬¬äºŒç« äºŒæˆ–ç¬¬äºŒç« ä¸‰ï¼‰ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒå™¨æ»…èŒéŽç¨‹åŠæ“作è¦æ ¼ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明滅èŒå™¨çš„æ“作éŽç¨‹ï¼Œè«¸å¦‚æ»…èŒç¨®é¡žï¼ˆå¦‚使用飽åˆè’¸æ°£ã€æµ¸æ°´æˆ–å™´æ°´æ–¹å¼ï¼‰ï¼Œ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">並註明所使用的滅èŒå™¨åŠå…¶è£½é€ 商ã€åž‹è™Ÿç‰ã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">說明滅èŒæ¢ä»¶åŠè¦æ ¼ï¼ˆå¦‚溫度ã€å£“力ã€æ™‚é–“åŠæœ€ä½Žã€æœ€é«˜</span><span style="font-size: 10pt;">FO</span><span style="font-family: 標楷體; font-size: 10pt;">值ç‰ï¼‰ã€‚</span> </p><p><span style="font-size: 10pt;"> 4.</span><span style="font-family: 標楷體; font-size: 10pt;">è£æˆ´åž‹å¼ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明具代表性的滅èŒå™¨è£è¼‰åž‹å¼ã€‚（附圖表說明）</span> </p><p><span style="font-size: 10pt;"> 5.</span><span style="font-family: 標楷體; font-size: 10pt;">監控方法：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明於例行性生產時監控滅èŒè£½ç¨‹çš„方法（如使用熱探測器ã€è©¦é©—瓶ã€ç”Ÿç‰©æˆ–化å¸</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">性指示劑），並註明其數é‡ã€æ“ºæ”¾ä½ç½®åŠåˆ¤å®šè¦æ ¼ç‰ã€‚</span> </p><p><span style="font-size: 10pt;"> 6.</span><span style="font-family: 標楷體; font-size: 10pt;">生產用滅èŒå™¨çš„å†ç¢ºæ•ˆï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å°ç”Ÿç”¢ç”¨çš„æ»…èŒå™¨æ‡‰åˆ¶è¨‚å†ç¢ºæ•ˆè¨ˆç•«ã€‚</span> </p><p><span style="font-size: 10pt;"> 7.</span><span style="font-family: 標楷體; font-size: 10pt;">å†è™•ç†ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å°å†åº¦è™•ç†çš„產å“（如å†æ¬¡åŠ 熱滅èŒï¼‰æ‡‰åˆ¶è¨‚確效計畫書，說明其確效的éŽç¨‹ï¼Œä¸¦</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">注æ„å†æ¬¡çš„åŠ ç†±æ»…èŒæ˜¯å¦æœƒå½±éŸ¿è©²æˆå“的定定性。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二ã€æ»…èŒéŽç¨‹çš„ç†±ç ”ç©¶</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">溫度分佈與熱滲é€è©¦é©—：</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">æ出滅èŒéŽç¨‹æœ‰é—œæº«åº¦åˆ†ä½ˆèˆ‡ç†±æ»²é€çš„實驗計畫書åŠå¯¦é©—çµæžœï¼Œé€™äº›çµæžœå¯è‰æ˜Ž</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒéŽç¨‹çš„å‡ä¸€æ€§ï¼Œå†ç¾æ€§ä¸¦ç¬¦åˆåˆ¶è¨‚çš„è¦æ ¼ã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒç¢ºæ•ˆç´€éŒ„應有連續三次æˆåŠŸçš„çµæžœï¼Œä»¥ç¢ºä¿æ»…èŒéŽç¨‹çš„一致性。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">熱探測器：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明熱探測器放置於滅èŒå™¨çš„ä½ç½®åŠæ•¸é‡ã€‚（附圖表說明）熱探測器在使用之å‰ï¼Œ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ‡‰é€²è¡Œæ ¡æ£ä»¥ç¢ºä¿å¯¦é©—之æ£ç¢ºæ€§ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">è£è¼‰å°ç†±å‚³å°Žçš„影響：</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">最å°åŠæœ€å¤§è£è¼‰é‡çš„ç ”ç©¶æ•¸æ“šä»¥æŽ¢è¨Žè£è¼‰é‡å¤šå¯¡ï¼Œå°ç†±è¼¸å…¥æˆå“的影響。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">如果容器相åŒä½†å……å¡«é‡ä¸åŒå‰‡è¦åšé€²ä¸€æ¥è©¦é©—紀錄。</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">紀錄è¦åŒ…括最高åŠæœ€ä½Žæº«åº¦ï¼ˆæº«åº¦ç¯„åœï¼‰ï¼Œç¶æŒæ»…èŒæº«åº¦åœç•™æœŸé–“çš„å¹³å‡æº«åº¦ï¼Œ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">最高ã€æœ€ä½Ž</span><span style="font-size: 10pt;">FO</span><span style="font-family: 標楷體; font-size: 10pt;">值，é”到滅èŒæº«åº¦çš„時間，試驗的日期åŠæ™‚間，使用滅èŒå™¨çš„型號</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ç‰ã€‚</span> </p><p><span style="font-size: 10pt;"> 3)</span><span style="font-family: 標楷體; font-size: 10pt;">這些試驗所使用的滅èŒå™¨æ‡‰èˆ‡è£½é€ æˆå“時所使用的相åŒã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">三ã€æ»…èŒæ•ˆæžœçš„ç ”ç©¶</span><span style="font-size: 10pt;"> -6</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧任何最終滅èŒéŽç¨‹çš„ç„¡èŒä¿è‰æ‡‰å„ªæ–¼</span><span style="font-size: 10pt;">10 </span><span style="font-family: 標楷體; font-size: 10pt;">çš„ç„¡èŒä¿è‰ã€‚這種標準的無èŒä¿è‰æ‡‰é©ç”¨</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ–¼æˆå“所有的無èŒçµ„æˆéƒ¨åˆ†ï¼ŒåŒ…括容器åŠå°è“‹ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧這些滅èŒæ–¹æ³•ä¿‚ä¾ç”¢å“åŠè£½ç¨‹çš„特性而è¨è¨ˆï¼Œä¸åŒè—¥å» ，å¯èƒ½ä½¿ç”¨ä¸åŒçš„方法，但</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">通常è¦æ供左列的資料。</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">è² è·èŒï¼ˆ</span><span style="font-size: 10pt;">BIOBURDEN ORGANISM</span><span style="font-family: 標楷體; font-size: 10pt;">）的特性：</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">使用ä¾å¾®ç”Ÿç‰©è² è·é‡å¤šå¯¡è€Œåˆ¶è¨‚çš„æ»…èŒæ³•è¼ƒä½¿ç”¨éŽåº¦æ»…èŒæ³•éœ€è¦æ›´å¤šçš„資料，來</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¿è‰æ»…èŒä¹‹å®Œæ•´ã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">æä¾›çš„è³‡æ–™åŒ…æ‹¬è² è·èŒçš„種類ã€æ•¸é‡ã€åŠè€å—性，應包括å¯èƒ½ä¾†è‡ªè—¥æ¶²ï¼Œå®¹å™¨åŠ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å°è“‹ä¹‹å¾®ç”Ÿç‰©ã€‚</span> </p><p><span style="font-size: 10pt;"> 3)</span><span style="font-family: 標楷體; font-size: 10pt;">èªªæ˜Žé‘‘åˆ¥è² è·èŒç‰¹æ€§çš„方法åŠçµæžœã€‚å¿…è¦æ™‚需鑑別è€ç†±æ€§æœ€å¼·çš„è² è·èŒã€‚</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">è² è·èŒçš„è¦æ ¼ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">æä¾›è² è·èŒæ—³è¦å‘Šèˆ‡è¡Œå‹•ç•Œé™è¦æ ¼ã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">èªªæ˜Žä¾‹è¡Œç›£æŽ§è² è·èŒçš„計畫以ä¿è‰è² è·èŒåœ¨ç¢ºæ•ˆæ‰€è¨å®šçš„è¦æ ¼ç¯„åœå…§ï¼Œè¨ˆç•«å…§å®¹</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">包括æ£ç¢ºä¹‹è©¦é©—æ–¹æ³•èˆ‡é »çŽ‡ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">生物指示劑的鑑定，è€å—性åŠå®‰å®šæ€§ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒç¢ºæ•ˆæ‰€ä½¿ç”¨çš„生物指示劑，應æ供其鑑別è€å—性（</span><span style="font-size: 10pt;">D</span><span style="font-family: 標楷體; font-size: 10pt;">值，</span><span style="font-size: 10pt;">Z</span><span style="font-family: 標楷體; font-size: 10pt;">值）åŠå®‰å®šæ€§çš„資</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">料。</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">如果生物指示劑是購自市é¢ï¼Œå¿…è¦æ™‚應該è‰å¯¦å…¶è·èŒæ•¸å’Œè€å—性，åŠå¯¦éš›æ“作的</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">è¦æ ¼ã€‚</span> </p><p><span style="font-size: 10pt;"> 4.</span><span style="font-family: 標楷體; font-size: 10pt;">生物指示劑的è€å—æ€§èˆ‡è² è·èŒçš„關係：</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">èªªæ˜Žç”Ÿç‰©æŒ‡ç¤ºåŠ‘çš„ç‰¹æ€§èˆ‡è² è·èŒçš„關係。</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">ä¾ç”¢å“çš„ç‹€æ³æ¸¬å®šå¾®ç”Ÿç‰©åœ¨è—¥æ¶²å…§æˆ–附於容器ã€å°è“‹è¡¨é¢å°æ»…èŒéŽç¨‹çš„è€å—性。</span> </p><p><span style="font-size: 10pt;"> 3)</span><span style="font-family: 標楷體; font-size: 10pt;">如果使用å¢å攜片必è¦æ™‚ç ”ç©¶å¢å置於攜片上與直接æ¤å…¥ç”¢å“的差異。</span> </p><p><span style="font-size: 10pt;"> 5.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物挑戰實驗：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æå‡ºçš„å¾®ç”Ÿç‰©æŒ‘æˆ°ç¢ºæ•ˆè©¦é©—å¿…é ˆèƒ½è‰æ˜Žç”¢å“在最難滅èŒçš„æ¢ä»¶ä¸‹</span> </p><p><span style="font-size: 10pt;"> -6</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">（如在最難滅èŒçš„è£è¼‰ç”¢å“åŠä½ç½®ï¼‰ï¼Œèƒ½å¾—到優於</span><span style="font-size: 10pt;">10 </span><span style="font-family: 標楷體; font-size: 10pt;">çš„ç„¡èŒä¿è‰ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">所稱最難滅èŒçš„產å“或ä½ç½®ä¿‚經由實驗得到的。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">å››ã€ç’°å¢ƒå¾®ç”Ÿç‰©çš„管制</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">éœ€åˆ¶è¨‚è£½é€ å ´æ‰€ã€åŽŸæ–™åŠè£½é€ 用水ç‰çš„微生物管制計畫。æ¤è¨ˆç•«æ‡‰åŒ…å«é©ç•¶çš„è¦æ ¼</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ã€æ¨™æº–ã€å–樣計畫ã€æ¸¬è©¦æ–¹æ³•ã€æ¸¬è©¦é »çŽ‡åŠè¡Œå‹•ç•Œé™ã€‚並按計畫實施ä¿ç•™æ•¸æ“šã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">五ã€å®¹å™¨ã€å°è“‹èˆ‡åŒ…è£çš„密å°å®Œæ•´æ€§</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">åŠ å·¥éŽç¨‹ä¸æ‰€å—外部壓力的模擬試驗：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">實驗è¨è¨ˆæ‡‰æ¨¡æ“¬è—¥å“在滅èŒéŽç¨‹ã€æ¬é‹ã€å„²å˜æ™‚所å—外力å°å®¹å™¨å°è“‹çµ„åˆçš„影響，</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">需è¦æ™‚å¯ç”¨ç‰©ç†æ€§ã€åŒ–å¸æ€§åŠç”Ÿç‰©æ€§çš„挑戰試驗。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">最嚴苛的滅èŒæ¢ä»¶ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">應使用最長的滅èŒè£½ç¨‹ä¾†æ¸¬è©¦å®¹å™¨ã€å°è“‹çš„密å°å®Œæ•´æ€§ã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">如果æˆå“經éŽä¸€æ¬¡ä»¥ä¸Šçš„æ»…èŒï¼Œå‰‡åœ¨è©¦é©—è¨è¨ˆæ‡‰åŒ…å«æ‰€æœ‰çš„æ»…èŒéŽç¨‹ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">多é‡é˜»éš”（</span><span style="font-size: 10pt;">MULTIPLE BARRIERS</span><span style="font-family: 標楷體; font-size: 10pt;">）：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æˆå“çš„æ¯ä¸€é˜»éš”如標示無èŒæ™‚ï¼Œæ‡‰å€‹åˆ¥åŠ ä»¥ç¢ºæ•ˆã€‚</span> </p><p><span style="font-size: 10pt;"> 4.</span><span style="font-family: 標楷體; font-size: 10pt;">試驗éˆæ•åº¦ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">應æ供測試容器ã€å°è“‹å¯†å°æ€§æ–¹æ³•çš„éˆæ•åº¦ã€‚</span> </p><p><span style="font-size: 10pt;"> 5.</span><span style="font-family: 標楷體; font-size: 10pt;">æˆå“有效期間或ä¿å˜æœŸé™å…§çš„密å°å®Œæ•´æ€§ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">檢測æˆå“在有效期間或ä¿å˜æœŸé™å…§é˜²æ¢å¾®ç”Ÿç‰©æ±¡æŸ“的密å°å®Œæ•´æ€§ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">å…ã€ç´°èŒå…§æ¯’ç´ è©¦é©—æ–¹æ³•</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明æˆå“å…§æ¯’ç´ æ¸¬è©¦çš„æ–¹æ³•ï¼šå…§å®¹æ‡‰åŒ…æ‹¬å¯¦é©—å®¤è¨å‚™åŠæ“作環境的é©åˆæ€§ï¼Œæˆå“å°</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å…§æ¯’ç´ æŠ‘åˆ¶æˆ–å¢žå¼·çš„è©¦é©—åŠçµæžœã€‚檢測無抑制時的濃度åŠæœ€å¤§æœ‰æ•ˆç¨€é‡‹å€æ•¸ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">七ã€ç„¡èŒè©¦é©—åŠæ”¾è¡Œè¦æ ¼</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">實驗計畫書內應說明於生產時如何é¸æ“‡ä»£è¡¨æ€§æ¨£å“來åšç„¡èŒè©¦é©—。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">說明在阻隔系統（</span><span style="font-size: 10pt;">BARRIER SYSTEMS</span><span style="font-family: 標楷體; font-size: 10pt;">）內æ“作無èŒè©¦é©—的方法。</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">有關阻隔系統的確效試驗視需è¦å¾—一併æ出。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">三</span> <span style="font-family: 標楷體; font-size: 10pt;">ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">其他的最終滅èŒéŽç¨‹</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¸Šè¿°ç¬¬äºŒç« ä¸€è‡³ä¸ƒçš„è¦å®šä¿‚說明蒸氣的滅èŒéŽç¨‹ï¼Œä½†å…¶ä»–如æˆå“ã€åŒ…æ或原料以單ç¨</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">或åˆä½µæ–¹å¼åˆ©ç”¨ç’°æ°§ä¹™çƒ¯æˆ–放射線（伽瑪射線）滅èŒæ™‚亦é©ç”¨ä¹‹ã€‚</span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">其滅èŒéŽç¨‹ç¢ºæ•ˆéœ€</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">包括è£è¼‰åž‹å¼ã€æœ€å¤§è£è¼‰é‡çš„確效；最低滅èŒæ¢ä»¶æ¸¬å®šæœ€ä¸æ˜“æ»…èŒåœ°æ–¹ï¼Œä»¥ç¢ºä¿æˆå“ç„¡</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">èŒã€‚æ»…èŒéŽç¨‹çš„å†ç¢ºæ•ˆã€å†æ»…èŒçš„è¦å®šï¼›ç”¢å“è² è·èŒçš„è¦æ ¼åŠç®¡åˆ¶è¨ˆç•«ï¼Œå®¹å™¨å°è“‹çµ„åˆ</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">密å°æ€§ç‰ï¼Œä»¥åŠæ»…èŒè£½ç¨‹å°è—¥å“物ç†æ€§æˆ–化å¸æ€§çš„影響。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一ã€ç’°æ°§ä¹™çƒ¯</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒå™¨ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明滅èŒå™¨çš„è¦æ ¼åŠæ“作方法，並註明è£æœ‰æˆå“時é åŠ æ¿•åŠå°Žå…¥æ°£é«”的控制ä½ç½®</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">（附圖說明）</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒæ¢ä»¶ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明滅èŒéŽç¨‹çš„æ¯ä¸€éšŽæ®µï¼Œå¦‚é å…ˆåŠ æ¿•ï¼Œæ»…èŒæ°£é«”的濃度ã€çœŸç©ºåŠæ°£é«”åŠ å£“éŽç¨‹</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ã€æ»…èŒçš„時間åŠæº«åº¦ã€æ¿•åº¦ï¼ŒæŽ’除滅èŒæ°£é«”，置æ›ç©ºæ°£åŠåŒ–å¸æ®˜ç•™ç‰©çš„測定ç‰éƒ½</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">需è¦æœ‰æ˜Žç¢ºçš„è¦å®šã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">制訂滅èŒéŽç¨‹ç®¡åˆ¶çš„標準作æ¥ï¼Œä»¥ç¢ºä¿æ–¼å¯¦éš›ç”Ÿç”¢æ™‚çš„æ»…èŒæ¢ä»¶ç¬¦åˆæ–¼ç¢ºæ•ˆæ‰€å®š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">çš„è¦æ ¼ç¯„åœå…§ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物法：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明在確效試驗時將å¢å置入樣å“內測試滅èŒæ•ˆæžœçš„微生物測試方法，例如所使用</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">的培養基，培養溫度åŠåŸ¹é¤ŠæœŸé–“ç‰ï¼ŒåŒæ™‚å¯¦éš›ç”Ÿç”¢æ™‚ä½¿ç”¨çš„å¾®ç”Ÿç‰©æ¸¬è©¦æ³•äº¦æ‡‰åŠ ä»¥</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明。</span> </p><p><span style="font-size: 10pt;"> 4.</span><span style="font-family: 標楷體; font-size: 10pt;">安定性：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">è—¥å“於有效期é™å…§æ‡‰åˆ¶è¨‚åµæ¸¬åŒ…è£çš„安定性åŠå®¹å™¨ã€å°è“‹çµ„åˆå¯†å°æ€§çš„計畫書。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二ã€æ”¾å°„ç·š</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">æ»…èŒçš„è¨æ–½åŠéŽç¨‹ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">標明放射線滅èŒè¨æ–½ã€‚（附圖說明）</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">說明放射線æºï¼Œèˆ‡æ”¾å°„線照射的方法（å³åœ¨ç…§å°„室內的移動），åŠç”¨ä¾†åµæ¸¬é‡ç”¢</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">照射所使用放射線劑é‡è¨ˆçš„åž‹å¼åŠä½ç½®ã€‚如果低劑é‡ä½ç½®ä¸¦ä¸æ˜¯ç”¨ä¾†ä½œç‚ºæ—¥å¸¸é‡</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">產åµæ¸¬çš„ä½ç½®ï¼Œå‰‡æ•¸æ“šæ¯”率介於高與低劑é‡ä½ç½®çš„關係需先了解。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">æˆå“的包è£ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明æˆå“置於包è£ç®±æˆ–在滅èŒç®±çš„排列方å¼ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">多次劑é‡åœ–ç¤ºç ”ç©¶ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">為顯示滅èŒéŽç¨‹ä¹‹å‡ä¸€æ€§åŠå†ç¾æ€§ï¼Œæ‡‰è©²é€²è¡Œå¤šæ¬¡åŠ‘é‡ä¹‹åˆ†æžç ”究以求高劑é‡èˆ‡ä½Ž</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">劑é‡ä¹‹æ–¹ä½ï¼Œä¸¦ä»¥åœ–示方å¼èªªæ˜Žã€‚</span> </p><p><span style="font-size: 10pt;"> 4.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物法：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">制訂確效åŠæŸ¥æ ¸æ»…èŒéŽç¨‹æ•ˆæžœçš„微生物方法åŠç®¡åˆ¶æ–¹å¼ã€‚</span> </p><p><span style="font-size: 10pt;"> 5.</span><span style="font-family: 標楷體; font-size: 10pt;">安定性：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æˆå“在有效期間或ä¿å˜æœŸé™å…§ï¼Œæ‡‰åˆ¶è¨‚åµæ¸¬åŒ…è£çš„安定性åŠå®¹å™¨å°è“‹çµ„åˆå¯†å°æ€§çš„</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">計畫書。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">å››</span> <span style="font-family: 標楷體; font-size: 10pt;">ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ç„¡èŒå……å¡«</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一ã€å» 房與è¨æ–½</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ç•¥è¿°è£½é€ å» æˆ¿èˆ‡è¨æ–½ã€‚</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">å¹³é¢åœ–：</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">ç„¡èŒå……å¡«è¨æ–½çš„å¹³é¢åœ–包括準備與儲å˜å€ï¼ŒéŽæ¿¾èˆ‡å……å¡«å€ï¼Œä»¥åŠç„¡èŒæ›´è¡£å®¤ã€‚</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">標示æ¯å€‹å€çš„空氣清淨度ç‰ç´šï¼ˆå¦‚</span><span style="font-size: 10pt;">100,10000,100000</span><span style="font-family: 標楷體; font-size: 10pt;">ç´šç‰ï¼‰ã€‚</span> </p><p><span style="font-size: 10pt;"> 3)</span><span style="font-family: 標楷體; font-size: 10pt;">標示隔離空間或防è·ç³»çµ±ä½ç½®ï¼ˆ</span><span style="font-size: 10pt;">ISOLATOR OR BARRIER</span><span style="font-family: 標楷體; font-size: 10pt;">）。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">è¨å‚™ä½ç½®ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">標示é‡è¦è¨å‚™çš„ä½ç½®ï¼Œå¦‚層æµè£ç½®ã€æ»…èŒå™¨ã€å‡æ™¶è¨å‚™åŠå……å¡«è¨å‚™ç‰ã€‚（應標示</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">於平é¢åœ–上）。</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">註明放置於隔離或防è·ç³»çµ±å…§çš„è¨å‚™ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二ã€è£½ç¨‹æ¦‚說</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">â€§èªªæ˜Žè£½é€ éŽç¨‹ä¸ï¼Œå¦‚物æµã€å……å¡«ã€å°è“‹ã€ç„¡èŒçµ„åˆç‰ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧於上述的平é¢åœ–上標示產å“從調é…至製æˆå“çš„æµç¨‹ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">â€§è£½é€ éŽç¨‹æ‡‰è€ƒæ…®å·¦åˆ—çš„å„é …ï¼š</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">藥液的éŽæ¿¾ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">說明藥液的éŽæ¿¾æµç¨‹ï¼ŒåŒ…æ‹¬æ¿¾å™¨çš„å…ˆå¾Œé †åºã€é 濾膜ã€åŠç´°èŒæ¿¾è†œç‰æ“作細節。</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">摘è¦èªªæ˜Žæ¿¾è†œé™¤èŒçš„效果åŠæˆå“與濾膜é…åˆæ€§çš„確效資料。說明濾膜å°æˆå“處方</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">的影響，如防è…劑或主æˆåˆ†æ˜¯å¦æœƒè¢«æ¿¾è†œå¸é™„或濾膜釋出物å°æˆå“的影響。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">儲å˜æœŸé–“çš„è¦å®šï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¾å„ªè‰¯è—¥å“è£½é€ æ¨™æº–è¦å®šæ‰€è£½é€ æˆå“應制訂æ¯ä¸€é‡è¦éšŽæ®µå®Œæˆçš„時é™ï¼Œä»¥ç¢ºä¿æˆå“</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å“質。所以從藥å“的調é…到充填至最終容器的æ¯ä¸€æ®µå„²å˜æœŸé–“都è¦åˆ¶è¨‚è¦æ ¼ï¼Œè¦æ ¼</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¸åŒ…括儲å˜å®¹å™¨ã€å„²å˜æº«åº¦ã€æ™‚é–“åŠå„²å˜æ¢ä»¶ç‰ã€‚åŒæ™‚也è¦èªªæ˜Žåœ¨å„²å˜æœŸé–“如何防</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ¢å¾®ç”Ÿç‰©æ±¡æŸ“的方法ç‰ï¼Œä¸Šè¿°æ–¹æ³•è¦åŠ 以確èªã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">關鑑性æ“作：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明æˆå“或æˆå“接觸的表é¢æ›éœ²æ–¼ç’°å¢ƒæ™‚（如æ¬é‹å·²æ»…èŒçš„容器或å°è“‹è‡³ç„¡èŒå……å¡«</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å€ï¼‰çš„æ“作方法，並說明所採用之隔離或防è·ç³»çµ±ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">三ã€å®¹å™¨ã€å°è“‹ã€è¨å‚™åŠåŽŸæ–™çš„æ»…èŒèˆ‡åŽ»ç†±åŽŸ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明容器ã€å°è“‹ã€å„組件åŠé˜²è·ç³»çµ±çš„æ»…èŒèˆ‡åŽ»ç†±åŽŸéŽç¨‹ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明這些éŽç¨‹çš„確效試驗包括熱分佈與熱滲é€ã€‚摘è¦èªªæ˜Žå¾®ç”Ÿç‰©çš„挑戰試驗（微生</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">物指示劑åŠå…§æ¯’ç´ ï¼‰åŠä¾‹è¡Œçš„管制程åºç‰ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧如有蒸氣滅èŒä»¥å¤–çš„æ»…èŒéŽç¨‹ä¹Ÿè¦æ出確效資料。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧æ出æ¯ä¸€ç¨®æ»…èŒéŽç¨‹æ‰€ç”¨çš„殺èŒç‰©è³ªï¼ˆ</span><span style="font-size: 10pt;">STERILANT </span><span style="font-family: 標楷體; font-size: 10pt;">）的分佈與滲é€åŠç¢ºèªæ»…èŒæ•ˆæžœ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">的方法（å¯åƒè¦‹ç¬¬äºŒç« ），數據ç‰è³‡æ–™ã€‚</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">藥液的原料分別滅èŒæ™‚：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">如果藥液的å„個原料是分別滅èŒå†ç¶“ç„¡èŒèª¿é…，則需æä¾›å„個滅èŒè£½ç¨‹çš„確效資料。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">批次紀錄上的滅èŒè³‡æ–™ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">申請時在完整的批次紀錄上任何容器å°è“‹çµ„件，如經滅èŒæˆ–去熱原製程應標示其</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">確效éŽç¨‹ã€‚確效資料å¯æ–¼æ‰¹æ¬¡ç´€éŒ„上載明åƒé–±ç¢ºæ•ˆå¯¦é©—計畫或標準書é¢ä½œæ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">å››ã€åŸ¹é¤ŠåŸºå……填試驗</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明培養基充填試驗的æ“作æ¥é©ŸåŠè¦æ ¼ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧使用與æˆå“相åŒçš„å……å¡«æ¥é©ŸåŠå®¹å™¨å°è“‹çµ„åˆä¾†åšç¢ºæ•ˆè©¦é©—，說明所使用的微生物試</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">驗方法。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧如果培養基充填試驗與產å“的製程上有任何差異，è¦åŠ 以註明。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧æ供最近培養基充填試驗的摘è¦ç´€éŒ„，包括失敗紀錄。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧使用與æˆå“生產時相åŒçš„生產線å–得之實驗數據。</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧æ¯ä¸€æ¬¡åŸ¹é¤ŠåŸºå……填試驗的摘è¦å ±å‘Šæ‡‰æ供左列資料：</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">充填室：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ä¾æœ¬æ‰‹å†Šç¬¬å››ç« 一ã€</span><span style="font-size: 10pt;">(1)</span><span style="font-family: 標楷體; font-size: 10pt;">之平é¢åœ–，標示所使用的無èŒå®¤ã€‚</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">容器ã€å°è“‹çš„å½¢å¼èˆ‡å¤§å°ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">æ¯ä¸€å®¹å™¨ä¹‹åŸ¹é¤ŠåŸºå……å¡«é‡ã€‚</span> </p><p><span style="font-size: 10pt;"> 4.</span><span style="font-family: 標楷體; font-size: 10pt;">使用何種培養基。</span> </p><p><span style="font-size: 10pt;"> 5.</span><span style="font-family: 標楷體; font-size: 10pt;">充填支數。</span> </p><p><span style="font-size: 10pt;"> 6.</span><span style="font-family: 標楷體; font-size: 10pt;">培養支數。</span> </p><p><span style="font-size: 10pt;"> 7.</span><span style="font-family: 標楷體; font-size: 10pt;">被污染的支數。</span> </p><p><span style="font-size: 10pt;"> 8.</span><span style="font-family: 標楷體; font-size: 10pt;">培養æ¢ä»¶ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明æ¯ä¸€çµ„的培養時間與溫度，如果培養的溫度超éŽäºŒç¨®æ™‚è¦è¨˜æ˜Žå…¶è¦æ ¼ã€‚</span> </p><p><span style="font-size: 10pt;"> 9.</span><span style="font-family: 標楷體; font-size: 10pt;">充填日期。</span> </p><p><span style="font-size: 10pt;"> 10.</span><span style="font-family: 標楷體; font-size: 10pt;">模擬：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ“作紀錄必需說明所模擬的æ“作程åºæ˜¯æ£å¸¸æ“作那一æ¥é©Ÿï¼Œé€™äº›æ¨¡æ“¬åŒ…括較慢的充</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">填速度，人員æ›ç，è¨å‚™çš„異常åŠä¿®ç†ï¼Œä»¥åŠæ¨¡æ“¬å‡æ™¶éŽç¨‹åŠå®¹å™¨å…§ä¸Šæ–¹æ°£é«”çš„ç½®</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ›ç‰ã€‚</span> </p><p><span style="font-size: 10pt;"> 11.</span><span style="font-family: 標楷體; font-size: 10pt;">微生物管制：</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明於培養基充填試驗時，微生物管制的資料（åƒè€ƒæœ¬æ‰‹å†Šç¬¬å››ç« å…）。</span> </p><p><span style="font-size: 10pt;"> 12.</span><span style="font-family: 標楷體; font-size: 10pt;">å……å¡«éŽç¨‹çš„åƒæ•¸ï¼ˆ</span><span style="font-size: 10pt;">PARAMETERS</span><span style="font-family: 標楷體; font-size: 10pt;">）</span><span style="font-size: 10pt;">:</span></p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">比較產å“充填時與培養基充填時所使用æ¢ä»¶æ˜¯å¦ç›¸åŒï¼Œå¦‚充填線的充填速度ã€å……å¡«</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">é‡ã€å……填支數ã€åŠå……填期間ç‰ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">五ã€åŸ¹é¤ŠåŸºå……填試驗失敗時有關æˆå“的處置</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明失敗å‰å¾Œæˆå“的處置，有關調查ã€è©•ä¼°è³‡æ–™åŠåˆ¤å®šï¼ˆæ”¾è¡Œæˆ–拒絕）ä¾æ“šç‰ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">å…ã€ç’°å¢ƒå¾®ç”Ÿç‰©çš„管制</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明æ£å¸¸ç”Ÿç”¢èˆ‡åŸ¹é¤ŠåŸºå……填試驗時的微生物管制計畫，計畫包括管制的種類ã€é »çŽ‡</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ã€åœ°é»žã€è¦å‘Šèˆ‡åˆ¤å®šè¦æ ¼åŠè¶…éŽè¦æ ¼æ™‚所採å–的措施。</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">微物管制的方法</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明環境管制計畫所使用的方法åŠææ–™</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧方法包括å–樣ã€é‹é€ã€æ¶ˆæ¯’劑的ä¸å’Œã€åŸ¹é¤ŠåŠçµæžœçš„計算ç‰ã€‚</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">‧說明左列微生物污染æºçš„管制è¦æ ¼åŠå…¶æ–¹æ³•ï¼š</span> </p><p><span style="font-size: 10pt;"> 1)</span><span style="font-family: 標楷體; font-size: 10pt;">空氣ä¸çš„微生物。</span> </p><p><span style="font-size: 10pt;"> 2)</span><span style="font-family: 標楷體; font-size: 10pt;">è¨æ–½è¡¨é¢çš„微生物。</span> </p><p><span style="font-size: 10pt;"> 3)</span><span style="font-family: 標楷體; font-size: 10pt;">人。</span> </p><p><span style="font-size: 10pt;"> 4)</span><span style="font-family: 標楷體; font-size: 10pt;">水系統。</span> </p><p><span style="font-size: 10pt;"> 5)</span><span style="font-family: 標楷體; font-size: 10pt;">åŽŸç‰©æ–™çš„è² è·èŒã€‚</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">é…µæ¯èŒã€é»´èŒåŠåŽæ°£æ€§å¾®ç”Ÿç‰©ï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明週期性或例行性管制方法åŠè¦æ ¼ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">超éŽé™åˆ¶ç¯„åœï¼š</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明超éŽé™åˆ¶ç¯„åœæ™‚應採å–的行動。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">七ã€å®¹å™¨ã€å°è“‹èˆ‡åŒ…è£çš„密å°å®Œæ•´æ€§</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">摘è¦èªªæ˜Žå®¹å™¨å°è“‹çµ„åˆå°é˜²æ¢å¾®ç”Ÿç‰©æ±¡æŸ“的密å°æ€§è©¦é©—方法與çµæžœã€‚說明內容åˆå§‹</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">的確效試驗åŠå®‰å®šæ€§å¯¦é©—計畫的試驗éŽç¨‹ï¼Œåƒ…æ供產å“çš„ç„¡èŒè©¦é©—åšç‚ºåˆå§‹çš„確效</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">是ä¸è¶³çš„。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">è¦å®šå¯†å°å®Œæ•´æ€§è©¦é©—方法的éˆæ•åº¦ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">å…«ã€ç´°èŒå…§æ¯’ç´ è©¦é©—æ–¹æ³•</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">說明æˆå“å…§æ¯’ç´ è©¦é©—æ–¹æ³•ï¼Œå…§å®¹åŒ…æ‹¬æˆå“å°å…§æ¯’ç´ çš„æŠ‘åˆ¶æˆ–å¢žå¼·çš„è©¦é©—åŠçµæžœï¼Œæ¸¬</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">定無抑制時濃度åŠæœ€å¤§çš„有效稀釋å€æ•¸ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">ä¹ã€ç„¡èŒè©¦é©—åŠæ”¾è¡Œè¦æ ¼</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">說明無èŒè©¦é©—的方法包括å–樣的辦法。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">如果試驗方法與藥典方法有明顯差異時，應è‰æ˜Žå…¶ç›¸ç‰æ€§ã€‚</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">說明在隔離系統內如何æ“作無èŒè©¦é©—å¿…è¦æ™‚å¾—æ供隔離系統的確效資料。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">第</span> <span style="font-family: 標楷體; font-size: 10pt;">五</span> <span style="font-family: 標楷體; font-size: 10pt;">ç« </span><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">微生物管制與å“質的ç¶è·</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">一ã€å®¹å™¨èˆ‡å°è“‹çµ„åˆçš„密å°æ€§</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">測試在æˆå“的有效期間或ä¿å˜æœŸé™å…§ã€å®¹å™¨èˆ‡å°è“‹çš„組åˆå…·æœ‰é˜²æ¢å¾®ç”Ÿç‰©æ±¡æŸ“ä¿æŒ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">ç„¡èŒå“質的能力。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">è«‹åƒè€ƒæœ¬æ‰‹å†Šç¬¬äºŒç« 五ã€åŠç¬¬å››ç« 七ã€ï¼Œå¦‚åŒå‰é¢æ‰€è¿°åˆå§‹éšŽæ®µçš„ç„¡èŒè©¦é©—ä¸è¶³ä»¥</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">è‰æ˜Žå®¹å™¨å°è“‹çµ„åˆå¯†å°æ€§ï¼ŒåŒæ™‚也需è¦æ供容器與å°è“‹çµ„åˆçš„密å°æ€§æ¸¬è©¦æ–¹æ³•çš„éˆ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">æ•åº¦ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">二ã€é˜²è…劑的效果</span> </p><p><span style="font-size: 10pt;"> 1.</span><span style="font-family: 標楷體; font-size: 10pt;">測試防è…劑的效果，å¯åˆ©ç”¨æˆå“放行時è¦å®šçš„最低濃度或ä¿å˜æœŸé™æ‰€è¦å®šçš„最低濃</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">度，二者å–其較低者來測試。</span> </p><p><span style="font-size: 10pt;"> 2.</span><span style="font-family: 標楷體; font-size: 10pt;">由於防è…劑的效果是以微生物被抑制的çµæžœä¾†åˆ¤å®šæ‰€ä»¥å¿…需以微生物的挑戰試驗來</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">測定。</span> </p><p><span style="font-size: 10pt;"> 3.</span><span style="font-family: 標楷體; font-size: 10pt;">在安定性實驗計畫書內需è¦å®šï¼Œæœ€åˆç”Ÿç”¢çš„三批æˆå“必需在執行安定性試驗最åˆåŠ</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">最終階段用微生物的挑戰試驗來測定防è…劑效果。</span> </p><p><span style="font-size: 10pt;"> 4.</span><span style="font-family: 標楷體; font-size: 10pt;">å¯ç”¨åŒ–å¸æª¢é©—方法測定安定性試驗期間內防è…劑的濃度。</span> </p><p><span style="font-size: 10pt;"> 5.</span><span style="font-family: 標楷體; font-size: 10pt;">ä¾æ“šæˆå“安定性實驗計畫書執行後續批次æˆå“之安定性試驗時，該試驗ä¸å¯ç”¨åŒ–å¸</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">方法來檢測防è…劑的濃度。</span> </p><p><span style="font-family: 標楷體; font-size: 10pt;">三ã€ç†±åŽŸæˆ–ç´°èŒå…§æ¯’ç´ è©¦é©—</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">無熱原的æˆå“在安定性試驗計畫書ä¸éœ€å¯¦æ–½å®‰å®šæ€§è©¦é©—的起始åŠæœ€çµ‚階段之熱原或</span> </p><p><span style="font-size: 10pt;"> </span><span style="font-family: 標楷體; font-size: 10pt;">å…§æ¯’ç´ è©¦é©—ã€‚</span> </p>2013-12-05
臨床試驗類,è—¥å“臨床試驗基準,銜接性試驗基準行政解釋銜接性試驗基準ï¼æŽ¥å—國外臨床資料之æ—ç¾¤å› ç´ è€ƒé‡è©³å¦‚附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4552&type=0
罕見疾病類,罕見疾病藥物,衛生ç¦åˆ©éƒ¨å—ç†ç½•è¦‹ç–¾ç—…藥物查驗登記審查費收費標準行政解釋衛生ç¦åˆ©éƒ¨å—ç†ç½•ç—…藥物查驗登記審查費收費標準<p><span style="font-family: calibri;"> </span></p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p><span style="font-family: 新細明體,serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">定義與範åœ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">收費基準</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">備註</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">新罕見疾病藥å“</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">罕見疾病防治åŠè—¥ç‰©æ³•è¦å®šä¹‹æ–°è—¥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">一○ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內新è¨å·¥å» ã€æ–°åŠ‘åž‹è¨ç«‹æŸ¥æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">å››ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">å››ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物製劑ã€é¡žæ¯’ç´ åŠèŒæ¶²ç‰åŸºå› 工程製劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">血液製劑ã€æŠ—æ¯’ç´ ã€ç–«è‹—ã€åˆ©ç”¨åŸºå› å·¥ç¨‹è£½é€ ä¹‹è—¥å“</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">一○ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內新è¨å·¥å» ã€æ–°åŠ‘åž‹è¨ç«‹æŸ¥æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">å››ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">å››ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">臨床試驗</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">è¨ˆç•«æ›¸å¯©æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">三ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 19.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 19.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">原料藥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">ä¾›è—¥å» è£½é€ ç½•è¦‹ç–¾ç—…è—¥å“之原料</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å…ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">自用原料輸入</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">åœ‹å…§è—¥å» è¼¸å…¥è‡ªç”¨ä¹‹å ±å‚™</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 22.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 22.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">罕見疾病用之新醫療器æ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«æ–°é†«ç™‚效能</span><span style="font-family: calibri;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">é ˆæª¢é™„è‡¨åºŠã€å®‰å…¨æ€§è©¦é©—å ±å‘Šç‰ä¹‹æ–°é†«ç™‚器æ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å…ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內醫療器æå» </span><span style="font-family: calibri;"> GMP</span><span style="font-family: 新細明體,serif;">æŸ¥æ ¸</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å››ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國外醫療器æå·¥å» å‚™æŸ¥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å››ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 13.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 13.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“變更</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">æ–°é©æ‡‰ç—‡ã€æ–°ç”¨æ³•ç”¨é‡ã€æ–°é¡žåˆ¥ã€æ–°è³¦å½¢åŠ‘</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">二ã€å››â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å§”è¨—è£½é€ ã€ç§»è½‰ã€åˆä½µã€ç”¢åœ°è®Šæ›´ã€é·å» </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä»¥å» æ¬¡è¨ˆ</span><span style="font-family: calibri;">)</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一ã€å…â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">其他變更或許å¯è‰ã€æ¨™ä»¿å–®éºå¤±è£œç™¼</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">醫療器æ變更</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å¢žåŠ æ–°é©ç”¨ç¯„åœ</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">二ã€å››â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å§”è¨—è£½é€ ã€ç§»è½‰ã€åˆä½µã€ç”¢åœ°è®Šæ›´ã€é·å» </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä»¥å» æ¬¡è¨ˆ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€å¢žåŠ è¦æ ¼</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一ã€å…â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">其他變更或許å¯è‰ã€æ¨™ä»¿å–®éºå¤±è£œç™¼</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一ã€â—‹â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">ä¹</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">展延</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">åŽŸæ ¸å‡†è¨±å¯è‰ã€å‚™æŸ¥å‡½æœ‰æ•ˆæœŸé–“展延</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">å…â—‹â—‹</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">產地è‰æ˜Žã€</span><span style="font-family: calibri;">GMP </span><span style="font-family: 新細明體,serif;">æŸ¥å» ã€é†«ç™‚器æ英文è‰æ˜Ž</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">åŽŸæ ¸å‡†è¨±å¯è‰ã€å‚™æŸ¥å‡½æœ‰æ•ˆæœŸé–“展延</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">é ˜è‰è²»ç”¨</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">æ–°å¢žé …ç›®</span> </p> </td> </tr> <tr> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 140px;border-color: #f0f0f0;"></td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05
臨床試驗類,è—¥å“臨床試驗基準,癌症治療藥å“臨床試驗基準行政解釋癌症治療藥å“臨床試驗基準詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4553&type=0
臨床試驗類,è—¥å“è‡¨åºŠè©¦é©—å ±å‘Šä¹‹æ ¼å¼åŠå…§å®¹åŸºæº–è¡Œæ”¿è§£é‡‹è‡¨åºŠè©¦é©—å ±å‘Šä¹‹æ ¼å¼åŠå…§å®¹åŸºæº–詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4554&type=0
化å¸è£½é€ 管制類,斷層掃æ用æ£å放射åŒä½ç´ 調製作æ¥è¦é»žè¡Œæ”¿è§£é‡‹æ–·å±¤æŽƒæ用æ£å放射åŒä½ç´ 調製作æ¥è¦é»ž<p style="text-align: center;"><b><span style="font-family: 新細明體,serif; font-size: 14pt;">斷層掃æ用æ£å放射åŒä½ç´ 調製作æ¥è¦é»ž</span></b><b> </b></p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">壹</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">斷層掃æ用æ£å放射åŒä½ç´ ，係指åŠè¡°æœŸå¾ˆçŸä¹‹æ£åæ ¸ç¨®ï¼Œä¾‹å¦‚æ°Ÿ</span><span style="font-size: 11pt;"> -</span></p><p><span style="font-size: 11pt;"> 18 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠè¡°æœŸç‚º</span><span style="font-size: 11pt;"> 109.7 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜ã€ç¢³</span><span style="font-size: 11pt;"> -11 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠè¡°æœŸç‚º</span><span style="font-size: 11pt;"> 20.4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜ã€æ°®</span><span style="font-size: 11pt;"> -13</span></p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠè¡°æœŸç‚º</span><span style="font-size: 11pt;"> 9.96 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜ã€æ°§</span><span style="font-size: 11pt;"> -15 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠè¡°æœŸç‚º</span><span style="font-size: 11pt;"> 2.03 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜ï¼Œä»¥åˆæˆæ–¹æ³•èª¿</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">製æˆæ£å放射åŒä½ç´ ï¼Œä¾›æ ¸å醫å¸å°ˆç§‘醫師執行病人之æ£å斷層掃æ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">使用。</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è²³</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ ¸å醫å¸å°ˆç§‘醫師為特定病人æ£å斷層掃æ之需è¦ï¼Œå¾—開立處方</span><span style="font-size: 11pt;"> (p-</span></p><p><span style="font-size: 11pt;"> rescription) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">交由藥局調製。藥局調製斷層掃æ用æ£å放射åŒä½ç´ </span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，應由å—éŽç„¡èŒæ“作訓練，åŠç¶“行政院原å能委員會指定之游離輻射</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">防è·è¨“ç·´ä¸¦é ˜æœ‰è¼»å°„å®‰å…¨è‰æ›¸æˆ–執照之藥師，於符åˆåŽŸå能委員會所</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è¦å®šä¹‹å ´æ‰€é€²è¡Œã€‚藥局得於å„該斷層掃æ用æ£å放射åŒä½ç´ 之有效期</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é™å…§ï¼Œé 先少é‡èª¿è£½ã€‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åƒ</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">藥局調製之斷層掃æ用æ£å放射åŒä½ç´ ，除供應該醫院之病人使用外</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，並得供應其他醫院使用。</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">肆</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製斷層掃æ用æ£å放射åŒä½ç´ ，應符åˆä¸‹åˆ—有關強度ã€å“質åŠç´”度</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">之作æ¥ç¨‹åºï¼š</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">原物料</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">æˆåˆ†ã€ææ–™ã€å®¹å™¨ã€å°è“‹ã€è¼”助å“</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的管制：</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">下列管制æˆåˆ†ã€ææ–™åŠè¼”助å“çš„é …ç›®éœ€å»ºç«‹åŠåŸ·è¡Œï¼Œä¸¦ä¸”éœ€æœ‰å°ˆäººè² </span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">責監ç£ï¼š</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">書é¢è¦æ ¼çš„建立</span> </p><p><span style="font-size: 11pt;"> 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ¯ä¸€æˆåˆ†</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">包括原料ã€è©¦è—¥ã€é¶æ¶²ã€æ°£é«”</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的鑑別ã€ç´”度åŠå“質</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。</span> </p><p><span style="font-size: 11pt;"> 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">會接觸到æ£å放射åŒä½ç´ 的容器ã€å°è“‹åŠå…¶å®ƒè¨å‚™è¡¨å±¤ä¹‹æ質</span><span style="font-size: 11pt;"> (</span></p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">包括輸é€ç®¡ç·šã€ç´”化è£ç½®ã€éŽæ¿¾è†œ</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的鑑別åŠå“質。</span> </p><p><span style="font-size: 11pt;"> 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分æžç”¨çš„輔助å“</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如溶劑ã€å±¤æžç®¡æŸ±åŠå°ç…§æ¨™æº–å“</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€ç„¡èŒè©¦é©—</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用培養基ã€å…§æ¯’ç´ è©¦è—¥åŠå…¶å®ƒç”¨æ–¼æ£å放射åŒä½ç´ å“管æ¥é©Ÿè¼”助</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å“的鑑別ã€ç´”度åŠå“質。</span> </p><p><span style="font-size: 11pt;"> 4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用於調製æ£å放射åŒä½ç´ çš„æˆåˆ†ã€å®¹å™¨ã€å°è“‹ã€ææ–™ã€è¼”助å“çš„</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é©ç•¶å„²å˜æ¢ä»¶</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如å°ç†±ã€å…‰ã€æ¿•åº¦ä¹‹è€ƒæ…®</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">相關資料之登錄</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">記錄æ¯æ‰¹ç”¨æ–¼æ£å放射åŒä½ç´ 調製之æˆåˆ†ã€å®¹å™¨ã€å°è“‹ã€ææ–™ã€è¼”</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">助å“的進貨ã€æŽ¥æ”¶æ—¥æœŸã€æ•¸é‡ã€è£½é€ 商ã€æ‰¹è™Ÿã€æœ‰æ•ˆæœŸé™ç‰ã€‚如製</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é€ å•†ç„¡æ¨™ç¤ºæœ‰æ•ˆæœŸé™ï¼Œæ‡‰åŸºæ–¼å…¶ç‰©ç†åŠåŒ–å¸ç‰¹æ€§åŠä½¿ç”¨ç¶“驗來訂出</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æˆåˆ†ã€ææ–™ã€è¼”助å“的有效期é™ã€‚å°æ–¼æœ‰å¯èƒ½è£‚解或組æˆæ”¹è®Šçš„有</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ©Ÿå—質ã€å應物ã€è©¦åŠ‘æ料，應ä¾æ“šè©²æˆåˆ†å®‰å®šæ€§çš„試驗çµæžœä¾†è¨‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">定有效期é™ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">原物料之檢驗</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">檢驗æ¯æ‰¹æ¬¡ä½¿ç”¨æ–¼æ£å放射åŒä½ç´ 調製的æˆåˆ†ã€å®¹å™¨åŠå°è“‹ã€ææ–™</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€è¼”助å“是å¦ç¬¦åˆæ‰€è¨‚定的書é¢è¦æ ¼ã€‚上述檢驗，除鑑別試驗外，</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">得視供應商所æä¾›æª¢é©—å ±å‘Šä¹‹å¯é 性評估後，酌予減å…。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å››</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">原物料之儲å˜</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">使用於æ£å放射åŒä½ç´ 調製æˆåˆ†ã€å®¹å™¨åŠå°è“‹ã€ææ–™åŠè¼”助å“應ä¾</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">據訂定的儲å˜æ¢ä»¶å˜æ”¾æ–¼ç®¡åˆ¶å€ã€‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製æ¥é©Ÿçš„確èª</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">需建立下列確èªèª¿è£½ç®¡åˆ¶ä½œæ¥é …目，且需由å—éŽç„¡èŒæ“作訓練，åŠç¶“</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">行政院原å能委員會指定之游離輻射防è·è¨“ç·´ä¸¦é ˜æœ‰è¼»å°„å®‰å…¨è‰æ›¸æˆ–</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŸ·ç…§ä¹‹è—¥å¸«ä¾†è² è²¬åŸ·è¡Œã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ£å放射åŒä½ç´ 之鑑別ã€ç´”度ã€å“質應建立書é¢è¦æ ¼ã€‚如ä¸è¯è—¥å…¸</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">有收錄者以ä¸è¯è—¥å…¸ç‚ºæº–。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å°æ–¼åŠ 入使用於æ£å放射åŒä½ç´ çš„é‡åŠ‘之無èŒéŽæ¿¾è†œ</span><span style="font-size: 11pt;"> (0.22</span><span style="font-family: 新細明體,serif; font-size: 11pt;">μ</span><span style="font-size: 11pt;">m)</span></p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠåŠ 入使用於æ£å放射åŒä½ç´ çš„å¸å…¥åŠ‘劑型之粒åéŽæ¿¾è†œ</span><span style="font-size: 11pt;"> (0.45</span><span style="font-family: 新細明體,serif; font-size: 11pt;">μ</span> </p><p><span style="font-size: 11pt;"> m)</span><span style="font-family: 新細明體,serif; font-size: 11pt;">，必需有書é¢åŠç¢ºæ•ˆæ¥é©Ÿï¼Œèª¿è£½æ¥é©Ÿå¿…需經常更新åŠç¢ºèªï¼Œæˆ–至</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å°‘æ¯å¹´æª¢è¦–或確èªä»¥ç¢ºä¿å…¶ç‚ºç¾è¡Œä½¿ç”¨çš„調製æ¥é©Ÿã€‚æ£å放射åŒä½</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç´ çš„æ›¸é¢èª¿è£½æ¥é©Ÿç¸½æª”案需å˜æ–¼æ£å放射åŒä½ç´ 調製ä¸å¿ƒå…§ã€‚為了</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供作åƒè€ƒï¼ŒéŽæœŸçš„書é¢èª¿è£½æ¥é©Ÿæª”案也需與ç¾è¡Œèª¿è£½ç‰ˆæœ¬ä¹‹ç¸½æª”案</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分開å˜æ–¼æ£å放射åŒä½ç´ 調製ä¸å¿ƒå…§ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åªæœ‰è¢«æŽˆæ¬Šçš„人å¯ä»¥æ›´æ”¹é›»è…¦åŠç›¸é—œè‡ªå‹•åŒ–è£ç½®ä¹‹èª¿è£½è»Ÿé«”。任何</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä¸Šè¿°çš„æ”¹è®Šå¿…é ˆè¨˜éŒ„å˜æª”åŠåŠ 以確èªï¼Œåªæœ‰ç¾è¡Œç‰ˆæœ¬è»Ÿé«”å¯ä½¿ç”¨æ–¼</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ£å放射åŒä½ç´ 調製æ¥é©Ÿã€‚使用於æ£å放射åŒä½ç´ 調製之軟體碟片</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠæ›¸é¢è³‡æ–™éœ€å˜æ–¼æ£å放射åŒä½ç´ 調製ä¸å¿ƒçš„總檔案內。為了供作</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åƒè€ƒï¼ŒéŽæœŸé›»è…¦è»Ÿé«”也需與總檔案分開儲å˜ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å››</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é©—è‰æ‰€åˆ¶å®šä¹‹èª¿è£½æ¥é©Ÿã€é›»è…¦è»Ÿé«”程å¼ã€è¨å‚™åŠè¨æ–½ç‰èƒ½èª¿è£½å‡ºç¬¦</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åˆè¦æ ¼çš„æ£å放射åŒä½ç´ 。如果ä¸è¯è—¥å…¸æœ‰æ”¶éŒ„者，則所調製之æ£</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å放射åŒä½ç´ 的純度åŠå“è³ªï¼Œå¿…é ˆç¬¦åˆä¸è¯è—¥å…¸ä¹‹åŸºæº–è¦ç¯„。如果</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">所調製的æ£å放射åŒä½ç´ 未列於ä¸è¯è—¥å…¸ï¼Œå‰‡æ¤é©—è‰é ˆåŒ…括：</span> </p><p><span style="font-size: 11pt;"> 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">書é¢è©•ä¼°æ”¾å°„化å¸çš„鑑別åŠç´”度ã€æ”¾å°„æ ¸ç¨®çš„é‘‘åˆ¥åŠç´”度ã€ç‰¹ç•°</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">活性ã€ç„¡èŒæ€§</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">é‡åŠ‘製劑</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€ç´°èŒå…§æ¯’ç´ å«é‡</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">é‡åŠ‘製劑</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€é…¸</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">鹼度ã€å¤–觀ã€ç«‹é«”化å¸ç´”度</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">用於é©ç”¨çš„化åˆç‰©</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€å¯èƒ½å˜åœ¨çš„</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">有機æ®ç™¼æ€§ä¸ç´”物ã€åœ¨åˆæˆæˆ–是純化éŽç¨‹ä¸æœƒä½¿ç”¨åˆ°ä¹‹å…¶ä»–有毒</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">化å¸ç‰©è³ªã€å®‰å®šåŠ‘或ä¿è—劑的有效濃度</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å¦‚æžœæœ‰åŠ å…¥å®‰å®šåŠ‘æˆ–ä¿</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è—劑</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€æ£å放射åŒä½ç´ 的化å¸ç´”度</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">包括分æžèµ·å§‹ç‰©è³ªã€å·²çŸ¥</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä¸é–“產物ã€å‰¯ç”¢ç‰©åŠå·²çŸ¥åˆ†è§£ç”¢ç‰©</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠé–‹å§‹èˆ‡æœ€çµ‚亞次批</span><span style="font-size: 11pt;"> (sub-</span></p><p><span style="font-size: 11pt;"> batch)</span><span style="font-family: 新細明體,serif; font-size: 11pt;">下產物的å‡è³ªæ€§</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">指æ£å放射åŒä½ç´ ä¹‹æ”¾å°„æ€§æ ¸ç¨®åŠè¡°æœŸ</span> </p><p><span style="font-size: 11pt;"> < 25 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。「亞批ã€</span><span style="font-size: 11pt;">(sub-batch) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">的定義為æ£å放射åŒä½ç´ </span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在特定的範åœå…§å…·æœ‰ä¸€è‡´çš„特性åŠå“質，使用在連續的多次照射</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä¸æ‰€ç”¢ç”Ÿçš„æ”¾å°„æ ¸ç¨®ï¼Œä¸¦ç¶“ç”±ä¸€å®šçš„åˆæˆåŠï¼æˆ–純化作æ¥æ‰€èª¿è£½</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">而æˆã€‚</span> </p><p><span style="font-size: 11pt;"> 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç”±æ“ä½œè€…ç°½ç« åŠè¨»è¨˜æ—¥æœŸï¼Œä¿ç•™ç´€éŒ„，以è‰æ˜Žå…¶èª¿è£½æ£å放射åŒ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä½ç´ æ¥é©Ÿã€è¨å‚™åŠè¨æ–½ç¬¦åˆæ—¢å®šä¹‹æ¨™æº–。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">任何調製éŽç¨‹ã€é›»è…¦è»Ÿé«”程å¼ã€æˆåˆ†è¦æ ¼ä¸Šçš„改變，而å¯èƒ½æœƒå½±éŸ¿</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">到產å“的鑑別ã€å“質或純度時，則驗è‰ç¨‹åºå¿…é ˆäºˆä»¥åŸ·è¡Œã€‚ä¾›äººä½¿</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用的æ£å放射åŒä½ç´ ，在其新的或更新éŽçš„調製程åºç²å¾—許å¯ä¹‹å‰</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，應å°é€£çºŒä¸‰æ‰¹ç”¢å“進行驗è‰ç¨‹åºï¼Œä¸¦ç¢ºä¿æ¤ç”¢å“符åˆè¦æ ¼ã€‚åªè¦</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">例行性的驗è‰çµæžœå‡èƒ½ç¬¦åˆè¦å®šï¼Œå‰‡å¯æ”¹ç‚ºæ¯å¹´è‡³å°‘執行一次。</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">安定性試驗åŠæœ‰æ•ˆæœŸé™</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ£å放射åŒä½ç´ 之有效期é™åŠå„²å˜æ¢ä»¶çš„書é¢è¨‚å®šï¼Œæ‡‰æ ¹æ“šå®‰å®šæ€§</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">試驗åŠç‰¹ç•°æ´»æ€§çš„çµæžœç‚ºåŸºç¤Žã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">進行安定性試驗的檢體應å–自è¦å®šçš„密閉容器。æ£å放射åŒä½ç´ å¿…</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é ˆåœ¨æœ«æ•ˆæœŸä»ç¬¦åˆæ‰€æœ‰è¦æ ¼ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">如果調製æ¥é©ŸéŽç¨‹ã€é›»è…¦è»Ÿé«”程å¼ã€æˆåˆ†è¦æ ¼çš„改變å¯èƒ½æœƒå½±éŸ¿åˆ°</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">產å“çš„å®‰å®šæ€§ï¼Œå‰‡å…¶å®‰å®šæ€§è©¦é©—å¿…é ˆå†è©•ä¼°ã€‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å››</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製供人使用的æ£å放射åŒä½ç´ </span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">所有的調製行為應確實地由åˆæ ¼åŠå—éŽè¨“練的人員來執行åŠå®Œæˆã€‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ ¹æ“šå·²å»ºç«‹çš„æ›¸é¢ç¨‹åºåŠæ–‡ä»¶å®Œæˆä¸‹åˆ—è¦æ±‚：</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在開始調製å‰ï¼Œæ‡‰å°‡ä¸å¿…è¦çš„ææ–™åŠæ¨™ç±¤è‡ªè©²å ´æ‰€è¨å‚™ä¸ç§»é™¤ï¼Œä¸¦</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æª¢è¦–å ´æ‰€åŠæ‰€æœ‰è¨å‚™çš„清淨度åŠé©ç”¨æ€§ã€‚å°æ–¼æ³¨å°„用的æ£å放射åŒ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä½ç´ ，所有使用於無èŒè–„膜éŽæ¿¾çš„æˆåˆ†ã€å®¹å™¨ã€å°è“‹åŠå…¶å®ƒæ料的</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ“作éŽç¨‹ï¼Œå‡å¿…é ˆåœ¨é©ç•¶æŽ§åˆ¶çš„環境下採用無èŒæ“作技術進行之。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">確èªå„æˆåˆ†ã€å®¹å™¨ã€å°è“‹åŠç”¨æ–¼èª¿è£½æ£å放射åŒä½ç´ 的其它物料的</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">特性ã€æ•¸é‡åŠé©ç”¨æ€§ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調劑æ¥é©Ÿä¸ä½¿ç”¨çš„所有æˆåˆ†æ‡‰äºˆä»¥æ¨™ç¤ºï¼Œä»¥ä¾¿ç¢ºèªåŠè¿½æº¯ä¹‹ç”¨ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å››</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在開始調製æ¥é©Ÿå‰ï¼Œæ¨™ç¤ºæœ€çµ‚æ£å放射åŒä½ç´ 的容器或用於調劑給</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">藥的è£ç½®ã€‚é™„åœ¨æœ€çµ‚å®¹å™¨ä¸Šçš„æ¨™ç±¤æˆ–è²¼ç´™å¿…é ˆå…·å‚™ä¸‹åˆ—è³‡æ–™ï¼šæ£å</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">放射åŒä½ç´ çš„å稱åŠæ·»åŠ 物</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：安定劑åŠä¿è—劑的å稱</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€æ‰¹è™Ÿ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ã€æ”¾å°„æ´»æ€§æ ¡æ£æ—¥æœŸåŠæ™‚é–“ã€æ ¡æ£æ™‚æ¯</span><span style="font-size: 11pt;">mL</span><span style="font-family: 新細明體,serif; font-size: 11pt;">的放射活性é‡ã€æ”¾å°„性物</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">質標誌åŠè¦èªžï¼Œä¸¦æ¨™ç¤ºã€Œæº¶æ¶²å¦‚有混æ¿æˆ–å«é¡†ç²’物時，請勿使用ã€</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。最終的æ£å放射åŒä½ç´ 應åŒæ™‚標示包括總放射活性ã€åœ¨æŒ‡å®šçš„æ ¡</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ£æ™‚間之放射活性濃度åŠæœ‰æ•ˆæ™‚間與日期。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ ¹æ“šç¾è¡Œç¶“éŽé©—è‰çš„æ¥é©Ÿä¾†èª¿è£½æ£å放射åŒä½ç´ ï¼Œå¿…é ˆä¿ç•™æ¯ä¸€æ‰¹</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製æ£å放射åŒä½ç´ 的書é¢ç´€éŒ„</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：在一次åˆæˆåŠç´”化éŽç¨‹ä¸æ‰€</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製出的產å“</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。æ¤æ›¸é¢ç´€éŒ„包括：</span> </p><p><span style="font-size: 11pt;"> 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">批號ã€è£½é€ å» å稱ã€æœ‰æ•ˆæ—¥æœŸï¼Œæ‰€æœ‰æˆåˆ†ã€å®¹å™¨ã€å°è“‹ä»¥åŠç”¨æ–¼</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製æ¥é©Ÿä¸ä½¿ç”¨æ料的數é‡ã€‚</span> </p><p><span style="font-size: 11pt;"> 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ¯ä¸€å€‹èª¿è£½æ¥é©Ÿèªªæ˜Žã€‚</span> </p><p><span style="font-size: 11pt;"> 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è² è²¬äººç°½ç« ï¼Œè‰æ˜Žæ¤æ‰¹ç”¢å“的調製æ¥é©Ÿæ£ç¢ºä¸”經éŽç¢ºèªã€‚</span> </p><p><span style="font-size: 11pt;"> 4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è² è²¬äººå¿…é ˆç¶“ç”±ç›®è¦–</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">應考慮視力åŠè¼»å°„暴露的é™åˆ¶</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，或經由</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é›»è…¦æˆ–å…¶å®ƒå›žé¥‹æ©Ÿè½‰åŠ ä»¥ç›£æŽ§ï¼Œè‰æ˜Žåœ¨èª¿è£½éŽç¨‹ä¸é—œéµæ¥é©Ÿå‡å·²</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">完æˆã€‚</span> </p><p><span style="font-size: 11pt;"> 5 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å°èª¿è£½éŽç¨‹ä¸éžè¨ˆç•«æ€§çš„å差，或éžé 期性çµæžœï¼Œæ‡‰åŒ…括調查çµ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">果書é¢è¨˜éŒ„。</span> </p><p><span style="font-size: 11pt;"> 6 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">放射åŒä½ç´ 的產率是利用åŒä½ç´ æ”¾å°„æ€§æ ¸ç¨®ä¹‹åŽŸå§‹æ ¸ç¨®ç¶“éŽè¡°è®Š</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä¿®æ£å¾Œçš„放射活度來計算。</span> </p><p><span style="font-size: 11pt;"> 7 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ¯ä¸€æ‰¹æ£å放射åŒä½ç´ 之原始分æžè³‡æ–™ã€‚</span> </p><p><span style="font-size: 11pt;"> 8 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製程åºå®Œæˆå¾Œï¼Œæ‡‰ç”±è² 責æ“ä½œè€…ç°½ç« åŠè¨»è¨˜æ—¥æœŸã€‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å“質管制</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">指定經éŽè¨“ç·´ã€åˆæ ¼çš„äººå“¡è² è²¬ç¢ºä¿å“質管制éŽç¨‹æ˜¯ç”±å—éŽè¨“ç·´çš„åˆ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ ¼äººå“¡ä¾†åŸ·è¡ŒåŠç¢ºå¯¦å®Œæˆã€‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ ¹æ“šæ—¢å®šä¹‹æ›¸é¢ç¨‹åºå®Œæˆä¸‹åˆ—äº‹é …ä¸¦åŠ ä»¥è¨˜éŒ„ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">以書é¢æ–¹å¼å»ºç«‹æ¯ä¸€æ‰¹æ£å放射åŒä½ç´ çš„å“質管制試驗ã€åˆ†æžæ¥é©Ÿ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠè¦æ ¼ã€‚如ä¸è¯è—¥å…¸æœ‰æ”¶éŒ„者以ä¸è¯è—¥å…¸ç‚ºæº–。</span> </p><p><span style="font-size: 11pt;"> 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å…·åŠè¡°æœŸâ‰§</span><span style="font-size: 11pt;">25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜æ ¸ç¨®çš„æ£å放射åŒä½ç´ ，æ¯ä¸€æ‰¹åŒä½ç´ </span><span style="font-size: 11pt;"> (</span></p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">一次的åˆæˆåŠç´”化æ“作所產生的物質</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在放行å‰ï¼Œå¿…é ˆå®Œæˆä¸‹åˆ—</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å“質管制檢驗：å£æœåŠæ³¨å°„劑型之åŒä½ç´ ï¼Œé ˆä½œé…¸é¹¼å€¼é‡æ¸¬åŠç›®</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">視檢查；所有劑型å‡é ˆä½œæ”¾å°„化å¸é‘‘別與純度測定åŠæ”¾å°„æ ¸ç¨®é‘‘</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">別定åŠç´”度測定；基於與åŒä½ç´ 有關的分佈或毒性å應的考é‡ï¼Œ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">應評估æ£å放射åŒä½ç´ 的特異活性；åŠåœ¨åˆæˆæˆ–純化éŽç¨‹ä¸æ‰€ä½¿</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用或產生之其他毒性物質與殘餘溶劑與安定劑或ä¿è—劑，應è‰æ˜Ž</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">符åˆæ‰€å®šä¹‹åŸºæº–內；測定æ£å放射åŒä½ç´ 的放射活性。</span> </p><p><span style="font-size: 11pt;"> 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ ¸ç¨®å…·åŠè¡°æœŸ</span><span style="font-size: 11pt;"> < 25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜ä¹‹æ£å放射åŒä½ç´ ，其「一批ã€å®šç¾©</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">為一天ä¸æ‰€èª¿è£½ä¹‹æ£å放射åŒä½ç´ 之所有相關亞批，在當天第一</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">亞批æ£å放射åŒä½ç´ 之å“è³ªç®¡åˆ¶å¿…é ˆå®Œæˆä¸‹åˆ—檢驗：å£æœåŠæ³¨å°„</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">劑之åŒä½ç´ ï¼Œé ˆä½œé…¸é¹¼å€¼é‡æ¸¬åŠç›®è¦–檢查；所有劑型å‡é ˆä½œæ”¾å°„</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">化å¸é‘‘別與純度測定åŠæ”¾å°„æ ¸ç¨®é‘‘åˆ¥èˆ‡ç´”åº¦æ¸¬å®šï¼›åŸºæ–¼èˆ‡åŒä½ç´ </span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">有關之分佈或毒性考é‡ï¼Œæ£å放射åŒä½ç´ 特異活性應作評估；åŠ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在åˆæˆæˆ–純化éŽç¨‹ä¸æ‰€ä½¿ç”¨æˆ–產生之其它毒性物質與殘餘溶劑，</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">與安定劑或ä¿è—劑應è‰æ˜Žç¬¦åˆæ‰€è¨‚定之基準內；測定æ£å放射åŒ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä½ç´ 的放射活性。</span> </p><p><span style="font-size: 11pt;"> 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ¯æ‰¹ä¾›æ³¨å°„用的æ£å放射åŒä½ç´ </span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">除了氧</span><span style="font-size: 11pt;"> -15 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">水之外</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ï¼Œé ˆåœ¨</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŒä½ç´ éŽæ¿¾å®Œæˆå¾Œï¼Œå®ŒæˆéŽæ¿¾è†œå®Œæ•´æ€§è©¦é©—，方å¯æ”¾è¡Œä¾›äººé«”使</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用。供注射用的氧</span><span style="font-size: 11pt;"> -15 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">水，å¯åœ¨éŽæ¿¾è†œå®Œæ•´æ€§è©¦é©—完æˆå‰å…ˆæ”¾</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è¡Œï¼Œä½†å¿…é ˆåœ¨æ”¾è¡Œå¾Œå„˜å¿«å®Œæˆä¸Šè¿°è©¦é©—。</span> </p><p><span style="font-size: 11pt;"> 4 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之æ£å放射åŒä½ç´ ï¼Œæ ¸ç¨®åŠè¡°æœŸâ‰§</span><span style="font-size: 11pt;">25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜è€…，在放</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">行供人體使用å‰é ˆå®Œæˆ</span><span style="font-size: 11pt;"> 20 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜å…§æ¯’ç´ </span><span style="font-size: 11pt;"> "</span><span style="font-family: 新細明體,serif; font-size: 11pt;">é™é‡è©¦é©—</span><span style="font-size: 11pt;">" (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠ å…¥é™½æ€§</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">標準å“，其濃度由</span><span style="font-size: 11pt;"> 5 EU/mL </span><span style="font-family: 新細明體,serif; font-size: 11pt;">至</span><span style="font-size: 11pt;"> 175 EU/V</span><span style="font-family: 新細明體,serif; font-size: 11pt;">，</span><span style="font-size: 11pt;">V </span><span style="font-family: 新細明體,serif; font-size: 11pt;">是在有效期é™æ™‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">產å“之最大體ç©ï¼Œä»¥</span><span style="font-size: 11pt;"> mL </span><span style="font-family: 新細明體,serif; font-size: 11pt;">表示</span><span style="font-size: 11pt;">)</span><span style="font-family: 新細明體,serif; font-size: 11pt;">ï¼›æ ¸ç¨®åŠè¡°æœŸ</span><span style="font-size: 11pt;">< 25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜è€…，應</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">於當天第一亞批å“質管制檢驗時完æˆ</span><span style="font-size: 11pt;"> 20 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜å…§æ¯’ç´ </span><span style="font-size: 11pt;"> "</span><span style="font-family: 新細明體,serif; font-size: 11pt;">é™é‡è©¦é©—</span> </p><p><span style="font-size: 11pt;"> " </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，方å¯æ”¾è¡Œä¾›äººé«”使用。</span> </p><p><span style="font-size: 11pt;"> 5 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之æ£å放射åŒä½ç´ ï¼Œæ ¸ç¨®åŠè¡°æœŸâ‰§</span><span style="font-size: 11pt;">25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜è€…ï¼Œé ˆé€</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">批執行標準</span><span style="font-size: 11pt;"> 60 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜ä¹‹ç´°èŒå…§æ¯’ç´ è©¦é©—ï¼›æ ¸ç¨®åŠè¡°æœŸ</span><span style="font-size: 11pt;">< 25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é˜è€…，應於當天第一亞批å“質管制檢驗時執行標準</span><span style="font-size: 11pt;"> 60 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜ä¹‹ç´°</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">èŒå…§æ¯’ç´ è©¦é©—ã€‚</span> </p><p><span style="font-size: 11pt;"> 6 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之æ£å放射åŒä½ç´ ï¼Œæ ¸ç¨®åŠè¡°æœŸâ‰§</span><span style="font-size: 11pt;">25.0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜è€…ï¼Œé ˆé€</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">批執行無èŒè©¦é©—ï¼›æ ¸ç¨®åŠè¡°æœŸ</span><span style="font-size: 11pt;">< 25.0</span><span style="font-family: 新細明體,serif; font-size: 11pt;">分é˜è€…，應於當天第一亞批</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å“質管制檢驗時執行無èŒè©¦é©—。本å“å¯åœ¨ç„¡èŒæª¢æŸ¥å®Œæˆå‰æ”¾è¡Œä½¿</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç”¨ï¼ŒæƒŸé ˆåœ¨åŒä½ç´ éŽæ¿¾å¾Œ</span><span style="font-size: 11pt;"> 24-72 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å°æ™‚內開始執行。å—測產å“é ˆ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">個別測試，ä¸å¾—æ··åˆè¨±å¤šç”¢å“樣本試驗。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供人使用å„批之æ£å放射åŒä½ç´ ，應è¨ç«‹æ›¸é¢ç¨‹åºä¾†å¯¦è¡Œå“質管制</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">試驗。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é©—è‰æ¸¬è©¦æ£å放射åŒä½ç´ å“質試驗之程åºåŠå„€å™¨ã€‚分æžå„€å™¨</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如氣</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">相層æžæˆ–液相層æž</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é ˆåœ¨é–‹å§‹å®‰è£æˆ–é‡è¦ç¶ä¿®å¾Œï¼Œä»¥å…§æˆ–外標準å“</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä¾†å¯¦æ–½æ ¡æ£æ“ä½œã€‚è©²æ ¡æ£å·¥ä½œå¿…éœ€æ ¹æ“šé©ç•¶çš„書é¢ç¨‹åºå®šæœŸåŸ·è¡Œ</span><span style="font-size: 11pt;"> (</span></p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：系統é©åˆæ€§è©¦é©—å¿…é ˆåŸ·è¡Œ</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å››</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å¿…é ˆä¾æ“šæ›¸é¢ç¨‹åºä¾†åŸ·è¡Œå„批æ£å放射åŒä½ç´ å“質管制試驗，並簽</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç« è©²è©¦é©—çš„çµæžœã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä¾æ“šå“質管制試驗çµæžœæ˜¯å¦ç¬¦åˆè¦æ ¼ï¼Œä¾†åˆ¤å®šå‡†ç”¨æˆ–拒用該批æ£å</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">放射åŒä½ç´ 。</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">如該批æ£å放射åŒä½ç´ å‡†ç”¨ï¼Œå‰‡å¿…é ˆåœ¨å“è³ªç®¡åˆ¶ç´€éŒ„ä¸Šç°½ç« åŠåŠ 註</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">日期。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å…</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">任何一批ä¸é€šéŽå“質管制試驗的æ£å放射åŒä½ç´ ï¼Œå¿…é ˆèª¿æŸ¥ä¸åˆæ ¼</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">çš„åŽŸå› ï¼Œä¸¦å°‡èª¿æŸ¥çµæžœå»ºæª”。</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å…</span><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ»…èŒåŠç„¡èŒç¢ºæ•ˆ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">需確èªæ£å放射åŒä½ç´ çš„ç„¡èŒæ€§ï¼Œå»ºç«‹ã€ä½œæˆæ›¸é¢ç´€éŒ„並確實執行下</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">列å„ç„¡èŒæ“作：</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">一</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製åŒä½ç´ 的儀器åŠçµ„æˆ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製æ£å放射åŒä½ç´ 的器æ必需經éŽé©ç•¶åœ°æ¸…洗，並ä¿æŒæ¸…潔狀態</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。接觸æ£å放射åŒä½ç´ 溶液的器æ，å¯è¨æ³•åŽ»é™¤å…§æ¯’ç´ åŠæ»…èŒè™•ç†</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">來除去微生物。該器æé ˆå˜æ”¾æ–¼æ¸…潔或無èŒçš„環境下。與æ£å放射</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŒä½ç´ 生產有關的物質，宜由已通éŽç„¡èŒè—¥å“è¦æ ¼é‘‘定的åˆæ ¼å» 商</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">來ç²å¾—，無èŒç“¶ã€æ³¨å°„é‡ã€è½‰ç§»çµ„</span><span style="font-size: 11pt;"> (transfer set) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åŠéŽæ¿¾è†œä¹Ÿå»º</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è°æŽ¡ç”¨åˆæ ¼å¸‚å”®å“。如該ç‰å™¨æ由調製單ä½è‡ªè¡Œæ»…èŒï¼Œå‰‡å¿…é ˆç¢ºèª</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ»…èŒéŽç¨‹åŠè£é…組件的無èŒæ€§ï¼Œä¸¦ä¸”定期確èªå…¶æ»…èŒæ•ˆèƒ½ã€‚注射用</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æº¶æ¶²å¿…é ˆç”¨éŽæ¿¾è†œé™¤èŒï¼Œä¸¦ä»¥ç„¡èŒæ“作移至一無èŒã€ç„¡ç†±åŽŸåŠå¤šåŠ‘</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é‡çš„瓶ä¸ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">二</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">環境控制</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供調製最終產å“的工作å€åŸŸå¿…é ˆæ¸…æ½”ã€‚ç„¡èŒå±¤æµæ“作å°</span><span style="font-size: 11pt;"> (aseptic</span></p><p><span style="font-size: 11pt;"> hood) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">應放置於人員進出需å—管制的å€åŸŸä¸ï¼Œä¸¦é˜²æ¢å¾®ç”Ÿç‰©æ±¡æŸ“。</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在使用無èŒå±¤æµæ“作å°æ™‚，需穿上清潔之實驗衣。æˆåˆ†ã€ç‰©æ–™åŠå„€</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">器移入無èŒå€éœ€ä»¥å®¹å™¨ç››è£æˆ–包裹之。供作最終產å“之容器ã€éŽæ¿¾</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">套組ã€é€æ°£çš„éŽæ¿¾è†œåŠæ³¨å°„é‡é å‡å¿…é ˆæ˜¯ç„¡èŒã€å¯æ‹‹æ£„å¼åŠåƒ…供單</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">次使用。éŽæ¿¾è†œçµ„è£åœ¨ç”¢å“收集瓶ä¸å¾Œï¼Œä»å¿…é ˆä¿æŒè©²çµ„è£å¥—組的</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç„¡èŒç‹€æ…‹ã€‚如任何套組的無èŒæ€§å—æï¼Œå‰‡è©²å¥—çµ„å¿…é ˆæ›´æ›ã€‚在æ’å…¥</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">最終產å“容器å‰ï¼Œè©²ç“¶å的瓶å£æ©¡çš®å¡žå¿…é ˆç”¨</span><span style="font-size: 11pt;"> 70 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">％乙醇或異丙醇</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç‰æ¶ˆæ¯’劑擦æ‹ï¼Œä¸¦è®“其在無èŒå±¤æµæ“作å°ä¸è‡ªç„¶æ®ç™¼ã€‚</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">三</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç„¡èŒå±¤æµæ“作å°</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製最終產å“çš„éŽæ¿¾è†œèˆ‡å®¹å™¨æ‡‰æ–¼ç„¡èŒå±¤æµæ“作å°å…§çµ„è£ã€‚ç„¡èŒæ“</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä½œå¿…é ˆæ–¼</span><span style="font-size: 11pt;"> 100 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">級之無èŒå·¥ä½œå€é€²è¡Œ</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：層æµæ“作å°æˆ–隔離箱</span><span style="font-size: 11pt;">)</span></p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。æ“作å°è¡¨é¢åŠå„€å™¨è¡¨é¢é ˆå®¹æ˜“清潔åŠæ¶ˆæ¯’ã€‚æ¶ˆæ¯’åŠ‘é ˆéŽæ¿¾æˆ–具有</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å» å•†çš„ç„¡èŒè‰æ˜Žæ›¸ã€‚在æ¯å¤©ä½¿ç”¨å‰åŠæ–°å„€å™¨ç§»å…¥ç„¡èŒå±¤æµæ“作å°å¾Œ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ï¼Œå¿…é ˆæ¸…æ½”åŠæ¶ˆæ¯’æ“作å°å…§éƒ¨è¡¨é¢ã€‚é‡å°ç„¡èŒå±¤æµæ“作å°çš„環境，</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é ˆå®šæœŸåŸ·è¡Œå¾®ç”Ÿç‰©è©¦é©—</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如：æ¯é€±</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，å¯ç”±æ“¦æ‹æ£’ã€æŽ¥è§¸åŸ¹é¤Šçš¿ã€</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">è½èŒè©¦é©—用培養皿或空氣採樣器ç‰æ–¹æ³•åŸ·è¡Œï¼Œæ‡¸æµ®æ–¼ç©ºæ°£ä¸çš„éžæ´»</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">性粒å計數，則å¯ä»¥é–“隔較長的時間檢查。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å››</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç„¡èŒæŠ€è¡“</span> </p><p><span style="font-size: 11pt;"> 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">所有無èŒæ“作，包括組è£ç„¡èŒçµ„件ã€èª¿è£½ã€éŽæ¿¾èˆ‡è™•ç†ç„¡èŒæº¶æ¶²</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ï¼Œéƒ½å¿…é ˆç¶“ç”±åˆæ ¼è€…去執行。覆蓋åŠé–‹å•Ÿç„¡èŒç‰©å“的防è·å¯†å°æ™‚</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ï¼Œå¿…é ˆåœ¨ç„¡èŒå±¤æµæ“作å°å…§æ“作。任何無èŒè¨å‚™æˆ–組件接觸到éž</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç„¡èŒè¡¨é¢æ™‚ï¼Œå¿…é ˆé‡æ–°æ›´æ›ã€‚ç„¡èŒçµ„件移出無èŒå±¤æµæ“作å°å‰æ‡‰</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">置於密å°å®¹å™¨å…§ã€‚æ“ä½œè€…å¿…é ˆç©¿ä¸Šæ¸…æ½”ä¹‹å¯¦é©—è¡£ä¾†åŸ·è¡Œç„¡èŒæ“作</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">éŽç¨‹ã€‚æ“作者手部伸入無èŒå±¤æµæ“作å°ä¹‹å‰ï¼Œæ‡‰æˆ´ä¸Šæ‰‹å¥—並經消</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">毒。</span> </p><p><span style="font-size: 11pt;"> 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç„¡èŒå€çš„æ“作應由通éŽå¾®ç”Ÿç‰©æ¸¬é©—åŠå®šæœŸè§€å¯Ÿè€…來執行。æ“作者</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ä½¿ç”¨æ–¼è£½é€ ç„¡èŒç”¢å“çš„ç„¡èŒæ“作技術，是以模擬測試來評估，å³</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">利用微生物的生長之培養基來å–代æ£å放射åŒä½ç´ 溶液，檢視連</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">接出氣å£åŠéŽæ¿¾çš„æ“作éŽç¨‹ï¼Œå¦‚出å£è™•é€£æŽ¥ä¹‹æ“作åŠéŽæ¿¾ã€‚確èª</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ£å放射åŒä½ç´ 容器內培養基的效能試驗是程åºæ¨¡æ“¬æ¸¬è©¦çš„一個</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">é—œéµæŽ§åˆ¶ã€‚模擬程åºçµæŸå¾Œï¼Œæœ€çµ‚產å“其容器應ç¨åŠ æ–動震盪，</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">直到培養基接觸到容器內部所有表é¢ï¼Œå®¹å™¨å’ŒåŸ¹é¤ŠåŸºæ‡‰åŸ¹é¤Šæ–¼</span><span style="font-size: 11pt;"> 3</span></p><p><span style="font-size: 11pt;"> 0 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">～</span><span style="font-size: 11pt;">35</span><span style="font-family: 新細明體,serif; font-size: 11pt;">℃ã€</span><span style="font-size: 11pt;">20</span><span style="font-family: 新細明體,serif; font-size: 11pt;">～</span><span style="font-size: 11pt;">25</span><span style="font-family: 新細明體,serif; font-size: 11pt;">℃或其他é©ç•¶æº«åº¦é”</span><span style="font-size: 11pt;"> 14 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">天以上，期間應æ¯éš”</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">一段時間檢查是å¦æœ‰å¾®ç”Ÿç‰©ç”Ÿé•·ã€‚通éŽæ¸¬è©¦çš„çµæžœå¿…é ˆæ˜¯å®¹å™¨å…§</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">沒有微生物生長。一個新的æ“ä½œè€…ï¼Œé ˆåŸ·è¡ŒåŠé€šéŽæ¨¡æ“¬æ¸¬è©¦ä¸‰æ¬¡</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">，方å¯è¢«èªå¯ç‚ºåˆæ ¼æ“作者。æ¯ä½åˆæ ¼æ“ä½œè€…é ˆæ¯å¹´é€šéŽæ¨¡æ“¬æ¸¬</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">試，有任何æ“作æ¥é©Ÿè®Šæ›´æ™‚，則æ“ä½œè€…å¿…é ˆé€šéŽè©²è®Šæ›´æ¥é©Ÿçš„模</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">擬測試。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">五</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">éŽæ¿¾éŽç¨‹çš„é©—è‰</span> </p><p><span style="font-size: 11pt;"> 1 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç„¡èŒéŽæ¿¾æ˜¯æ£å放射åŒä½ç´ 溶液ä¸ç§»åŽ»å¾®ç”Ÿç‰©æœ€å¾Œé—œéµçš„防è·æŽª</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">施，這個é‡è¦æ¥é©Ÿå¿…é ˆèƒ½å¤ è‰å¯¦åœ¨ç‰¹å®šç‹€æ³ä¸‹èƒ½åˆ©ç”¨éŽæ¿¾è†œä¾†é˜»</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ“‹å¾®ç”Ÿç‰©ã€‚è£½é€ åŠæ¶ˆæ¯’éŽæ¿¾å™¨çš„å» å•†ï¼Œä¸€èˆ¬æœƒæä¾›éŽæ¿¾æ¢ä»¶</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">壓力和æµé‡</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。當éŽæ¿¾æ£å放射åŒä½ç´ 時，切勿超éŽä¸Šè¿°çš„éŽæ¿¾</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ¢ä»¶ã€‚å°é…¸é¹¼å€¼è¿‘乎ä¸æ€§çš„大部分水溶液，有關éŽæ¿¾å™¨é˜»æ“‹å¾®ç”Ÿ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">物能力的è‰æ˜Žå¯å¾žéŽæ¿¾å™¨å» 商ç²å¾—。驗è‰æ¯æ‰¹éŽæ¿¾å™¨ç¬¦åˆè¦æ ¼çš„</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">書é¢è‰æ˜Žå¿…é ˆæŸ¥è‰åŠå˜æª”。</span> </p><p><span style="font-size: 11pt;"> 2 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在使用æŸä¸€æ‰¹éŽæ¿¾å™¨å‰ï¼Œä½¿ç”¨è€…å¿…é ˆä»»é¸ä¸€å€‹éŽæ¿¾å™¨ä¾†æ¸¬è©¦å…¶å®Œ</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">整性，以è‰å¯¦éŽæ¿¾å™¨åŠå¤–殼並無失去ä¿ç•™å¾®ç”Ÿç‰©çš„èƒ½åŠ›ã€‚å» å•†æ‡‰</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ供完整性測試的方法，或者使用經éŽç¢ºæ•ˆçš„其它方法。</span> </p><p><span style="font-size: 11pt;"> 3 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">在æ£å放射åŒä½ç´ éŽæ¿¾å¾Œï¼Œæ‡‰ä»¥</span><span style="font-size: 11pt;"> "</span><span style="font-family: 新細明體,serif; font-size: 11pt;">起泡點</span><span style="font-size: 11pt;">(Bubble Point)" </span><span style="font-family: 新細明體,serif; font-size: 11pt;">測試</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç‰æ–¹æ³•æª¢è¦–ç„¡èŒéŽæ¿¾è†œçš„完整性後始得放行。</span> </p><p><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">å…</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">最終產å“的微生物測試</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">供注射用之æ£å放射åŒä½ç´ ï¼Œå¿…é ˆæ˜¯ç„¡èŒä¸”ä¸å«å…§æ¯’ç´ ï¼Œé€™å…©é …å¯</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">用無èŒè©¦é©—åŠç´°èŒå…§æ¯’ç´ è©¦é©—åŠ ä»¥è‰æ˜Žã€‚ç´°èŒå…§æ¯’ç´ è©¦é©—æ˜¯å¿…é ˆåœ¨</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">調製之後立å³åŸ·è¡Œï¼›è€Œç„¡èŒè©¦é©—，å¯ä»¥åœ¨èª¿è£½å¾Œ</span><span style="font-size: 11pt;"> 24-72 </span><span style="font-family: 新細明體,serif; font-size: 11pt;">å°æ™‚內執</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">行。æ¯æ‰¹åŒä½ç´ å¿…é ˆå€‹åˆ¥æ¸¬è©¦ï¼Œä¸”ä¸å¯æ··åˆæ•¸å€‹æ‰¹æ¬¡çš„åŒä½ç´ 後å†</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">åšå¾®ç”Ÿç‰©æ¸¬è©¦ã€‚若微生物檢驗ä¸é€šéŽï¼Œå¿…é ˆèª¿æŸ¥å…¶åŽŸå› ä¸¦åŠ ä»¥ä¿®æ£</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">。如果記錄顯示連續æˆåŠŸåœ°é€šéŽç„¡èŒè©¦é©—，則僅有æ¯å¤©é¦–批é…製的</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ£å放射åŒä½ç´ å¿…é ˆé€²è¡Œç„¡èŒè©¦é©—。然而當調製ä¸åŒæ£å放射åŒä½</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ç´ æ™‚æˆ–æ›´æ›æ–°ç„¡èŒå™¨æ</span><span style="font-size: 11pt;"> (</span><span style="font-family: 新細明體,serif; font-size: 11pt;">如éŽæ¿¾å™¨æˆ–最終產å“容器</span><span style="font-size: 11pt;">) </span><span style="font-family: 新細明體,serif; font-size: 11pt;">ï¼Œå‰‡å¿…é ˆæ¸¬è©¦</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ¯æ‰¹æ£å放射åŒä½ç´ 之無èŒæ€§ï¼Œç›´åˆ°å»ºç«‹é€£çºŒæˆåŠŸé€šéŽæ¸¬è©¦ç´€éŒ„，</span> </p><p><span style="font-size: 11pt;"> </span><span style="font-family: 新細明體,serif; font-size: 11pt;">æ–¹å¯åƒ…測試æ¯å¤©é¦–批åŒä½ç´ çš„ç„¡èŒæ€§ã€‚</span> </p>2013-12-05
臨床試驗類,醫療法法律醫療法<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為促進醫療事æ¥ä¹‹å¥å…¨ç™¼å±•ï¼Œåˆç†åˆ†å¸ƒé†«ç™‚資æºï¼Œæ高醫療å“質，ä¿éšœç—…人權益，增進國民å¥åº·ï¼Œç‰¹åˆ¶å®šæœ¬æ³•ã€‚本法未è¦å®šè€…，é©ç”¨å…¶ä»–法律è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱醫療機構，係指供醫師執行醫療æ¥å‹™ä¹‹æ©Ÿæ§‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱公立醫療機構，係指由政府機關ã€å…¬ç‡Ÿäº‹æ¥æ©Ÿæ§‹æˆ–公立å¸æ ¡æ‰€è¨ç«‹ä¹‹é†«ç™‚機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱ç§ç«‹é†«ç™‚機構，係指由醫師è¨ç«‹ä¹‹é†«ç™‚機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱醫療法人，包括醫療財團法人åŠé†«ç™‚社團法人。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱醫療財團法人，係指以從事醫療事æ¥è¾¦ç†é†«ç™‚機構為目的，由æ助人æ助一定財產，經ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ä¸¦å‘法院登記之財團法人。</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱醫療社團法人，係指以從事醫療事æ¥è¾¦ç†é†«ç™‚機構為目的，經ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ç™»è¨˜ä¹‹ç¤¾åœ˜æ³•äººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱法人附è¨é†«ç™‚機構，係指下列醫療機構：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç§ç«‹é†«å¸é™¢ã€æ ¡ç‚ºå¸ç”Ÿè‡¨åºŠæ•™å¸éœ€è¦é™„è¨ä¹‹é†«é™¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å…¬ç›Šæ³•äººä¾æœ‰é—œæ³•å¾‹è¦å®šè¾¦ç†é†«ç™‚æ¥å‹™æ‰€è¨ä¹‹é†«ç™‚機構。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¶ä»–ä¾æ³•å¾‹è¦å®šï¼Œæ‡‰å°å…¶å“¡å·¥æˆ–æˆå“¡æ供醫療衛生æœå‹™æˆ–緊急醫療救è·ä¹‹äº‹æ¥å–®ä½ã€å¸æ ¡æˆ–機構所附è¨ä¹‹é†«å‹™å®¤ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱教å¸é†«é™¢ï¼Œä¿‚指其教å¸ã€ç ”究ã€è¨“ç·´è¨æ–½ï¼Œç¶“ä¾æœ¬æ³•è©•é‘‘å¯ä¾›é†«å¸«æˆ–其他醫事人員之訓練åŠé†«å¸é™¢ã€æ ¡å¸ç”Ÿè‡¨åºŠè¦‹ç¿’ã€å¯¦ç¿’之醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱人體試驗，係指醫療機構ä¾é†«å¸ç†è«–於人體施行新醫療技術ã€æ–°è—¥å“ã€æ–°é†«ç™‚器æåŠå¸å藥生體å¯ç”¨çŽ‡ã€ç”Ÿé«”相ç‰æ€§ä¹‹è©¦é©—ç ”ç©¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗之施行應尊é‡æŽ¥å—試驗者之自主æ„願，並ä¿éšœå…¶å¥åº·æ¬Šç›Šèˆ‡éš±ç§æ¬Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱醫療廣告，係指利用傳æ’媒體或其他方法，宣傳醫療æ¥å‹™ï¼Œä»¥é”æ‹›å¾ æ‚£è€…é†«ç™‚ç‚ºç›®çš„ä¹‹è¡Œç‚ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬æ³•æ‰€ç¨±é†«äº‹äººå“¡ï¼Œä¿‚æŒ‡é ˜æœ‰ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸ç™¼ä¹‹é†«å¸«ã€è—¥å¸«ã€è·ç†å¸«ã€ç‰©ç†æ²»ç™‚師ã€è·èƒ½æ²»ç™‚師ã€é†«äº‹æª¢é©—師ã€é†«äº‹æ”¾å°„師ã€ç‡Ÿé¤Šå¸«ã€è—¥åŠ‘生ã€è·å£«ã€åŠ©ç”¢å£«ã€ç‰©ç†æ²»ç™‚生ã€è·èƒ½æ²»ç™‚生ã€é†«äº‹æª¢é©—生ã€é†«äº‹æ”¾å°„士åŠå…¶ä»–醫事專門è·æ¥è‰æ›¸ä¹‹äººå“¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">本法所稱醫師，係指醫師法所稱之醫師ã€ä¸é†«å¸«åŠç‰™é†«å¸«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱主管機關：在ä¸å¤®ç‚ºè¡Œæ”¿é™¢è¡›ç”Ÿç½²ï¼›åœ¨ç›´è½„市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">醫療機構</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構è¨æœ‰ç—…房收治病人者為醫院，僅應門診者為診所；éžä»¥ç›´æŽ¥è¨ºæ²»ç—…人為目的而辦ç†é†«ç™‚æ¥å‹™ä¹‹æ©Ÿæ§‹ç‚ºå…¶ä»–醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …診所得è¨ç½®ä¹å¼µä»¥ä¸‹ä¹‹è§€å¯Ÿç—…床；婦產科診所，得ä¾é†«ç™‚æ¥å‹™éœ€è¦è¨ç½®å張以下產科病床。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構之類別與å„類醫療機構應è¨ç½®ä¹‹æœå‹™è¨æ–½ã€äººå“¡åŠè¨ºç™‚科別è¨ç½®æ¢ä»¶ç‰ä¹‹è¨ç½®æ¨™æº–，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二家以上診所得於åŒä¸€å ´æ‰€è¨ç½®ç‚ºè¯åˆè¨ºæ‰€ï¼Œä½¿ç”¨å…±åŒè¨æ–½ï¼Œåˆ†åˆ¥åŸ·è¡Œé–€è¨ºæ¥å‹™ï¼›å…¶ç®¡ç†è¾¦æ³•ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院之è¨ç«‹æˆ–擴充，應經主管機關許å¯å¾Œï¼Œå§‹å¾—ä¾å»ºç¯‰æ³•æœ‰é—œè¦å®šç”³è«‹å»ºç¯‰åŸ·ç…§ï¼›å…¶è¨ç«‹åˆ†é™¢è€…，亦åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫院è¨ç«‹æˆ–擴充之許å¯ï¼Œå…¶ç”³è«‹äººä¹‹è³‡æ ¼ã€å¯©æŸ¥ç¨‹åºåŠåŸºæº–ã€é™åˆ¶æ¢ä»¶ã€æ’¤éŠ·ã€å»¢æ¢åŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構之開æ¥ï¼Œæ‡‰å‘所在地直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸»ç®¡æ©Ÿé—œç”³è«‹æ ¸å‡†ç™»è¨˜ï¼Œç¶“ç™¼çµ¦é–‹æ¥åŸ·ç…§ï¼Œå§‹å¾—ç‚ºä¹‹ï¼›å…¶ç™»è¨˜äº‹é …å¦‚æœ‰è®Šæ›´ï¼Œæ‡‰æ–¼äº‹å¯¦ç™¼ç”Ÿä¹‹æ—¥èµ·ä¸‰å日內辦ç†è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …é–‹æ¥ç”³è«‹ï¼Œå…¶ç”³è«‹äººä¹‹è³‡æ ¼ã€ç”³è«‹ç¨‹åºã€æ‡‰æª¢å…·æ–‡ä»¶åŠå…¶ä»–應éµè¡Œä¹‹äº‹é …，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç§ç«‹é†«ç™‚機構é”ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¸€å®šè¦æ¨¡ä»¥ä¸Šè€…，應改以醫療法人型態è¨ç«‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構å稱之使用ã€è®Šæ›´ï¼Œæ‡‰ä»¥æ‰€åœ¨åœ°ç›´è½„市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…ç‚ºé™ï¼›å…¶å稱使用ã€è®Šæ›´åŽŸå‰‡ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">éžé†«ç™‚機構，ä¸å¾—使用醫療機構或類似醫療機構之å稱。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«ç™‚æ©Ÿæ§‹æ‡‰ç½®è² è²¬é†«å¸«ä¸€äººï¼Œå°å…¶æ©Ÿæ§‹é†«ç™‚æ¥å‹™ï¼Œè² ç£å°Žè²¬ä»»ã€‚ç§ç«‹é†«ç™‚æ©Ÿæ§‹ï¼Œä¸¦ä»¥å…¶ç”³è«‹äººç‚ºè² è²¬é†«å¸«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è² è²¬é†«å¸«ï¼Œä»¥åœ¨ä¸å¤®ä¸»ç®¡æ©Ÿé—œæŒ‡å®šä¹‹é†«é™¢ã€è¨ºæ‰€æŽ¥å—二年以上之醫師訓練並å–å¾—è‰æ˜Žæ–‡ä»¶è€…為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è² è²¬é†«å¸«å› æ•…ä¸èƒ½åŸ·è¡Œæ¥å‹™ï¼Œæ‡‰æŒ‡å®šåˆæ–¼è² è²¬é†«å¸«è³‡æ ¼ä¹‹é†«å¸«ä»£ç†ã€‚代ç†æœŸé–“超éŽå››å五日者，應由被代ç†é†«å¸«å ±è«‹åŽŸç™¼é–‹æ¥åŸ·ç…§æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …代ç†æœŸé–“，ä¸å¾—逾一年。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應將其開æ¥åŸ·ç…§ã€è¨ºç™‚時間åŠå…¶ä»–æœ‰é—œè¨ºç™‚äº‹é …æ示於明顯</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">處所。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構收å–醫療費用之標準，由直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸»ç®¡æ©Ÿé—œæ ¸å®š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構收å–é†«ç™‚è²»ç”¨ï¼Œæ‡‰é–‹çµ¦è¼‰æ˜Žæ”¶è²»é …ç›®åŠé‡‘é¡ä¹‹æ”¶æ“šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構ä¸å¾—é•å收費標準，超é¡æˆ–æ“…ç«‹æ”¶è²»é …ç›®æ”¶è²»ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構æ‡æ¥ã€åœæ¥æ™‚，應於事實發生後三åæ—¥å…§ï¼Œå ±è«‹åŽŸç™¼é–‹æ¥åŸ·</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">照機關備查。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …åœæ¥ä¹‹æœŸé–“，以一年為é™ï¼›é€¾ä¸€å¹´è€…，應於屆至日起三å日內辦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç†æ‡æ¥ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構未ä¾å‰é …è¦å®šè¾¦ç†æ‡æ¥æ™‚，主管機關得逕予æ‡æ¥ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構é·ç§»è€…，準用關於è¨ç«‹åŠé–‹æ¥ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構復æ¥æ™‚，準用關於開æ¥ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應ä¿æŒç’°å¢ƒæ•´æ½”ã€ç§©åºå®‰å¯§ï¼Œä¸å¾—妨礙公共衛生åŠå®‰å…¨ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為ä¿éšœç—…人就醫安全，任何人ä¸å¾—以強暴ã€è„…è¿«ã€æ嚇或其他éžæ³•ä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">方法，滋擾醫療機構秩åºæˆ–妨礙醫療æ¥å‹™ä¹‹åŸ·è¡Œã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•åå‰é …è¦å®šè€…，è¦å¯Ÿæ©Ÿé—œæ‡‰å”助排除或制æ¢ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«é™¢é™¤å…¶å»ºç¯‰æ§‹é€ ã€è¨å‚™æ‡‰å…·å‚™é˜²ç«ã€é¿é›£ç‰å¿…è¦ä¹‹è¨æ–½å¤–，並應建</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">立緊急ç½å®³æ‡‰è®ŠæŽªæ–½ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …緊急ç½å®³æ‡‰è®ŠæŽªæ–½åŠæª¢æŸ¥è¾¦æ³•ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應ä¾æ³•ä»¤è¦å®šæˆ–ä¾ä¸»ç®¡æ©Ÿé—œä¹‹é€šçŸ¥ï¼Œæå‡ºå ±å‘Šï¼Œä¸¦æŽ¥å—主管</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ©Ÿé—œå°å…¶äººå“¡é…ç½®ã€è¨å‚™ã€é†«ç™‚收費ã€é†«ç™‚作æ¥ã€è¡›ç”Ÿå®‰å…¨ã€è¨ºç™‚ç´€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">錄ç‰ä¹‹æª¢æŸ¥åŠè³‡æ–™è’集。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ–¼é‡å¤§ç½å®³ç™¼ç”Ÿæ™‚，醫療機構應éµå¾žä¸»ç®¡æ©Ÿé—œæŒ‡æ®ã€æ´¾é£ï¼Œæ供醫療</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœå‹™åŠå”助辦ç†å…¬å…±è¡›ç”Ÿï¼Œä¸å¾—è¦é¿ã€å¦¨ç¤™æˆ–拒絕。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構ä¾å‰é …è¦å®šæä¾›æœå‹™æˆ–å”助所生之費用或æ失，主管機關應</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">酌予補償。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰è¾¦ç†é†«é™¢è©•é‘‘。直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關å°è½„å€å…§</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構æ¥å‹™ï¼Œæ‡‰å®šæœŸå¯¦æ–½ç£å°Žè€ƒæ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">公立醫院得邀請當地社會人士組æˆç‡Ÿé‹è«®è©¢å§”å“¡æœƒï¼Œå°±åŠ å¼·åœ°å€é†«ç™‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœå‹™ï¼Œæä¾›æ„見。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">公立醫院應æ撥年度醫療收入扣除費用後餘é¡ä¹‹ç™¾åˆ†ä¹‹å以上，辦ç†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ‰é—œç ”ç©¶ç™¼å±•ã€äººæ‰åŸ¹è¨“ã€å¥åº·æ•™è‚²ã€é†«ç™‚æ•‘æ¿Ÿã€ç¤¾å€é†«ç™‚æœå‹™åŠå…¶</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">他社會æœå‹™äº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">醫療法人</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">通則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人之è¨ç«‹ã€çµ„ç¹”åŠç®¡ç†ï¼Œä¾æœ¬æ³•ä¹‹è¦å®šï¼›æœ¬æ³•æœªè¦å®šè€…，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æ°‘法之è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人，éžä¾æœ¬æ³•è¦å®šï¼Œä¸å¾—è¨ç«‹ï¼›å…¶çµ„ç¹”ã€ç®¡ç†ã€èˆ‡è‘£äº‹é–“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之權利義務ã€ç ´ç”¢ã€è§£æ•£åŠæ¸…算，本法未è¦å®šè€…，準用民法之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人得è¨ç«‹é†«é™¢ã€è¨ºæ‰€åŠå…¶ä»–醫療機構。其è¨ç«‹ä¹‹å®¶æ•¸åŠè¦æ¨¡ï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">得為必è¦ä¹‹é™åˆ¶ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …è¨ç«‹å®¶æ•¸åŠè¦æ¨¡ä¹‹é™åˆ¶ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人經ä¸å¤®ä¸»ç®¡æ©Ÿé—œåŠç›®çš„事æ¥ä¸»ç®¡æ©Ÿé—œä¹‹è¨±å¯ï¼Œå¾—附è¨ä¸‹åˆ—æ©Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">構：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€è·ç†æ©Ÿæ§‹ã€ç²¾ç¥žå¾©å¥æ©Ÿæ§‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€é—œæ–¼é†«å¸ç ”究之機構。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€è€äººç¦åˆ©æ³•ç‰ç¤¾æœƒç¦åˆ©æ³•è¦è¦å®šä¹‹ç›¸é—œç¦åˆ©æ©Ÿæ§‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …附è¨æ©Ÿæ§‹ä¹‹è¨ç«‹æ¢ä»¶ã€ç¨‹åºåŠå…¶ä»–ç›¸é—œäº‹é …ï¼Œä»ä¾å„該相關法è¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人應有足以é”æˆå…¶è¨ç«‹ç›®çš„所必è¦ä¹‹è²¡ç”¢ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …所稱必è¦ä¹‹è²¡ç”¢ï¼Œä¾å…¶è¨ç«‹ä¹‹è¦æ¨¡èˆ‡é‹ç”¨æ¢ä»¶ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人，應è¨è‘£äº‹æœƒï¼Œç½®è‘£äº‹é•·ä¸€äººï¼Œä¸¦ä»¥è‘£äº‹é•·ç‚ºæ³•äººä¹‹ä»£è¡¨äººã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人，å°æ–¼è‘£äº‹æœƒèˆ‡ç›£å¯Ÿäººä¹‹çµ„織與è·æ¬Šã€è‘£äº‹ã€è‘£äº‹é•·èˆ‡ç›£å¯Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人之é´é¸è³‡æ ¼ã€é¸è˜èˆ‡è§£è˜ç¨‹åºã€æœƒè°å¬é–‹èˆ‡æ±ºè°ç¨‹åºåŠå…¶ä»–有關事</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é …ç‰ï¼Œæ‡‰è¨‚ç«‹ç« å‰‡ï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人應建立會計制度，採曆年制åŠæ¬Šè²¬ç™¼ç”Ÿåˆ¶ï¼Œå…¶è²¡å‹™æ”¶æ”¯å…·åˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法憑è‰ï¼Œè¨ç½®å¿…è¦ä¹‹æœƒè¨ˆç´€éŒ„，符åˆå…¬èªä¹‹æœƒè¨ˆè™•ç†æº–則，並應ä¿å˜</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人應於年度終了五個月內，å‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œç”³å ±ç¶“董事會通éŽ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠç›£å¯Ÿäººæ‰¿èªä¹‹å¹´åº¦è²¡å‹™å ±å‘Šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …è²¡å‹™å ±å‘Šç·¨è£½æº–å‰‡ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人除é©ç”¨å‰è¿°è¦å®šå¤–；其會計制度，並應ä¾å…¬å¸æ³•ç›¸é—œè¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">定辦ç†ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—隨時命令醫療法人æ出財務ã€æ¥å‹™å ±å‘Šæˆ–檢查其財</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‹™ã€æ¥å‹™ç‹€æ³ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人å°æ–¼å‰é …之命令或檢查，ä¸å¾—è¦é¿ã€å¦¨ç¤™æˆ–拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 35 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人ä¸å¾—為公å¸ä¹‹ç„¡é™è²¬ä»»è‚¡æ±æˆ–åˆå¤¥äº‹æ¥ä¹‹åˆå¤¥äººï¼›å¦‚為公å¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之有é™è²¬ä»»è‚¡æ±æ™‚，其所有投資總é¡åŠå°å–®ä¸€å…¬å¸ä¹‹æŠ•è³‡é¡æˆ–其比例</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應ä¸å¾—超éŽä¸€å®šä¹‹é™åˆ¶ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …投資é™åˆ¶ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«ç™‚æ³•äººå› æŽ¥å—被投資公å¸ä»¥ç›ˆé¤˜æˆ–å…¬ç©å¢žè³‡é…股所得之股份，ä¸è¨ˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…¥å‰é …投資總é¡æˆ–投資é¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 36 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人財產之使用，應å—ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¹‹ç›£ç£ï¼Œä¸¦æ‡‰ä»¥æ³•äººå義登</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">記或儲å˜ï¼›éžç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œä¸å¾—å°å…¶ä¸å‹•ç”¢ç‚ºè™•åˆ†ã€å‡ºç§Ÿã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">出借ã€è¨å®šè² æ“”ã€è®Šæ›´ç”¨é€”或å°å…¶è¨å‚™ç‚ºè¨å®šè² 擔。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 37 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人ä¸å¾—為ä¿è‰äººã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人之資金，ä¸å¾—貸與董事ã€ç¤¾å“¡åŠå…¶ä»–個人或éžé‡‘èžæ©Ÿæ§‹ï¼›äº¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¾—以其資產為董事ã€ç¤¾å“¡æˆ–任何他人æ供擔ä¿ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç§äººåŠåœ˜é«”å°æ–¼é†«ç™‚財團法人之æ贈，得ä¾æœ‰é—œç¨…法之è¦å®šæ¸›å…稅</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">賦。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人所得稅ã€åœŸåœ°ç¨…åŠæˆ¿å±‹ç¨…之減å…，ä¾æœ‰é—œç¨…法之è¦å®šè¾¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç†ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法修æ£æ–½è¡Œå‰å·²è¨ç«‹ä¹‹ç§ç«‹é†«ç™‚機構，於本法修æ£æ–½è¡Œå¾Œä¸‰å¹´å…§æ”¹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¨ç‚ºé†«ç™‚法人，將原供醫療使用之土地無償移轉該醫療法人續作原來</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之使用者，ä¸èª²å¾µåœŸåœ°å¢žå€¼ç¨…。但於å†æ¬¡ç§»è½‰ç¬¬ä¸‰äººæ™‚，以該土地無</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">償移轉å‰ä¹‹åŽŸè¦å®šåœ°åƒ¹æˆ–å‰æ¬¡ç§»è½‰ç¾å€¼ç‚ºåŽŸåœ°åƒ¹ï¼Œè¨ˆç®—漲價總數é¡ï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">課徵土地增值稅。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 39 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人經ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ï¼Œå¾—與其他åŒè³ªæ€§é†«ç™‚法人åˆä½µä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人經ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯åˆä½µå¾Œï¼Œæ‡‰æ–¼å…©é€±å…§ä½œæˆè²¡ç”¢ç›®éŒ„åŠè³‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”¢è² å‚µè¡¨ï¼Œä¸¦é€šçŸ¥å‚µæ¬Šäººã€‚å…¬å¸æ³•ç¬¬ä¸ƒå三æ¢ç¬¬äºŒé …ã€ç¬¬ä¸ƒåå››æ¢ç¬¬</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸€é …ä¹‹è¦å®šæº–用之。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å› åˆä½µè€Œæ¶ˆæ»…之醫療法人，其權利義務由åˆä½µå¾Œå˜çºŒæˆ–å¦ç«‹ä¹‹é†«ç™‚法</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人概括承å—。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éžé†«ç™‚法人，ä¸å¾—使用醫療法人或類似之å稱。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 41 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人辦ç†ä¸å–„ã€é•å法令或è¨ç«‹è¨±å¯æ¢ä»¶è€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—視</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">其情節予以糾æ£ã€é™æœŸæ•´é “改善ã€åœæ¢å…¶å…¨éƒ¨æˆ–一部之門診或ä½é™¢æ¥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‹™ã€å‘½å…¶åœæ¥æˆ–廢æ¢å…¶è¨±å¯ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«ç™‚æ³•äººå› å…¶è‡ªæœ‰è³‡ç”¢ä¹‹æ¸›å°‘æˆ–å› å…¶è¨ç«‹ä¹‹æ©Ÿæ§‹æ‡æ¥ã€è®Šæ›´æˆ–被廢æ¢</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">許å¯ï¼Œè‡´æœªç¬¦åˆä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬ä¸‰å二æ¢ç¬¬äºŒé …所為之è¦å®šï¼Œä¸å¤®</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">主管機關得é™æœŸä»¤å…¶æ”¹å–„；逾期未改善者，得廢æ¢å…¶è¨±å¯ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人有下列情事之一者，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—廢æ¢å…¶è¨±å¯ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€ç¶“æ ¸å‡†åœæ¥ï¼Œé€¾æœŸé™å°šæœªè¾¦ç†å¾©æ¥ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€å‘½åœæ¢å…¨éƒ¨æˆ–一部門診或ä½é™¢æ¥å‹™ï¼Œè€Œæœªåœæ¢ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€å‘½åœæ¥è€Œæœªåœæ¥æˆ–逾åœæ¥æœŸé™ä»æœªæ•´é “改善。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€å—廢æ¢é–‹æ¥åŸ·ç…§è™•åˆ†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">醫療財團法人</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 42 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人之è¨ç«‹ï¼Œæ‡‰æª¢å…·æåŠ©ç« ç¨‹ã€è¨ç«‹è¨ˆç•«æ›¸åŠç›¸é—œæ–‡ä»¶ï¼Œç”³</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …醫療財團法人經許å¯å¾Œï¼Œæ助人或éºå›‘執行人應於三å日內ä¾æ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠ©ç« ç¨‹é´è˜è‘£äº‹ï¼Œæˆç«‹è‘£äº‹æœƒï¼Œä¸¦å°‡è‘£äº‹å冊於董事會æˆç«‹ä¹‹æ—¥èµ·ä¸‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åæ—¥å…§ï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å®šï¼Œä¸¦æ–¼æ ¸å®šå¾Œä¸‰å日內å‘該管地方法</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">院辦ç†æ³•äººç™»è¨˜ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ助人或éºå›‘執行人，應於醫療財團法人完æˆæ³•äººç™»è¨˜ä¹‹æ—¥èµ·ä¸‰å€‹æœˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">內，將所æ助之全部財產移æ¸æ³•äººæ‰€æœ‰ï¼Œä¸¦å ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ助人或éºå›‘執行人未於期é™å…§å°‡æ助財產移æ¸æ³•äººæ‰€æœ‰ï¼Œç¶“é™æœŸä»¤</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">其完æˆï¼Œé€¾æœŸä»æœªå®Œæˆè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—廢æ¢å…¶è¨±å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 43 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人之董事，以ä¹äººè‡³å五人為é™ï¼›å…¶ä¸ä¸‰åˆ†ä¹‹ä¸€ä»¥ä¸Šæ‡‰å…·</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫師åŠå…¶ä»–é†«äº‹äººå“¡è³‡æ ¼ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">外國人充任董事，其人數ä¸å¾—超éŽç¸½åé¡ä¸‰åˆ†ä¹‹ä¸€ï¼›è‘£äº‹ç›¸äº’間，有</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é…å¶åŠä¸‰è¦ªç‰ä»¥å…§è¡€è¦ªã€å§»è¦ªé—œä¿‚者，亦åŒã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">董事會開會時，董事應親自出å¸ï¼Œä¸å¾—委託他人代ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 44 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人æåŠ©ç« ç¨‹ä¹‹è®Šæ›´ï¼Œæ‡‰å ±ç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人董事長ã€è‘£äº‹ã€è²¡ç”¢æˆ–å…¶ä»–ç™»è¨˜äº‹é …å¦‚æœ‰è®Šæ›´ï¼Œæ‡‰ä¾ä¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">央主管機關之è¦å®šå ±è«‹è¨±å¯ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰äºŒé …之變更，應於ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯å¾Œä¸‰å日內，å‘該管法院辦ç†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">變更登記。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 45 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人之董事，任期屆滿未能改é¸æˆ–出缺未能補任，顯然妨礙</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">董事會組織å¥å…¨ä¹‹è™žè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—ä¾å…¶ä»–董事ã€åˆ©å®³é—œä¿‚人之</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請或ä¾è·æ¬Šï¼Œé¸ä»»è‘£äº‹å……任之；其é¸ä»»è¾¦æ³•ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人之董事é•åæ³•ä»¤æˆ–ç« ç¨‹ï¼Œæœ‰æ害該法人或其è¨ç«‹æ©Ÿæ§‹ä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">利益或致其ä¸èƒ½æ£å¸¸ç‡Ÿé‹ä¹‹è™žè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—ä¾å…¶ä»–董事或利害</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">關係人之è²è«‹æˆ–ä¾è·æ¬Šï¼Œå‘½ä»¤è©²è‘£äº‹æš«åœè¡Œä½¿è·æ¬Šæˆ–解任之。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …董事之暫åœè¡Œä½¿è·æ¬Šï¼ŒæœŸé–“ä¸å¾—超éŽå…個月。於暫åœè¡Œä½¿è·æ¬Šä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœŸé–“å…§ï¼Œå› äººæ•¸ä¸è¶³é¡¯ç„¶å¦¨ç¤™è‘£äº‹æœƒçµ„ç¹”å¥å…¨ä¹‹è™žè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應é¸ä»»è‡¨æ™‚董事暫代之。é¸ä»»è‡¨æ™‚董事毋需變更登記；其é¸ä»»ï¼Œæº–用</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …é¸ä»»è¾¦æ³•ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 46 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療財團法人應æ撥年度醫療收入çµé¤˜ä¹‹ç™¾åˆ†ä¹‹å以上，辦ç†æœ‰é—œç ”究發展ã€äººæ‰åŸ¹è¨“ã€å¥åº·æ•™è‚²ï¼›ç™¾åˆ†ä¹‹å以上辦ç†é†«ç™‚æ•‘æ¿Ÿã€ç¤¾å€é†«ç™‚æœå‹™åŠå…¶ä»–社會æœå‹™äº‹é …；辦ç†ç¸¾æ•ˆå“著者，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œçŽå‹µä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">醫療社團法人</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 47 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人之è¨ç«‹ï¼Œæ‡‰æª¢å…·çµ„ç¹”ç« ç¨‹ã€è¨ç«‹è¨ˆç•«æ›¸åŠç›¸é—œæ–‡ä»¶ï¼Œç”³è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫療社團法人經許å¯å¾Œï¼Œæ‡‰æ–¼ä¸‰å日內ä¾å…¶çµ„ç¹”ç« ç¨‹æˆç«‹è‘£äº‹æœƒï¼Œä¸¦æ–¼è‘£äº‹æœƒæˆç«‹ä¹‹æ—¥èµ·ä¸‰åæ—¥å…§ï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œç™»è¨˜ï¼Œç™¼çµ¦æ³•äººç™»è¨˜è‰æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 48 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人è¨ç«‹æ™‚ï¼Œæ‡‰ç™»è¨˜ä¹‹äº‹é …å¦‚ä¸‹ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ³•äººè¨ç«‹ç›®çš„åŠå稱。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¸»äº‹å‹™æ‰€åŠåˆ†äº‹å‹™æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è‘£äº‹é•·ã€è‘£äº‹ã€ç›£å¯Ÿäººä¹‹å§“ååŠä½æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è²¡ç”¢ç¨®é¡žåŠæ•¸é¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è¨ç«‹æ©Ÿæ§‹ä¹‹æ‰€åœ¨åœ°åŠé¡žåˆ¥èˆ‡è¦æ¨¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è²¡ç”¢ç¸½é¡åŠå„社員之出資é¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è¨±å¯ä¹‹å¹´ã€æœˆã€æ—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 49 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法人ä¸å¾—為醫療社團法人之社員。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人æ¯ä¸€ç¤¾å“¡ä¸å•å‡ºè³‡å¤šå¯¡ï¼Œå‡æœ‰ä¸€è¡¨æ±ºæ¬Šã€‚ä½†å¾—ä»¥ç« ç¨‹è¨‚å®šï¼ŒæŒ‰å‡ºè³‡å¤šå¯¡æ¯”ä¾‹åˆ†é…表決權。</span> </p><p><span style="font-family: 新細明體,serif;">é†«ç™‚ç¤¾åœ˜æ³•äººå¾—æ–¼ç« ç¨‹ä¸æ˜Žå®šï¼Œç¤¾å“¡æŒ‰å…¶å‡ºè³‡é¡ï¼Œä¿æœ‰å°æ³•äººä¹‹è²¡ç”¢æ¬Šåˆ©ï¼Œä¸¦å¾—將其æŒåˆ†å…¨éƒ¨æˆ–部分轉讓於第三人。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形，擔任董事ã€ç›£å¯Ÿäººä¹‹ç¤¾å“¡å°‡å…¶æŒåˆ†è½‰è®“於第三人時，應å‘ä¸å¤®ä¸»ç®¡æ©Ÿé—œå ±å‚™ã€‚其轉讓全部æŒåˆ†è€…，自動解任。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 50 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人之董事，以三人至ä¹äººç‚ºé™ï¼›å…¶ä¸ä¸‰åˆ†ä¹‹äºŒä»¥ä¸Šæ‡‰å…·é†«å¸«åŠå…¶ä»–é†«äº‹äººå“¡è³‡æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">外國人充任董事，其人數ä¸å¾—超éŽç¸½åé¡ä¸‰åˆ†ä¹‹ä¸€ï¼Œä¸¦ä¸å¾—充任董事長。</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人應è¨ç›£å¯Ÿäººï¼Œå…¶åé¡ä»¥è‘£äº‹åé¡ä¹‹ä¸‰åˆ†ä¹‹ä¸€ç‚ºé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">監察人ä¸å¾—兼任董事或è·å“¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">董事會開會時，董事應親自出å¸ï¼Œä¸å¾—委託他人代ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 51 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«ç™‚ç¤¾åœ˜æ³•äººçµ„ç¹”ç« ç¨‹ä¹‹è®Šæ›´ï¼Œæ‡‰å ±ç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人董事長ã€è‘£äº‹ã€è²¡ç”¢æˆ–å…¶ä»–ç™»è¨˜äº‹é …å¦‚æœ‰è®Šæ›´ï¼Œæ‡‰ä¾ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¹‹è¦å®šï¼Œè¾¦ç†è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人解散時，應辦ç†è§£æ•£ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 52 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人之董事，任期屆滿未能改é¸æˆ–出缺未能補任，顯然妨礙董事會組織å¥å…¨ä¹‹è™žè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—ä¾å…¶ä»–董事ã€åˆ©å®³é—œä¿‚人之申請或ä¾è·æ¬Šï¼Œå‘½ä»¤é™æœŸå¬é–‹è‡¨æ™‚總會補é¸ä¹‹ã€‚總會逾期ä¸èƒ½å¬é–‹ï¼Œä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—é¸ä»»è‘£äº‹å……任之；其é¸ä»»è¾¦æ³•ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人之董事é•åæ³•ä»¤æˆ–ç« ç¨‹ï¼Œæœ‰æ害該法人或其è¨ç«‹æ©Ÿæ§‹ä¹‹åˆ©ç›Šæˆ–致其ä¸èƒ½æ£å¸¸ç‡Ÿé‹ä¹‹è™žè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—ä¾å…¶ä»–董事或利害關係人之è²è«‹æˆ–ä¾è·æ¬Šï¼Œå‘½ä»¤è§£ä»»ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療社團法人之董事會決è°é•åæ³•ä»¤æˆ–ç« ç¨‹ï¼Œæœ‰æ害該法人或其è¨ç«‹æ©Ÿæ§‹ä¹‹åˆ©ç›Šæˆ–致其ä¸èƒ½æ£å¸¸ç‡Ÿé‹ä¹‹è™žè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—ä¾è·æ¬Šï¼Œå‘½ä»¤è§£æ•£è‘£äº‹æœƒï¼Œå¬é–‹ç¤¾å“¡ç¸½æœƒé‡æ–°æ”¹é¸ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 53 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人çµé¤˜ä¹‹åˆ†é…，應æ撥百分之å以上，辦ç†ç ”究發展ã€äººæ‰åŸ¹è¨“ã€å¥åº·æ•™è‚²ã€é†«ç™‚æ•‘æ¿Ÿã€ç¤¾å€é†«ç™‚æœå‹™åŠå…¶ä»–社會æœå‹™äº‹é …基金；並應æ撥百分之二å以上作為營é‹åŸºé‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 54 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人，有下列情形之一者，解散之：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç™¼ç”Ÿç« 程所定之解散事由。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¨ç«‹ç›®çš„ä¸èƒ½é”到時。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€èˆ‡å…¶ä»–醫療法人之åˆä½µã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç ´ç”¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ’¤éŠ·è¨ç«‹è¨±å¯æˆ–命令解散。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ç¸½æœƒä¹‹æ±ºè°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æ¬ 缺社員。</span> </p><p><span style="font-family: 新細明體,serif;">ä¾å‰é …ç¬¬ä¸€æ¬¾äº‹ç”±è§£æ•£æ™‚ï¼Œæ‡‰å ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ï¼›ä¾å‰é …第二款至第七款事由解散時，應經ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¹‹è¨±å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 55 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療社團法人解散後，除åˆä½µæˆ–ç ´ç”¢å¤–ï¼Œå…¶è³¸é¤˜è²¡ç”¢ä¹‹æ¸å±¬ï¼Œä¾çµ„ç¹”ç« ç¨‹ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">醫療æ¥å‹™</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 56 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應ä¾å…¶æä¾›æœå‹™ä¹‹æ€§è³ªï¼Œå…·å‚™é©ç•¶ä¹‹é†«ç™‚å ´æ‰€åŠå®‰å…¨è¨æ–½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構å°æ–¼æ‰€å±¬é†«äº‹äººå“¡åŸ·è¡Œç›´æŽ¥æŽ¥è§¸ç—…人體液或血液之醫療處置時，應自ä¸è¯æ°‘國一百零一年起，五年內按比例é€æ¥å®Œæˆå…¨é¢æ供安全é‡å…·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 57 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應ç£å°Žæ‰€å±¬é†«äº‹äººå“¡ï¼Œä¾å„該醫事專門è·æ¥æ³•è¦è¦å®šï¼ŒåŸ·è¡Œæ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構ä¸å¾—è˜åƒ±æˆ–å®¹ç•™æœªå…·é†«äº‹äººå“¡è³‡æ ¼è€…ï¼ŒåŸ·è¡Œæ‡‰ç”±ç‰¹å®šé†«äº‹äººå“¡åŸ·è¡Œä¹‹æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 58 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構ä¸å¾—置臨床助ç†åŸ·è¡Œé†«ç™‚æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 59 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院於診療時間外，應ä¾å…¶è¦æ¨¡åŠæ¥å‹™éœ€è¦ï¼ŒæŒ‡æ´¾é©ç•¶äººæ•¸ä¹‹é†«å¸«å€¼ç，以照顧ä½é™¢åŠæ€¥è¨ºç—…人。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 60 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院ã€è¨ºæ‰€é‡æœ‰å±æ€¥ç—…人，應先予é©ç•¶ä¹‹æ€¥æ•‘，並å³ä¾å…¶äººå“¡åŠè¨å‚™èƒ½åŠ›äºˆä»¥æ•‘治或採å–å¿…è¦æŽªæ–½ï¼Œä¸å¾—無故拖延。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …å±æ€¥ç—…人如係低收入或路倒病人，其醫療費用éžæœ¬äººæˆ–å…¶æ‰¶é¤Šç¾©å‹™äººæ‰€èƒ½è² æ“”è€…ï¼Œç”±ç›´è½„å¸‚ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府社會行政主管機關ä¾æ³•è£œåŠ©ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 61 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構，ä¸å¾—以ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šç¦æ¢ä¹‹ä¸æ£ç•¶æ–¹æ³•ï¼Œæ‹›æ”¬ç—…人。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構åŠå…¶äººå“¡ï¼Œä¸å¾—利用æ¥å‹™ä¸Šæ©Ÿæœƒç²å–ä¸æ£ç•¶åˆ©ç›Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 62 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院應建立醫療å“質管ç†åˆ¶åº¦ï¼Œä¸¦æª¢è¨Žè©•ä¼°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">為æå‡é†«ç™‚æœå‹™å“質，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—訂定辦法，就特定醫療技術ã€æª¢æŸ¥ã€æª¢é©—或醫療儀器，è¦å®šå…¶é©æ‡‰ç—‡ã€æ“ä½œäººå“¡è³‡æ ¼ã€æ¢ä»¶åŠå…¶ä»–應éµè¡Œäº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 63 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構實施手術，應å‘病人或其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–é—œä¿‚äººèªªæ˜Žæ‰‹è¡“åŽŸå› ã€æ‰‹è¡“æˆåŠŸçŽ‡æˆ–å¯èƒ½ç™¼ç”Ÿä¹‹ä½µç™¼ç—‡åŠå±éšªï¼Œä¸¦ç¶“å…¶åŒæ„，簽具手術åŒæ„書åŠéº»é†‰åŒæ„書，始得為之。但情æ³ç·Šæ€¥è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …åŒæ„書之簽具，病人為未æˆå¹´äººæˆ–無法親自簽具者，得由其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–關係人簽具。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …æ‰‹è¡“åŒæ„書åŠéº»é†‰åŒæ„æ›¸æ ¼å¼ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 64 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構實施ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¦å®šä¹‹ä¾µå…¥æ€§æª¢æŸ¥æˆ–治療，應å‘病人或其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–關係人說明，並經其åŒæ„，簽具åŒæ„書後，始得為之。但情æ³ç·Šæ€¥è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …åŒæ„書之簽具，病人為未æˆå¹´äººæˆ–無法親自簽具者，得由其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–關係人簽具。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 65 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構å°æŽ¡å–之組織檢體或手術切å–之器官，應é€è«‹ç—…ç†æª¢æŸ¥ï¼Œä¸¦å°‡çµæžœå‘ŠçŸ¥ç—…人或其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–關係人。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構å°æ–¼å‰é …之組織檢體或手術切å–之器官，應就臨床åŠç—…ç†è¨ºæ–·ä¹‹çµæžœï¼Œä½œæˆåˆ†æžã€æª¢è¨ŽåŠè©•ä¼°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 66 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院ã€è¨ºæ‰€å°æ–¼è¨ºæ²»ä¹‹ç—…人交付藥劑時，應於容器或包è£ä¸Šè¼‰æ˜Žç—…人姓åã€æ€§åˆ¥ã€è—¥åã€åŠ‘é‡ã€æ•¸é‡ã€ç”¨æ³•ã€ä½œç”¨æˆ–é©æ‡‰ç—‡ã€è¦èªžæˆ–副作用ã€é†«ç™‚機構å稱與地點ã€èª¿åŠ‘者姓ååŠèª¿åŠ‘å¹´ã€æœˆã€æ—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 67 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應建立清晰ã€è©³å¯¦ã€å®Œæ•´ä¹‹ç—…æ·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …所稱病æ·ï¼Œæ‡‰åŒ…括下列å„款之資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é†«å¸«ä¾é†«å¸«æ³•åŸ·è¡Œæ¥å‹™æ‰€è£½ä½œä¹‹ç—…æ·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å„é …æª¢æŸ¥ã€æª¢é©—å ±å‘Šè³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¶ä»–å„類醫事人員執行æ¥å‹™æ‰€è£½ä½œä¹‹ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">醫院å°æ–¼ç—…æ·ï¼Œæ‡‰è£½ä½œå„é …ç´¢å¼•åŠçµ±è¨ˆåˆ†æžï¼Œä»¥åˆ©ç ”究åŠæŸ¥è€ƒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 68 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應ç£å°Žå…¶æ‰€å±¬é†«äº‹äººå“¡æ–¼åŸ·è¡Œæ¥å‹™æ™‚，親自記載病æ·æˆ–製作紀錄，並簽åæˆ–è“‹ç« åŠåŠ 註執行年ã€æœˆã€æ—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …ç—…æ·æˆ–紀錄如有增刪，應於增刪處簽åæˆ–è“‹ç« åŠè¨»æ˜Žå¹´ã€æœˆã€æ—¥ï¼›åˆªæ”¹éƒ¨åˆ†ï¼Œæ‡‰ä»¥ç•«ç·šåŽ»é™¤ï¼Œä¸å¾—塗燬。</span> </p><p><span style="font-family: 新細明體,serif;">醫囑應於病æ·è¼‰æ˜Žæˆ–以書é¢ç‚ºä¹‹ã€‚但情æ³æ€¥è¿«æ™‚，得先以å£é æ–¹å¼ç‚ºä¹‹ï¼Œä¸¦æ–¼äºŒåå››å°æ™‚內完æˆæ›¸é¢ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 69 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構以電å文件方å¼è£½ä½œåŠè²¯å˜ä¹‹ç—…æ·ï¼Œå¾—å…å¦ä»¥æ›¸é¢æ–¹å¼è£½ä½œï¼›å…¶è³‡æ ¼æ¢ä»¶èˆ‡è£½ä½œæ–¹å¼ã€å…§å®¹åŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 70 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構之病æ·ï¼Œæ‡‰æŒ‡å®šé©ç•¶å ´æ‰€åŠäººå“¡ä¿ç®¡ï¼Œä¸¦è‡³å°‘ä¿å˜ä¸ƒå¹´ã€‚但未æˆå¹´è€…之病æ·ï¼Œè‡³å°‘應ä¿å˜è‡³å…¶æˆå¹´å¾Œä¸ƒå¹´ï¼›äººé«”試驗之病æ·ï¼Œæ‡‰æ°¸ä¹…ä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é†«ç™‚æ©Ÿæ§‹å› æ•…æœªèƒ½ç¹¼çºŒé–‹æ¥ï¼Œå…¶ç—…æ·æ‡‰äº¤ç”±æ‰¿æŽ¥è€…ä¾è¦å®šä¿å˜ï¼›ç„¡æ‰¿æŽ¥è€…時，病人或其代ç†äººå¾—è¦æ±‚醫療機構交付病æ·ï¼›å…¶é¤˜ç—…æ·æ‡‰ç¹¼çºŒä¿å˜å…個月以上，始得銷燬。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構具有æ£ç•¶ç†ç”±ç„¡æ³•ä¿å˜ç—…æ·æ™‚，由地方主管機關ä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構å°æ–¼é€¾ä¿å˜æœŸé™å¾—銷燬之病æ·ï¼Œå…¶éŠ·ç‡¬æ–¹å¼æ‡‰ç¢ºä¿ç—…æ·å…§å®¹ç„¡æ´©æ¼ä¹‹è™žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 71 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應ä¾å…¶è¨ºæ²»ä¹‹ç—…人è¦æ±‚，æ供病æ·è¤‡è£½æœ¬ï¼Œå¿…è¦æ™‚æä¾›ä¸æ–‡ç—…æ·æ‘˜è¦ï¼Œä¸å¾—ç„¡æ•…æ‹–å»¶æˆ–æ‹’çµ•ï¼›å…¶æ‰€éœ€è²»ç”¨ï¼Œç”±ç—…äººè² æ“”ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 72 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構åŠå…¶äººå“¡å› æ¥å‹™è€ŒçŸ¥æ‚‰æˆ–æŒæœ‰ç—…人病情或å¥åº·è³‡è¨Šï¼Œä¸å¾—ç„¡</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">æ•…æ´©æ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 73 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院ã€è¨ºæ‰€å› é™æ–¼äººå“¡ã€è¨å‚™åŠå°ˆé•·èƒ½åŠ›ï¼Œç„¡æ³•ç¢ºå®šç—…äººä¹‹ç—…å› æˆ–æ供完整治療時，應建è°ç—…人轉診。但å±æ€¥ç—…人應ä¾ç¬¬å…åæ¢ç¬¬ä¸€é …è¦å®šï¼Œå…ˆäºˆé©ç•¶ä¹‹æ€¥æ•‘，始å¯è½‰è¨ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …轉診，應填具轉診病æ·æ‘˜è¦äº¤äºˆç—…人，ä¸å¾—無故拖延或拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 74 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院ã€è¨ºæ‰€è¨ºæ²»ç—…人時，得ä¾éœ€è¦ï¼Œä¸¦ç¶“病人或其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–關係人之åŒæ„，商洽病人原診治之醫院ã€è¨ºæ‰€ï¼Œæ供病æ·è¤‡è£½æœ¬æˆ–ç—…æ·æ‘˜è¦åŠå„ç¨®æª¢æŸ¥å ±å‘Šè³‡æ–™ã€‚åŽŸè¨ºæ²»ä¹‹é†«é™¢ã€è¨ºæ‰€ä¸å¾—æ‹’çµ•ï¼›å…¶æ‰€éœ€è²»ç”¨ï¼Œç”±ç—…äººè² æ“”ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 75 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院得應出院病人之è¦æ±‚，為其安排é©ç•¶ä¹‹é†«ç™‚å ´æ‰€åŠäººå“¡ï¼Œç¹¼çºŒè¿½è¹¤ç…§é¡§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫院å°å°šæœªæ²»ç™’而è¦æ±‚出院之病人，得è¦æ±‚病人或其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–關係人，簽具自動出院書。</span> </p><p><span style="font-family: 新細明體,serif;">病人經診治並ä¾é†«å›‘通知å¯å‡ºé™¢æ™‚，應å³è¾¦ç†å‡ºé™¢æˆ–轉院。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 76 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫院ã€è¨ºæ‰€å¦‚無法令è¦å®šä¹‹ç†ç”±ï¼Œå°å…¶è¨ºæ²»ä¹‹ç—…人，ä¸å¾—拒絕開給出生è‰æ˜Žæ›¸ã€è¨ºæ–·æ›¸ã€æ»äº¡è‰æ˜Žæ›¸æˆ–æ»ç”¢è‰æ˜Žæ›¸ã€‚開給å„é …è¨ºæ–·æ›¸æ™‚ï¼Œæ‡‰åŠ›æ±‚æ…Žé‡ï¼Œå°¤å…¶æ˜¯æœ‰é—œæ»äº¡ä¹‹åŽŸå› 。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …診斷書如係病人為申請ä¿éšªç†è³ 之用者，應以ä¸æ–‡è¨˜è¼‰ï¼Œæ‰€è¨˜ç—…å如與ä¿éšªå¥‘ç´„ç—…åä¸ä¸€è‡´ï¼Œå¦ä»¥åŠ 註方å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫院ã€è¨ºæ‰€å°æ–¼éžç—…æ»æˆ–å¯ç–‘為éžç—…æ»è€…ï¼Œæ‡‰å ±è«‹æª¢å¯Ÿæ©Ÿé—œä¾æ³•ç›¸é©—。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 77 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構應接å—政府委託，å”助辦ç†å…¬å…±è¡›ç”Ÿã€ç¹¼çºŒæ•™è‚²ã€åœ¨è·è¨“ç·´ã€ç½å®³æ•‘助ã€æ€¥é›£æ•‘助ã€ç¤¾æœƒç¦åˆ©åŠæ°‘防ç‰æœ‰é—œé†«ç™‚æœå‹™äº‹å®œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 78 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為æ高國內醫療技術水準或é 防疾病上之需è¦ï¼Œæ•™å¸é†«é™¢ç¶“æ“¬å®šè¨ˆç•«ï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œæˆ–經ä¸å¤®ä¸»ç®¡æ©Ÿé—œå§”託者，得施行人體試驗。但å¸å藥生體å¯ç”¨çŽ‡ã€ç”Ÿé«”相ç‰æ€§ä¹‹äººé«”è©¦é©—ç ”ç©¶å¾—å…經ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¹‹æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">éžæ•™å¸é†«é™¢ä¸å¾—施行人體試驗。但醫療機構有特殊專長，經ä¸å¤®ä¸»ç®¡æ©Ÿé—œåŒæ„者，得準用å‰é …è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構施行人體試驗應先將人體試驗計畫，æ經醫療科技人員ã€æ³•å¾‹å°ˆå®¶åŠç¤¾æœƒå…¬æ£äººå£«æˆ–民間團體代表，且任一性別ä¸å¾—低於三分之一之人員會åŒå¯©æŸ¥é€šéŽã€‚審查人員並應éµå®ˆåˆ©ç›Šè¿´é¿åŽŸå‰‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗計畫內容變更時，應ä¾å‰ä¸‰é …è¦å®šç¶“審查åŠæ ¸å‡†æˆ–åŒæ„後，始得施行。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構施行人體試驗時，應善盡醫療上必è¦ä¹‹æ³¨æ„，並應先å–得接å—試驗者之書é¢åŒæ„；接å—試驗者以有æ„æ€èƒ½åŠ›ä¹‹æˆå¹´äººç‚ºé™ã€‚但顯有益於特定人å£ç¾¤æˆ–特殊疾病罹患者å¥åº·æ¬Šç›Šä¹‹è©¦é©—，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …但書之接å—試驗者為é™åˆ¶è¡Œç‚ºèƒ½åŠ›äººï¼Œæ‡‰å¾—其本人與法定代ç†äººåŒæ„；接å—試驗者為無行為能力人，應得其法定代ç†äººåŒæ„。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …æ›¸é¢ï¼Œé†«ç™‚æ©Ÿæ§‹æ‡‰è‡³å°‘è¼‰æ˜Žä¸‹åˆ—äº‹é …ï¼Œä¸¦æ–¼æŽ¥å—試驗者或法定代ç†äººåŒæ„å‰ï¼Œä»¥å…¶å¯ç†è§£æ–¹å¼å…ˆè¡Œå‘ŠçŸ¥ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è©¦é©—目的åŠæ–¹æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¯é 期風險åŠå‰¯ä½œç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é 期試驗效果。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å…¶ä»–å¯èƒ½ä¹‹æ²»ç™‚æ–¹å¼åŠèªªæ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æŽ¥å—試驗者得隨時撤回åŒæ„之權利。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è©¦é©—有關之æ害補償或ä¿éšªæ©Ÿåˆ¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å—試者個人資料之ä¿å¯†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å—試者生物檢體ã€å€‹äººè³‡æ–™æˆ–å…¶è¡ç”Ÿç‰©ä¹‹ä¿å˜èˆ‡å†åˆ©ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …告知åŠæ›¸é¢åŒæ„，醫療機構應給予充分時間考慮，並ä¸å¾—以脅迫或其他ä¸æ£ç•¶æ–¹å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫師ä¾å‰å››é …è¦å®šæ–½è¡Œäººé«”è©¦é©—ï¼Œå› è©¦é©—æœ¬èº«ä¸å¯é è¦‹ä¹‹å› ç´ ï¼Œè‡´ç—…äººæ»äº¡æˆ–傷害者，ä¸ç¬¦åˆ‘法第å三æ¢æˆ–第åå››æ¢ä¹‹æ•…æ„或éŽå¤±è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">除本法å¦æœ‰è¦å®šè€…外，å‰äºŒæ¢æœ‰é—œäººé«”試驗之申請程åºã€å¯©æŸ¥ä½œæ¥åŸºæº–åŠåˆ©ç›Šè¿´é¿åŽŸå‰‡ã€è³‡è¨Šæ露ã€ç›£ç£ç®¡ç†ã€æŸ¥æ ¸ã€å…¶ä»–告知內容ç‰äº‹é …，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79-2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構å°ä¸åŒæ„åƒèˆ‡äººé«”試驗者或撤回åŒæ„之接å—試驗者，應施行常è¦æ²»ç™‚，ä¸å¾—減æå…¶æ£ç•¶é†«ç™‚權益。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 80 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構施行人體試驗期間，應ä¾ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¹‹é€šçŸ¥æå‡ºè©¦é©—æƒ…å½¢å ±å‘Šï¼›ä¸å¤®ä¸»ç®¡æ©Ÿé—œèªæœ‰å®‰å…¨ä¹‹è™žè€…，醫療機構應å³åœæ¢è©¦é©—。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構於人體試驗施行完æˆæ™‚，應作æˆè©¦é©—å ±å‘Šï¼Œå ±è«‹ä¸å¤®ä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 81 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構診治病人時，應å‘病人或其法定代ç†äººã€é…å¶ã€è¦ªå±¬æˆ–關係人告知其病情ã€æ²»ç™‚æ–¹é‡ã€è™•ç½®ã€ç”¨è—¥ã€é 後情形åŠå¯èƒ½ä¹‹ä¸è‰¯å應。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 82 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療æ¥å‹™ä¹‹æ–½è¡Œï¼Œæ‡‰å–„盡醫療上必è¦ä¹‹æ³¨æ„。</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構åŠå…¶é†«äº‹äººå“¡å› 執行æ¥å‹™è‡´ç”Ÿæ害於病人，以故æ„或éŽå¤±ç‚ºé™ï¼Œè² æå®³è³ å„Ÿè²¬ä»»ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 83 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¸æ³•é™¢æ‡‰æŒ‡å®šæ³•é™¢è¨ç«‹é†«äº‹å°ˆæ¥æ³•åºï¼Œç”±å…·æœ‰é†«äº‹ç›¸é—œå°ˆæ¥çŸ¥è˜æˆ–審判經驗之法官，辦ç†é†«äº‹ç³¾ç´›è¨´è¨Ÿæ¡ˆä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">醫療廣告</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 84 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éžé†«ç™‚機構，ä¸å¾—為醫療廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 85 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«ç™‚å»£å‘Šï¼Œå…¶å…§å®¹ä»¥ä¸‹åˆ—äº‹é …ç‚ºé™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é†«ç™‚機構之å稱ã€é–‹æ¥åŸ·ç…§å—號ã€åœ°å€ã€é›»è©±åŠäº¤é€šè·¯ç·šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é†«å¸«ä¹‹å§“åã€æ€§åˆ¥ã€å¸æ·ã€ç¶“æ·åŠå…¶é†«å¸«ã€å°ˆç§‘醫師è‰æ›¸å—號。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¨æ°‘å¥åº·ä¿éšªåŠå…¶ä»–éžå•†æ¥æ€§ä¿éšªä¹‹ç‰¹ç´„醫院ã€è¨ºæ‰€å—樣。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¨ºç™‚科別åŠè¨ºç™‚時間。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€é–‹æ¥ã€æ‡æ¥ã€åœæ¥ã€å¾©æ¥ã€é·ç§»åŠå…¶å¹´ã€æœˆã€æ—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å…¶ä»–經ä¸å¤®ä¸»ç®¡æ©Ÿé—œå…¬å‘Šå®¹è¨±ç™»è¼‰æˆ–æ’æ”¾äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">利用廣æ’ã€é›»è¦–之醫療廣告，在å‰é …內容範åœå…§ï¼Œå¾—以å£èªžåŒ–æ–¹å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">但應先經所在地直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療機構以網際網路æ供之資訊，除有第一百零三æ¢ç¬¬äºŒé …å„款所定情形外，ä¸å—ç¬¬ä¸€é …æ‰€å®šå…§å®¹ç¯„åœä¹‹é™åˆ¶ï¼Œå…¶ç®¡ç†è¾¦æ³•ç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 86 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療廣告ä¸å¾—以下列方å¼ç‚ºä¹‹ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å‡å€Ÿä»–人å義為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åˆ©ç”¨å‡ºå”®æˆ–贈與醫療刊物為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä»¥å…¬é–‹ç¥–傳秘方或公開ç”å•ç‚ºå®£å‚³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ‘˜éŒ„醫å¸åˆŠç‰©å…§å®¹ç‚ºå®£å‚³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è—‰æŽ¡è¨ªæˆ–å ±å°Žç‚ºå®£å‚³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€èˆ‡é•åå‰æ¢è¦å®šå…§å®¹ä¹‹å»£å‘Šè¯åˆæˆ–並排為宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ä»¥å…¶ä»–ä¸æ£ç•¶æ–¹å¼ç‚ºå®£å‚³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 87 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">廣告內容暗示或影射醫療æ¥å‹™è€…，視為醫療廣告。</span> </p><p><span style="font-family: 新細明體,serif;">醫å¸æ–°çŸ¥æˆ–ç ”ç©¶å ±å‘Šä¹‹ç™¼è¡¨ã€ç—…人衛生教育ã€å¸è¡“性刊物，未涉åŠæ‹›å¾ 醫療æ¥å‹™è€…，ä¸è¦–為醫療廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å…</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">醫事人力åŠè¨æ–½åˆ†å¸ƒ</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 88 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œç‚ºä¿ƒé€²é†«ç™‚資æºå‡è¡¡ç™¼å±•ï¼Œçµ±ç±Œè¦åŠƒç¾æœ‰å…¬ç§ç«‹é†«ç™‚機構åŠäººåŠ›åˆç†åˆ†å¸ƒï¼Œå¾—劃分醫療å€åŸŸï¼Œå»ºç«‹åˆ†ç´šé†«ç™‚制度，訂定醫療網計畫。</span> </p><p><span style="font-family: 新細明體,serif;">主管機關得ä¾å‰é …醫療網計畫，å°é†«ç™‚資æºç¼ºä¹å€åŸŸï¼ŒçŽå‹µæ°‘é–“è¨ç«‹é†«ç™‚機構ã€è·ç†ä¹‹å®¶æ©Ÿæ§‹ï¼›å¿…è¦æ™‚，得由政府è¨ç«‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 89 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療å€åŸŸä¹‹åŠƒåˆ†ï¼Œæ‡‰è€ƒæ…®å€åŸŸå…§é†«ç™‚資æºåŠäººå£åˆ†å¸ƒï¼Œå¾—超越行政å€åŸŸä¹‹ç•Œé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 90 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨‚定醫療網計畫時，直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關應ä¾è©²è¨ˆç•«ï¼Œå°±è½„å€å…§é†«ç™‚機構之è¨ç«‹æˆ–擴充，予以審查。但一定è¦æ¨¡ä»¥ä¸Šå¤§åž‹é†«é™¢ä¹‹è¨ç«‹æˆ–æ“´å……ï¼Œæ‡‰å ±ç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å°æ–¼é†«ç™‚è¨æ–½éŽè³¸å€åŸŸï¼Œä¸»ç®¡æ©Ÿé—œå¾—é™åˆ¶é†«ç™‚機構或è·ç†æ©Ÿæ§‹ä¹‹è¨ç«‹æˆ–擴充。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 91 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œç‚ºä¿ƒé€²é†«ç™‚事æ¥ç™¼å±•ã€æå‡é†«ç™‚å“質與效率åŠå‡è¡¡é†«ç™‚資æºï¼Œæ‡‰æŽ¡å–çŽå‹µæŽªæ–½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …çŽå‹µæŽªæ–½ä¹‹é …ç›®ã€æ–¹å¼åŠå…¶ä»–é…åˆæŽªæ–½ä¹‹è¾¦æ³•ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 92 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—è¨ç½®é†«ç™‚發展基金，供å‰æ¢æ‰€å®šçŽå‹µä¹‹ç”¨ï¼›å…¶åŸºé‡‘之收支ã€ä¿ç®¡åŠé‹ç”¨è¾¦æ³•ï¼Œç”±è¡Œæ”¿é™¢å®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 93 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構購置åŠä½¿ç”¨å…·æœ‰å±éšªæ€§é†«ç™‚儀器，ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ–¼å¿…è¦æ™‚得予審查åŠè©•ä¼°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä»¥å…¬ç›Šç‚ºç›®çš„ä¹‹ç¤¾åœ˜æ³•äººæˆ–è²¡åœ˜æ³•äººï¼Œæ–¼ç« ç¨‹æ‰€å®šç›®çš„ç¯„åœå…§ï¼Œç‚ºæŽ¨å‹•é†«ç™‚技術å‡ç´šç™¼å±•ç ”究計畫，而其投資金é¡é€¾ä¸€å®šé–€æª»è€…，得經ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨±å¯ï¼Œä¾ç¬¬ä¸‰åæ¢åŠç¬¬ä¸‰å一æ¢ä¹‹è¦å®šè¨ç«‹é†«ç™‚法人醫療機構，購置åŠä½¿ç”¨å…·æœ‰å±éšªæ€§é†«ç™‚儀器。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …æ‰€ç¨±ä¹‹å…·æœ‰å±éšªæ€§é†«ç™‚å„€å™¨ä¹‹é …ç›®åŠå…¶å¯©æŸ¥åŠè©•ä¼°è¾¦æ³•ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">七</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">æ•™å¸é†«é™¢</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 94 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為æ高醫療水準，醫院得申請評鑑為教å¸é†«é™¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 95 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ•™å¸é†«é™¢ä¹‹è©•é‘‘，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œæœƒå•†ä¸å¤®æ•™è‚²ä¸»ç®¡æ©Ÿé—œå®šæœŸè¾¦ç†ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰å°‡æ•™å¸é†«é™¢è©•é‘‘çµæžœï¼Œä»¥æ›¸é¢é€šçŸ¥ç”³è«‹è©•é‘‘醫院，並</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">將評鑑åˆæ ¼ä¹‹æ•™å¸é†«é™¢åå–®åŠå…¶è³‡æ ¼æœ‰æ•ˆæœŸé–“ç‰æœ‰é—œäº‹é …公告之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 96 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ•™å¸é†«é™¢æ‡‰æ“¬å…·è¨“練計畫，辦ç†é†«å¸«åŠå…¶ä»–醫事人員訓練åŠç¹¼çºŒæ•™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">育，並接å—醫å¸é™¢ã€æ ¡å¸ç”Ÿè‡¨åºŠè¦‹ç¿’ã€å¯¦ç¿’。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰é …辦ç†é†«å¸«èˆ‡å…¶ä»–醫事人員訓練åŠæŽ¥å—醫å¸é™¢ã€æ ¡å¸ç”Ÿè‡¨åºŠè¦‹ç¿’ã€å¯¦ç¿’之人數，應ä¾æ ¸å®šè¨“練容é‡ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 97 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ•™å¸é†«é™¢æ‡‰æŒ‰å¹´ç·¨åˆ—ç ”ç©¶ç™¼å±•åŠäººæ‰åŸ¹è¨“經費，其所å 之比率，ä¸å¾—</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">少於年度醫療收入總é¡ç™¾åˆ†ä¹‹ä¸‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å…«</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">醫事審è°å§”員會</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 98 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ‡‰è¨ç½®é†«äº‹å¯©è°å§”員會，ä¾å…¶ä»»å‹™åˆ†åˆ¥è¨ç½®å„種å°çµ„，其任務如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é†«ç™‚制度之改進。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é†«ç™‚技術之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€äººé«”試驗之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¸æ³•æˆ–檢察機關之委託鑑定。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å°ˆç§‘醫師制度之改進。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€é†«å¾·ä¹‹ä¿ƒé€²ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ä¸€å®šè¦æ¨¡ä»¥ä¸Šå¤§åž‹é†«é™¢è¨ç«‹æˆ–擴充之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å…¶ä»–有關醫事之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫事審è°å§”員會之組織ã€æœƒè°ç‰ç›¸é—œè¦å®šï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 99 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關應è¨ç½®é†«äº‹å¯©è°å§”員會，任務如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é†«ç™‚機構è¨ç«‹æˆ–擴充之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é†«ç™‚收費標準之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é†«ç™‚çˆè°ä¹‹èª¿è™•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€é†«å¾·ä¹‹ä¿ƒé€²ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å…¶ä»–有關醫事之審è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫事審è°å§”員會之組織ã€æœƒè°ç‰ç›¸é—œè¦å®šï¼Œç”±ç›´è½„市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 100 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰äºŒæ¢ä¹‹é†«äº‹å¯©è°å§”員會委員，應就ä¸å…·æ°‘æ„代表ã€é†«ç™‚法人代表身分之醫事ã€æ³•å¸å°ˆå®¶ã€å¸è€…åŠç¤¾æœƒäººå£«é´è˜ä¹‹ï¼Œå…¶ä¸æ³•å¸å°ˆå®¶åŠç¤¾æœƒäººå£«ä¹‹æ¯”例，ä¸å¾—少於三分之一。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">ä¹</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">罰則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 101 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第å七æ¢ç¬¬ä¸€é …ã€ç¬¬åä¹æ¢ç¬¬ä¸€é …ã€ç¬¬äºŒåæ¢ã€ç¬¬äºŒå二æ¢ç¬¬ä¸€é …ã€ç¬¬äºŒå三æ¢ç¬¬ä¸€é …ã€ç¬¬äºŒåå››æ¢ç¬¬ä¸€é …ã€ç¬¬äº”åå…æ¢ç¬¬äºŒé …è¦å®šè€…，經予è¦å‘Šè™•åˆ†ï¼Œä¸¦é™æœŸæ”¹å–„；屆期未改善者，處新臺幣一è¬å…ƒä»¥ä¸Šäº”è¬å…ƒä»¥ä¸‹ç½°é°ï¼ŒæŒ‰æ¬¡é€£çºŒè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 102 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有下列情形之一者，處新臺幣一è¬å…ƒä»¥ä¸Šäº”è¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦ä»¤é™æœŸæ”¹å–„；屆期未改善者，按次連續處罰：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é•å第二å五æ¢ç¬¬ä¸€é …ã€ç¬¬äºŒåå…æ¢ã€ç¬¬äºŒå七æ¢ç¬¬ä¸€é …ã€ç¬¬äº”åä¹æ¢ã€ç¬¬å…åæ¢ç¬¬ä¸€é …ã€ç¬¬å…å五æ¢ã€ç¬¬å…åå…æ¢ã€ç¬¬å…å七æ¢ç¬¬ä¸€é …ã€ç¬¬ä¸‰é …ã€ç¬¬å…åå…«æ¢ã€ç¬¬ä¸ƒåæ¢ã€ç¬¬ä¸ƒå一æ¢ã€ç¬¬ä¸ƒå三æ¢ã€ç¬¬ä¸ƒåå››æ¢ã€ç¬¬ä¸ƒåå…æ¢æˆ–第八åæ¢ç¬¬äºŒé …è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é•åä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬å二æ¢ç¬¬ä¸‰é …è¦å®šæ‰€å®šä¹‹è¨ç½®æ¨™æº–。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é•åä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬å三æ¢è¦å®šæ‰€å®šä¹‹ç®¡ç†è¾¦æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€é•åä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬å…åä¹æ¢è¦å®šæ‰€å®šä¹‹è¾¦æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">有下列情形之一，經ä¾å‰é …è¦å®šè™•ç½°ä¸¦ä»¤é™æœŸæ”¹å–„；屆期未改善者，得處一個月以上一年以下åœæ¥è™•åˆ†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é•å第二å五æ¢ç¬¬ä¸€é …或第å…åå…æ¢è¦å®šè€…。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é•åä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬å二æ¢ç¬¬ä¸‰é …è¦å®šæ‰€å®šä¹‹è¨ç½®æ¨™æº–者。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é•åä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬å三æ¢è¦å®šæ‰€å®šä¹‹ç®¡ç†è¾¦æ³•è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€é•åä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬å…åä¹æ¢è¦å®šæ‰€å®šä¹‹è¾¦æ³•è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 103 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有下列情形之一者，處新臺幣五è¬å…ƒä»¥ä¸ŠäºŒå五è¬å…ƒä»¥ä¸‹ç½°é°ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é•å第å五æ¢ç¬¬ä¸€é …ã€ç¬¬å七æ¢ç¬¬äºŒé …ã€ç¬¬äºŒå二æ¢ç¬¬äºŒé …ã€ç¬¬äºŒå三æ¢ç¬¬å››é …ã€ç¬¬äº”é …ã€ç¬¬äº”å七æ¢ç¬¬ä¸€é …ã€ç¬¬å…å一æ¢ã€ç¬¬å…å三æ¢ç¬¬ä¸€é …ã€ç¬¬å…åå››æ¢ã€ç¬¬ä¸ƒå二æ¢ã€ç¬¬å…«å五æ¢ã€ç¬¬å…«åå…æ¢è¦å®šæˆ–æ“…è‡ªè®Šæ›´æ ¸å‡†ä¹‹å»£å‘Šå…§å®¹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é•åä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬å…å二æ¢ç¬¬äºŒé …ã€ç¬¬ä¹å三æ¢ç¬¬äºŒé …è¦å®šæ‰€å®šä¹‹è¾¦æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é†«ç™‚機構è˜åƒ±æˆ–å®¹ç•™æœªå…·é†«å¸«ä»¥å¤–ä¹‹é†«äº‹äººå“¡è³‡æ ¼è€…ï¼ŒåŸ·è¡Œæ‡‰</span> <span style="font-family: 新細明體,serif;">由特定醫事人員執行之æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療廣告é•å第八å五æ¢ã€ç¬¬å…«åå…æ¢è¦å®šæˆ–æ“…è‡ªè®Šæ›´æ ¸å‡†å…§å®¹è€…ï¼Œé™¤ä¾å‰é …è¦å®šè™•ç½°å¤–，其有下列情形之一者，得處一個月以上一年以下åœæ¥è™•åˆ†æˆ–廢æ¢å…¶é–‹æ¥åŸ·ç…§ï¼Œä¸¦ç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œåŠéŠ·å…¶è² 責醫師之醫師è‰æ›¸ä¸€å¹´ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å…§å®¹è™›å½ã€èª‡å¼µã€æªæ›²äº‹å¯¦æˆ–有傷風化。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä»¥éžæ³•å¢®èƒŽç‚ºå®£å‚³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¸€å¹´å…§å·²å—處罰三次。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第八åå››æ¢è¦å®šç‚ºé†«ç™‚廣告者，處新臺幣五è¬å…ƒä»¥ä¸ŠäºŒå五è¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 105 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第七åå…«æ¢ç¬¬ä¸€é …æˆ–ç¬¬äºŒé …è¦å®šï¼Œæœªç¶“ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€å§”託或åŒæ„，施行人體試驗者，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œè™•æ–°è‡ºå¹£äºŒåè¬å…ƒä»¥ä¸Šä¸€ç™¾è¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦ä»¤å…¶ä¸æ¢æˆ–終æ¢äººé«”試驗；情節é‡å¤§è€…，並得處一個月以上一年以下åœæ¥è™•åˆ†æˆ–廢æ¢å…¶é–‹æ¥åŸ·ç…§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å第七åå…«æ¢ç¬¬ä¸‰é …或ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬ä¸ƒåä¹æ¢ä¹‹ä¸€æŽˆæ¬Šæ‰€å®šè¾¦æ³•æœ‰é—œå¯©æŸ¥ä½œæ¥åŸºæº–者，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œè™•æ–°è‡ºå¹£åè¬å…ƒä»¥ä¸Šäº”åè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦å¾—令其ä¸æ¢è©²é …人體試驗或第七åå…«æ¢ç¬¬ä¸‰é …所定之審查。</span> </p><p><span style="font-family: 新細明體,serif;">é•å第七åä¹æ¢ã€ç¬¬ä¸ƒåä¹æ¢ä¹‹äºŒã€ç¬¬å…«åæ¢ç¬¬ä¸€é …或ä¸å¤®ä¸»ç®¡æ©Ÿé—œä¾ç¬¬ä¸ƒåä¹æ¢ä¹‹ä¸€æŽˆæ¬Šæ‰€å®šè¾¦æ³•æœ‰é—œç›£ç£ç®¡ç†æˆ–æŸ¥æ ¸äº‹é …ä¹‹è¦å®šè€…，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œè™•æ–°è‡ºå¹£åè¬å…ƒä»¥ä¸Šäº”åè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œæœ‰å®‰å…¨æˆ–æ害å—試者權益之虞時，å¦å¾—令其終æ¢äººé«”試驗；情節é‡å¤§è€…，並得就其全部或一部之相關æ¥å‹™æˆ–é•åè¦å®šä¹‹ç§‘別ã€æœå‹™é …目，處一個月以上一年以下åœæ¥è™•åˆ†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å第七åå…«æ¢ç¬¬å››é …è¦å®šè€…，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œè™•æ–°è‡ºå¹£äº”è¬å…ƒä»¥ä¸ŠäºŒå五è¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦ä»¤å…¶ä¸æ¢è©²äººé«”試驗；情節é‡å¤§è€…，並得令其終æ¢è©²äººé«”試驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 106 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第二åå››æ¢ç¬¬äºŒé …è¦å®šè€…，處新臺幣三è¬å…ƒä»¥ä¸Šäº”è¬å…ƒä»¥ä¸‹ç½°é°ã€‚其觸犯刑法者，應移é€å¸æ³•æ©Ÿé—œè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 107 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第å…å一æ¢ç¬¬äºŒé …ã€ç¬¬å…å二æ¢ç¬¬äºŒé …ã€ç¬¬å…å三æ¢ç¬¬ä¸€é …ã€ç¬¬å…åå››æ¢ç¬¬ä¸€é …ã€ç¬¬å…åå…«æ¢ã€ç¬¬ä¸ƒå二æ¢ã€ç¬¬ä¸ƒåå…«æ¢ã€ç¬¬ä¸ƒåä¹æ¢æˆ–第ä¹å三æ¢ç¬¬äºŒé …è¦å®šè€…，除ä¾ç¬¬ä¸€ç™¾é›¶äºŒæ¢ã€ç¬¬ä¸€ç™¾é›¶ä¸‰æ¢æˆ–第一百零五æ¢è¦å®šè™•ç½°å¤–，å°å…¶è¡Œç‚ºäººäº¦è™•ä»¥å„該æ¢ä¹‹ç½°é°ï¼›å…¶è§¸çŠ¯åˆ‘事法律者，並移é€å¸æ³•æ©Ÿé—œè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …行為人如為醫事人員，並ä¾å„該醫事專門è·æ¥æ³•è¦è¦å®šæ‡²è™•ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 108 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構有下列情事之一者，處新臺幣五è¬å…ƒä»¥ä¸Šäº”åè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦å¾—按其情節就é•åè¦å®šä¹‹è¨ºç™‚科別ã€æœå‹™é …目或其全部或一部之門診ã€ä½é™¢æ¥å‹™ï¼Œè™•ä¸€å€‹æœˆä»¥ä¸Šä¸€å¹´ä»¥ä¸‹åœæ¥è™•åˆ†æˆ–廢æ¢å…¶é–‹æ¥åŸ·ç…§ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å±¬é†«ç™‚æ¥å‹™ç®¡ç†ä¹‹æ˜Žé¡¯ç–å¤±ï¼Œè‡´é€ æˆç—…患傷亡者。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ˜ŽçŸ¥èˆ‡äº‹å¯¦ä¸ç¬¦è€Œè¨˜è¼‰ç—…æ·æˆ–出具診斷書ã€å‡ºç”Ÿè‰æ˜Žæ›¸ã€æ»äº¡è‰æ˜Žæ›¸æˆ–æ»ç”¢è‰æ˜Žæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŸ·è¡Œä¸å¤®ä¸»ç®¡æ©Ÿé—œè¦å®šä¸å¾—執行之醫療行為。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä½¿ç”¨ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¦å®šç¦æ¢ä½¿ç”¨ä¹‹è—¥ç‰©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å®¹ç•™é•å醫師法第二åå…«æ¢è¦å®šä¹‹äººå“¡åŸ·è¡Œé†«ç™‚æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¾žäº‹æœ‰å‚·é¢¨åŒ–或å±å®³äººé«”å¥åº·ç‰ä¸æ£ç•¶æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è¶…æ”¶é†«ç™‚è²»ç”¨æˆ–æ“…ç«‹æ”¶è²»é …ç›®æ”¶è²»ç¶“æŸ¥å±¬å¯¦ï¼Œè€Œæœªä¾é™å°‡è¶…收部分退還病人。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 109 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構å—åœæ¥è™•åˆ†è€Œä¸åœæ¥è€…，廢æ¢å…¶é–‹æ¥åŸ·ç…§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 110 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構å—廢æ¢é–‹æ¥åŸ·ç…§è™•åˆ†è€…ï¼Œå…¶è² è²¬é†«å¸«æ–¼ä¸€å¹´å…§ä¸å¾—在原å€æˆ–其他處所申請è¨ç«‹é†«ç™‚機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 111 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構å—廢æ¢é–‹æ¥åŸ·ç…§è™•åˆ†ï¼Œä»ç¹¼çºŒé–‹æ¥è€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—åŠéŠ·å…¶è² 責醫師之醫師è‰æ›¸äºŒå¹´ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 112 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人é•å第三åå››æ¢ç¬¬äº”é …ã€ç¬¬ä¸‰å七æ¢ç¬¬ä¸€é …è¦å®šç‚ºä¿è‰äººè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—處新臺幣åè¬å…ƒä»¥ä¸Šäº”åè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦å¾—é™æœŸå‘½å…¶æ”¹å–„；逾期未改善者，得連續處罰之。其所為之ä¿è‰ï¼Œä¸¦ç”±è¡Œç‚ºäººè‡ªè² ä¿è‰è²¬ä»»ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療法人é•å第三å七æ¢ç¬¬äºŒé …è¦å®šï¼Œé™¤ç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—處董事長新臺幣åè¬å…ƒä»¥ä¸Šäº”åè¬å…ƒä»¥ä¸‹ç½°é°å¤–ï¼Œé†«ç™‚æ³•äººå¦‚æœ‰å› è€Œå—æå®³æ™‚ï¼Œè¡Œç‚ºäººä¸¦æ‡‰è² è³ å„Ÿè²¬ä»»ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 113 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療法人é•å第三åå››æ¢ç¬¬äºŒé …ã€ç¬¬ä¸‰å五æ¢ç¬¬ä¸€é …或第四åæ¢ä¹‹è¦å®šè€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—處新臺幣一è¬å…ƒä»¥ä¸Šåè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦é™æœŸå‘½å…¶è£œæ£ã€‚逾期未補æ£è€…，並得連續處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">é†«ç™‚æ³•äººæœ‰æ‡‰ç™»è¨˜ä¹‹äº‹é …è€Œæœªç™»è¨˜è€…ï¼Œä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—å°æ‡‰ç”³è«‹ç™»è¨˜ä¹‹ç¾©å‹™äººè™•æ–°è‡ºå¹£ä¸€è¬å…ƒä»¥ä¸Šåè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦é™æœŸå‘½å…¶è£œæ£ã€‚逾期未補æ£è€…，並得連續處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …æƒ…å½¢ï¼Œæ‡‰ç”³è«‹ç™»è¨˜ä¹‹ç¾©å‹™äººç‚ºæ•¸äººæ™‚ï¼Œæ‡‰å…¨é«”è² é€£å¸¶è²¬ä»»ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 114 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">董事ã€ç›£å¯Ÿäººé•å第四åä¹æ¢ç¬¬å››é …è¦å®šæœªå ±å‚™è€…，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—處該董事或監察人新臺幣五è¬å…ƒä»¥ä¸ŠäºŒåè¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">醫療法人經許å¯è¨ç«‹å¾Œï¼Œæœªä¾å…¶è¨ç«‹è¨ˆç•«æ›¸è¨ç«‹é†«ç™‚機構，ä¸å¤®ä¸»ç®¡æ©Ÿé—œå¾—é™æœŸå‘½å…¶æ”¹å–„；逾期未改善者，得廢æ¢å…¶è¨±å¯ã€‚å…¶è¨ç«‹è¨ˆç•«è®Šæ›´è€…，亦åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 115 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所定之罰é°ï¼Œæ–¼ç§ç«‹é†«ç™‚æ©Ÿæ§‹ï¼Œè™•ç½°å…¶è² è²¬é†«å¸«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">本法所定之罰é°ï¼Œæ–¼é†«ç™‚法人è¨ç«‹ä¹‹é†«ç™‚機構，處罰醫療法人。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …å‰æ®µè¦å®šï¼Œæ–¼ä¾ç¬¬ä¸€ç™¾é›¶ä¸ƒæ¢è¦å®šè™•ç½°ä¹‹è¡Œç‚ºäººç‚ºè² 責醫師者，ä¸å¦ç‚ºè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 116 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所定之罰é°ã€åœæ¥åŠå»¢æ¢é–‹æ¥åŸ·ç…§ï¼Œé™¤æœ¬æ³•å¦æœ‰è¦å®šå¤–，由直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 117 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•æ‰€è™•ä¹‹ç½°é°ï¼Œç¶“é™æœŸç¹³ç´ï¼Œå±†æœŸæœªç¹³ç´è€…，ä¾æ³•ç§»é€å¼·åˆ¶åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 118 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è»äº‹æ©Ÿé—œæ‰€å±¬é†«ç™‚機構åŠå…¶é™„è¨æ°‘眾診療機構之è¨ç½®åŠç®¡ç†ï¼Œä¾æœ¬æ³•ä¹‹è¦å®šã€‚但所屬醫療機構涉åŠåœ‹é˜²å®‰å…¨äº‹å‹™è€ƒé‡ä¹‹éƒ¨åˆ†ï¼Œå…¶ç®¡ç†ä¾åœ‹é˜²éƒ¨ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 119 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法修æ£æ–½è¡Œå‰å·²è¨ç«‹ä¹‹é†«ç™‚機構與本法è¦å®šä¸ç¬¦è€…，應於本法修æ£æ–½è¡Œä¹‹æ—¥èµ·ä¸€å¹´å…§è¾¦ç†è£œæ£ï¼›å±†æœŸä¸è£œæ£è€…，由原許å¯æ©Ÿé—œå»¢æ¢å…¶è¨±å¯ã€‚但有特殊情æ³ä¸èƒ½æ–¼ä¸€å¹´å…§å®Œæˆè£œæ£ï¼Œç¶“申請ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…，得展延之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 120 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法修æ£æ–½è¡Œå‰é ˜æœ‰ä¸å¤®ä¸»ç®¡æ©Ÿé—œæ ¸ç™¼ä¹‹åœ‹è¡“æ傷接骨技術員登記è‰è€…繼續有效，其管ç†è¾¦æ³•ç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 121 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¾¦ç†é†«é™¢è©•é‘‘，得收å–評鑑費；直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">主管機關ä¾æœ¬æ³•æ ¸ç™¼åŸ·ç…§æ™‚，得收å–執照費。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è©•é‘‘è²»åŠåŸ·ç…§è²»ä¹‹è²»é¡ï¼Œç”±ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 122 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法施行細則，由ä¸å¤®ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 123 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法自公布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1024&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1025&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6046&type=0
藥政管ç†é¡ž,藥事法法律藥事法<p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事之管ç†ï¼Œä¾æœ¬æ³•ä¹‹è¦å®šï¼›æœ¬æ³•æœªè¦å®šè€…，ä¾å…¶ä»–有關法律之è¦å®šã€‚但管制藥å“管ç†æ¢ä¾‹æœ‰è¦å®šè€…，優先é©ç”¨è©²æ¢ä¾‹ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …所稱藥事，指藥物ã€è—¥å•†ã€è—¥å±€åŠå…¶æœ‰é—œäº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱衛生主管機關：在ä¸å¤®ç‚ºè¡Œæ”¿é™¢è¡›ç”Ÿç½²ï¼›åœ¨ç›´è½„市為直轄市政府；在縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">政府。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—å°ˆè¨è—¥ç‰©ç®¡ç†æ©Ÿé—œï¼Œç›´è½„市åŠç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關於必è¦æ™‚äº¦å¾—å ±å‡†è¨ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱藥物，係指藥å“åŠé†«ç™‚器æ。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱試驗用藥物，係指醫療效能åŠå®‰å…¨å°šæœªç¶“è‰å¯¦ï¼Œå°ˆä¾›å‹•ç‰©æ¯’性藥ç†è©•ä¼°æˆ–臨床試驗用之藥物。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱藥å“，係指左列å„款之一之原料藥åŠè£½åŠ‘：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¼‰æ–¼ä¸è¯è—¥å…¸æˆ–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šä¹‹å…¶ä»–å„國藥典ã€å…¬å®šä¹‹åœ‹å®¶è™•æ–¹é›†ï¼Œæˆ–å„該補充典ç±ä¹‹è—¥å“。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æœªè¼‰æ–¼å‰æ¬¾ï¼Œä½†ä½¿ç”¨æ–¼è¨ºæ–·ã€æ²»ç™‚ã€æ¸›è¼•æˆ–é 防人類疾病之藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¶ä»–足以影響人類身體çµæ§‹åŠç”Ÿç†æ©Ÿèƒ½ä¹‹è—¥å“。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç”¨ä»¥é…製å‰ä¸‰æ¬¾æ‰€åˆ—之藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱新藥，係指經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥èªå®šå±¬æ–°æˆåˆ†ã€æ–°ç™‚效複方或新使用途徑製劑之藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬æ³•æ‰€ç¨±è£½åŠ‘ï¼Œä¿‚æŒ‡ä»¥åŽŸæ–™è—¥ç¶“åŠ å·¥èª¿è£½ï¼Œè£½æˆä¸€å®šåŠ‘åž‹åŠåŠ‘é‡ä¹‹è—¥å“。製劑分為醫師處方藥å“ã€é†«å¸«è—¥å¸«è—¥åŠ‘生指示藥å“ã€æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …æˆè—¥ä¹‹åˆ†é¡žã€å¯©æ ¸ã€å›ºæœ‰æˆæ–¹è£½åŠ‘製售之申請ã€æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘販賣之管ç†åŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱æˆè—¥ï¼Œä¿‚æŒ‡åŽŸæ–™è—¥ç¶“åŠ å·¥èª¿è£½ï¼Œä¸ç”¨å…¶åŽŸå稱，其摻入之藥å“，ä¸è¶…éŽä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€è¦å®šä¹‹é™é‡ï¼Œä½œç”¨ç·©å’Œï¼Œç„¡ç©è“„性，è€ä¹…儲å˜ï¼Œä½¿ç”¨ç°¡ä¾¿ï¼Œä¸¦æ˜Žç¤ºå…¶æ•ˆèƒ½ã€ç”¨é‡ã€ç”¨æ³•ï¼Œæ¨™æ˜Žæˆè—¥è¨±å¯è‰å—號，其使用ä¸å¾…醫師指示，å³ä¾›æ²»ç™‚疾病之用者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱固有æˆæ–¹è£½åŠ‘，係指ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¸å®šå…¬å‘Šå…·æœ‰é†«ç™‚效能之傳統ä¸è—¥è™•æ–¹èª¿è£½</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之方劑。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱管制藥å“，係指管制藥å“管ç†æ¢ä¾‹ç¬¬ä¸‰æ¢è¦å®šæ‰€ç¨±ä¹‹ç®¡åˆ¶è—¥å“。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱毒劇藥å“，係指列載於ä¸è¯è—¥å…¸æ¯’劇藥表ä¸ä¹‹è—¥å“；表ä¸æœªåˆ—載者，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱醫療器æ，係用於診斷ã€æ²»ç™‚ã€æ¸›è¼•ã€ç›´æŽ¥é 防人類疾病ã€èª¿ç¯€ç”Ÿè‚²ï¼Œæˆ–足以影響人類身體çµæ§‹åŠæ©Ÿèƒ½ï¼Œä¸”éžä»¥è—¥ç†ã€å…疫或代è¬æ–¹æ³•ä½œç”¨æ–¼äººé«”，以é”æˆå…¶ä¸»è¦åŠŸèƒ½ä¹‹å„€å™¨ã€å™¨æ¢°ã€ç”¨å…·ã€ç‰©è³ªã€è»Ÿé«”ã€é«”外試劑åŠå…¶ç›¸é—œç‰©å“。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫療器æ，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‡‰è¦–實際需è¦ï¼Œå°±å…¶ç¯„åœã€ç¨®é¡žã€ç®¡ç†åŠå…¶ä»–應管ç†äº‹é …，訂定醫療器æ管ç†è¾¦æ³•è¦ç¯„之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱藥商，係指左列å„款è¦å®šä¹‹æ¥è€…：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“或醫療器æ販賣æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“或醫療器æè£½é€ æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱藥å“販賣æ¥è€…，係指左列å„款è¦å®šä¹‹æ¥è€…：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¶“營西藥批發ã€é›¶å”®ã€è¼¸å…¥åŠè¼¸å‡ºä¹‹æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¶“營ä¸è—¥æ‰¹ç™¼ã€é›¶å”®ã€èª¿åŠ‘ã€è¼¸å…¥åŠè¼¸å‡ºä¹‹æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱藥å“è£½é€ æ¥è€…，係指經營藥å“ä¹‹è£½é€ ã€åŠ 工與其產å“批發ã€è¼¸å‡ºåŠè‡ªç”¨åŽŸæ–™è¼¸å…¥ä¹‹æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è—¥å“è£½é€ æ¥è€…輸入自用原料，應於æ¯æ¬¡é€²å£å‰å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹æ ¸å‡†å¾Œï¼Œå§‹å¾—進å£ï¼›å·²é€²å£ä¹‹è‡ªç”¨åŽŸæ–™ï¼Œéžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œä¸å¾—轉售或轉讓。</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ æ¥è€…，得兼營自製產å“之零售æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱醫療器æ販賣æ¥è€…，係指經營醫療器æ之批發ã€é›¶å”®ã€è¼¸å…¥åŠè¼¸å‡ºä¹‹æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">經營醫療器æ租賃æ¥è€…，準用本法關於醫療器æ販賣æ¥è€…之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱醫療器æè£½é€ æ¥è€…ï¼Œä¿‚æŒ‡è£½é€ ã€è£é…醫療器æ，與其產å“之批發ã€è¼¸å‡ºåŠè‡ªç”¨åŽŸæ–™è¼¸å…¥ä¹‹æ¥è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫療器æè£½é€ æ¥è€…，得兼營自製產å“之零售æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱藥局，係指藥師或藥劑生親自主æŒï¼Œä¾æ³•åŸ·è¡Œè—¥å“調劑ã€ä¾›æ‡‰æ¥å‹™ä¹‹è™•æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …藥局得兼營藥å“åŠä¸€å®šç‰ç´šä¹‹é†«ç™‚器æ零售æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …所稱一定ç‰ç´šä¹‹é†«ç™‚器æ之範åœåŠç¨®é¡žï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱å½è—¥ï¼Œä¿‚指藥å“經稽查或檢驗有左列å„款情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æœªç¶“æ ¸å‡†ï¼Œæ“…è‡ªè£½é€ è€…ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ‰€å«æœ‰æ•ˆæˆåˆ†ä¹‹åç¨±ï¼Œèˆ‡æ ¸å‡†ä¸ç¬¦è€…。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å°‡ä»–人產å“抽æ›æˆ–摻雜者。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¡—改或更æ›æœ‰æ•ˆæœŸé–“之標示者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬æ³•æ‰€ç¨±åŠ£è—¥ï¼Œä¿‚æŒ‡æ ¸å‡†ä¹‹è—¥å“經稽查或檢驗有左列情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ“…è‡ªæ·»åŠ éžæ³•å®šè‘—色劑ã€é˜²è…劑ã€é¦™æ–™ã€çŸ¯å‘³åŠ‘åŠè³¦å½¢åŠ‘者。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ‰€å«æœ‰æ•ˆæˆåˆ†ä¹‹è³ªã€é‡æˆ–å¼·åº¦ï¼Œèˆ‡æ ¸å‡†ä¸ç¬¦è€…。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“ä¸ä¸€éƒ¨æˆ–全部å«æœ‰æ±¡ç©¢æˆ–異物者。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æœ‰é¡¯æ˜Žè®Šè‰²ã€æ··æ¿ã€æ²ˆæ¾±ã€æ½®è§£æˆ–å·²è…化分解者。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¸»æ²»æ•ˆèƒ½èˆ‡æ ¸å‡†ä¸ç¬¦è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è¶…éŽæœ‰æ•ˆæœŸé–“或ä¿å˜æœŸé™è€…。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å› 儲è—éŽä¹…或儲è—方法ä¸ç•¶è€Œè®Šè³ªè€…。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è£å…¥æœ‰å®³ç‰©è³ªæ‰€è£½æˆä¹‹å®¹å™¨æˆ–使用回收容器者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱ç¦è—¥ï¼Œä¿‚指藥å“有左列å„款情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ˜Žä»¤å…¬å‘Šç¦æ¢è£½é€ ã€èª¿åŠ‘ã€è¼¸å…¥ã€è¼¸å‡ºã€è²©è³£æˆ–陳列之毒害藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æœªç¶“æ ¸å‡†æ“…è‡ªè¼¸å…¥ä¹‹è—¥å“。但旅客或隨交通工具æœå‹™äººå“¡æ”œå¸¶è‡ªç”¨è—¥å“進å£è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第二款自用藥å“之é™é‡ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæœƒåŒè²¡æ”¿éƒ¨å…¬å‘Šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱ä¸è‰¯é†«ç™‚器æ，係指醫療器æ經稽查或檢驗有左列å„款情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä½¿ç”¨æ™‚易生å±éšªï¼Œæˆ–å¯æ傷人體，或使診斷發生錯誤者。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å«æœ‰æ¯’質或有害物質，致使用時有æ人體å¥åº·è€…。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¶…éŽæœ‰æ•ˆæœŸé–“或ä¿å˜æœŸé™è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ€§èƒ½æˆ–有效æˆåˆ†ä¹‹è³ªã€é‡æˆ–å¼·åº¦ï¼Œèˆ‡æ ¸å‡†ä¸ç¬¦è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱藥物廣告，係指利用傳æ’方法，宣傳醫療效能，以é”æ‹›å¾ éŠ·å”®ç‚ºç›®çš„ä¹‹è¡Œç‚ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱標籤，係指藥å“或醫療器æ之容器上或包è£ä¸Šï¼Œç”¨ä»¥è¨˜è¼‰æ–‡å—ã€åœ–畫或記號之標示物。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所稱仿單，係指藥å“或醫療器æé™„åŠ ä¹‹èªªæ˜Žæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">藥商之管ç†</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">凡申請為藥商者，應申請直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ç™»è¨˜ï¼Œç¹³ç´åŸ·ç…§è²»ï¼Œé ˜å¾—許å¯åŸ·ç…§å¾Œï¼Œæ–¹å‡†ç‡Ÿæ¥ï¼›å…¶ç™»è¨˜äº‹é …如有變更時，應辦ç†è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …ç™»è¨˜äº‹é …ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商分è¨ç‡Ÿæ¥è™•æ‰€æˆ–åˆ†å» ï¼Œä»æ‡‰ä¾ç¬¬ä¸€é …è¦å®šï¼Œå„別辦ç†è—¥å•†ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商申請åœæ¥ï¼Œæ‡‰å°‡è—¥å•†è¨±å¯åŸ·ç…§åŠè—¥ç‰©è¨±å¯è‰éš¨ç¹³ç•¶åœ°è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¼Œæ–¼åŸ·ç…§ä¸Šè¨˜æ˜Žåœæ¥ç†ç”±åŠæœŸé™ï¼Œä¿Ÿæ ¸å‡†å¾©æ¥æ™‚發還之。æ¯æ¬¡åœæ¥æœŸé–“ä¸å¾—超éŽä¸€å¹´ï¼Œåœæ¥æœŸæ»¿æœªç¶“ç•¶åœ°è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ç¹¼çºŒåœæ¥è€…，應於åœæ¥æœŸæ»¿å‰ä¸‰å日內申請復æ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商申請æ‡æ¥æ™‚ï¼Œæ‡‰å°‡å…¶æ‰€é ˜è—¥å•†è¨±å¯åŸ·ç…§åŠè—¥ç‰©è¨±å¯è‰ä¸€ä½µç¹³éŠ·ï¼›å…¶ä¸ç¹³éŠ·è€…，由原發è‰ç…§ä¹‹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¨»éŠ·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商屆期ä¸ç”³è«‹åœæ¥ã€æ‡æ¥æˆ–復æ¥ç™»è¨˜ï¼Œç¶“直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŸ¥æ ¸ç™¼ç¾åŽŸå€å·²ç„¡ç‡Ÿæ¥äº‹å¯¦è€…，應由原發è‰ç…§ä¹‹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¼Œå°‡å…¶æœ‰é—œè‰ç…§è¨»éŠ·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å本法è¦å®šï¼Œç¶“衛生主管機關處分åœæ¢å…¶ç‡Ÿæ¥è€…，其è‰ç…§ä¾ç¬¬ä¸€é …è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">西藥販賣æ¥è€…之藥å“åŠå…¶è²·è³£ï¼Œæ‡‰ç”±å°ˆä»»è—¥å¸«é§åº—管ç†ã€‚但ä¸å”®è³£éº»é†‰è—¥å“者，得由專任藥劑生為之。</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è—¥è²©è³£æ¥è€…之藥å“åŠå…¶è²·è³£ï¼Œæ‡‰ç”±å°ˆä»»ä¸é†«å¸«æˆ–修習ä¸è—¥èª²ç¨‹é”é©ç•¶æ¨™æº–之藥師或藥劑生é§åº—管ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">西藥ã€ä¸è—¥è²©è³£æ¥è€…，分è¨ç‡Ÿæ¥è™•æ‰€ï¼Œä»æ‡‰ä¾ç¬¬ä¸€é …åŠç¬¬äºŒé …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¥¿è—¥è£½é€ æ¥è€…，應由專任藥師é§å» 監製；ä¸è—¥è£½é€ æ¥è€…，應由專任ä¸é†«å¸«æˆ–修習ä¸è—¥èª²ç¨‹é”é©ç•¶æ¨™æº–之藥師é§å» 監製。</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è—¥è£½é€ æ¥è€…ï¼Œä»¥è¥¿è—¥åŠ‘åž‹è£½é€ ä¸è—¥ï¼Œæˆ–æ‘»å…¥è¥¿è—¥è£½é€ ä¸è—¥æ™‚，除ä¾å‰é …è¦å®šå¤–，應由專任藥師監製。</span> </p><p><span style="font-family: 新細明體,serif;">西藥ã€ä¸è—¥è£½é€ æ¥è€…，è¨ç«‹åˆ†å» ，ä»æ‡‰ä¾å‰äºŒé …è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商è˜ç”¨ä¹‹è—¥å¸«ã€è—¥åŠ‘生或ä¸é†«å¸«ï¼Œå¦‚有解è˜æˆ–è¾è˜ï¼Œæ‡‰å³å¦è˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">從事人用生物藥å“è£½é€ æ¥è€…，應è˜ç”¨åœ‹å…§å¤–大å¸é™¢æ ¡ä»¥ä¸Šé†«è—¥æˆ–生物å¸ç‰ç³»ç•¢æ¥ï¼Œå…·æœ‰å¾®ç”Ÿç‰©å¸ã€å…ç–«å¸è—¥å“è£½é€ å°ˆé–€çŸ¥è˜ï¼Œä¸¦æœ‰äº”å¹´ä»¥ä¸Šè£½é€ ç¶“é©—ä¹‹æŠ€è¡“äººå“¡ï¼Œé§å» è² è²¬è£½é€ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療器æè²©è³£æˆ–è£½é€ æ¥è€…，應視其類別，è˜ç”¨æŠ€è¡“人員。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …醫療器æ類別åŠæŠ€è¡“äººå“¡è³‡æ ¼ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> <span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商僱用之推銷員，應由該æ¥è€…å‘當地之直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">主管機關登記後，方准執行推銷工作。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …推銷員，以å‘藥局ã€è—¥å•†ã€è¡›ç”Ÿé†«ç™‚機構ã€é†«å¸ç ”究機構åŠç¶“衛生主管機關准予登記為兼售藥物者推銷其å—僱藥商所製售或經銷之藥物為é™ï¼Œ</span> </p><p><span style="font-family: 新細明體,serif;">並ä¸å¾—有沿途推銷ã€è¨æ”¤å‡ºå”®æˆ–擅將藥物拆å°ã€æ”¹è£æˆ–éžæ³•å»£å‘Šä¹‹è¡Œç‚ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">藥局之管ç†åŠè—¥å“之調劑</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å±€æ‡‰è«‹é ˜è—¥å±€åŸ·ç…§ï¼Œä¸¦æ–¼æ˜Žé¡¯è™•æ¨™ç¤ºç¶“ç‡Ÿè€…ä¹‹èº«åˆ†å§“å。其è¨ç«‹ã€è®Šæ›´ç™»è¨˜ï¼Œæº–用第二å七æ¢ç¬¬ä¸€é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥局兼營第åä¹æ¢ç¬¬äºŒé …之æ¥å‹™ï¼Œæ‡‰é©ç”¨é—œæ–¼è—¥å•†ä¹‹è¦å®šã€‚ä½†ç„¡é ˆå¦è¡Œè«‹é ˜è—¥å•†è¨±å¯åŸ·ç…§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 35 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">修習ä¸è—¥èª²ç¨‹é”é©ç•¶æ¨™æº–之藥師，親自主æŒä¹‹è—¥å±€ï¼Œå¾—兼營ä¸è—¥ä¹‹èª¿åŠ‘ã€ä¾›æ‡‰æˆ–零售æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 36 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥師親自主æŒä¹‹è—¥å±€ï¼Œå…·æœ‰é‘‘定è¨å‚™è€…，得執行藥å“之鑑定æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 37 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“之調劑，éžä¾ä¸€å®šä½œæ¥ç¨‹åºï¼Œä¸å¾—為之；其作æ¥æº–則，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …調劑應由藥師為之。但ä¸å«éº»é†‰è—¥å“者，得由藥劑生為之。</span> </p><p><span style="font-family: 新細明體,serif;">醫院ä¸ä¹‹è—¥å“之調劑，應由藥師為之。但本法八å二年二月五日修æ£æ–½è¡Œå‰å·²åœ¨é†«é™¢ä¸æœå‹™ä¹‹è—¥åŠ‘生，é©ç”¨å‰é …è¦å®šï¼Œä¸¦å¾—繼續或轉院任è·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è—¥ä¹‹èª¿åŠ‘，除法律å¦æœ‰è¦å®šå¤–，應由ä¸é†«å¸«ç›£ç£ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥師法第å二æ¢ã€ç¬¬åå…æ¢è‡³ç¬¬äºŒåæ¢ä¹‹è¦å®šï¼Œæ–¼è—¥åŠ‘生調劑藥å“時準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">藥物之查驗登記</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 39 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ ã€è¼¸å…¥è—¥å“，應將其æˆåˆ†ã€è¦æ ¼ã€æ€§èƒ½ã€è£½æ³•ä¹‹è¦æ—¨ï¼Œæª¢é©—è¦æ ¼èˆ‡æ–¹æ³•åŠæœ‰é—œè³‡æ–™æˆ–è‰ä»¶ï¼Œé€£åŒåŽŸæ–‡å’Œä¸æ–‡æ¨™ç±¤ã€åŽŸæ–‡å’Œä¸æ–‡ä»¿å–®åŠæ¨£å“，並繳ç´è²»ç”¨ï¼Œç”³è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŸ¥é©—ç™»è¨˜ï¼Œç¶“æ ¸å‡†ç™¼çµ¦è—¥å“許å¯è‰å¾Œï¼Œå§‹å¾—è£½é€ æˆ–è¼¸å…¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹è—¥å“è©¦è£½ç¶“æ ¸å‡†è¼¸å…¥åŽŸæ–™è—¥è€…ï¼Œä¸é©ç”¨å‰é …è¦å®šï¼›å…¶ç”³è«‹æ¢ä»¶åŠæ‡‰ç¹³è²»ç”¨ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …è¼¸å…¥è—¥å“，應由藥å“許å¯è‰æ‰€æœ‰äººåŠå…¶æŽˆæ¬Šè€…輸入。</span> </p><p><span style="font-family: 新細明體,serif;">ç”³è«‹ç¬¬ä¸€é …è—¥å“查驗登記ã€ä¾ç¬¬å››åå…æ¢è¦å®šè¾¦ç†è—¥å“許å¯è‰è®Šæ›´ã€ç§»è½‰ç™»è¨˜åŠä¾ç¬¬å››å七æ¢è¦å®šè¾¦ç†è—¥å“許å¯è‰å±•å»¶ç™»è¨˜ã€æ›ç™¼åŠè£œç™¼ï¼Œå…¶ç”³è«‹æ¢ä»¶ã€å¯©æŸ¥ç¨‹åºã€æ ¸å‡†åŸºæº–åŠå…¶ä»–應éµè¡Œä¹‹äº‹é …，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä»¥è—¥å“查驗登記審查準則定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ ã€è¼¸å…¥é†«ç™‚器æ，應å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹æŸ¥é©—登記並繳ç´è²»ç”¨ï¼Œç¶“æ ¸å‡†ç™¼çµ¦é†«ç™‚å™¨æ許å¯è‰å¾Œï¼Œå§‹å¾—è£½é€ æˆ–è¼¸å…¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …輸入醫療器æ，應由醫療器æ許å¯è‰æ‰€æœ‰äººæˆ–其授權者輸入。</span> </p><p><span style="font-family: 新細明體,serif;">申請醫療器æ查驗登記ã€è¨±å¯è‰è®Šæ›´ã€ç§»è½‰ã€å±•å»¶ç™»è¨˜ã€æ›ç™¼åŠè£œç™¼ï¼Œå…¶ç”³è«‹æ¢ä»¶ã€å¯©æŸ¥ç¨‹åºã€æ ¸å‡†åŸºæº–åŠå…¶ä»–應éµè¡Œä¹‹äº‹é …，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç‚ºç¶è·å…¬ç›Šä¹‹ç›®çš„，於必è¦æ™‚，得公開所æŒæœ‰åŠä¿ç®¡è—¥å•†ç”³è«‹è£½é€ 或輸入藥物所檢附之藥物æˆåˆ†ã€ä»¿å–®ç‰ç›¸é—œè³‡æ–™ã€‚但å°æ–¼è—¥å•†ç”³è«‹æ–°è—¥æŸ¥é©—登記屬於營æ¥ç§˜å¯†ä¹‹è³‡æ–™ï¼Œæ‡‰ä¿å¯†ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …å¾—å…¬é–‹äº‹é …ä¹‹ç¯„åœåŠæ–¹å¼ï¼Œå…¶è¾¦æ³•ç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> <span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40-2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼æ ¸ç™¼æ–°è—¥è¨±å¯è‰æ™‚，應公開申請人檢附之已</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">æ露專利å—號或案號。</span> </p><p><span style="font-family: 新細明體,serif;">æ–°æˆåˆ†æ–°è—¥è¨±å¯è‰è‡ªæ ¸ç™¼ä¹‹æ—¥èµ·äº”年內，其他藥商éžç¶“許å¯è‰æ‰€æœ‰äººåŒæ„，ä¸å¾—引據其申請資料申請查驗登記。</span> </p><p><span style="font-family: 新細明體,serif;">æ–°æˆåˆ†æ–°è—¥è¨±å¯è‰æ ¸ç™¼ä¹‹æ—¥èµ·ä¸‰å¹´å¾Œï¼Œå…¶ä»–藥商得ä¾æœ¬æ³•åŠç›¸é—œæ³•è¦æœ‰é—œè—¥å“查驗登記審查之è¦å®šæ出åŒæˆåˆ†ã€åŒåŠ‘åž‹ã€åŒåŠ‘é‡åŠåŒå–®ä½å«é‡è—¥å“之查驗登記申請，符åˆè¦å®šè€…，得於新æˆåˆ†æ–°è—¥è¨±å¯è‰æ ¸ç™¼å±†æ»¿äº”年之翌日起發給藥å“許å¯è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æ–°æˆåˆ†æ–°è—¥åœ¨å¤–國å–得上市許å¯å¾Œä¸‰å¹´å…§ï¼Œå¿…é ˆå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹æŸ¥é©—ç™»è¨˜ï¼Œå§‹å¾—æº–ç”¨ç¬¬äºŒé …ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">新藥專利權ä¸åŠæ–¼è—¥å•†ç”³è«‹æŸ¥é©—登記å‰æ‰€é€²è¡Œä¹‹ç ”究ã€æ•™å¸æˆ–試驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 41 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為ææ˜‡è—¥ç‰©è£½é€ å·¥æ¥æ°´æº–與臨床試驗å“質，å°æ–¼è—¥ç‰©ç§‘æŠ€ä¹‹ç ”ç©¶ç™¼å±•ï¼Œä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ¯å¹´æ‡‰å§”託專æ¥é†«ç™‚團體辦ç†æ•™è‚²è¨“練，培育臨床試驗人æ‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æ–°èˆˆè—¥ç‰©ç§‘æŠ€ä¹‹ç ”ç©¶ç™¼å±•ï¼Œå¾—ç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæœƒåŒä¸å¤®å·¥æ¥ä¸»ç®¡æ©Ÿé—œçŽå‹µä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …çŽå‹µä¹‹è³‡æ ¼æ¢ä»¶ã€å¯©è°ç¨‹åºåŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæœƒåŒä¸å¤®å·¥æ¥ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 42 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°æ–¼è£½é€ ã€è¼¸å…¥ä¹‹è—¥ç‰©ï¼Œæ‡‰è¨‚定作æ¥æº–å‰‡ï¼Œä½œç‚ºæ ¸ç™¼ã€è®Šæ›´åŠå±•å»¶è—¥ç‰©è¨±å¯è‰ä¹‹åŸºæº–。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …作æ¥æº–則，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 43 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ ã€è¼¸å…¥è—¥ç‰©ä¹‹æŸ¥é©—登記申請書åŠè¼¸å‡ºè—¥ç‰©ä¹‹ç”³è«‹æ›¸ï¼Œå…¶æ ¼å¼ã€æ¨£å“份數ã€æœ‰é—œè³‡æ–™æˆ–è‰æ›¸è²»ã€æŸ¥é©—費之金é¡ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 44 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗用藥物，應經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å§‹å¾—ä¾›ç¶“æ ¸å¯ä¹‹æ•™å¸é†«é™¢è‡¨åºŠè©¦é©—，以確èªå…¶å®‰å…¨èˆ‡é†«ç™‚效能。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 45 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥ä¹‹è—¥ç‰©ï¼Œä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—指定期間，監視其安全性。</span> </p><p><span style="font-family: 新細明體,serif;">藥商於å‰é …安全監視期間應éµè¡Œäº‹é …，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 45-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構ã€è—¥å±€åŠè—¥å•†å°æ–¼å› 藥物所引起之嚴é‡ä¸è‰¯åæ‡‰ï¼Œæ‡‰è¡Œé€šå ±ï¼›å…¶æ–¹å¼ã€å…§å®¹åŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 46 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†è£½é€ ã€è¼¸å…¥ä¹‹è—¥ç‰©ï¼Œéžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¹‹æ ¸å‡†ï¼Œä¸å¾—è®Šæ›´åŽŸç™»è¨˜äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†è£½é€ ã€è¼¸å…¥ä¹‹è—¥ç‰©è¨±å¯è‰ï¼Œå¦‚有移轉時，應辦ç†ç§»è½‰ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 47 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©è£½é€ ã€è¼¸å…¥è¨±å¯è‰æœ‰æ•ˆæœŸé–“為五年，期滿ä»é ˆç¹¼çºŒè£½é€ ã€è¼¸å…¥è€…，應事先申請ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å±•å»¶ä¹‹ã€‚但æ¯æ¬¡å±•å»¶ï¼Œä¸å¾—超éŽäº”年。屆期未申請或ä¸å‡†å±•å»¶è€…，註銷其許å¯è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …許å¯è‰å¦‚有污æ或éºå¤±ï¼Œæ‡‰æ•˜æ˜Žç†ç”±ï¼Œç”³è«‹åŽŸæ ¸ç™¼æ©Ÿé—œæ›ç™¼æˆ–補發，並應將原許å¯è‰åŒæ™‚ç¹³éŠ·ï¼Œæˆ–ç”±æ ¸ç™¼æ©Ÿé—œå…¬å‘Šè¨»éŠ·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 48 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©æ–¼å…¶è£½é€ ã€è¼¸å…¥è¨±å¯è‰æœ‰æ•ˆæœŸé–“內，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé‡æ–°è©•ä¼°ç¢ºå®šæœ‰å®‰å…¨æˆ–醫療效能疑慮者，得é™æœŸä»¤è—¥å•†æ”¹å–„，屆期未改善者，廢æ¢å…¶è¨±å¯è‰ã€‚但安全疑慮é‡å¤§è€…，得逕予廢æ¢ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 48-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">第三åä¹æ¢ç¬¬ä¸€é …è£½é€ ã€è¼¸å…¥è—¥å“，應標示ä¸æ–‡æ¨™ç±¤ã€ä»¿å–®æˆ–包è£ï¼Œå§‹å¾—è²·è³£ã€æ‰¹ç™¼ã€é›¶å”®ã€‚但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šæœ‰çª’礙難行者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">藥物之販賣åŠè£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 49 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商ä¸å¾—買賣來æºä¸æ˜Žæˆ–無藥商許å¯åŸ·ç…§è€…之藥å“或醫療器æ。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 50 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é ˆç”±é†«å¸«è™•æ–¹ä¹‹è—¥å“，éžç¶“醫師處方，ä¸å¾—調劑供應。但左列å„款情形ä¸åœ¨æ¤é™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŒæ¥è—¥å•†ä¹‹æ‰¹ç™¼ã€è²©è³£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é†«é™¢ã€è¨ºæ‰€åŠæ©Ÿé—œã€åœ˜é«”ã€å¸æ ¡ä¹‹é†«ç™‚機構或檢驗åŠå¸è¡“ç ”ç©¶æ©Ÿæ§‹ä¹‹è³¼è²·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¾ä¸è¯è—¥å…¸ã€åœ‹æ°‘處方é¸è¼¯è™•æ–¹ä¹‹èª¿åŠ‘。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …é ˆç¶“é†«å¸«è™•æ–¹ä¹‹è—¥å“，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°±ä¸ã€è¥¿è—¥å“分別定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 51 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">西藥販賣æ¥è€…，ä¸å¾—兼售ä¸è—¥ï¼›ä¸è—¥è²©è³£æ¥è€…，ä¸å¾—兼售西藥。但æˆè—¥ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 52 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“販賣æ¥è€…，ä¸å¾—兼售農藥ã€å‹•ç‰©ç”¨è—¥å“或其他毒性化å¸ç‰©è³ªã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 53 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“販賣æ¥è€…輸入之藥å“得分è£å¾Œå‡ºå”®ï¼Œå…¶åˆ†è£æ‡‰ä¾ä¸‹åˆ—è¦å®šè¾¦ç†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è£½åŠ‘：申請ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å¾Œï¼Œç”±ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之藥å“è£½é€ æ¥è€…分è£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŽŸæ–™è—¥ï¼šç”±ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之藥å“è£½é€ æ¥è€…分è£ï¼›åˆ†è£å¾Œï¼Œæ‡‰å ±è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …申請分è£ä¹‹æ¢ä»¶ã€ç¨‹åºã€å ±è«‹å‚™æŸ¥ä¹‹æœŸé™ã€ç¨‹åºåŠå…¶ä»–分è£å‡ºå”®æ‰€æ‡‰éµå¾ªä¹‹äº‹é …，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 54 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“或醫療器æç¶“æ ¸å‡†ç™¼çµ¦è—¥ç‰©è¼¸å…¥è¨±å¯è‰å¾Œï¼Œç‚ºç¶è·åœ‹å®¶æ¬Šç›Šï¼Œä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—åŠ ä»¥ç®¡åˆ¶ã€‚ä½†åœ¨ç®¡åˆ¶å‰å·²æ ¸å‡†çµåŒ¯ç°½è‰è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 55 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥ä¹‹è—¥ç‰©æ¨£å“或贈å“，ä¸å¾—出售。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …樣å“è´ˆå“管ç†è¾¦æ³•ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 56 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†è£½å”®ä¹‹è—¥ç‰©ï¼Œå¦‚è¼¸å‡ºåœ‹å¤–éŠ·å”®æ™‚ï¼Œå…¶æ‡‰è¼¸å…¥åœ‹å®¶è¦æ±‚è‰æ˜Žæ–‡å—者，應於輸出å‰ï¼Œç”±è£½é€ å» å•†ç”³è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç™¼çµ¦è¼¸å‡ºè‰æ˜Žæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …藥物，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰ä¸æ•·åœ‹å…§éœ€è¦ä¹‹è™žæ™‚，得é™åˆ¶å…¶è¼¸å‡ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 57 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ è—¥ç‰©ï¼Œæ‡‰ç”±è—¥ç‰©è£½é€ å·¥å» ç‚ºä¹‹ï¼›è—¥ç‰©è£½é€ å·¥å» ï¼Œæ‡‰ä¾è—¥ç‰©è£½é€ å·¥å» è¨å» 標準è¨ç«‹ï¼Œä¸¦ä¾å·¥å» 管ç†è¼”導法è¦å®šï¼Œè¾¦ç†å·¥å» 登記。但ä¾å·¥å» 管ç†è¼”導法è¦å®šå…辦ç†å·¥å» 登記，或經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ç‚ºç ”ç™¼è€Œè£½é€ è€…ï¼Œä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥ç‰©è£½é€ ï¼Œå…¶å» æˆ¿è¨æ–½ã€è¨å‚™ã€çµ„織與人事ã€ç”Ÿç”¢ã€å“質管制ã€å„²å˜ã€é‹éŠ·ã€å®¢æˆ¶ç”³è¨´åŠå…¶ä»–應éµè¡Œäº‹é …，應符åˆè—¥ç‰©å„ªè‰¯è£½é€ 準則之è¦å®šï¼Œä¸¦ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæª¢æŸ¥åˆæ ¼ï¼Œå–å¾—è—¥ç‰©è£½é€ è¨±å¯å¾Œï¼Œå§‹å¾—è£½é€ ã€‚ä½†ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šç„¡éœ€ç¬¦åˆè—¥ç‰©å„ªè‰¯è£½é€ 準則之醫療器æè£½é€ æ¥è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">符åˆå‰é …è¦å®šï¼Œå–å¾—è—¥ç‰©è£½é€ è¨±å¯ä¹‹è—¥å•†ï¼Œå¾—ç¹³ç´è²»ç”¨ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³é ˜è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è¼¸å…¥è—¥ç‰©ä¹‹åœ‹å¤–è£½é€ å» ï¼Œæº–ç”¨å‰äºŒé …è¦å®šï¼Œä¸¦ç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šæœŸæˆ–ä¾å¯¦éš›éœ€è¦èµ´åœ‹å¤–è£½é€ å» æª¢æŸ¥ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …è—¥ç‰©è£½é€ å·¥å» è¨å» 標準，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæœƒåŒä¸å¤®å·¥æ¥ä¸»ç®¡æ©Ÿé—œå®šä¹‹ï¼›ç¬¬äºŒé …è—¥ç‰©å„ªè‰¯è£½é€ æº–å‰‡ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬äºŒé …è—¥ç‰©è£½é€ è¨±å¯èˆ‡ç¬¬ä¸‰é …è‰æ˜Žæ–‡ä»¶ä¹‹ç”³è«‹æ¢ä»¶ã€å¯©æŸ¥ç¨‹åºèˆ‡åŸºæº–ã€æ ¸ç™¼ã€æ•ˆæœŸã€å»¢æ¢ã€è¿”é‚„ã€è¨»éŠ·åŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 57-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¾žäº‹è—¥ç‰©ç ”ç™¼ä¹‹æ©Ÿæ§‹æˆ–å…¬å¸ï¼Œå…¶ç ”發用藥物，應於符åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¦å®šä¹‹å·¥å» æˆ–å ´æ‰€è£½é€ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …å·¥å» æˆ–å ´æ‰€éžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œä¸å¾—兼製其他產å“ï¼›å…¶æ‰€è£½é€ ä¹‹ç ”ç™¼ç”¨è—¥ç‰©ï¼Œéžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œä¸å¾—使用於人體。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 58 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©å·¥å» ï¼Œéžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œä¸å¾—å§”è¨—ä»–å» è£½é€ æˆ–æŽ¥å—å§”è¨—è£½é€ è—¥ç‰©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å…</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">管制藥å“åŠæ¯’劇藥å“之管ç†</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 59 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">西藥販賣æ¥è€…åŠè¥¿è—¥è£½é€ æ¥è€…，購å˜æˆ–售賣管制藥å“åŠæ¯’劇藥å“，應將藥å“å稱ã€æ•¸é‡ï¼Œè©³åˆ—簿冊，以備檢查。管制藥å“並應專è¨æ«¥æ«ƒåŠ 鎖儲è—。管制藥å“åŠæ¯’劇藥å“之標籤，應載明è¦èªžåŠè¶³ä»¥è¦æƒ•ä¹‹åœ–案或é¡è‰²ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 60 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">管制藥å“åŠæ¯’劇藥å“ï¼Œé ˆæœ‰é†«å¸«ä¹‹è™•æ–¹ï¼Œå§‹å¾—èª¿åŠ‘ã€ä¾›æ‡‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …管制藥å“æ‡‰æ†‘é ˜å—人之身分è‰æ˜Žä¸¦å°‡å…¶å§“åã€åœ°å€ã€çµ±ä¸€ç·¨è™ŸåŠæ‰€é ˜å—å“é‡ï¼Œè©³éŒ„簿冊，連åŒè™•æ–¹ç®‹ä¿å˜ä¹‹ï¼Œä»¥å‚™æª¢æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">管制藥å“之處方åŠèª¿åŠ‘，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—é™åˆ¶ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 61 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（刪除）</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 62 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">第五åä¹æ¢åŠç¬¬å…åæ¢æ‰€è¦å®šä¹‹è™•æ–¹ç®‹ã€ç°¿å†Šï¼Œå‡æ‡‰ä¿å˜äº”年。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 63 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（刪除）</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 64 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥è²©è³£æ¥è€…åŠä¸è—¥è£½é€ æ¥è€…，éžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œä¸å¾—售賣或使用管制藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è—¥è²©è³£æ¥è€…åŠä¸è—¥è£½é€ æ¥è€…售賣毒劇性之ä¸è—¥ï¼Œéžæœ‰ä¸é†«å¸«ç°½åã€è“‹ç« 之處方箋，ä¸å¾—出售；其購å˜æˆ–出售毒劇性ä¸è—¥ï¼Œæº–用第五åä¹æ¢ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">七</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">藥物廣告之管ç†</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 65 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éžè—¥å•†ä¸å¾—為藥物廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 66 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商刊æ’藥物廣告時，應於刊æ’å‰å°‡æ‰€æœ‰æ–‡å—ã€åœ–畫或言詞，申請ä¸å¤®æˆ–ç›´è½„å¸‚è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼Œä¸¦å‘傳æ’æ¥è€…é€é©—æ ¸å‡†æ–‡ä»¶ã€‚åŽŸæ ¸å‡†æ©Ÿé—œç™¼ç¾å·²æ ¸å‡†ä¹‹è—¥ç‰©å»£å‘Šå…§å®¹æˆ–刊æ’æ–¹å¼å±å®³æ°‘眾å¥åº·æˆ–有é‡å¤§å±å®³ä¹‹è™žæ™‚，應令藥商立å³åœæ¢åˆŠæ’並é™æœŸæ”¹å–„，屆期未改善者，廢æ¢ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥ç‰©å»£å‘Šåœ¨æ ¸å‡†ç™»è¼‰ã€åˆŠæ’期間ä¸å¾—è®Šæ›´åŽŸæ ¸å‡†äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">傳æ’æ¥è€…ä¸å¾—刊æ’未經ä¸å¤®æˆ–ç›´è½„å¸‚è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€èˆ‡æ ¸å‡†äº‹é …ä¸ç¬¦ã€å·²å»¢æ¢æˆ–經令立å³åœæ¢åˆŠæ’並é™æœŸæ”¹å–„而尚未改善之藥物廣告。</span> </p><p><span style="font-family: 新細明體,serif;">接å—委託刊æ’之傳æ’æ¥è€…，應自廣告之日起å…個月，ä¿å˜å§”託刊æ’廣告者之姓å</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">法人或團體å稱</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€èº«åˆ†è‰æˆ–事æ¥ç™»è¨˜è‰å—號ã€ä½å±…所</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">事務所或營æ¥æ‰€</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŠé›»è©±ç‰è³‡æ–™ï¼Œä¸”於主管機關è¦æ±‚æ供時，ä¸å¾—è¦é¿ã€å¦¨ç¤™æˆ–拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 66-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物廣告，經ä¸å¤®æˆ–ç›´è½„å¸‚è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…ï¼Œå…¶æœ‰æ•ˆæœŸé–“ç‚ºä¸€å¹´ï¼Œè‡ªæ ¸ç™¼è‰æ˜Žæ–‡ä»¶ä¹‹æ—¥èµ·ç®—。期滿ä»éœ€ç¹¼çºŒå»£å‘Šè€…ï¼Œå¾—ç”³è«‹åŽŸæ ¸å‡†ä¹‹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å®šå±•å»¶ä¹‹ï¼›æ¯æ¬¡å±•å»¶ä¹‹æœŸé–“，ä¸å¾—超éŽä¸€å¹´ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …æœ‰æ•ˆæœŸé–“ï¼Œæ‡‰è¨˜æ˜Žæ–¼æ ¸å‡†è©²å»£å‘Šä¹‹è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 67 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é ˆç”±é†«å¸«è™•æ–¹æˆ–ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘ŠæŒ‡å®šä¹‹è—¥ç‰©ï¼Œå…¶å»£å‘Šä»¥ç™»è¼‰æ–¼å¸è¡“性醫療刊物為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 68 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物廣告ä¸å¾—以左列方å¼ç‚ºä¹‹ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å‡å€Ÿä»–人å義為宣傳者。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åˆ©ç”¨æ›¸åˆŠè³‡æ–™ä¿è‰å…¶æ•ˆèƒ½æˆ–性能。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—‰æŽ¡è¨ªæˆ–å ±å°Žç‚ºå®£å‚³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä»¥å…¶ä»–ä¸æ£ç•¶æ–¹å¼ç‚ºå®£å‚³ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 69 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éžæœ¬æ³•æ‰€ç¨±ä¹‹è—¥ç‰©ï¼Œä¸å¾—為醫療效能之標示或宣傳。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 70 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">採訪ã€å ±å°Žæˆ–宣傳，其內容暗示或影射醫療效能者，視為藥物廣告。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å…«</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">稽查åŠå–ç· </span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 71 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¼Œå¾—æ´¾å“¡æª¢æŸ¥è—¥ç‰©è£½é€ æ¥è€…，販賣æ¥è€…之處所è¨æ–½åŠæœ‰é—œæ¥å‹™ï¼Œä¸¦å¾—出具單據抽驗其藥物，æ¥è€…ä¸å¾—無故拒絕。但抽驗數é‡ä»¥è¶³ä¾›æª¢é©—之用者為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥ç‰©è£½é€ æ¥è€…之檢查，必è¦æ™‚得會åŒå·¥æ¥ä¸»ç®¡æ©Ÿé—œç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">本æ¢æ‰€åˆ—實施檢查辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæœƒåŒä¸å¤®å·¥æ¥ä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 71-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç‚ºåŠ å¼·è¼¸å…¥è—¥ç‰©ä¹‹é‚Šå¢ƒç®¡ç†ï¼Œä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—公告其輸入時應抽查ã€æª¢é©—åˆæ ¼å¾Œï¼Œå§‹å¾—輸入。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …輸入藥物之抽查åŠæª¢é©—æ–¹å¼ã€æ–¹æ³•ã€é …ç›®ã€ç¯„åœã€æ”¶è²»åŠå…¶ä»–應éµè¡Œäº‹é …之辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 72 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">衛生主管機關得派員檢查醫療機構或藥局之有關æ¥å‹™ï¼Œä¸¦å¾—出具單據抽驗其藥物，å—檢者ä¸å¾—無故拒絕。但抽驗數é‡ä»¥è¶³ä¾›æª¢é©—之用者為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 73 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">直轄市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關應æ¯å¹´å®šæœŸè¾¦ç†è—¥å•†åŠè—¥å±€æ™®æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商或藥局å°æ–¼å‰é …普查，ä¸å¾—拒絕ã€è¦é¿æˆ–妨礙。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 74 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æ“šå¾®ç”Ÿç‰©å¸ã€å…ç–«å¸å¸ç†è£½é€ 之血清ã€æŠ—æ¯’ç´ ã€ç–«è‹—ã€é¡žæ¯’ç´ åŠèŒæ¶²ç‰ï¼Œéžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼æ¯æ‰¹ç”¢å“è¼¸å…¥æˆ–è£½é€ å¾Œï¼Œæ´¾å“¡æŠ½å–樣å“，經檢驗åˆæ ¼ï¼Œä¸¦åŠ 貼查訖å°ç·˜ï¼Œä¸å¾—銷售。檢驗å°ç·˜ä½œæ¥è¾¦æ³•ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …生物藥å“之原液，其輸入以生物藥å“è£½é€ æ¥è€…為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 75 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物之標籤ã€ä»¿å–®æˆ–包è£ï¼Œæ‡‰ä¾æ ¸å‡†ï¼Œåˆ†åˆ¥åˆŠè¼‰å·¦åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å» 商å稱åŠåœ°å€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å“ååŠè¨±å¯è‰å—號。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ‰¹è™Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è£½é€ 日期åŠæœ‰æ•ˆæœŸé–“或ä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¸»è¦æˆåˆ†å«é‡ã€ç”¨é‡åŠç”¨æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ä¸»æ²»æ•ˆèƒ½ã€æ€§èƒ½æˆ–é©æ‡‰ç—‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å‰¯ä½œç”¨ã€ç¦å¿ŒåŠå…¶ä»–注æ„äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å…¶ä»–ä¾è¦å®šæ‡‰åˆŠè¼‰äº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第四款經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ˜Žä»¤å…¬å‘Šå…予刊載者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 76 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">經許å¯è£½é€ ã€è¼¸å…¥ä¹‹è—¥ç‰©ï¼Œç¶“發ç¾æœ‰é‡å¤§å±å®³æ™‚，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé™¤æ‡‰éš¨æ™‚公告ç¦æ¢å…¶è£½é€ ã€è¼¸å…¥å¤–，並廢æ¢å…¶è—¥ç‰©è¨±å¯è‰ï¼›å…¶å·²è£½é€ 或輸入者，應é™æœŸç¦æ¢å…¶è¼¸å‡ºã€èª¿åŠ‘ã€è²©è³£ã€ä¾›æ‡‰ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„圖販賣而陳列，必è¦æ™‚並得沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 77 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關，å°æ–¼æ¶‰å«Œä¹‹å½è—¥ã€åŠ£è—¥ã€ç¦è—¥æˆ–ä¸è‰¯é†«ç™‚器æ，就å½è—¥ã€ç¦è—¥éƒ¨åˆ†ï¼Œæ‡‰å…ˆè¡Œå°±åœ°å°å˜ï¼Œä¸¦æŠ½å–樣å“予以檢驗後，å†è¡Œè™•ç†ï¼›å°±åŠ£è—¥ã€ä¸è‰¯é†«ç™‚器æ部分，得先行就地å°å˜ï¼Œä¸¦æŠ½å–樣å“予以檢驗後，å†è¡Œè™•ç†ã€‚å…¶å°è¡›ç”Ÿæœ‰é‡å¤§å±å®³è€…ï¼Œæ‡‰æ–¼å ±è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å¾Œï¼Œæ²’入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è¦å®šæ–¼æœªç¶“æ ¸å‡†è€Œè£½é€ ã€è¼¸å…¥ä¹‹é†«ç™‚器æ，準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 78 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">經稽查或檢驗為å½è—¥ã€åŠ£è—¥ã€ç¦è—¥åŠä¸è‰¯é†«ç™‚器æ，除ä¾æœ¬æ³•æœ‰é—œè¦å®šè™•ç†å¤–，並應為下列處分：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è£½é€ 或輸入å½è—¥ã€ç¦è—¥åŠé ‚替使用許å¯è‰è€…ï¼Œæ‡‰ç”±åŽŸæ ¸å‡†æ©Ÿé—œï¼Œå»¢æ¢å…¶å…¨éƒ¨è—¥ç‰©è¨±å¯è‰ã€è—¥å•†è¨±å¯åŸ·ç…§ã€è—¥ç‰©è£½é€ 許å¯åŠå…¬å¸ã€å•†æ¥ã€å·¥å» ä¹‹å…¨éƒ¨æˆ–éƒ¨åˆ†ç™»è¨˜äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è²©è³£æˆ–æ„圖販賣而陳列å½è—¥ã€ç¦è—¥è€…，由直轄市或縣（市）衛生主管機關，公告其公å¸æˆ–商號之å稱ã€åœ°å€ã€è² 責人姓åã€è—¥å“å稱åŠé•å情節；å†æ¬¡é•å者，得åœæ¢å…¶ç‡Ÿæ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è£½é€ ã€è¼¸å…¥ã€è²©è³£æˆ–æ„圖販賣而陳列劣藥ã€ä¸è‰¯é†«ç™‚器æ者，由直轄市或縣（市）衛生主管機關，公告其公å¸æˆ–商號之å稱ã€åœ°å€ã€è² 責人姓åã€è—¥ç‰©å稱åŠé•å情節；其情節é‡å¤§æˆ–å†æ¬¡é•å者，得廢æ¢å…¶å„該藥物許å¯è‰ã€è—¥ç‰©è£½é€ 許å¯åŠåœæ¢å…¶ç‡Ÿæ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è¦å®šï¼Œæ–¼æœªç¶“æ ¸å‡†è€Œè£½é€ ã€è¼¸å…¥ä¹‹é†«ç™‚器æ，準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">查ç²ä¹‹å½è—¥æˆ–ç¦è—¥ï¼Œæ²’入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">查ç²ä¹‹åŠ£è—¥æˆ–ä¸è‰¯é†«ç™‚器æï¼Œå¦‚ä¿‚æœ¬åœ‹è£½é€ ï¼Œç¶“æª¢é©—å¾Œä»å¯æ”¹è£½ä½¿ç”¨è€…，應由直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關，派員監ç£åŽŸè£½é€ å» å•†é™æœŸæ”¹è£½ï¼›å…¶ä¸èƒ½æ”¹è£½æˆ–å±†æœŸæœªæ”¹è£½è€…ï¼Œæ²’å…¥éŠ·ç‡¬ä¹‹ï¼›å¦‚ä¿‚æ ¸å‡†è¼¸å…¥è€…ï¼Œæ‡‰å³å°å˜ï¼Œä¸¦ç”±ç›´è½„市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關責令原進å£å•†é™æœŸé€€é‹å‡ºå£ï¼Œå±†æœŸæœªèƒ½é€€è²¨è€…，沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è¦å®šæ–¼ç¶“ä¾æ³•èªå®šç‚ºæœªç¶“æ ¸å‡†è€Œè£½é€ ã€è¼¸å…¥ä¹‹é†«ç™‚器æ，準用之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 80 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©æœ‰ä¸‹åˆ—æƒ…å½¢ä¹‹ä¸€è€…ï¼Œå…¶è£½é€ æˆ–è¼¸å…¥ä¹‹æ¥è€…，應å³é€šçŸ¥é†«ç™‚機構ã€è—¥å±€åŠè—¥å•†ï¼Œä¸¦ä¾è¦å®šæœŸé™å›žæ”¶å¸‚å”®å“，連åŒåº«å˜å“一併ä¾æœ¬æ³•æœ‰é—œè¦å®šè™•ç†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸé ˜æœ‰è¨±å¯è‰ï¼Œç¶“公告ç¦æ¢è£½é€ 或輸入。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¶“ä¾æ³•èªå®šç‚ºå½è—¥ã€åŠ£è—¥æˆ–ç¦è—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¶“ä¾æ³•èªå®šç‚ºä¸è‰¯é†«ç™‚器ææˆ–æœªç¶“æ ¸å‡†è€Œè£½é€ ã€è¼¸å…¥ä¹‹é†«ç™‚器æ。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥ç‰©è£½é€ å·¥å» ï¼Œç¶“æª¢æŸ¥ç™¼ç¾å…¶è—¥ç‰©ç¢ºæœ‰æ害使用者生命ã€èº«é«”或å¥åº·ä¹‹äº‹å¯¦ï¼Œæˆ–有æ害之虞。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è£½é€ ã€è¼¸å…¥è—¥ç‰©è¨±å¯è‰æœªç”³è«‹å±•å»¶æˆ–ä¸å‡†å±•å»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€åŒ…è£ã€æ¨™ç±¤ã€ä»¿å–®ç¶“æ ¸å‡†è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å…¶ä»–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šæ‡‰å›žæ”¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è£½é€ ã€è¼¸å…¥æ¥è€…回收å‰é …å„款藥物時，醫療機構ã€è—¥å±€åŠè—¥å•†æ‡‰äºˆé…åˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 81 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">舉發或ç·ç²å½è—¥ã€åŠ£è—¥ã€ç¦è—¥åŠä¸è‰¯é†«ç™‚器æ，應予çŽå‹µã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">ä¹</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">罰則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 82 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ æˆ–è¼¸å…¥å½è—¥æˆ–ç¦è—¥è€…，處å年以下有期徒刑，得併科新臺幣一åƒè¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">犯å‰é …ä¹‹ç½ªï¼Œå› è€Œè‡´äººæ–¼æ»è€…，處無期徒刑或å年以上有期徒刑，致é‡å‚·è€…，處七年以上有期徒刑。</span> </p><p><span style="font-family: 新細明體,serif;">å› éŽå¤±çŠ¯ç¬¬ä¸€é …之罪者，處三年以下有期徒刑ã€æ‹˜å½¹æˆ–科新臺幣五åè¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …ä¹‹æœªé‚犯罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 83 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">明知為å½è—¥æˆ–ç¦è—¥ï¼Œè€Œè²©è³£ã€ä¾›æ‡‰ã€èª¿åŠ‘ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„圖販賣而陳列者，處七年以下有期徒刑，得併科新臺幣五百è¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">犯å‰é …ä¹‹ç½ªï¼Œå› è€Œè‡´äººæ–¼æ»è€…，處七年以上有期徒刑，致é‡å‚·è€…，處三年以上å二年以下有期徒刑。</span> </p><p><span style="font-family: 新細明體,serif;">å› éŽå¤±çŠ¯ç¬¬ä¸€é …之罪者，處二年以下有期徒刑ã€æ‹˜å½¹æˆ–科新臺幣三åè¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …ä¹‹æœªé‚犯罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 84 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœªç¶“æ ¸å‡†æ“…è‡ªè£½é€ æˆ–è¼¸å…¥é†«ç™‚å™¨æ者，處三年以下有期徒刑，得併科新å°å¹£åè¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">明知為å‰é …之醫療器æ而販賣ã€ä¾›æ‡‰ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„圖販賣而陳列者，ä¾å‰é …è¦å®šè™•ç½°ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å› éŽå¤±çŠ¯å‰é …之罪者，處å…月以下有期徒刑ã€æ‹˜å½¹æˆ–æ–°å°å¹£äº”è¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 85 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ æˆ–è¼¸å…¥ç¬¬äºŒå一æ¢ç¬¬ä¸€æ¬¾ä¹‹åŠ£è—¥æˆ–第二å三æ¢ç¬¬ä¸€æ¬¾ã€ç¬¬äºŒæ¬¾ä¹‹ä¸è‰¯é†«ç™‚器æ者，處一年以下有期徒刑或拘役，得併科新å°å¹£ä¸‰è¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">å› éŽå¤±çŠ¯å‰é …之罪或明知為å‰é …之劣藥或ä¸è‰¯é†«ç™‚器æ，而販賣ã€ä¾›æ‡‰ã€èª¿åŠ‘ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„圖販賣而陳列者，處å…月以下有期徒刑或拘役，得併科新å°å¹£ä¸€è¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">å› éŽå¤±è€Œè²©è³£ã€ä¾›æ‡‰ã€èª¿åŠ‘ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„åœ–è²©è³£è€Œé™³åˆ—ç¬¬ä¸€é …ä¹‹åŠ£è—¥æˆ–ä¸è‰¯é†«ç™‚器æ者，處拘役或新å°å¹£ä¸€è¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 86 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">擅用或冒用他人藥物之å稱ã€ä»¿å–®æˆ–標籤者，處一年以下有期徒刑ã€æ‹˜å½¹æˆ–科或併科新å°å¹£äº”è¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">明知為å‰é …之藥物而輸入ã€è²©è³£ã€ä¾›æ‡‰ã€èª¿åŠ‘ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„圖販賣而陳列者，處å…月以下有期徒刑ã€æ‹˜å½¹æˆ–科或併科新å°å¹£ä¸‰è¬å…ƒä»¥ä¸‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 87 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法人之代表人，法人或自然人之代ç†äººã€å—雇人，或其他從æ¥äººå“¡ï¼Œå› 執行æ¥å‹™ï¼ŒçŠ¯ç¬¬å…«å二æ¢è‡³ç¬¬å…«åå…æ¢ä¹‹ç½ªè€…，除ä¾å„該æ¢è¦å®šè™•ç½°å…¶è¡Œç‚ºäººå¤–，å°è©²æ³•äººæˆ–自然人亦科以å„該æ¢ä¹‹ç½°é‡‘。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 88 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•æŸ¥ç²ä¾›è£½é€ ã€èª¿åŠ‘å½è—¥ã€ç¦è—¥ä¹‹å™¨æ，ä¸å•å±¬æ–¼çŠ¯äººèˆ‡å¦ï¼Œæ²’收之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 89 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">公務員å‡å€Ÿè·å‹™ä¸Šä¹‹æ¬ŠåŠ›ã€æ©Ÿæœƒæˆ–æ–¹æ³•ï¼ŒçŠ¯æœ¬ç« å„æ¢ä¹‹ç½ªæˆ–åŒ…åº‡ä»–äººçŠ¯æœ¬ç« å„æ¢ä¹‹ç½ªè€…，ä¾å„該æ¢ä¹‹è¦å®šï¼ŒåŠ é‡å…¶åˆ‘至二分之一。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 90 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ æˆ–è¼¸å…¥ç¬¬äºŒå一æ¢ç¬¬äºŒæ¬¾è‡³ç¬¬å…«æ¬¾ä¹‹åŠ£è—¥æˆ–第二å三æ¢ç¬¬ä¸‰æ¬¾ã€ç¬¬å››æ¬¾ä¹‹ä¸è‰¯é†«ç™‚器æ者，處新å°å¹£å…è¬å…ƒä»¥ä¸Šä¸‰åè¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">販賣ã€ä¾›æ‡‰ã€èª¿åŠ‘ã€é‹é€ã€å¯„è—ã€ç‰™ä¿ã€è½‰è®“或æ„圖販賣而陳列å‰é …之劣藥或ä¸è‰¯é†«ç™‚器æ者，處新å°å¹£ä¸‰è¬å…ƒä»¥ä¸Šå五è¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">犯å‰äºŒé …è¦å®šä¹‹ä¸€è€…，å°å…¶è—¥ç‰©ç®¡ç†äººã€ç›£è£½äººï¼Œäº¦è™•ä»¥å„è©²é …ä¹‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 91 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第å…å五æ¢æˆ–第八åæ¢ç¬¬ä¸€é …第一款至第四款è¦å®šä¹‹ä¸€è€…，處新臺幣二åè¬å…ƒä»¥ä¸Šäº”百è¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å第å…åä¹æ¢è¦å®šè€…，處新臺幣å…åè¬å…ƒä»¥ä¸ŠäºŒåƒäº”百è¬å…ƒä»¥ä¸‹ç½°é°ï¼Œå…¶é•æ³•ç‰©å“沒入銷燬之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 92 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第二å七æ¢ç¬¬ä¸€é …ã€ç¬¬ä¸‰é …ã€ç¬¬äºŒåä¹æ¢ã€ç¬¬ä¸‰å一æ¢ã€ç¬¬ä¸‰åå…æ¢ã€ç¬¬ä¸‰å七æ¢ç¬¬äºŒé …ã€ç¬¬ä¸‰é …ã€ç¬¬ä¸‰åä¹æ¢ç¬¬ä¸€é …ã€ç¬¬å››åæ¢ç¬¬ä¸€é …ã€ç¬¬å››åå››æ¢ã€ç¬¬å››å五æ¢ä¹‹ä¸€ã€ç¬¬å››åå…æ¢ã€ç¬¬å››åä¹æ¢ã€ç¬¬äº”åæ¢ç¬¬ä¸€é …ã€ç¬¬äº”å一æ¢è‡³ç¬¬äº”å三æ¢ã€ç¬¬äº”å五æ¢ç¬¬ä¸€é …ã€ç¬¬äº”å七æ¢ç¬¬ä¸€é …ã€ç¬¬äºŒé …ã€ç¬¬å››é …ã€ç¬¬äº”å七æ¢ä¹‹ä¸€ã€ç¬¬äº”åå…«æ¢ã€ç¬¬äº”åä¹æ¢ã€ç¬¬å…åæ¢ã€ç¬¬å…åå››æ¢ã€ç¬¬ä¸ƒå一æ¢ç¬¬ä¸€é …ã€ç¬¬ä¸ƒå二æ¢ã€ç¬¬ä¸ƒåå››æ¢ã€ç¬¬ä¸ƒå五æ¢è¦å®šä¹‹ä¸€è€…，處新臺幣三è¬å…ƒä»¥ä¸Šå五è¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å第五åä¹æ¢è¦å®šï¼Œæˆ–調劑ã€ä¾›æ‡‰æ¯’劇藥å“é•å第å…åæ¢ç¬¬ä¸€é …è¦å®šè€…，å°å…¶è—¥å“管ç†äººã€ç›£è£½äººï¼Œäº¦è™•ä»¥å‰é …之罰é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å第五å七æ¢ç¬¬äºŒé …æˆ–ç¬¬å››é …è¦å®šè€…，除ä¾ç¬¬ä¸€é …è¦å®šè™•ç½°å¤–，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—å…¬å¸ƒè—¥å» æˆ–è—¥å•†å單，並令其é™æœŸæ”¹å–„，改善期間得åœæ¢å…¶ä¸€éƒ¨æˆ–å…¨éƒ¨è£½é€ ã€è¼¸å…¥åŠç‡Ÿæ¥ï¼›å±†æœŸæœªæ”¹å–„者，ä¸å‡†å±•å»¶å…¶è—¥ç‰©è¨±å¯è‰ï¼Œä¸”ä¸å—ç†è©²è£½é€ å» å…¶ä»–è—¥ç‰©ä¹‹æ–°ç”³è«‹æ¡ˆä»¶ï¼›å…¶æƒ…ç¯€é‡å¤§è€…，並得廢æ¢å…¶ä¸€éƒ¨æˆ–å…¨éƒ¨ä¹‹è—¥ç‰©è£½é€ è¨±å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å第å…åå…æ¢ç¬¬ä¸€é …ã€ç¬¬äºŒé …ã€ç¬¬å…å七æ¢ã€ç¬¬å…åå…«æ¢è¦å®šä¹‹ä¸€è€…，處新臺幣二åè¬å…ƒä»¥ä¸Šäº”百è¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 93 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第åå…æ¢ç¬¬äºŒé …ã€ç¬¬äºŒåå…«æ¢ã€ç¬¬ä¸‰åæ¢ã€ç¬¬ä¸‰å二æ¢ç¬¬ä¸€é …ã€ç¬¬ä¸‰å三æ¢ã€ç¬¬ä¸‰å七æ¢ç¬¬ä¸€é …ã€ç¬¬ä¸‰åå…«æ¢æˆ–第å…å二æ¢è¦å®šä¹‹ä¸€ï¼Œæˆ–有左列情形之一者，處新臺幣三è¬å…ƒä»¥ä¸Šå五è¬å…ƒä»¥ä¸‹ç½°é°ï¼š</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€æˆè—¥ã€å›ºæœ‰æˆæ–¹è£½åŠ‘ä¹‹è£½é€ ã€æ¨™ç¤ºåŠè²©å”®é•åä¸å¤®è¡›ç”Ÿä¸»ç®¡</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">æ©Ÿé—œä¾ç¬¬å…«æ¢ç¬¬ä¸‰é …è¦å®šæ‰€å®šè¾¦æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é†«ç™‚器æ之分級åŠç®¡ç†é•åä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾ç¬¬å三æ¢ç¬¬äºŒé …è¦å®šæ‰€å®šè¾¦æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥ç‰©æ¨£å“ã€è´ˆå“之使用åŠåŒ…è£é•åä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾ç¬¬äº”</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å五æ¢ç¬¬äºŒé …è¦å®šæ‰€å®šè¾¦æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•å第åå…æ¢ç¬¬äºŒé …或第三åæ¢è¦å®šè€…，除ä¾å‰é …è¦å®šè™•ç½°å¤–，衛生主管機關並得åœæ¢å…¶ç‡Ÿæ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 94 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•å第三åå››æ¢ç¬¬ä¸€é …ã€ç¬¬ä¸ƒå三æ¢ç¬¬äºŒé …ã€ç¬¬å…«åæ¢ç¬¬ä¸€é …ç¬¬äº”æ¬¾è‡³ç¬¬ä¸ƒæ¬¾æˆ–ç¬¬äºŒé …è¦å®šä¹‹ä¸€è€…，處新臺幣二è¬å…ƒä»¥ä¸Šåè¬å…ƒä»¥ä¸‹ç½°é°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 95 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">傳æ’æ¥è€…é•å第å…åå…æ¢ç¬¬ä¸‰é …è¦å®šè€…，處新臺幣二åè¬å…ƒä»¥ä¸Šäº”百è¬å…ƒä»¥ä¸‹ç½°é°ï¼Œå…¶ç¶“衛生主管機關通知é™æœŸåœæ¢è€Œä»ç¹¼çºŒåˆŠæ’者，處新臺幣å…åè¬å…ƒä»¥ä¸ŠäºŒåƒäº”百è¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦æ‡‰æŒ‰æ¬¡é€£çºŒè™•ç½°ï¼Œè‡³å…¶åœæ¢åˆŠæ’為æ¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">傳æ’æ¥è€…é•å第å…åå…æ¢ç¬¬å››é …è¦å®šè€…，處新臺幣å…è¬å…ƒä»¥ä¸Šä¸‰åè¬å…ƒä»¥ä¸‹ç½°é°ï¼Œä¸¦æ‡‰æŒ‰æ¬¡é€£çºŒè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 96 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é•åç¬¬ä¸ƒç« è¦å®šä¹‹è—¥ç‰©å»£å‘Šï¼Œé™¤ä¾æœ¬ç« è¦å®šè™•ç½°å¤–ï¼Œè¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ç™»å ±å…¬å‘Šå…¶è² è²¬äººå§“åã€è—¥ç‰©å稱åŠæ‰€çŠ¯æƒ…節，情節é‡å¤§è€…，並得廢æ¢è©²è—¥ç‰©è¨±å¯è‰ï¼›å…¶åŽŸå“å二年內亦ä¸å¾—申請使用。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …經廢æ¢è—¥ç‰©è¨±å¯è‰ä¹‹é•è¦è—¥ç‰©å»£å‘Šï¼Œä»æ‡‰ç”±åŽŸæ 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新細明體,serif;">第</span><span style="font-family: calibri;"> 97-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾è—¥å“查驗登記審查準則åŠé†«ç™‚器æ查驗登記審查準則æ出申請之案件，其é€é©—藥物經檢驗與申請資料ä¸ç¬¦è€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè‡ªæª¢é©—çµæžœç¢ºå®šæ—¥èµ·å…個月內，ä¸äºˆå—ç†å…¶è£½é€ å» å…¶ä»–è—¥ç‰©ä¹‹æ–°ç”³è«‹æ¡ˆä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形於申復期間申請é‡æ–°æª¢é©—ä»æœªé€šéŽè€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè‡ªé‡æ–°æª¢é©—çµæžœç¢ºå®šæ—¥èµ·ä¸€å¹´å…§ï¼Œä¸äºˆå—ç†å…¶è£½é€ å» å…¶ä»–è—¥ç‰©ä¹‹æ–°ç”³è«‹æ¡ˆä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 98 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（刪除）</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 99 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•è¦å®šè™•ç½°ä¹‹ç½°é°ï¼Œå—罰人ä¸æœæ™‚，得於處罰通知é€é”後å五日內，以書é¢æ出異è°ï¼Œç”³è«‹å¾©æ ¸ã€‚但以一次為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">科處罰é°æ©Ÿé—œæ‡‰æ–¼æŽ¥åˆ°å‰é …ç•°è°æ›¸å¾Œå五日內，將該案é‡è¡Œå¯©æ ¸ï¼Œèªç‚ºæœ‰ç†ç”±è€…，應變更或撤銷原處罰。</span> </p><p><span style="font-family: 新細明體,serif;">å—罰人ä¸æœå‰é …å¾©æ ¸æ™‚ï¼Œå¾—ä¾æ³•æ起訴願åŠè¡Œæ”¿è¨´è¨Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 99-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•ç”³è«‹è—¥ç‰©æŸ¥é©—登記ã€è¨±å¯è‰è®Šæ›´ã€ç§»è½‰åŠå±•å»¶ä¹‹æ¡ˆä»¶ï¼Œæœªç²æ ¸å‡†è€…，申請人得自處分書é€é”之日起四個月內，敘明ç†ç”±æ出申復。但以一次為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°å‰é …申復èªæœ‰ç†ç”±è€…，應變更或撤銷原處分。</span> </p><p><span style="font-family: 新細明體,serif;">申復人ä¸æœå‰é …申復決定時，得ä¾æ³•æ起訴願åŠè¡Œæ”¿è¨´è¨Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 100 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法所定之罰é°ï¼Œç”±ç›´è½„市ã€ç¸£</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生主管機關處罰之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 101 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•æ‡‰å—處罰者，除ä¾æœ¬æ³•è™•ç½°å¤–，其有犯罪嫌疑者，應移é€å¸æ³•æ©Ÿé—œè™•ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 102 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫師以診療為目的，並具有本法è¦å®šä¹‹èª¿åŠ‘è¨å‚™è€…，得ä¾è‡ªé–‹è™•æ–¹ï¼Œè¦ªè‡ªç‚ºè—¥å“之調劑。</span> </p><p><span style="font-family: 新細明體,serif;">全民å¥åº·ä¿éšªå¯¦æ–½äºŒå¹´å¾Œï¼Œå‰é …è¦å®šä»¥åœ¨ä¸å¤®æˆ–直轄市衛生主管機關公告無藥事人員執æ¥ä¹‹åé 地å€æˆ–醫療急迫情形為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 103 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法公布後，於å…å三年五月三å一日å‰ä¾è¦å®šæ›é ˜ä¸è—¥è²©è³£æ¥ä¹‹è—¥å•†è¨±å¯åŸ·ç…§æœ‰æ¡ˆè€…，得繼續經營第å五æ¢ä¹‹ä¸è—¥è²©è³£æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«å二年二月五日å‰æ›¾ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æ ¸ï¼Œäºˆä»¥åˆ—å†Šç™»è¨˜è€…ï¼Œæˆ–é ˜æœ‰ç¶“ç‡Ÿä¸è—¥è‰æ˜Žæ–‡ä»¶ä¹‹ä¸è—¥å¾žæ¥äººå“¡ï¼Œä¸¦ä¿®ç¿’ä¸è—¥èª²ç¨‹é”é©ç•¶æ¨™æº–，得繼續經營ä¸è—¥è²©è³£æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …ä¸è—¥è²©è³£æ¥å‹™ç¯„åœåŒ…括︰ä¸è—¥æåŠä¸è—¥è£½åŠ‘之輸入ã€è¼¸å‡ºåŠæ‰¹ç™¼ï¼›ä¸è—¥æåŠéžå±¬ä¸é†«å¸«è™•æ–¹è—¥å“之零售；ä¸å«æ¯’劇ä¸è—¥æ或ä¾å›ºæœ‰æˆæ–¹èª¿é…而æˆä¹‹å‚³çµ±ä¸¸ã€æ•£ã€è†ã€ä¸¹ã€åŠç…Žè—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">上述人員ã€ä¸é†«å¸«æª¢å®šè€ƒè©¦åŠæ ¼æˆ–在未è¨ä¸è—¥å¸«ä¹‹å‰æ›¾è˜ä»»ä¸é†«å¸«ã€è—¥å¸«åŠè—¥åŠ‘生é§åº—管ç†ä¹‹ä¸è—¥å•†æœŸæ»¿ä¸‰å¹´ä»¥ä¸Šä¹‹è² 責人，經修習ä¸è—¥èª²ç¨‹é”é©ç•¶æ¨™æº–ï¼Œé ˜æœ‰åœ°æ–¹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè‰æ˜Žæ–‡ä»¶ï¼›ä¸¦ç¶“國家考試åŠæ ¼è€…，其æ¥å‹™ç¯„åœå¦‚左︰</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä¸è—¥æåŠä¸è—¥è£½åŠ‘之輸入ã€è¼¸å‡ºåŠæ‰¹ç™¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¸è—¥æåŠéžå±¬ä¸é†«å¸«è™•æ–¹è—¥å“之零售。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¸å«æ¯’劇ä¸è—¥æ或ä¾å›ºæœ‰æˆæ–¹èª¿é…而æˆä¹‹å‚³çµ±ä¸¸ã€æ•£ã€è†ã€ä¸¹ã€åŠç…Žè—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¸é†«å¸«è™•æ–¹è—¥å“之調劑。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …考試，由考試院會åŒè¡Œæ”¿é™¢å®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">民國七åå…«å¹´å二月三å一日å‰æ¥ç¶“æ ¸å‡†ç™»è¨˜é ˜ç…§ç‡Ÿæ¥ä¹‹è¥¿è—¥è²©è³£æ¥è€…ã€è¥¿è—¥ç¨®å•†ï¼Œå…¶æ‰€è˜è«‹å°ˆä»»ç®¡ç†ä¹‹è—¥å¸«æˆ–藥劑生å…å—第二åå…«æ¢ç¬¬ä¸€é …é§åº—管ç†ä¹‹é™åˆ¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‰æ¢æ‰€ç¨±æ°‘國七åå…«å¹´å二月三å一日å‰æ¥ç¶“æ ¸å‡†ç™»è¨˜é ˜ç…§ç‡Ÿæ¥ä¹‹è¥¿è—¥è²©è³£æ¥è€…ã€è¥¿è—¥ç¨®å•†ï¼Œä¿‚æŒ‡å…¶è—¥å•†è² è²¬äººæ–¼ä¸ƒåä¹å¹´ä¸€æœˆä¸€æ—¥ä»¥å¾Œï¼Œæœªæ›¾è®Šæ›´ä¸”ä»ç¹¼çºŒç‡Ÿæ¥è€…。但營æ¥é …ç›®ç™»è¨˜ç‚ºé›¶å”®ä¹‹è—¥å•†ï¼Œå› è² è²¬äººæ»äº¡ï¼Œè€Œç”±å…¶é…å¶ç‚ºè² 責人繼續營æ¥è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬æ³•ç”³è«‹è‰ç…§æˆ–äº‹é …æˆ–å‡½è©¢è—¥å“查驗登記審查準則åŠé†«ç™‚器æ查驗登記審查準則ç‰ç›¸é—œè¦å®šï¼Œæ‡‰ç¹³ç´è²»ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …應繳費用種類åŠå…¶è²»é¡ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å„級衛生主管機關於必è¦æ™‚，得將藥物抽查åŠæª¢é©—之一部或全部，委任所屬機關或委託相關機關（構）辦ç†ï¼›å…¶å§”ä»»ã€å§”託åŠå…¶ç›¸é—œäº‹é …之辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104-4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—就藥物檢驗æ¥å‹™ï¼Œè¾¦ç†æª¢é©—機構之èªè‰ï¼›å…¶èªè‰åŠç®¡ç†è¾¦æ³•ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …èªè‰å·¥ä½œï¼Œå¾—委任所屬機關或委託其他機關（構）辦ç†ï¼›å…¶å§”ä»»ã€å§”託åŠå…¶ç›¸é—œäº‹é …之辦法，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 105 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法施行細則，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 106 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本法自公布日施行。</span> </p><p><span style="font-family: 新細明體,serif;">本法ä¸è¯æ°‘國八åå…年五月七日修æ£å…¬å¸ƒä¹‹ç¬¬äº”å三æ¢æ–½è¡Œæ—¥æœŸï¼Œç”±è¡Œæ”¿é™¢å®šä¹‹ï¼›ä¸è¯æ°‘國ä¹å五年五月五日修æ£ä¹‹æ¢æ–‡ï¼Œè‡ªä¸è¯æ°‘國ä¹å五年七月一日施行。</span> </p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1027&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1042&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6047&type=0
藥政管ç†é¡ž,藥事法施行細則法è¦å‘½ä»¤è—¥äº‹æ³•æ–½è¡Œç´°å‰‡<p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則ä¾è—¥äº‹æ³•</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">第一百零五æ¢è¦å®šè¨‚定之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 2 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第七æ¢ï¼Œç”¨è©žå®šç¾©å¦‚下：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一ã€æ–°æˆåˆ†ï¼šæŒ‡æ–°ç™¼æ˜Žä¹‹æˆåˆ†å¯ä¾›è—¥ç”¨è€…。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二ã€æ–°ç™‚æ•ˆè¤‡æ–¹ï¼šæŒ‡å·²æ ¸å‡†è—¥å“具有新é©æ‡‰ç—‡ã€é™ä½Žå‰¯ä½œç”¨ã€æ”¹å–„療效強度ã€æ”¹å–„療效時間或改變使用劑é‡ä¹‹æ–°é†«ç™‚æ•ˆèƒ½ï¼Œæˆ–äºŒç¨®ä»¥ä¸Šå·²æ ¸å‡†æˆåˆ†ä¹‹è¤‡æ–¹è£½åŠ‘具有優於å„該單一æˆåˆ†è—¥å“之醫療效能者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三ã€æ–°ä½¿ç”¨é€”å¾‘ï¼šæŒ‡å·²æ ¸å‡†è—¥å“改變其使用途徑者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 3 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第八æ¢ç¬¬äºŒé …所稱醫師處方藥å“，係指經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©å®šï¼Œåœ¨è—¥å“許å¯è‰ä¸Šï¼Œè¼‰æ˜Žé ˆç”±é†«å¸«è™•æ–¹æˆ–é™ç”±é†«å¸«ä½¿ç”¨è€…。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 4 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æœ¬æ³•æ‰€ç¨±ç¨½æŸ¥ï¼Œä¿‚æŒ‡é—œæ–¼è—¥ç‰©æœ‰ç„¡ç¶“æ ¸å‡†æŸ¥é©—ç™»è¨˜åŠèˆ‡åŽŸæ ¸å‡†æŸ¥é©—登記或è¦å®šæ˜¯å¦ç›¸ç¬¦ä¹‹æª¢æŸ¥äº‹é …。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">本法所稱檢驗，係指關於藥å“之性狀ã€æˆåˆ†ã€è³ªã€é‡æˆ–強度ç‰åŒ–é©—é‘‘å®šäº‹é …ï¼Œæˆ–é†«ç™‚å™¨æ之化å¸ã€ç‰©ç†ã€æ©Ÿæ¢°ã€æ質ç‰é‘‘å®šäº‹é …ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 5 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二åæ¢ç¬¬ä¸€æ¬¾æ‰€ç¨±æœªç¶“æ ¸å‡†ï¼Œæ“…è‡ªè£½é€ è€…ï¼Œä¸åŒ…括éžè²©è³£ä¹‹ç ”究ã€è©¦è£½ä¹‹è—¥å“。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">å‰é …è—¥å“æ‡‰å‚™æœ‰ç ”ç©¶æˆ–è©¦è£½ç´€éŒ„ï¼Œä¸¦ä»¥ç„¡å•†å“化之包è£è€…為é™ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 6 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二å二æ¢ç¬¬äºŒæ¬¾æ‰€ç¨±æœªç¶“æ ¸å‡†æ“…è‡ªè¼¸å…¥ä¹‹è—¥å“，係指該藥å“未曾由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾æœ¬æ³•ç¬¬ä¸‰åä¹æ¢è¦å®šæ ¸ç™¼è¼¸å…¥è¨±å¯è‰è€…。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 7 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二å三æ¢ç¬¬ä¸€æ¬¾æ‰€ç¨±ä½¿ç”¨ï¼Œä¿‚指ä¾æ¨™ç±¤æˆ–仿單刊載之用法，作æ£å¸¸åˆç†ä¹‹ä½¿ç”¨è€…。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 8 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二å五æ¢æ‰€ç¨±æ¨™ç±¤ï¼ŒåŒ…括直接標示於醫療器æ上之文å—ã€åœ–畫或記號。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 9 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二å七æ¢ç¬¬äºŒé …è¦å®šè—¥å•†ç™»è¨˜äº‹é …如左：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一ã€è—¥å•†ç¨®é¡žã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二ã€ç‡Ÿæ¥é …目。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三ã€è—¥å•†å稱。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">å››ã€åœ°å€ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">五ã€è² 責人。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">å…ã€è—¥ç‰©ç®¡ç†ã€ç›£è£½æˆ–技術人員。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">七ã€å…¶ä»–æ‡‰è¡Œç™»è¨˜äº‹é …ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 10 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¾æœ¬æ³•ç¬¬äºŒå七æ¢ç¬¬ä¸€é …è¦å®šç”³è«‹è—¥å•†ç™»è¨˜è€…，應填具申請書，連åŒåŸ·ç…§è²»åŠä¸‹åˆ—æ–‡ä»¶ï¼Œç”³è«‹ç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ï¼š</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一ã€ä¾æœ¬æ³•è¦å®šï¼Œæ‡‰è˜ç”¨è—¥ç‰©ç®¡ç†ã€ç›£è£½æˆ–技術人員者，其所è˜äººå“¡ä¹‹åŸ·</span><span style="font-size: 14pt;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¥åŸ·ç…§æˆ–è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二ã€è—¥å•†ç‚ºå…¬å¸çµ„織者，其公å¸ç™»è¨˜ã€å…¬å¸çµ„ç¹”ç« ç¨‹å½±æœ¬ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三ã€è—¥ç‰©è²©è³£æ¥è€…，其營æ¥åœ°å€ã€å ´æ‰€ï¼ˆè²¯å˜è—¥å“倉庫）åŠä¸»è¦è¨å‚™ä¹‹å¹³é¢ç•¥åœ–。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">å››ã€è—¥ç‰©è£½é€ æ¥è€…ï¼Œå…¶å·¥å» ç™»è¨˜è‰æ˜Žæ–‡ä»¶åŠå…¶å½±æœ¬ã€‚但ä¾å·¥å» 管ç†è¼”導法è¦å®šå…辦ç†å·¥å» 登記者，å…附。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">五ã€ç›´è½„市或縣（市）衛生主管機關所定之其他文件。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">æ–°è¨ç«‹å…¬å¸çµ„織之藥商，得由衛生主管機關先發給籌è¨è¨±å¯æ–‡ä»¶ï¼Œä¿Ÿå–å¾—å…¬å¸ç™»è¨˜æˆ–å·¥å» ç™»è¨˜è‰æ˜Žæ–‡ä»¶å¾Œï¼Œå†æ ¸ç™¼è—¥å•†è¨±å¯åŸ·ç…§ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 11 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請藥商登記者，其藥商種類åŠæ‡‰è¼‰æ˜Žä¹‹ç‡Ÿæ¥é …目，應ä¾æœ¬æ³•ç¬¬åå››æ¢è‡³ç¬¬åå…«æ¢ä¹‹è¦å®šã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">西藥販賣æ¥è€…，由藥劑生é§åº—管ç†æ™‚，其營æ¥é …ç›®æ‡‰åŠ è¨»ä¸è²©è³£éº»é†‰è—¥å“。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商經營醫用放射性藥å“者，應ä¾æœ‰é—œæ³•ä»¤è¦å®šï¼Œç”³è«‹æ ¸å‡†å¾Œå§‹å¾—販賣。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 12 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è—¥å“è£½é€ æ¥è€…ä¾æœ¬æ³•ç¬¬åå…æ¢è¦å®šåœ¨å…¶è£½é€ åŠ å·¥ä¹‹åŒä¸€è™•æ‰€ç¶“營自製產å“之批發ã€è¼¸å‡ºã€è‡ªç”¨åŽŸæ–™è¼¸å…¥åŠå…¼ç‡Ÿè‡ªè£½ç”¢å“之零售æ¥å‹™è€…，得由其監製人兼為管ç†ä¹‹ã€‚但兼營éžæœ¬è—¥å•†ç”¢å“之販賣æ¥å‹™æˆ–分è¨è™•æ‰€ç¶“營å„該æ¥å‹™è€…，應分別è˜ç®¡ç†äººå“¡ï¼Œä¸¦è¾¦ç†è—¥å“販賣æ¥ä¹‹è—¥å•†ç™»è¨˜ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è—¥å“è£½é€ æ¥è€…ä¾æœ¬æ³•ç¬¬äº”åå…«æ¢è¦å®šï¼Œå§”è¨—ä»–å» è£½é€ ä¹‹ç”¢å“，其批發ã€</span><span style="font-size: 14pt;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸出åŠé›¶å”®ï¼Œå¾—ä¾å‰é …å‰æ®µè¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 13 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">醫療器æè£½é€ æ¥è€…ä¾æœ¬æ³•ç¬¬ä¸‰å二æ¢è¦å®šæ‡‰è˜æŠ€è¡“人員之醫療器æ類別åŠå…¶æŠ€è¡“äººå“¡è³‡æ ¼ï¼Œä¾å·¦åˆ—è¦å®šï¼š</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">一ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">è£½é€ ä¸€èˆ¬é†«ç™‚è¨å‚™ã€è‡¨åºŠæª¢é©—è¨å‚™åŠç”Ÿç‰©ææ–™è¨å‚™è€…，應è˜åœ‹å…§å…¬ç«‹æˆ–立案之ç§ç«‹å°ˆç§‘以上å¸æ ¡æˆ–經教育部承èªä¹‹åœ‹å¤–專科以上å¸æ ¡ç†ã€å·¥ã€é†«ã€è¾²ç‰ç›¸é—œç§‘ã€ç³»ã€æ‰€ç•¢æ¥ä¹‹å°ˆä»»æŠ€è¡“人員é§å» 監製。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">二ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">è£½é€ éš±å½¢çœ¼é¡é¡ç‰‡æ¶ˆæ¯’藥水</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">éŒ </span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ã€ç§»æ¤å™¨å®˜ä¿å˜æ¶²ã€è¡›ç”Ÿææ–™ã€è¡›ç”Ÿæ£‰æ¢æ¥è€…，應è˜å°ˆä»»è—¥å¸«é§å» 監製。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 14 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商許å¯åŸ·ç…§ã€è—¥å±€åŸ·ç…§ï¼Œæ‡‰æ‡¸æŽ›æ–¼ç‡Ÿæ¥è™•æ‰€ä¹‹æ˜Žé¡¯ä½</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">置。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 15 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二å七æ¢ç¬¬ä¸€é …所稱應辦ç†è®Šæ›´ç™»è¨˜ä¹‹äº‹é …，包括</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è—¥å•†ç™»è¨˜äº‹é …ä¹‹è®Šæ›´åŠè‡ªè¡Œåœæ¥ã€å¾©æ¥æˆ–æ‡æ¥ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å‰é …應辦ç†è®Šæ›´ç™»è¨˜äº‹é …，藥商應自事實發生之日起å五</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">日內，å‘åŽŸæ ¸å‡†ç™»è¨˜ä¹‹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹è¾¦ç†è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 16 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商辦ç†è®Šæ›´ç™»è¨˜ï¼Œé™¤é·å€è®Šæ›´ç™»è¨˜ï¼Œæ‡‰å…ˆå‘衛生主管機</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">關申請辦ç†å¤–，其他公å¸çµ„織或商æ¥ç™»è¨˜äº‹é …之變更，應</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å…ˆå‘商æ¥ä¸»ç®¡æ©Ÿé—œè¾¦å¦¥å„該變更登記。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 17 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商ä¾æœ¬æ³•ç¬¬äºŒåå…«æ¢æˆ–第二åä¹æ¢è¦å®šè˜ç”¨ä¹‹ç®¡ç†æˆ–</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">監製人員，或第三å一æ¢ã€ç¬¬ä¸‰å二æ¢è¦å®šè˜ç”¨ä¹‹æŠ€è¡“人</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å“¡ï¼Œå› è§£è˜ã€è¾è˜æˆ–å…¶ä»–åŽŸå› ä¸èƒ½åŸ·è¡Œå…¶ä»»å‹™è€Œæœªå¦è¡Œè˜</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">置時，應å³åœæ¢ç‡Ÿæ¥ï¼Œä¸¦ç”³è«‹åœæ¥æˆ–æ‡æ¥ä¹‹ç™»è¨˜ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 18 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è—¥å“販賣æ¥è€…ä¾æœ¬æ³•ç¬¬äºŒåå…«æ¢è¦å®šè˜ç”¨ä¹‹è—¥å¸«ã€è—¥åŠ‘生</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">或ä¸é†«å¸«ï¼Œæˆ–本法第åä¹æ¢è¦å®šè¦ªè‡ªä¸»æŒè—¥å±€æ¥å‹™ä¹‹è—¥</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">師ã€è—¥åŠ‘生，å‡æ‡‰è¦ªè‡ªåœ¨ç‡Ÿæ¥å ´æ‰€åŸ·è¡Œæ¥å‹™ï¼Œå…¶ä¸åœ¨å ´æ™‚，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">應於門å£æ‡¸æŽ›æ˜Žé¡¯æ¨™ç¤ºã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 19 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 20 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 21 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 22 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 22-1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¾æœ¬æ³•ç¬¬ä¸‰åä¹æ¢ç¬¬äºŒé …è¦å®šç”³è«‹è¼¸å…¥è©¦è£½è—¥å“原料</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥者，應繳ç´è²»ç”¨ï¼Œä¸¦å¡«å…·ç”³è«‹æ›¸åŠæª¢é™„下列資料，é€</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸è¾¦ï¼š</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一ã€è—¥å•†è¨±å¯åŸ·ç…§ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二ã€è©¦è£½è¨ˆç•«æ›¸ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三ã€ç¶“æ¿Ÿéƒ¨å·¥å» ç™»è¨˜è‰æ˜Žæ–‡ä»¶ã€‚ä½†ç ”ç™¼å–®ä½ï¼Œå…附。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å››ã€å§”託其他藥商辦ç†è¼¸å…¥è©¦è£½è—¥å“原料藥者，其委託</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">書ã€å§”託者åŠå—委託者之藥商許å¯åŸ·ç…§ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 23 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 23-1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°æ–¼è—¥ç‰©ä¹‹æŸ¥é©—，得委託衛生財團法</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">人或其他相關團體ã€æ©Ÿæ§‹è¾¦ç†å¸è¡“æ€§ç ”ç©¶ã€å®‰å…¨ã€è‡¨åºŠ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">試驗ç‰æŠ€è¡“性資料之審查æ¥å‹™ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 24 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第三åä¹æ¢ã€ç¬¬å››åæ¢æ‰€ç¨±è—¥ç‰©æŸ¥é©—ç™»è¨˜äº‹é …å¦‚å·¦ï¼š</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一ã€è—¥ç‰©ä¸æ–‡åŠå¤–æ–‡å“å。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二ã€è—¥å“處方åŠè—¥å“劑型。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三ã€é†«ç™‚器ææˆåˆ†ã€ææ–™ã€çµæ§‹åŠè¦æ ¼ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å››ã€è—¥ç‰©æ¨™ç±¤ã€ä»¿å–®åŠåŒ…è£ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五ã€è—¥å“之直接包è£ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å…ã€é©æ‡‰ç—‡ã€æ•ˆèƒ½ã€æ€§èƒ½ã€ç”¨æ³•ã€ç”¨é‡åŠé¡žåˆ¥ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">七ã€è—¥ç‰©è£½é€ 方法ã€æª¢é©—è¦æ ¼åŠæª¢é©—方法。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å…«ã€è—¥å•†å稱。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¹ã€è£½é€ å» å» ååŠå» å€ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一○ã€å…¶ä»–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŒ‡å®šç™»è¨˜äº‹é …。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 25 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 26 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 27 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">åœ‹å…§è£½é€ ä¹‹è—¥ç‰©ï¼Œå…¶æ¨™ç±¤ã€ä»¿å–®ã€åŒ…è£æ‡‰ä»¥ä¸æ–‡ç‚ºä¸»ï¼Œæ‰€</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">附外文文å—應å°æ–¼ä¸æ–‡ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">åœ‹å¤–è¼¸å…¥ä¹‹è—¥ç‰©ï¼Œé™¤æ‡‰åŠ é™„ä¸æ–‡ä»¿å–®å¤–，其標籤ã€åŒ…è£å‡</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">應å¦ä»¥ä¸æ–‡è¼‰æ˜Žå“åã€é¡žåˆ¥ã€è¨±å¯è‰å—號åŠè¼¸å…¥è—¥å•†å</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">稱ã€åœ°å€ï¼Œä¸”應以ä¸æ–‡æˆ–ä¾ç¿’慣能辨明之方å¼åˆŠè¼‰æœ‰æ•ˆæœŸ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">間或ä¿å˜æœŸé™ï¼›å…¶ä¸æ–‡å“å之文å—ä¸å¾—å°æ–¼å¤–文。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 28 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商å稱之變更，涉åŠæ¬Šåˆ©ä¹‹ç§»è½‰è€…，應由雙方共åŒæ出</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 29 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 30 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 31 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸出藥物為應輸出地å€è³¼è²·è€…之è¦æ±‚ï¼Œé ˆè®Šæ›´è—¥ç‰©å稱ã€</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">標籤ã€ä»¿å–®ã€åŒ…è£æˆ–é™„åŠ å¤–æ–‡è€…ï¼Œæ‡‰æª¢é™„å…¶æ‰€è®Šæ›´ä¹‹å¯¦æ¨£</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å„二份，申請ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å®šã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å‰é …經變更å稱ã€æ¨™ç±¤ã€ä»¿å–®ã€åŒ…è£æˆ–é™„åŠ å¤–æ–‡ä¹‹è—¥ç‰©ï¼Œ</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¸å¾—用於內銷。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 32 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 33 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第四åä¹æ¢æ‰€ç¨±ä¸å¾—買賣，包括ä¸å¾—將藥物供應éžè—¥</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å±€ã€éžè—¥å•†åŠéžé†«ç™‚機構。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 34 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¾æœ¬æ³•ç¬¬äº”å三æ¢ç¬¬äºŒé …為輸入原料藥之分è£ï¼Œæ‡‰ç”±è¼¸å…¥</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之藥商於符åˆå„ªè‰¯è—¥å“è£½é€ è¦ç¯„ä¹‹è—¥å» åˆ†è£å¾Œï¼Œå¡«å…·ç”³è«‹</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">書，連åŒè—¥å“許å¯è‰å½±æœ¬ã€æµ·é—œæ ¸ç™¼ä¹‹é€²å£å ±å–®å‰¯æœ¬ã€åŽŸ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å» æª¢é©—æˆç¸¾æ›¸ã€æª¢é©—方法åŠå…¶ä»–指定文件，申請ä¸å¤®è¡›ç”Ÿ</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">主管機關備查。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">經分è£ä¹‹åŽŸæ–™è—¥ï¼Œä»¥éŠ·å”®è—¥å“è£½é€ æ¥è€…為é™ï¼›æ‰€ä½¿ç”¨ä¹‹æ¨™</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ç±¤æ‡‰åˆ†åˆ¥åˆŠè¼‰å·¦åˆ—äº‹é …ï¼š</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一ã€å» 商å稱åŠåœ°å€ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二ã€å“ååŠè¨±å¯è‰å—號。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三ã€æ•ˆèƒ½æˆ–é©æ‡‰ç—‡ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å››ã€æ‰¹è™Ÿã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五ã€åˆ†è£è—¥å•†å稱åŠåœ°å€ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å…ã€åˆ†è£æ—¥æœŸã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">七ã€è£½é€ 日期åŠæœ‰æ•ˆæœŸé–“或ä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å…«ã€å…¶ä»–ä¾è¦å®šæ‡‰åˆŠè¼‰äº‹é …。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å‰é …第七款經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ˜Žä»¤å…¬å‘Šå…刊載者，ä¸åœ¨</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¤é™ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 35 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">生物藥å“之容器ã€æ¨™ç±¤ã€ä»¿å–®åŠåŒ…è£ï¼Œé™¤æ‡‰ä¾æœ¬æ³•ç¬¬ä¸ƒå</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五æ¢è¦å®šåˆŠè¼‰å¤–，å«æœ‰é˜²è…劑者，應標明防è…劑å«é‡ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 36 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¾æœ¬æ³•ç¬¬ä¸ƒåå››æ¢æ‰€è¦å®šè¾¦ç†ä¹‹è—¥å“檢驗å°ç·˜ï¼Œå…¶å¯©æŸ¥æˆ–</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">檢驗çµæžœç‚ºä¸åˆæ ¼è€…，國外輸入藥å“應由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關派員監ç£åŽŸè¼¸å…¥è—¥å•†é™æœŸé€€é‹ï¼›æœ¬åœ‹è£½é€ è—¥</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å“å¯æ”¹è£½ä½¿ç”¨è€…，由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;">(</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關派員監</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ç£åŽŸè£½é€ å» å•†é™æœŸæ”¹è£½ã€‚屆期未能退é‹æˆ–改製，或ä¸èƒ½æ”¹</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">製者，應予以銷燬。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 37 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物有本法第八åæ¢ç¬¬ä¸€é …第一款至第四款所列情形之</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一者，藥商ã€è—¥å±€åŠé†«ç™‚機構，應自公告或ä¾æ³•èªå®šä¹‹æ—¥</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">起，立å³åœæ¢è¼¸å…¥ã€è£½é€ ã€æ‰¹ç™¼ã€é™³åˆ—ã€èª¿åŠ‘ã€é›¶å”®ï¼›å…¶</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è£½é€ æˆ–è¼¸å…¥ä¹‹æ¥è€…，並應於回收期é™å…§å›žæ”¶å¸‚å”®å“，連åŒ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">庫å˜å“ä¾æœ¬æ³•ç¬¬ä¸ƒåä¹æ¢è¦å®šè™•ç†ï¼›å›žæ”¶æœŸé™ç”±ä¸å¤®è¡›ç”Ÿ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">主管機關ä¾å€‹æ¡ˆæ€§è³ªæ±ºå®šï¼Œæœ€é•·ä¸å¾—超éŽäºŒå€‹æœˆã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物有本法第八åæ¢ç¬¬ä¸€é …第五款或第å…款情形之一</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è€…ï¼Œå…¶è£½é€ æˆ–è¼¸å…¥ä¹‹æ¥è€…，應自藥物許å¯è‰åˆ°æœŸæˆ–包è£ã€</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">標籤ã€ä»¿å–®ç¶“æ ¸å‡†è®Šæ›´ä¹‹æ—¥èµ·å…個月內收回市售å“，連åŒ</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">庫å˜å“é€ç¶“ç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé©—ç« å¾Œï¼Œå§‹å¾—</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">販賣。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è£½é€ æˆ–è¼¸å…¥æ¥è€…執行藥物回收作æ¥å‰ï¼Œæ‡‰è¨‚定回收作æ¥è¨ˆ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">畫書，載明回收程åºã€å›žæ”¶æœŸé™ã€åŸ·è¡Œæˆæžœå ±å‘Šæ›¸å ±å‚™ä¹‹</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">期é™åŠå…¶ä»–ç›¸é—œäº‹é …å ±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‚™æŸ¥å¾Œï¼Œä¾è©²è¨ˆ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">畫書執行；並於執行çµæŸå¾Œï¼Œè£½ä½œå›žæ”¶å ±å‘Šæ›¸ï¼Œå ±å„ç´šè¡›</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">生主管機關備查。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 38 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å–ç· å½è—¥ã€åŠ£è—¥ã€ç¦è—¥ã€ä¸è‰¯é†«ç™‚器æåŠæœªç¶“許å¯è£½é€ 或</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸入之醫療器æ，直轄市衛生主管機關得è¨ç½®æŸ¥ç·ä¸å¿ƒï¼›</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關得è¨ç½®æŸ¥ç·å°çµ„。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 39 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發å½è—¥ã€åŠ£è—¥ã€ç¦è—¥ã€ä¸è‰¯é†«ç™‚器ææˆ–æœªç¶“æ ¸å‡†è£½é€ æˆ–</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸入之醫療器æ經ç·ç²è€…，應由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">管機關ä¾å·¦åˆ—æ¨™æº–è¨ˆé»žæ ¸ç™¼çŽé‡‘：</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">一ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">èˆ‰ç™¼è£½é€ æˆ–è¼¸å…¥å½è—¥ã€ç¦è—¥æˆ–æœªç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥é†«ç™‚å™¨æ</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">者：四至å點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">二ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發以批發方å¼è½‰å”®</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">讓</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å½è—¥ã€ç¦è—¥æˆ–æœªç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥é†«ç™‚å™¨æ者：二至五點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">三ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發零售ã€é‹é€ã€å„²</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">寄</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è—ã€ç‰™ä¿æˆ–æ„圖販賣而陳列å½è—¥ã€ç¦è—¥æˆ–æœªç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥é†«ç™‚å™¨æ者：二至三點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">å››ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">èˆ‰ç™¼è£½é€ ã€è¼¸å…¥ã€è²©è³£åŠ£è—¥æˆ–ä¸è‰¯é†«ç™‚器æ者：二至</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三點。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¯é»žçŽé‡‘之數é¡ï¼Œç”±ç›´è½„市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關視情</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ³è¨‚定，並編列é 算支應之。ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼å¿…è¦æ™‚，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">得編列ç·ç²çŽé‡‘補助之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 40 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二人以上è¯å舉發å‰æ¢ä¹‹æ¡ˆä»¶ï¼Œå…¶çŽé‡‘應由原舉發人è¯å</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å…·é ˜ã€‚äºŒäººä»¥ä¸Šåˆ†åˆ¥èˆ‰ç™¼æ¡ˆä»¶è€Œæœ‰ç›¸åŒéƒ¨åˆ†è€…，其çŽé‡‘應</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">發給最先舉發者；如無法分別先後時，平å‡åˆ†ç™¼ä¹‹ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 41 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å”助查ç·æ©Ÿé—œç·ç²å½è—¥ã€åŠ£è—¥ã€ç¦è—¥ã€ä¸è‰¯é†«ç™‚器æåŠæœª</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥ä¹‹é†«ç™‚å™¨æ者，其çŽå‹µæº–用關於舉發人</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之è¦å®šã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 42 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¾æœ¬ç´°å‰‡æ‡‰ç™¼çµ¦çŽé‡‘者，應由ç·ç²å½è—¥ã€åŠ£è—¥ã€ç¦è—¥ã€ä¸</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">良醫療器æåŠæœªç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥é†«ç™‚å™¨æ之機關敘明</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">事實申請之。但åŒæ™‚符åˆ</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則或其他法令è¦å®šçµ¦äºˆçŽå‹µè€…，ä¸å¾—é‡è¤‡çµ¦çŽã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 43 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">å°æ–¼èˆ‰ç™¼äººæˆ–å”助ç·ç²å½è—¥ã€åŠ£è—¥ã€ç¦è—¥ã€ä¸è‰¯é†«ç™‚器æ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">åŠæœªç¶“æ ¸å‡†è£½é€ æˆ–è¼¸å…¥é†«ç™‚å™¨æ者之姓å，應嚴予ä¿å¯†ï¼Œ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¸å¾—æ´©æ¼ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 44 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">登載或宣æ’è—¥ç‰©å»£å‘Šï¼Œæ‡‰ç”±é ˜æœ‰è—¥ç‰©è¨±å¯è‰ä¹‹è—¥å•†ï¼Œå¡«å…·</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請書，連åŒè—¥ç‰©è¨±å¯è‰å½±æœ¬ã€æ ¸å®šä¹‹æ¨™ç±¤ã€ä»¿å–®æˆ–包è£</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">影本ã€å»£å‘Šå…§å®¹åŠå¯©æŸ¥è²»ï¼Œç”³è«‹ä¸å¤®æˆ–直轄市衛生主管機</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">é—œæ ¸å‡†å¾Œç‚ºä¹‹ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 45 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告所用之文å—圖畫，應以ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€æ ¸å®š</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之藥物å稱ã€åŠ‘åž‹ã€è™•æ–¹å…§å®¹ã€ç”¨é‡ã€ç”¨æ³•ã€æ•ˆèƒ½ã€æ³¨æ„</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">äº‹é …ã€åŒ…è£åŠå» 商å稱ã€åœ°å€ç‚ºé™ã€‚</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">ä¸è—¥æ之廣告所用文å—，其效能應以本è‰ç¶±ç›®æ‰€è¼‰è€…為</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">é™ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 46 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">è—¥ç‰©å»£å‘Šæ‡‰å°‡å» å•†å稱ã€è—¥ç‰©è¨±å¯è‰åŠå»£å‘Šæ ¸å‡†æ–‡ä»¶å—</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">號，一併登載或宣æ’。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 47 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告之內容，具有左列情形之一者，應予刪除或ä¸äºˆ</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ ¸å‡†ï¼š</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一ã€æ¶‰åŠæ€§æ–¹é¢ä¹‹æ•ˆèƒ½è€…。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二ã€åˆ©ç”¨å®¹å™¨åŒ…è£æ›çŽæˆ–使用çŽå‹µæ–¹æ³•ï¼Œæœ‰åŠ©é•·æ¿«ç”¨è—¥ç‰©</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之虞者。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">三ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">表示使用該藥物而治癒æŸç¨®ç–¾ç—…或改進æŸæ–¹é¢é«”質</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">åŠå¥åº·æˆ–æé€ è™›å½æƒ…事藉以宣æšè—¥ç‰©è€…。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">å››ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">誇張藥物效能åŠå®‰å…¨æ€§è€…。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 48 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 49 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 50 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第一百零二æ¢ç¬¬äºŒé …所稱醫療急迫情形，係指醫師於</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">é†«ç™‚æ©Ÿæ§‹ç‚ºæ€¥è¿«é†«ç™‚è™•ç½®ï¼Œé ˆç«‹å³ä½¿ç”¨è—¥å“之情æ³ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 51 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 52 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢ï¼ˆåˆªé™¤ï¼‰</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 53 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法åŠæœ¬ç´°å‰‡æ‰€å®šæ–‡æ›¸æ ¼å¼ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 54 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">æ¢</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則自發布日施行。</span> </p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6068&type=0
藥政管ç†é¡ž,藥物回收作æ¥å¯¦æ–½è¦é»žè¡Œæ”¿è§£é‡‹è—¥ç‰©å›žæ”¶ä½œæ¥å¯¦æ–½è¦é»ž<p style="text-align: center;"><span style="font-family: 標楷體; font-size: 20pt;">藥物回收作æ¥å¯¦æ–½è¦é»ž </span></p><p style="text-align: center;"> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">一ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç‚ºç¶è·äººæ°‘å¥åº·åŠç¢ºä¿åˆæ³•è—¥ç‰©çš„å“質與安全，並有利藥物回收作æ¥ä¹‹é€²è¡Œï¼Œå½™é›†è—¥ç‰©å›žæ”¶ç›¸é—œè¦å®šï¼Œè¨‚定本è¦é»žã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">二ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">è—¥ç‰©è£½é€ æˆ–è¼¸å…¥æ¥è€…有事實足èªå…¶æ供之藥物有å±å®³ä½¿ç”¨è€…安全ã€å¥åº·æˆ–其他權益之虞時，應ä¾æœ¬è¦é»žå›žæ”¶å¸‚å”®å“，醫療機構ã€è—¥å±€åŠè—¥å•†æ‡‰äºˆé…åˆï¼Œä¸å¤®ã€ç›´è½„市åŠç¸£ï¼ˆå¸‚）衛生主管機關並應ç£å°Žå›žæ”¶ä½œæ¥ä¹‹åŸ·è¡Œã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">三ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">回收藥物之å±å®³ç¨‹åº¦ï¼Œåˆ†ç‚ºä¸‹åˆ—三級： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（一） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第一級å±å®³ï¼šæŒ‡è—¥ç‰©æœ‰ä¸‹åˆ—情形之一者： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">屬藥事法第八åæ¢ç¬¬ä¸€é …第一款所指之藥物。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">2. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ä¾æ¶ˆè²»è€…ä¿è·æ³•ç¬¬ä¸‰å三æ¢åŠä¸‰åå…«æ¢è¦å®šï¼Œè¨±å¯è£½é€ ã€è¼¸å…¥ä¹‹è—¥ç‰©ç¶“èªå®šæœ‰ç™¼ç”Ÿé‡å¤§æ害之虞者。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">3. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">劣藥ã€ä¸è‰¯é†«ç™‚器æ或藥事法第八åæ¢ç¬¬ä¸€é …第四款所指之藥物，且有發生é‡å¤§æ害之虞者。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">4. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">å½è—¥ã€ç¦è—¥æˆ–æœªç¶“æ ¸å‡†è€Œè£½é€ ã€è¼¸å…¥ä¹‹é†«ç™‚器æ。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（二） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第二級å±å®³ï¼šæŒ‡è—¥ç‰©æœ‰ä¸‹åˆ—情形之一者： </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">劣藥ã€ä¸è‰¯é†«ç™‚器æ或藥事法第八åæ¢ç¬¬ä¸€é …第四款所指之藥物，但無發生é‡å¤§æ害之虞者。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">2. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ä¾æ¶ˆè²»è€…ä¿è·æ³•ç¬¬ä¸‰å三æ¢åŠç¬¬ä¸‰åå…«æ¢è¦å®šï¼Œè¨±å¯è£½é€ ã€è¼¸å…¥ä¹‹è—¥ç‰©ç¶“èªå®šæœ‰ç™¼ç”Ÿéžé‡å¤§æ害之虞者。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（三） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第三級å±å®³ï¼šæŒ‡è—¥ç‰©æœ‰æ害使用者安全ã€å¥åº·æˆ–其他權益之虞，而éžå±¬ç¬¬ä¸€ç´šæˆ–第二級å±å®³è€…。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">å››ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">å„ç´šå±å®³è—¥ç‰©ä¹‹å›žæ”¶è™•ç½®æ–¹æ³•ï¼š </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（一） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第一級å±å®³åŠç¬¬äºŒç´šå±å®³ï¼šä¸å¤®ã€ç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‡‰å‘½è—¥ç‰©è£½é€ æˆ–è¼¸å…¥ä¹‹æ¥è€…ä¾è¦å®šæœŸé™å…§å›žæ”¶å¸‚å”®å“。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（二） </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">第三級å±å®³ï¼šä¸å¤®ã€ç›´è½„市或縣（市）衛生主管機關得建è°è—¥ç‰©è£½é€ 或輸入之æ¥è€…自衛生主管機關通知之日起å…個月內回收市售å“。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">為掌æ¡è—¥ç‰©å›žæ”¶è¨Šæ¯ï¼Œå„級衛生主管機關為å‰é …è™•ç½®æ™‚ï¼Œæ‡‰ç›¸äº’é€šå ±ã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">屬第一級å±å®³è€…，直轄市或縣(市)衛生主管機關應於å„級衛生主管機關通知æ¥è€…執行回收作æ¥å¾Œå日內，至相關醫療機構ã€è—¥å±€åŠè—¥å•†é€²è¡ŒæŠ½æŸ¥ï¼Œç¢ºèªå±å®³è—¥ç‰©ç¢ºå¯¦ä¸‹æž¶ã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">五ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ä¸å¤®ã€ç›´è½„市或縣（市）衛生主管機關得於機關網站公布藥物回收相關資訊，如經發ç¾ç‚ºç¬¬ä¸€ç´šå±å®³è€…，並得於大眾傳æ’媒體公布之。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">å…ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ä¸å¤®ã€ç›´è½„市或縣（市）衛生主管機關得ä¾æ¶ˆè²»è€…ä¿è·æ³•ç¬¬ä¸‰åå…æ¢åŠç¬¬ä¸‰åå…«æ¢ã€æ¶ˆè²»è€…ä¿è·æ³•æ–½è¡Œç´°å‰‡ç¬¬ä¸‰åå››æ¢åŠ</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">è—¥ç‰©è£½é€ å·¥å» è¨å» 標準</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">相關è¦å®šï¼Œè¦æ±‚è—¥ç‰©è£½é€ æˆ–è¼¸å…¥æ¥è€…ä¾ä¸‹åˆ—程åºè¾¦ç†è—¥ç‰©å›žæ”¶ä½œæ¥ï¼š </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（一）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">平時應建立回收作æ¥ç¨‹åºåŠç¢ºå¯¦å®Œæ•´çš„é‹éŠ·ç´€éŒ„（內容包括產å“之å稱ã€å«é‡ã€åŠ‘åž‹ã€æ‰¹è™Ÿï¼Œå—貨者之å稱ã€åœ°å€ã€å‡ºå» 日期åŠæ•¸é‡ï¼‰ï¼Œä½œç‚ºå›žæ”¶ä½œæ¥ä¹‹ä¾æ“šã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">（二）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">執行å±å®³è—¥ç‰©ä¹‹å›žæ”¶ä½œæ¥æ™‚，應訂定回收作æ¥è¨ˆç•«æ›¸ï¼Œå…¶å…§å®¹åŒ…括下列å„é …è³‡æ–™ï¼š </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物之å“åã€è¦æ ¼åŠè—¥ç‰©è¨±å¯è‰å—號。 </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">2. </span><span style="font-family: 標楷體; font-size: 14pt;">藥物之批號或åºè™Ÿç‰è˜åˆ¥è³‡æ–™èˆ‡ç·¨è™Ÿã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">3. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">回收藥物於國內ã€å¤–之銷售å°è±¡åŠå…¶éŠ·å”®æ•¸é‡ï¼Œä»¥åŠç¸½éŠ·å”®æ•¸é‡ã€‚</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">4. </span><span style="font-family: 標楷體; font-size: 14pt;">è—¥ç‰©å›žæ”¶ä¹‹åŽŸå› åŠå…¶å¯èƒ½ç”¢ç”Ÿä¹‹å±éšªã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">5. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">通知該藥物供應者之方å¼åŠå…§å®¹ï¼Œä»¥åŠå…¶ä»–</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">擬採å–之相關動作</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（三）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">將回收作æ¥è¨ˆç•«æ›¸é€šå ±ä¸‹å‘½å›žæ”¶ä¹‹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¼Œè‹¥ä¸‹å‘½æ©Ÿé—œç‚º</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">直轄市或縣（市）衛生主管機關者，則應副知ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œ</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">。回收作æ¥è‹¥å±¬æ¥è€…發動者，亦åŒã€‚</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（四）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ä¾æ“šé‹éŠ·ç´€éŒ„åŠå›žæ”¶ä½œæ¥è¨ˆç•«æ›¸é€²è¡Œå±å®³è—¥ç‰©ä¹‹å›žæ”¶ï¼Œä¸¦ç«‹å³é€šçŸ¥é†«ç™‚機構ã€è—¥å±€åŠè—¥å•†ï¼Œä¸”留紀錄備查。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（五）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">已回收的產å“於決定最終處置方å¼å‰ï¼Œæ‡‰äºˆè˜åˆ¥èˆ‡æ¨™ç¤ºä¸¦åˆ†åˆ¥å„²å˜ã€‚</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（å…）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ä¾å›žæ”¶ä½œæ¥è¨ˆç•«æ›¸åŸ·è¡Œå®Œç•¢è€…，應將其處ç†éŽç¨‹åŠçµæžœï¼Œå®Œæˆå›žæ”¶å ±å‘Šæ›¸ï¼Œä¸¦æ–¼å›žæ”¶æœŸé™å…§å‡½å ±ä¸å¤®åŠæ‰€è½„地方衛生主管機關。</span> </p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">（七）</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">å›žæ”¶å ±å‘Šæ›¸å…§å®¹æ‡‰åŒ…æ‹¬ä¸‹åˆ—å„é …è³‡æ–™ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">1. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物之å“åã€è¦æ ¼åŠè—¥ç‰©è¨±å¯è‰å—號。　 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">2. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">藥物之批號或åºè™Ÿç‰è˜åˆ¥è³‡æ–™èˆ‡ç·¨è™Ÿã€‚ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">3. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">銷售總數é‡åŠå¯¦éš›å›žæ”¶ç¸½æ•¸é‡ã€‚ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">4. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">市售å“åŠåº«å˜å“回收完畢日期，åŠå…¶å¾ŒçºŒè™•ç½®æ–¹å¼åŠè™•ç½®æ—¥æœŸã€‚如已銷燬者，並檢附銷燬éŽç¨‹ä¹‹æ‹ç…§æˆ–錄影紀錄。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">5. </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">回收事件分æžï¼ŒåŒ…括å“è³ªç¼ºå¤±æƒ…å½¢ä¹‹ç™¼ç”ŸåŽŸå› åŠé 防矯æ£æŽªæ–½ã€‚ </span></p><p style="line-height: 20pt;"><span style="font-family: 標楷體; font-size: 14pt;">七ã€<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">直轄市或縣（市）衛生主管機關應確èªæ¥è€…å°æ–¼æ”¶å›žä¹‹å¸‚å”®å“åŠåº«å˜å“後續之處置方法åŠçµæžœã€‚</span> </p><p style="line-height: 20pt;"><s><span style="font-family: 標楷體; color: blue; font-size: 14pt; text-decoration: none;"> </span></s></p>2013-12-05
藥政管ç†é¡ž,藥物安全監視管ç†è¾¦æ³•æ³•è¦å‘½ä»¤è—¥ç‰©å®‰å…¨ç›£è¦–管ç†è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾è—¥äº‹æ³•ç¬¬å››å五æ¢ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法é©ç”¨ç¯„åœå¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥äº‹æ³•ç¬¬ä¸ƒæ¢æ‰€ç¨±ä¹‹æ–°è—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¶“行政院衛生署</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本署</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">公告指定之醫療器æ。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¶ä»–經本署公告èªå®šé©ç”¨è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æŸ¥é©—ç™»è¨˜å¯©æ ¸é€šéŽç™¼è‰ä¹‹æ–°è—¥ï¼Œå…¶å®‰å…¨ç›£è¦–期間自發è‰æ—¥èµ·äº”年。</span> </p><p><span style="font-family: 新細明體,serif;">å‰æ¢ç¬¬äºŒæ¬¾ä¹‹ç›£è¦–期間，自發è‰æ—¥èµ·ä¸‰å¹´ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰æ¢ç¬¬ä¸‰æ¬¾ä¹‹ç›£è¦–期間，ä¾æœ¬ç½²ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物安全監視期間，æŒæœ‰è—¥ç‰©è¨±å¯è‰ä¹‹è—¥å•†æ‡‰ç©æ¥µæ”¶é›†åœ‹å…§ã€å¤–藥物使用之安全資料，除ä¾åš´é‡è—¥ç‰©ä¸è‰¯åæ‡‰é€šå ±è¾¦æ³•ä¹‹è¦å®šç‚ºé€šå ±å¤–，其他藥物ä¸è‰¯åæ‡‰é ˆä¸€ä½µæ”¶éŒ„ï¼Œä¸¦åˆ—æ–¼è—¥ç‰©å®šæœŸå®‰å…¨æ€§å ±å‘Šå…§ï¼Œä¾æœ¬ç½²æŒ‡å®šæ™‚é–“é€šå ±ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">藥商未ä¾å‰é …è¦å®šé€²è¡Œé€šå ±è€…，本署得é‡æ–°è©•ä¼°å…¶å®‰å…¨æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">於國內完æˆè‡¨åºŠè©¦é©—æˆ–éŠœæŽ¥æ€§è©¦é©—ä¸¦ç¶“æœ¬ç½²æ ¸å‡†ä¹‹æ–°è—¥ï¼Œå…¶æ–°è—¥å®‰å…¨ç›£è¦–æœŸé–“ï¼Œå„醫療院所ä¸å¾—å†è¦æ±‚個別之進藥臨床試驗或試用。但以驗收為目的之產å“化驗，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6069&type=0
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則法è¦å‘½ä»¤è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則<p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則ä¾è—¥äº‹æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第四å二æ¢ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©ä¹‹å§”è¨—è£½é€ åŠæª¢é©—，應ä¾æœ¬æº–則之è¦å®šï¼›æœ¬æº–則未è¦å®šè€…，é©ç”¨å…¶ä»–有關法令之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬æº–å‰‡æ‰€ç¨±å§”è¨—è£½é€ ï¼Œä¿‚æŒ‡å°‡è—¥ç‰©åœ¨è£½ç¨‹ä¸ä¹‹ä»»ä¸€éšŽæ®µæˆ–é€£çºŒéšŽæ®µæˆ–å…¨ç¨‹å§”è¨—ä»–å» è£½é€ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱委託檢驗，係指將藥物技術層é¢ä¹‹ç ”究發展ã€è£½ç¨‹ä¸ä¹‹ç®¡åˆ¶ä½œæ¥åŠåŽŸç‰©æ–™ã€åŠè£½å“或產å“之å“質管制與安定性試驗ç‰é …ç›®ï¼Œå§”è¨—ä»–å» æˆ–ç›¸é—œå–®ä½åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å§”è¨—è£½é€ æˆ–æª¢é©—è—¥ç‰©ï¼Œæ‡‰äº‹å…ˆç”³è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç”³è«‹è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—，é™æŒæœ‰è—¥ç‰©è¨±å¯è‰æˆ–申請藥物查驗登記之藥商。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†å§”è¨—è£½é€ æˆ–æª¢é©—ä¹‹è—¥ç‰©ï¼Œé™¤æ³•å¾‹å¦æœ‰è¦å®šå¤–，其產å“è²¬ä»»ç”±å§”è¨—è€…è² è²¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å§”è¨—è£½é€ æˆ–æª¢é©—å¥‘ç´„æœ‰æ•ˆæœŸé–“å±†æ»¿ä¸å†çºŒç´„æˆ–å› æ•…ä¸é€”è§£ç´„ï¼Œæˆ–è®Šæ›´å§”è¨—æª¢é©—é …ç›®æ™‚ï¼Œå§”è¨—è€…æ‡‰å…ˆè¦“å¦¥å…¶ä»–å—è¨—å» æˆ–ç›¸é—œå–®ä½ï¼Œé‡æ–°ä¾è¦å®šç”³è«‹å§”è¨—è£½é€ æˆ–æª¢é©—ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">è—¥ç‰©ä¹‹å§”è¨—è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—è¨—è£½é€ å» ï¼Œæ‡‰ç‚ºç¬¦åˆè—¥ç‰©è£½é€ å·¥å» è¨å» 標準第三編</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱藥å“å„ªè‰¯è£½é€ è¦ç¯„</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">或第四編</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱醫療器æå„ªè‰¯è£½é€ è¦ç¯„</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¦å®šä¹‹è—¥ç‰©å·¥å» 。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å§”è¨—è£½é€ è€…æ‡‰å…ˆè¦“å¦¥å—è¨—å» ï¼Œä¸¦å¡«å…·ç”³è«‹æ›¸åŠæª¢é™„é›™æ–¹ç°½ç«‹ä¹‹å§”è¨—è£½é€ å¥‘ç´„ç‰ç›¸é—œæ–‡ä»¶ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†å§”è¨—è£½é€ ä¹‹è—¥ç‰©ï¼Œå…¶æ¨™ç±¤åŠåŒ…è£ï¼Œé™¤æ‡‰ç¬¦åˆæœ¬æ³•åŠæœ‰é—œæ³•ä»¤è¦å®šå¤–，並應刊載å—è¨—å» åŠå§”託者之å稱ã€åœ°å€ã€‚但å—è¨—å» ä¹‹å稱ã€åœ°å€ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…，得以刊載其所在國別替代之。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …藥物之仿單，除應符åˆæœ¬æ³•åŠæœ‰é—œæ³•ä»¤è¦å®šå¤–ï¼Œä¸¦æ‡‰åˆ†åˆ¥æ¨™ç¤ºè£½é€ å» åŠå§”託者之å—樣，包括å—è¨—å» åŠå§”託者之å稱ã€åœ°å€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†å§”è¨—è£½é€ ä¹‹è—¥ç‰©ï¼Œå…¶è¨±å¯è‰æœ‰æ•ˆæœŸé–“之展延，應由許å¯è‰æŒæœ‰è€…ä¾æœ¬æ³•åŠæœ‰é—œæ³•ä»¤è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">藥物之委託檢驗</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">符åˆä¸‹åˆ—è¦å®šä¹‹ä¸€è€…，得接å—委託檢驗藥物：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„ä¹‹è—¥å» ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¬¦åˆé†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„之醫療器æå» ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¬¦åˆéžè‡¨åºŠè©¦é©—優良æ“作è¦ç¯„è¦å®šä¹‹åœ‹å…§å¤–å¸è¡“ç ”ç©¶æ©Ÿæ§‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å…¶ä»–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°ˆæ¡ˆæ ¸å‡†è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">委託者與å—託者應訂立委託檢驗契約，列明其委託檢驗範åœä¹‹ç›¸é—œäº‹é …ã€ä½œæ¥è¨ˆç•«æ›¸åŠæ¨™æº–作æ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">委託者應先覓妥å—託檢驗者，並填具申請書åŠæª¢é™„雙方簽立之委託檢驗契約ç‰ç›¸é—œæ–‡ä»¶ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—視實際需è¦ï¼Œå°å—託者進行ç¾å ´æŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¶“æ ¸å‡†ä¹‹å§”è¨—æª¢é©—ï¼Œå§”è¨—è€…æ‡‰æª¢é™„ä¾æª¢é©—所需二å€ä»¥ä¸Šæ•¸é‡ä¹‹æª¢é«”，é€äº¤å—託者檢驗；其驗餘完整包è£ä¹‹æª¢é«”，由å—託者å°ç·˜å¾Œï¼Œäº¤é‚„委託者自行ä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則自發布日施行。</span> </p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6071&type=0
藥政管ç†é¡ž,è—¥ç‰©ç§‘æŠ€ç ”ç©¶ç™¼å±•çŽå‹µè¾¦æ³•æ³•è¦å‘½ä»¤è—¥ç‰©ç§‘æŠ€ç ”ç©¶ç™¼å±•çŽå‹µè¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾è—¥äº‹æ³•ç¬¬å››å一æ¢ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱藥物，指藥事法所稱之藥å“åŠé†«ç™‚器æ。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法é©ç”¨é¤çŽå‹µå°è±¡ç‚ºåœ‹å…§ä¹‹è—¥ç‰©è£½é€ å» åŠå¾žäº‹è—¥ç‰©ç ”發之自然人ã€æ³•äººã€æ©Ÿæ§‹æˆ–åœ˜é«”ï¼Œå…¶ç ”ç™¼æˆæžœç¬¦åˆæœ¬è¾¦æ³•ä¹‹çŽå‹µæ¢ä»¶è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法é©ç”¨ä¹‹çŽå‹µæ¢ä»¶å¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åœ‹å…§è‡ªè¡Œç ”發，å–得國內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">專利，在我國或其他先進國家首先上市之新發明藥物者。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å–得國內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å°ˆåˆ©ä¹‹æŽˆæ¬Šï¼Œåœ¨åœ‹å…§ç ”ç™¼ï¼Œæ‰€ç”Ÿç”¢è£½å“ç‚ºæˆ‘åœ‹æˆ–å…¶ä»–å…ˆé€²åœ‹å®¶é¦–å…ˆæ ¸å‡†æˆ–ä¸Šå¸‚ä¹‹æ–°ç™¼æ˜Žè—¥ç‰©è€…ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åœ‹å…§ç ”發之未上市藥物，å–得國內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å°ˆåˆ©æˆ–æŽˆæ¬Šï¼Œä¸”ç¶“æ ¸å‡†åœ¨åœ‹å…§</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">é€²è¡Œè‡¨åºŠè©¦é©—ç ”ç©¶ï¼Œæœ‰å…·é«”æˆæ•ˆè€…。</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">人體試驗階段一ã€éšŽæ®µäºŒæˆ–階段三，å„階段得分別æ出申請çŽå‹µ</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: 新細明體,serif;">å››ã€åœ‹å…§ç ”ç™¼æˆ–è£½é€ è—¥ç‰©ï¼Œæœ‰é‡è¦ä¸”å…·é«”ä¹‹å¸‚å ´æˆæ•ˆè€…。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åœ‹å…§ç ”ç™¼æˆ–è£½é€ è—¥ç‰©ä»¥é€²æ¥æ€§ï¼Œå–得國內外專利，且å°è—¥ç‰©è£½é€ å·¥æ¥ç™¼å±•æœ‰å…·é«”è²¢ç»è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€åœ‹å…§ç ”ç™¼æˆ–è£½é€ ä¹‹æ–°åŽŸæ–™è—¥ã€è³¦å½¢åŠ‘ã€é†«ç™‚器ææ質ã€é›¶çµ„件或其他方å¼ï¼Œå°ææ˜‡æˆ‘åœ‹è—¥ç‰©è£½é€ å·¥æ¥æœ‰é¡¯è‘—è²¢ç»è€…。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¼•é€²åœ‹å¤–å…ˆé€²ç§‘æŠ€ï¼Œæ–¼åœ‹å…§ç ”ç©¶ä¸¦ç”¢è£½ç”Ÿç‰©è£½åŠ‘è—¥å“，å°åœ‹äººç–¾ç—…之醫療有顯著貢ç»è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€åœ‹å…§è‡ªè¡Œé–‹ç™¼æ–°è¨å‚™è£ç½®ã€è£½ç¨‹æˆ–分æžæª¢é©—方法，å°æ”¹é€²è—¥ç‰©è£½é€ 或檢驗技術有é‡å¤§æˆæ•ˆè€…。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€é…åˆä¸å¤®è¡›ç”Ÿæˆ–å·¥æ¥ä¸»ç®¡æ©Ÿé—œæ”¿ç–ï¼ŒæŽ¨å‹•æœ¬åœ‹è—¥ç‰©è£½é€ å·¥æ¥ç™¼å±•ï¼Œææ˜‡è—¥ç‰©ç ”ç™¼æ°´æº–ï¼Œç¸¾æ•ˆå“著者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為審è°ä¾æœ¬è¾¦æ³•ç”³è«‹çŽå‹µä¹‹æ¡ˆä»¶ï¼Œæ‡‰çµ„æˆè—¥ç‰©ç ”發審è°å§”員會</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱審è°æœƒ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">審è°æœƒç½®å§”å“¡ä¹äººè‡³å三人，由行政院衛生署åŠç¶“濟部工æ¥å±€å°±è¡Œæ”¿é™¢è¡›ç”Ÿç½²ã€ç¶“濟部工æ¥å±€ã€ç§‘技相關代表ã€å¸è¡“機構ã€å·¥æ¥ç•Œä¹‹ä»£è¡¨åŠæœ‰é—œå¸è€…å…±åŒé´é¸çµ„æˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">審è°æœƒç”±å§”員相互推é¸ä¸€äººç‚ºä¸»å¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">審è°æœƒå§”å“¡å‡ç‚ºç„¡çµ¦è·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">審è°æœƒä¹‹ä»»å‹™å¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å¯©æŸ¥çŽå‹µå°è±¡ä¹‹è³‡æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¯©è°å„é …çŽå‹µç”³è«‹æ¡ˆä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ ¸å®šçŽå‹µåé¡åŠæ ¸çµ¦çŽå‹µé»žæ•¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å…¶ä»–ä¾æœ¬è¾¦æ³•æ‡‰ç¶“審è°æœƒå¯©è°ä¹‹äº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾æœ¬è¾¦æ³•ç”³è«‹çŽå‹µä¹‹æ¡ˆä»¶ï¼Œæ‡‰ç”±å¯©è°æœƒå¯©è°é€šéŽå¾Œï¼Œå†ç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæœƒåŒä¸å¤®å·¥æ¥ä¸»ç®¡æ©Ÿé—œçŽå‹µä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …之申請審è°ï¼Œæ¯å¹´è¾¦ç†ä¸€æ¬¡ã€‚å¿…è¦æ™‚å¾—å¢žåŠ è¾¦ç†æ¬¡æ•¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">符åˆæœ¬è¾¦æ³•ç¬¬å››æ¢è¦å®šï¼Œä¸¦ç¶“審è°æœƒå¯©è°é€šéŽä¹‹å—çŽå‹µè€…ï¼Œå¾—é ’çµ¦è—¥ç‰©è²¢ç»çŽåº§ä¸€åº§åŠçŽé‡‘，çŽé‡‘é¡åº¦ä¾ä¸‹åˆ—æ¨™æº–è¨ˆé»žæ ¸çµ¦ä¹‹çŽé‡‘：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¬¦åˆç¬¬å››æ¢ç¬¬ä¸€æ¬¾ä¹‹æ¢ä»¶è€…：å…å點至一百點。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¬¦åˆç¬¬å››æ¢ç¬¬äºŒæ¬¾æˆ–第三款之æ¢ä»¶è€…：五å點至八å點。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¬¦åˆç¬¬å››æ¢ç¬¬å››æ¬¾è‡³ç¬¬å…«æ¬¾æ¢ä»¶ä¹‹ä¸€è€…：三å點至七å點。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç¬¦åˆç¬¬å››æ¢ç¬¬ä¹æ¬¾ä¹‹æ¢ä»¶è€…：二å點至五å點。</span> </p><p><span style="font-family: 新細明體,serif;">æ¯é»žçŽé‡‘之數é¡ï¼ŒæŒ‰å¹´ç”±è¡Œæ”¿é™¢è¡›ç”Ÿç½²åŠç¶“濟部工æ¥å±€è¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所需之çŽå‹µç¶“費，由下列財æºç±ŒæŽªï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¡Œæ”¿é™¢è¡›ç”Ÿç½²åŠç¶“濟部工æ¥å±€é€å¹´ç·¨åˆ—é 算支應。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç”¢æ¥ç•Œæ贈之回饋金。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç§äººæˆ–團體指定用於本辦法çŽå‹µä¹‹æ助。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é‡äºŒå€‹ä»¥ä¸ŠçŽå‹µå°è±¡ï¼Œç‚ºç›¸åŒä¹‹ç™¼æ˜Žæˆ–ç ”ç©¶ï¼Œåˆ†åˆ¥ç”³è«‹çŽå‹µæ™‚，應就最先申請者çŽå‹µä¹‹ã€‚二個以上çŽå‹µå°è±¡å…±åŒç”³è«‹çŽå‹µæ™‚，其所å—çŽå‹µç‚ºè©²å…±åŒç”³è«‹äººæ‰€å…±æœ‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çŽå‹µå°è±¡ç¬¦åˆç¬¬å››æ¢ä¹‹çŽå‹µæ¢ä»¶è€…，得由相關公ã€å”ã€å¸æœƒç‰åœ˜é«”推薦或直接å‘行政院衛生署æ出申請。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> 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臨床試驗類,è—¥ç‰©åŸºå› é«”å¸ç ”究之å—檢者åŒæ„書內容åƒè€ƒæŒ‡å¼•è¡Œæ”¿è§£é‡‹è—¥ç‰©åŸºå› é«”å¸ç ”究者之å—檢者åŒæ„書內容åƒè€ƒæŒ‡å¼•è©³å¦‚附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=67&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=68&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4555&type=0
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藥政管ç†é¡ž,藥物回收作æ¥å¯¦æ–½è¦é»žè¡Œæ”¿è§£é‡‹89å¹´5月16æ—¥_衛生ç¦åˆ©éƒ¨å…¬å‘Šã€Œè—¥ç‰©å›žæ”¶ä½œæ¥å¯¦æ–½è¦é»žã€.詳如附件2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4629&type=0
查驗登記類,藥物資料公開辦法法è¦å‘½ä»¤è—¥ç‰©è³‡æ–™å…¬é–‹è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾è—¥äº‹æ³•ç¬¬å››åæ¢ä¹‹ä¸€ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¿…è¦æ™‚å¾—å…¬é–‹å…¶æ‰€ç‚ºä¹‹è—¥ç‰©æ ¸å‡†å¯©æŸ¥å ±å‘Šæ‘˜è¦ï¼ŒåŠæŒæœ‰ã€ä¿ç®¡è—¥å•†ç”³è«‹è—¥ç‰©æŸ¥é©—登記所檢附之下列資料。但藥商申請新藥查驗登記所檢附之營æ¥ç§˜å¯†è³‡æ–™ï¼Œæ‡‰ä¿å¯†ä¹‹ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥ç‰©æˆåˆ†åŠä»¿å–®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è‡¨åºŠè©¦é©—計畫摘è¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“風險管ç†è¨ˆç•«åŠè—¥ç‰©å®‰å…¨ç›¸é—œè³‡è¨Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬é–‹è—¥ç‰©æŸ¥é©—登記資料，其方å¼å¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åˆŠè¼‰æ–¼æ”¿åºœå…¬å ±æˆ–其他出版å“。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åˆ©ç”¨é›»ä¿¡ç¶²è·¯å‚³é€æˆ–其他方å¼ä¾›å…¬çœ¾ç·šä¸ŠæŸ¥è©¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¶ä»–足以使公眾得知之方å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=69&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=70&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6073&type=0
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,è—¥ç‰©è£½é€ å·¥å» è¨å» 標準法è¦å‘½ä»¤è—¥ç‰©è£½é€ å·¥å» è¨å» 標準<p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">ç·¨</span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本標準ä¾è—¥äº‹æ³•ï¼ˆä»¥ä¸‹ç°¡ç¨±æœ¬æ³•ï¼‰ç¬¬äº”å七æ¢ç¬¬äº”é …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©è£½é€ å·¥å» æˆ–å ´æ‰€ä¹‹è¨å‚™åŠè¡›ç”Ÿæ¢ä»¶ï¼Œæ‡‰ç¬¦åˆæœ¬æ¨™æº–之è¦å®šï¼›æœ¬æ¨™æº–未è¦å®šè€…，ä¾å…¶ä»–有關法令之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ–°è¨ã€é·ç§»ã€æ“´å»ºã€å¾©æ¥æˆ–å¢žåŠ åŽŸæ–™è—¥ã€åŠ‘åž‹ã€åŠ å·¥é …ç›®ã€å“é …ä¹‹åœ‹ç”¢è—¥ç‰©è£½é€ å·¥å» ï¼Œå¦‚ç¬¦åˆç¬¬äºŒç·¨åŠå·¥å» 管ç†è¼”導法è¦å®šè€…，由直轄市或縣（市）工æ¥ä¸»ç®¡æ©Ÿé—œä¾ç”³è«‹æ ¸ç™¼å·¥å» 登記è‰æ˜Žæ–‡ä»¶æˆ–æ ¸å‡†è®Šæ›´ç™»è¨˜ï¼Œä¸¦ç”±ç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾ç”³è«‹æ ¸ç™¼è£½é€ æ¥è—¥å•†è¨±å¯åŸ·ç…§æˆ–æ ¸å‡†è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¾å‰é …è¦å®šå–å¾—å·¥å» ç™»è¨˜è‰æ˜Žæ–‡ä»¶åŠè£½é€ æ¥è—¥å•†è¨±å¯åŸ·ç…§æˆ–ç¶“æ ¸å‡†è®Šæ›´ç™»è¨˜ä¹‹åœ‹ç”¢è—¥ç‰©è£½é€ å·¥å» ï¼Œå¦‚ç¶“æª¢æŸ¥ç¬¦åˆè—¥ç‰©å„ªè‰¯è£½é€ 準則之è¦å®šè€…，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°±æª¢æŸ¥åˆæ ¼ä¹‹é …ç›®ï¼Œæ ¸ç™¼ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ç¯„ä¹‹è—¥ç‰©è£½é€ è¨±å¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åœ‹å¤–è—¥ç‰©è£½é€ å·¥å» å¦‚ç¶“æª¢æŸ¥ç¬¦åˆè—¥ç‰©å„ªè‰¯è£½é€ 準則之è¦å®šè€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå°±æª¢æŸ¥åˆæ ¼ä¹‹é …ç›®ï¼Œæ ¸ç™¼ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">ç·¨</span> <span style="font-family: 新細明體,serif;">è¨å» 基本æ¢ä»¶</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©è£½é€ å·¥å» ï¼Œæ‡‰å…·å‚™ä¸‹åˆ—åŸºæœ¬æ¢ä»¶åŠå…±åŒè¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å·¥å» å» å€æ‡‰é¸æ“‡ç’°å¢ƒæ¸…æ½”ã€ç©ºæ°£æ–°é®®ä¹‹åœ°å¸¶ï¼›å…¶è£½é€ ã€åŠ å·¥åŠåˆ†è£ä½œæ¥å ´æ‰€ï¼Œæ‡‰ä¾å»ºç¯‰ç›¸é—œæ³•è¦ï¼Œä¸¦èˆ‡å·¥å» 周åœé‚Šç•Œä¿æŒè¶³ä»¥é¿å…污染åŠé˜²ç«éœ€è¦ä¹‹é©ç•¶è·é›¢ã€‚生物藥å“或生物技術產å“ä¹‹è£½é€ å·¥å» åŠè¨æ–½ï¼Œå°ç—…原體之安全防è·ï¼Œä¸å¾—妨礙公共衛生åŠå®‰å…¨ï¼›å» 內之排水æºä¸¦æ‡‰åŠ 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style="font-family: 新細明體,serif;">散（粉）劑藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç²‰ç¢Žè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¯©ç²‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ··åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç²‰å¡µæ”¶é›†è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å…¶ä»–相關è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è† å›ŠåŠ‘ã€è»Ÿè† 囊劑藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç²‰ç¢Žè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¯©ç²‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ··åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æº¶è† 調åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è»Ÿè† è†œåŠ å·¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è»Ÿè† 囊充填壓製è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è‡ªå‹•è† 囊充填或åŠè‡ªå‹•è† 囊充填è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€ç²‰å¡µæ”¶é›†è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …ç¬¬äº”æ¬¾è‡³ç¬¬ä¸ƒæ¬¾ï¼Œä¿‚è£½é€ è»Ÿè† å›Šå·¥å» å¸¸ç”¨ä¹‹è¨å‚™ï¼›ç¬¬äº”款åŠç¬¬å…款所定è¨å‚™ä¹‹è£ç½®å ´æ‰€ï¼Œæ‡‰èˆ‡å…¶ä»–å ´æ‰€éš”é–‹ï¼›ç¬¬å…款åŠç¬¬ä¸ƒæ¬¾æ‰€å®šè¨å‚™ä¹‹å ´æ‰€ï¼Œæ‡‰å…·å‚™ç©ºæ°£æº«åº¦åŠæ¿•åº¦ä¹‹èª¿ç¯€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">顆粒劑ã€éŒ 劑（å«çœ¼ç”¨éŒ 劑）ã€è‘—è¡£éŒ åŠ‘ã€ä¸¸åŠ‘è—¥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç²‰ç¢Žè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¯©ç²‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ··åˆæˆ–ç…‰åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€é€ ç²’è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ•´ç²’è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å£“éŒ è¨å‚™æˆ–製丸è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æº¶è† 或糖漿調åˆã€å™´éœ§æˆ–包衣ã€é€é¢¨ã€ä¹¾ç‡¥ã€ç£¨å…‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å¤–殼模器ã€åŠ 光器。</span> </p><p><span style="font-family: 新細明體,serif;">åã€ç²‰å¡µæ”¶é›†è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第八款所定è¨å‚™ä¹‹å ´æ‰€ï¼Œæ‡‰èˆ‡å…¶ä»–å ´æ‰€éš”é–‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">çœ¼ç”¨éŒ åŠ‘è£½é€ å·¥å» ï¼Œå¦æ‡‰è¦–需è¦è¨ç½®æ»…èŒè¨å‚™ã€ç©ºæ°£æ½”æ·¨ã€ç„¡èŒå……填（分è£ï¼‰åŠç„¡èŒè©¦é©—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">乳劑藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ”ªæ‹Œä¹³åŒ–è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¹³åŠ‘調勻è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¹³åŠ‘充填（分è£ï¼‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">懸液劑ã€é…ŠåŠ‘ã€æµ¸è†åŠ‘ã€æµæµ¸è†åŠ‘ã€æ¶²åŠ‘（å«çœ¼ç”¨æ¶²åŠ‘ã€è¡€æ¶²é€æžæ¶²ã€çŒæ´—用液劑）藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è’¸é¤¾æ°´æˆ–ç´”æ·¨æ°´ä¹‹è£½é€ è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ¶²åŠ‘調é…容器或液劑澄清槽或瓷缸。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ»²æ¼‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æµ¸æ¼¬è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€éŽæ¿¾è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ”ªæ‹Œè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å®šé‡å……填（分è£ï¼‰åŠå®¹å™¨å°é–‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€åŠ 熱濃縮（減壓）è£ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ»…èŒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">çœ¼ç”¨æ¶²åŠ‘è£½é€ å·¥å» ï¼Œå¦æ‡‰è¦–需è¦è¨ç½®ç©ºæ°£æ½”æ·¨ã€ç„¡èŒå……填（分è£ï¼‰åŠç„¡èŒè©¦é©—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">氣化噴霧劑藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ”ªæ‹Œè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å……å¡«è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">軟è†ï¼ˆå«çœ¼ç”¨è»Ÿè†ï¼‰ã€æ “劑藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç²‰æœ«ç ”磨è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¯©ç²‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŠ 熱釜。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€èª¿å‹»è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å……填（分è£ï¼‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è»Ÿè†ç®¡å°é–‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æ “劑模型冷å‡è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æ»…èŒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€ç²‰å¡µæ”¶é›†è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第五款åŠç¬¬å…款所定之è¨å‚™ï¼Œæ–¼ä¸è£è»Ÿè†ç®¡ä¹‹å·¥å» ，得å…è¨ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">眼用軟è†è£½é€ å·¥å» ï¼Œå¦æ‡‰è¦–需è¦è¨ç½®ç©ºæ°£æ½”æ·¨ã€ç„¡èŒå……填（分è£ï¼‰åŠç„¡èŒè©¦é©—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">棒劑藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ··åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å……å¡«è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">貼劑藥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŠ 熱è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ”ªæ‹Œã€æåˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¡—布è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è£åˆ‡è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ¤å…¥åŠ‘è—¥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å£“製或模製è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ»…èŒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">注射劑（å«è…¹è†œé€æžæ¶²ï¼‰è—¥å“è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ³¨å°„ç”¨æ°´ä¹‹è£½é€ è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å®‰ç“¿åˆ‡æ–·è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å®¹å™¨ä¹¾ç‡¥æ»…èŒè¨å‚™åŠå†·å»ã€ä¿ç®¡è¨å‚™ï¼šæ‡‰é˜²æ¢å®¹å™¨ä¹‹æ±¡æŸ“，並應有效滅èŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ³¨å°„藥劑溶液éŽæ¿¾è¨å‚™ï¼šæ‡‰å…·å‚™åŽ»ç†±åŽŸåŠé™¤èŒéŽæ¿¾è¨å‚™ã€‚但粉末狀態者，å…è¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æº–確衡é‡ä¹‹å……å¡«è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ³¨å°„劑容器å°é–‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æ»…èŒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æ³¨å°„劑容器å°é–‰ç‹€æ…‹åŠæ´©æ¼æª¢é©—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ³¨å°„劑異物檢查è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€æ¶ˆæ¯’室：供員工手腳洗滌消毒之用。</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€æ›´è¡£å®¤ï¼šä¾›å“¡å·¥æ›´æ›å·²æ»…èŒä¹‹å·¥ä½œè¡£å¸½ã€å£ç½©ã€æ‰‹å¥—åŠéž‹å±¥ä¹‹ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€è—¥æ¶²èª¿è£½å®¤ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€è—¥åŠ‘å……å¡«åŠå®¹å™¨å°é–‰å®¤ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€å‹•ç‰©è©¦é©—ä¹‹å ´æ‰€ã€è¨æ–½åŠè¨å‚™ï¼Œä¸¦é…置所需之動物åŠå…¶é£¼é¤Šè§€å¯Ÿå ´æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€ç”ŸèŒæ•¸è©¦é©—ã€ç„¡èŒè©¦é©—æˆ–å…¶ä»–æª¢é©—æ‰€éœ€ä¹‹å ´æ‰€ã€è¨æ–½åŠè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€å‡æ™¶ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第å二款åŠç¬¬å三款之å„室，應與其他作æ¥å ´æ‰€åš´æ ¼åŠƒåˆ†ï¼Œä¸¦æ‡‰è¨ç½®èƒ½åš´å¯†é—œé–‰ä¹‹é›™é‡é–€æˆ¶ã€ç©ºæ°£æ½”æ·¨ã€æ»…èŒã€æº«åº¦åŠæ¿•åº¦èª¿ç¯€ç‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">熱原試驗應以éžæ´»é«”動物替代方å¼å„ªå…ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æŠ—ç”Ÿç´ è—¥å“è£½åŠ‘å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ³¨å°„ç”¨æŠ—ç”Ÿç´ è£½åŠ‘ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆä¸€ï¼‰æ¶²ç‹€æŠ—ç”Ÿç´ è£½åŠ‘ï¼Œæ‡‰å…·å‰æ¢æ‰€åˆ—è¨å‚™ï¼›ç²‰ç‹€æŠ—ç”Ÿç´ è£½åŠ‘ï¼Œé™¤è¦–å…¶å¯¦éš›éœ€è¦è¨ç½®å‰æ¢æ‰€åˆ—有關è¨å‚™å¤–ï¼Œä¸¦æ‡‰å¢žåŠ è¨ç½®é©ç•¶æŽ§åˆ¶æº«åº¦èˆ‡æ¿•åº¦ä¹‹ç„¡èŒå……填（分è£ï¼‰è¨å‚™åŠè‡ªå‹•æˆ–åŠè‡ªå‹•ç²¾å¯†å¤©ç§¤ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（二）通於室外之門窗，應è¨ç½®èƒ½åš´å¯†é—œé–‰ä¹‹é›™é‡é–€çª—。</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆä¸‰ï¼‰æ‡‰å…·å‚™æŠ—ç”Ÿç´ åŽŸæ–™åŠç”¢å“之力價與安全試驗è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆå››ï¼‰åŠ å·¥åˆ†è£å ´æ‰€ï¼Œæ‡‰è¨ç½®é 備室（供分è£ææ–™åŠå®¹å™¨ä¹‹ä¹¾ç‡¥æ»…èŒèˆ‡å„²è—åŠå¾žäº‹å…¶ä»–分è£æº–備工作之用）åŠåˆ†è£å®¤ï¼ˆæ‡‰è¨ç½®é©ç•¶æŽ§åˆ¶æ¿•åº¦ä¹‹ç„¡èŒè¨å‚™åŠè‡ªå‹•æˆ–åŠè‡ªå‹•ç²¾å¯†å¤©ç§¤ï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€éžæ³¨å°„ç”¨æŠ—ç”Ÿç´ è£½åŠ‘ï¼ˆå¦‚è† å›ŠåŠ‘ã€éŒ 劑ã€æ¶²åŠ‘ã€è»Ÿè†ç‰ï¼‰ï¼šé™¤</span> <span style="font-family: 新細明體,serif;">應比照å„該製劑è¦å®šä¹‹å„é …è¨å‚™å¤–ï¼Œå…¶åŠ å·¥åˆ†è£å ´æ‰€ï¼Œæ‡‰è¦–實際需è¦è¨ç½®ç©ºæ°£æ½”æ·¨ã€æ»…èŒã€æº«åº¦åŠæ¿•åº¦èª¿ç¯€ç‰è¨å‚™ï¼Œä¸¦æ‡‰å…·å‚™å‰æ¬¾ç¬¬äºŒç›®åŠç¬¬ä¸‰ç›®æ‰€å®šä¹‹è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é’é»´ç´ é¡žè—¥å“ä¹‹è£½é€ ã€åŠ å·¥ã€åˆ†è£ã€åŒ…è£åŠå…¶ä»–作æ¥å ´æ‰€ï¼Œæ‡‰æœ‰å®Œå…¨éš”é–‹ä¹‹å» æˆ¿ï¼Œå…¶ç©ºæ°£è™•ç†ç³»çµ±ä¸¦æ‡‰èˆ‡å…¶ä»–è—¥å“之系統å„自ç¨ç«‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物藥å“或生物技術產å“è£½é€ å·¥å» ï¼Œé™¤ä½œæ¥å ´æ‰€ä¹‹å®¤å…§å¤©èŠ±æ¿ã€ç‰†å£ã€é–€çª—ã€åœ°é¢ç‰ä¹‹æ§‹é€ è¨å‚™ï¼Œæ‡‰ä¾¿æ–¼æ´—滌åŠæ¶ˆæ¯’外，應視需è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è£½é€ ã€è©¦é©—用動物åŠæŽ¥ç¨®å¾®ç”Ÿç‰©å¾Œä¹‹å‹•ç‰©é£¼é¤Šéš”離è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å®‰å…¨è©¦é©—èˆ‡ç”Ÿç‰©æª¢å®šå ´æ‰€ã€è¨æ–½åŠè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å‹•ç‰©æŽ¡è¡€åŠå‹•ç‰©ä¾†æºè£½é€ ç—˜è‹—ä¹‹è£½é€ å» ï¼Œæ‡‰æœ‰è¶³å¤ æ²–æ´—ä¹‹æ°´æºè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä½œæ¥å ´æ‰€æ‡‰æœ‰æ¸…ç†æ±¡æ°´åŠæ¶ˆæ¯’è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¾®ç”Ÿç‰©åŸ¹é¤Šè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¾®ç”Ÿç‰©éŽæ¿¾è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¾®ç”Ÿç‰©æŽ¥ç¨®åŠæŽ¡å–è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å†·å‡ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€ç¨€é‡‹åŽŸæ¶²èª¿è£½è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€å……填（分è£ï¼‰åŠå®¹å™¨å¯†å°è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€å¾®ç”Ÿç‰©ä¹‹è²¯è—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€è£½é€ éŽç¨‹ä¸ä¹‹ä¸é–“產å“åŠæœ€çµ‚產å“之貯è—è¨å‚™ï¼šè²¯è—è¨å‚™ä¹‹å®¤æº«ï¼Œæ‡‰é©åˆå„貯è—產å“之溫度。</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€èª¿åŠ‘用溶液åŠåŸ¹é¤ŠåŸºèª¿è£½è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€ä½¿ç”¨å‰ã€å¾Œä¹‹è£½é€ 與檢驗用之器具åŠå„種溶液ã€åŸ¹é¤ŠåŸºç‰ä¹‹æ»…èŒæ¶ˆæ¯’è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€æ’溫器ã€æ»…èŒè¨å‚™ã€å†·è—åŠå†·å‡è¨å‚™ï¼Œä¸¦é™„è£è‡ªå‹•èª¿ç¯€å™¨ã€æº«åº¦è¨ˆåŠå…¶ä»–å¿…è¦ä¹‹ç´€éŒ„儀器。</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€å‹•ç‰©å±é«”åŠå…¶ä»–污物焚化或銷毀è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å七ã€å“¡å·¥æ›´è¡£åŠæ²æµ´è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…«ã€å‹•ç‰©è§£å‰–åŠè‡Ÿå™¨ç£¨ç¢Žè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åä¹ã€å…¶ä»–相關è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æ“作芽å¢ã€ç´°èŒåŠç—…æ¯’å ´æ‰€ï¼Œæ‡‰èˆ‡å…¶ä»–å ´æ‰€å®Œå…¨éš”é›¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …ç¬¬ä¸ƒæ¬¾è‡³ç¬¬å款所定è¨å‚™ä¹‹å ´æ‰€ï¼Œé ˆä¿‚ç„¡èŒå®¤è¨å‚™ï¼Œä¸¦æ‡‰è£è¨æ‰€éœ€ä¹‹ç„¡èŒç©ºæ°£èª¿ç¯€å™¨ã€‚ç¬¬ä¸€é …ç¬¬å款è¨å‚™ä¹‹å ´æ‰€æ‡‰è£è¨ä¹‹ç„¡èŒç©ºæ°£èª¿ç¯€å™¨ï¼Œé ˆä¿‚ç„¡èŒæ¸›æ¿•ç©ºæ°£èª¿ç¯€å™¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥ç£¨ç²‰å·¥å» ，應視需è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç²‰ç¢Žè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¯©ç²‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç²‰å¡µæ”¶é›†è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åˆ†è£åŠåŒ…è£è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥é£²ç‰‡ç‚®è£½å·¥å» ，應視需è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ·¨é¸åŠ å·¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åˆ‡è£½è™•ç†è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åˆ‡è£½è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç‚®è£½è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€åˆ†è£åŠåŒ…è£è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å…¶ä»–相關è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥è†è—¥ï¼ˆç¡¬è†ã€æ²¹è†ï¼‰åŠè—¥è† å¸ƒè£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç²‰ç¢Žè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ··åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç†¬è†é‡œçˆæ”ªæ‹Œè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è†è—¥å¡—布è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è£åˆ‡è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥ç¢Žç‰‡è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åˆ‡ç‰‡ï¼ˆç¢Žï¼‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¯©ç²’è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ··åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥æ¶²åŠ‘ã€éœ²åŠ‘ã€é…’劑ã€è†æ»‹åŠ‘ã€è† åŠ‘è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åˆ‡æ–·ï¼ˆç¢Žï¼‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æµ¸æ¼¬è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€éŽæ¿¾è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç…Žç†¬æˆ–濃縮è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è’¸é¤¾è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ”ªæ‹Œè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æ¶²é«”充填（分è£ï¼‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è† 模盤åŠåˆ‡è† 刀。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥æ¿ƒç¸®è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åˆ‡æ–·ï¼ˆç¢Žï¼‰è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€èƒå–è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€éŽæ¿¾è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ¸›å£“濃縮è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ’溫或減壓乾燥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¡¬ç©ºè† å›Šè£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æº¶è† è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ¨¡è£½è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¹¾ç‡¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è£æˆªåŠå¥—åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ¶ˆæ¯’æ»…èŒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¾®ç”Ÿç‰©æª¢æŸ¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ä½œæ¥å ´æ‰€ï¼Œæ‡‰è¨ç½®ç©ºæ°£æ½”æ·¨ã€æº«åº¦ã€æ¿•åº¦ç‰èª¿ç¯€è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«ç”¨æ°£é«”è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å„²å˜è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è’¸ç™¼è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç©ºæ°£å£“縮è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç´”化è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€çŒå……或充填è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€åˆ†é›¢è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€åˆæˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">衛生ææ–™é¡žè£½é€ å·¥å» ï¼Œé™¤å„作æ¥å ´æ‰€æ‡‰è¦–其性質予以å€åˆ†éš”離外，應視需è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å½ˆæ£‰æ©Ÿã€å±•æ£‰æ©Ÿæˆ–æ¢³æ£‰æ©Ÿï¼šå§”è¨—æ•´æ£‰å» åŠ å·¥è€…ï¼Œå¾—å…è¨ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŠ 壓脫脂è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ¼‚æ´—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è„«æ°´è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¹¾ç‡¥è¨å‚™ï¼ˆä¹¾ç‡¥å®¤ï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ç´¡ç´—æ©Ÿã€ç¹”布機ç‰ç´¡ç¹”è¨å‚™ï¼šå§”è¨—æ£‰ç¹”å» åŠ å·¥è€…ï¼Œå¾—å…è¨ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ç´—布è£åˆ‡è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€ç¹ƒå¸¶è£åˆ‡è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ•·æ–™ç¶“乾燥後，應有é©ç•¶é˜²æ¢å†æ±¡æŸ“之è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€çµ†å‰µè†åŸºåŠ‘或藥æ料煉åˆè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€æµ¸æ¼¬èª¿åˆè¨å‚™ï¼šä¿‚採用溶劑法者，應具有之è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€å¡—布è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€ä¹¾ç‡¥åŠæ»…èŒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€åº•å¸ƒåŠ å·¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€è£åˆ‡åŠæ²å¸ƒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€è—¥ç”¨ç´—布浸漬乾燥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å七ã€è¦–需è¦è¨ç½®åŠè£½å“或最終產å“之無èŒæª¢æŸ¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …ç¬¬ä¸€æ¬¾è‡³ç¬¬äº”æ¬¾ï¼Œä¿‚è£½é€ è—¥ç”¨è„«è„‚æ£‰è€…å¸¸ç”¨ä¹‹è¨å‚™ï¼›ç¬¬äºŒæ¬¾è‡³ç¬¬å…«æ¬¾ï¼Œä¿‚è£½é€ è—¥ç”¨ç´—å¸ƒç¹ƒå¸¶è€…å¸¸ç”¨ä¹‹è¨å‚™ï¼›ç¬¬å款至第åäº”æ¬¾ï¼Œä¿‚è£½é€ çµ†å‰µè†è€…常用之è¨å‚™ï¼›ç¬¬å五款åŠç¬¬åå…æ¬¾ï¼Œä¿‚è£½é€ æ€¥æ•‘ç”¨çµ†å‰µè†ã€è—¥ç”¨ç´—布者常用之è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">注射ç’é¡žè£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç“¦æ–¯åŠ å·¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç ”ç£¨åŠ å·¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åˆ»åº¦åŠ å·¥è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æª¢æŸ¥ç’管接é è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€çŽ»ç’ƒé¹¼æ€§åº¦è©¦é©—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è£‚紋檢查器。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ç†±è¡æ“Šè©¦é©—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æ¨™æº–容é‡æ¸¬å®šå™¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ°£å¯†æª¢æŸ¥å™¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†«ç™‚ç”¨é›»æ°£å™¨æ¢°è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è»ŠåºŠã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é‘½åºŠã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åƒæ–¤é¼Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç£¨åºŠæˆ–ç ‚è¼ªæ©Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å››åˆ†ä¹‹ä¸€é¦¬åŠ›ä»¥ä¸Šä¹‹é›»å‹•è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ²–床。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è©¦é©—用é…電盤。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æª¢é›»å™¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€é›»é˜»æ¸¬å®šå™¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">採血åŠè¼¸è¡€ç”¨å™¨å…·é¡žï¼ˆä½¿ç”¨å¡‘è† ç®¡ï¼‰è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é«˜é€Ÿæ”ªæ‹Œè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å†·å»æ”ªæ‹Œè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è† ç²’è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€é«˜å£“蒸氣滅èŒè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€é«˜é€±æ³¢ç†”接è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è£½é€ ç„¡èŒæ°´è£ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ç„¡èŒæ“作室。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">注射é‡è£½é€ å·¥å» ï¼Œæ‡‰è¦–éœ€è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç›´ç·šè¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç ”磨è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é‡åº§è»Šè£½è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¥—緊用器具。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å½Žæ›²è©¦é©—器。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å½ˆæ€§è©¦é©—器。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¼•æ‹”試驗器。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€é‰—é¢è¨ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ¸¬å¾®è¨ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€æ¸¬å¾®å°ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">分è£ã€åŒ…è£åŠæ¨™ç¤ºä½œæ¥å ´æ‰€ï¼Œæ‡‰è¦–需è¦è¨ç½®ä¸‹åˆ—è¨å‚™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¡¡é‡å™¨åŠå…¶ä»–å¿…è¦ä¹‹åˆ†è£è¨å‚™ï¼ˆå¦‚人工計數器或自動分è£è¨å‚™ç‰ï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é˜²æ¿•ç”¨åŒ…è£è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç“¶æ “或瓶用å°è“‹è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŠè‡ªå‹•æˆ–自動安瓿å°å—è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ‰¹è™Ÿå°è£½è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è¿´è½‰å·¥ä½œå°æˆ–普通作æ¥å°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療器æè£½é€ å·¥å» ï¼Œå…¶è¨å‚™æ‡‰è¦–產å“實際需è¦è¨ç½®ä¹‹ï¼›å°å…¶ç”¨ä»¥è‰æ˜Žç”¢å“符åˆè¦å®šè¦æ±‚之檢驗ã€é‡æ¸¬åŠè©¦é©—è¨å‚™ï¼Œæ‡‰äºˆè¨˜éŒ„ã€ç®¡åˆ¶ã€æ ¡æ£åŠç¶è·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">ç·¨</span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本標準自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6074&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6075&type=0
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,è—¥ç‰©è£½é€ å·¥å» è¨å» 標準,è—¥ç‰©è£½é€ æ¥è€…檢查辦法,生物藥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•,è—¥å“å§”è¨—è£½é€ å¯¦æ–½è¦é»ž,è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則法è¦å‘½ä»¤è—¥ç‰©è£½é€ 許å¯åŠå„ªè‰¯è£½é€ è‰æ˜Žæ–‡ä»¶æ ¸ç™¼è¾¦æ³•<table width="632" style="height: 97px; width: 632px;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; width: 13%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt;"><b><span style="font-size: 11.5pt; font-family: 細明體;"></span></b></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;"></span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; width: 13%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt;"><b><span style="font-size: 11.5pt; font-family: 細明體;"> </span></b></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;"></span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt;"><b><span style="font-size: 11.5pt; font-family: 細明體;"> </span></b></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;"></span></p> </td> </tr> </tbody></table><table width="630" style="width: 472.5pt;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 1 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法ä¾è—¥äº‹æ³•ç¬¬äº”å七æ¢ç¬¬å…é …è¦å®šè¨‚定之。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 2 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">åœ‹ç”¢è—¥ç‰©è£½é€ æ¥è€…經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾è—¥ç‰©è£½é€ æ¥è€…檢查辦法之è¦å®šï¼Œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查符åˆè—¥ç‰©å„ªè‰¯è£½é€ 準則è¦å®šè€…，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç™¼è—¥ç‰©è£½é€ 許 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å¯ã€‚ä¾ç¬¬å››æ¢ç¬¬äºŒé …è¦å®šï¼Œå°±è¨±å¯æœ‰æ•ˆæœŸé–“申請展延者，亦åŒã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 3 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 130%;"> </p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ è¨±å¯æ‡‰ç™»è¨˜ä¸‹åˆ—äº‹é …ï¼š </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€è—¥ç‰©è£½é€ å·¥å» å稱。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€è—¥ç‰©è£½é€ å·¥å» åœ°å€ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三ã€è¨±å¯ç·¨è™Ÿã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å››ã€å°ˆä»»é§å» 監製人或管ç†ä»£è¡¨ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">五ã€è¨±å¯é …目或作æ¥å…§å®¹ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å…ã€æœ‰æ•ˆæœŸé™ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …ç¬¬ä¸€æ¬¾æˆ–ç¬¬å››æ¬¾ç™»è¨˜äº‹é …æœ‰è®Šæ›´è€…ï¼Œæ‡‰è‡ªè®Šæ›´äº‹å¯¦ç™¼ç”Ÿä¹‹æ—¥èµ·ä¸‰åæ—¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">內，檢附附表一所列資料，並繳ç´è²»ç”¨ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹è®Šæ›´ç™» </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">記。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …ç¬¬äº”æ¬¾ä¹‹ç”³è«‹è®Šæ›´ï¼Œæ‡‰ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾è—¥ç‰©è£½é€ æ¥è€…檢查辦 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">法檢查åˆæ ¼å¾Œï¼Œå§‹å¾—æ ¸å‡†ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 4 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">國產藥å“è£½é€ æ¥è€…ä¹‹è£½é€ è¨±å¯ï¼Œæœ‰æ•ˆæœŸé–“為二年；其生產產å“之劑型ã€ä½œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æ¥å…§å®¹åŠæ·æ¬¡æª¢æŸ¥ç´€éŒ„è‰¯å¥½è€…ï¼Œå¾—å¢žåŠ ä¸€å¹´è‡³äºŒå¹´ã€‚åœ‹ç”¢é†«ç™‚å™¨æè£½é€ æ¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è€…ä¹‹è£½é€ è¨±å¯ï¼Œæœ‰æ•ˆæœŸé–“為三年。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…æ‡‰æ–¼è—¥ç‰©è£½é€ è¨±å¯æœ‰æ•ˆæœŸé–“屆滿å…個月å‰ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">機關申請展延。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 5 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è¼¸å…¥è—¥ç‰©åœ‹å¤–è£½é€ å» ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾è—¥ç‰©è£½é€ æ¥è€…檢查辦法è¦å®šï¼Œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查符åˆè—¥ç‰©å„ªè‰¯è£½é€ 準則è¦å®šè€…，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç™¼çµ¦æ ¸å®šæ–‡ä»¶ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ä¾ç¬¬ä¸ƒæ¢ç¬¬äºŒé …è¦å®šï¼Œå°±æ ¸å®šæ–‡ä»¶æœ‰æ•ˆæœŸé–“申請展延者，亦åŒã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 6 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 130%;"> </p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰æ¢ä¹‹æ ¸å®šæ–‡ä»¶æ‡‰ç™»è¨˜ä¸‹åˆ—äº‹é …ï¼š </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€è—¥ç‰©è£½é€ å·¥å» å稱。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€è—¥ç‰©è£½é€ å·¥å» åœ°å€ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三ã€æ ¸å®šç·¨è™Ÿã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å››ã€æ ¸å®šé …目或作æ¥å…§å®¹ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">五ã€æœ‰æ•ˆæœŸé™ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å…ã€ä»£ç†è¼¸å…¥ä¹‹è—¥å•†ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …第一款ã€ç¬¬äºŒæ¬¾ã€ç¬¬å››æ¬¾æˆ–第å…æ¬¾ç™»è¨˜äº‹é …æœ‰è®Šæ›´è€…ï¼Œä»£ç†è¼¸å…¥ä¹‹è—¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">商應自變更事實發生之日起ä¹å日內，檢附附表一所列資料，並繳ç´è²»ç”¨ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹è®Šæ›´ç™»è¨˜ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …ç¬¬äºŒæ¬¾ä¹‹è®Šæ›´ï¼Œä»¥é–€ç‰Œæ•´ç·¨è€…ç‚ºé™ã€‚涉åŠé·ç§»è€…，應ä¾è—¥ç‰©è£½é€ æ¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">者檢查辦法申請檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …ç¬¬å››æ¬¾ä¹‹ç”³è«‹è®Šæ›´ï¼Œæ‡‰ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾è—¥ç‰©è£½é€ æ¥è€…檢查辦 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">法檢查åˆæ ¼å¾Œï¼Œå§‹å¾—æ ¸å‡†ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 7 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">輸入藥å“åœ‹å¤–è£½é€ å» ç¬¦åˆè—¥ç‰©å„ªè‰¯è£½é€ æº–å‰‡ä¹‹æ ¸å®šæ–‡ä»¶ï¼Œæœ‰æ•ˆæœŸé–“ç‚ºäºŒå¹´ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">；其生產產å“之劑型ã€ä½œæ¥å…§å®¹åŠæ·æ¬¡æª¢æŸ¥ç´€éŒ„è‰¯å¥½è€…ï¼Œå¾—å¢žåŠ ä¸€å¹´è‡³äºŒ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">年。輸入醫療器æåœ‹å¤–è£½é€ å» ç¬¦åˆè—¥ç‰©å„ªè‰¯è£½é€ æº–å‰‡ä¹‹æ ¸å®šæ–‡ä»¶ï¼Œæœ‰æ•ˆæœŸ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">間為三年。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">代ç†è¼¸å…¥ä¹‹è—¥å•†æ‡‰æ–¼æ ¸å®šæ–‡ä»¶æœ‰æ•ˆæœŸé–“屆滿å…個月å‰ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">關申請展延。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 8 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"> <p style="text-align: center; line-height: 130%;"> </p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥商å–å¾—è—¥ç‰©è£½é€ è¨±å¯è€…，得填具申請書åŠæª¢é™„é™„è¡¨äºŒæ‰€åˆ—è³‡æ–™ï¼Œä¸¦ç¹³ç´ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">費用，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³é ˜è—¥ç‰©å„ªè‰¯è£½é€ è‰æ˜Žæ–‡ä»¶ï¼ˆä»¥ä¸‹ç°¡ç¨±è‰æ˜Žæ–‡ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">件）。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è¼¸å…¥è—¥ç‰©åœ‹å¤–è£½é€ å» ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯¦åœ°æª¢æŸ¥ç¬¦åˆè—¥ç‰©å„ªè‰¯è£½é€ 準則 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è¦å®šè€…，代ç†è¼¸å…¥ä¹‹è—¥å•†å¾—ä¾å‰é …è¦å®šç”³è«‹è‰æ˜Žæ–‡ä»¶ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 9 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥商å–å¾—è—¥ç‰©è£½é€ è¨±å¯æˆ–符åˆè—¥ç‰©å„ªè‰¯è£½é€ æº–å‰‡ä¹‹æ ¸å®šæ–‡ä»¶å¾Œï¼Œç¶“ä¸å¤®è¡› </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">生主管機關廢æ¢åŽŸè¨±å¯æˆ–æ ¸å®šä¹‹ä¸€éƒ¨æˆ–å…¨éƒ¨è€…ï¼Œè—¥å•†æ‡‰è¿”é‚„åŽŸé ˜ä¹‹è‰æ˜Žæ–‡ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">件，未返還者，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€•äºˆå…¬å‘Šè¨»éŠ·ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 10 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…åœæ¥æ™‚ï¼Œæ‡‰å°‡åŽŸé ˜ä¹‹è‰æ˜Žæ–‡ä»¶äº¤ä»˜ç•¶åœ°è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¿ç®¡ï¼Œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">俟復æ¥æ™‚發還；未交付者，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—逕予註銷該è‰æ˜Žæ–‡ä»¶ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…æ‡æ¥æ™‚ï¼Œæ‡‰å ±è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå»¢æ¢å…¶è—¥ç‰©è£½é€ 許å¯ï¼Œä¸¦ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è¿”é‚„åŽŸé ˜ä¹‹è‰æ˜Žæ–‡ä»¶ï¼Œæœªè¿”還者，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€•äºˆå…¬å‘Šè¨»éŠ·ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…申請復æ¥æ™‚，應ä¾è—¥ç‰©è£½é€ æ¥è€…檢查辦法è¦å®šç”³è«‹æª¢æŸ¥ï¼Œç¶“ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查åˆæ ¼å¾Œï¼Œå§‹å¾—è£½é€ ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…åœæ¥æœŸæ»¿æœªè¾¦ç†ç¹¼çºŒåœæ¥ã€æ‡æ¥æˆ–復æ¥ç™»è¨˜ï¼Œç¶“查è‰ç„¡ç‡Ÿæ¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">事實者，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‡‰å»¢æ¢å…¶è—¥ç‰©è£½é€ 許å¯åŠè¨»éŠ·åŽŸé ˜ä¹‹è‰æ˜Žæ–‡ä»¶ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è¼¸å…¥è—¥ç‰©åœ‹å¤–è£½é€ å» ç¶“æŸ¥è‰ç„¡ç‡Ÿæ¥äº‹å¯¦è€…，準用å‰é …è¦å®šã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 11 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法所定å„é …æ›¸è¡¨æ ¼å¼ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 12 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法自發布日施行。 </span></p> </td> </tr> </tbody></table><div style="border-top: windowtext 1pt solid; border-right: medium none; border-bottom: medium none; padding-bottom: 0cm; padding-top: 1pt; padding-left: 0cm; border-left: medium none; padding-right: 0cm;"><p style="padding-bottom: 0cm; text-align: center; padding-top: 0cm; padding-left: 0cm; padding-right: 0cm;border: medium none;"><span style="font-size: 8pt; font-family: 新細明體,serif; display: none;">表單的底部</span> </p></div><p><span style="font-family: calibri;"> </span></p>2013-12-05
其他類,衛生ç¦åˆ©éƒ¨é£Ÿå“藥物管ç†ç½²å°ˆæ¡ˆè«®è©¢è¼”å°Žè¦é»žè¡Œæ”¿è§£é‡‹è¡›ç”Ÿç¦åˆ©éƒ¨é£Ÿå“藥物管ç†ç½²å°ˆæ¡ˆè«®è©¢è¼”å°Žè¦é»ž<p style="line-height: 20pt; margin: 9pt 0cm 0pt 6pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 20pt;">衛生ç¦åˆ©éƒ¨é£Ÿå“藥物管理署</span><b><span style="font-size: 20pt;">è—¥å“專案諮詢輔導è¦é»ž </span></b></span></p><p style="text-align: right; line-height: 20pt; margin: 9pt 36pt 0pt 6pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">100</span><span style="font-family: 標楷體; font-size: 14pt;">å¹´</span><span style="font-family: arial,sans-serif; font-size: 14pt;">08</span><span style="font-family: 標楷體; font-size: 14pt;">月</span><span style="font-family: arial,sans-serif; font-size: 14pt;">2</span><span style="font-family: 標楷體; font-size: 14pt;">日公告 </span></p><p style="text-align: right; line-height: 20pt; margin: 9pt 36pt 0pt 6pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">102</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">å¹´</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">7</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">月</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">26</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">æ—¥ä¿®æ£ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 34pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">一ã€</span><span style="color: windowtext; font-size: 14pt;">è¡›</span><span style="color: windowtext; font-size: 14pt;">生ç¦åˆ©éƒ¨é£Ÿå“藥物管理署</span></span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">(</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">以下簡稱本署</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">)</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">為å”åŠ©æˆ‘åœ‹è£½è—¥ç”¢æ¥ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">之發展，é‡å°åœ‹å…§æº–å‚™ä¸Šå¸‚æˆ–ç ”ç™¼ä¸ä¹‹æ–°</span><span style="font-size: 14pt;">è—¥</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">å«ç”Ÿç‰©è—¥å“</span><span style="font-family: arial,sans-serif; font-size: 14pt;">)</span><span style="font-family: 標楷體; font-size: 14pt;">進行專 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">案諮詢輔導，特訂定本è¦é»žã€‚ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 34pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">二ã€</span><span style="font-size: 14pt;">專案諮詢輔導目標：</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">專案諮詢輔導目標在å”助專案é”åˆ°ä¸‹åˆ—ç ”ç™¼é‡Œç¨‹ç¢‘ï¼šè‡¨åºŠå‰é€² </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">臨床試驗階段</span><span style="font-family: arial,sans-serif; font-size: 14pt;">(First in human)</span><span style="font-family: 標楷體; font-size: 14pt;">ã€é€²å…¥ä¸‹ä¸€æœŸè‡¨åºŠè©¦é©—ã€é€²å…¥ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;">Phase III</span><span style="font-family: 標楷體; font-size: 14pt;">樞ç´æ€§è©¦é©—ã€ç”³è«‹è—¥å“查驗登記ã€å–å¾—è—¥å“許å¯è‰ï¼Œ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">或技術移轉ã€ç²å¾—國外藥å“許å¯è‰ã€ç²åœ‹å¤–法è¦å–®ä½æ ¸å‡†åŸ·è¡Œ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 27.85pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">臨床試驗ã€ç²å¾—生技çŽç« ç‰ã€‚</span><span style="font-family: arial,sans-serif; font-size: 14pt;"> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 104pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">三ã€</span><span style="font-size: 14pt;">ç”³è«‹è³‡æ ¼ï¼š</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">本</span><span style="color: windowtext; font-size: 14pt;">署得ä¾å» </span><span style="font-size: 14pt;">å•†ä¹‹ç”³è«‹æˆ–å°±åœ‹å…§æº–å‚™ä¸Šå¸‚æˆ–ç ”ç™¼ä¸ä¹‹æ–°è—¥</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">å«ç”Ÿ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">物藥å“</span><span style="font-size: 14pt;">)</span><span style="font-size: 14pt;">進行專案</span><span style="font-size: 14pt;">諮詢輔導</span><span style="font-size: 14pt;">。</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 30.1pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">å››ã€ç”³è«‹æ–‡ä»¶ï¼š </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 35pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;"> </span><span style="font-family: 標楷體;"><span style="font-size: 14pt;">å» å•†æ出å‰é …申請，應填妥如附件之申請表，並檢附ä¸è¶…éŽ</span><span style="color: windowtext; font-size: 14pt;">二</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 34.8pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">å</span><span style="font-size: 14pt;">é ä¹‹è³‡æ–™ï¼Œèªªæ˜Žä»¥ä¸‹äº‹é …ï¼š</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 40.5pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">（一）藥å“敘述，說明其ä¸çš„新科技或新臨床è°é¡Œï¼Œä¸¦è«‹æ供充足之背景說明ã€ç ”發ç¾æ³ã€åœ‹å…§å¤–相關文ç»æˆ–資料。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">（二）概述藥å“é 期的臨床應用。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體; font-size: 14pt;">五ã€è©•é¸ç¨‹åºï¼š </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 78.95pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">（一）</span><span style="color: windowtext; font-size: 14pt;">本署就產å“之「創新程度ã€ã€ã€Œè²¢ç»ç¨‹åº¦ã€ã€ã€Œæ—©æ”¶ç¨‹åº¦ã€èˆ‡ã€Œæ»¿è¶³æ³•è¦ç¨‹åº¦ã€ç‰å››é …評估指標，åˆæ¥è©•é¸ç”³è«‹æ¡ˆã€‚</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 78.95pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">（二）經本署åˆ</span><span style="font-size: 14pt;">æ¥è©•é¸ç¬¦åˆè©•ä¼°æŒ‡æ¨™è€…ï¼Œä¸”å» å•†åŒæ„列為財團法人醫藥å“查驗ä¸å¿ƒï¼ˆä»¥ä¸‹ç°¡ç¨±é†«è—¥å“查驗ä¸å¿ƒï¼‰ä¹‹ã€Œè—¥ç‰©æ³•è¦ç§‘å¸è«®è©¢è¼”導指標案件</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(Index</span><span style="font-family: 標楷體; font-size: 14pt;">，以下簡稱</span><span style="font-family: arial,sans-serif; font-size: 14pt;">IDX)</span><span style="font-family: 標楷體;"><span style="font-size: 14pt;">ã€</span><span style="font-size: 14pt;">，æ£å¼æˆ<a name="OLE_LINK1">為專案諮詢輔導案件</a>。</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">å…ã€</span><span style="font-size: 14pt;">輔導</span><span style="font-size: 14pt;">æ–¹å¼ï¼š</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 72pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 14pt;">（一）本</span><span style="color: windowtext; font-size: 14pt;">署得組æˆå°ˆæ¡ˆè«®è©¢è¼”導團隊，æˆå“¡åŒ…å«æœ¬ç½²æŒ‡å®šäººå“¡ã€é†«è—¥å“查驗ä¸å¿ƒå¯©æŸ¥äººå“¡ï¼Œå¿…è¦æ™‚邀請本署藥å“è«®è°å°çµ„委員åŠå°ˆå®¶å¸è€…åŠ å…¥ã€‚</span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 72pt;" class="Default"><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">（二）專案輔導團隊將æ¯å£èˆ‡å°ˆæ¡ˆå» 商è¯ç¹‹ï¼Œè©¢å•ç›®å‰ä¹‹ç ”發進度ã€é å®šå·¥ä½œé …ç›®ã€å¾…è§£æ±ºäº‹é …ã€é ä¼°å•é¡Œè§£æ±ºæ™‚é–“ã€æ˜¯å¦æœ‰è°é¡Œéœ€å¾µè©¢æ³•è¦å–®ä½ï¼Œå¿…è¦æ™‚å¬é–‹å» 商會è°ã€‚ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 72pt;" class="Default"><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">（三）專案輔導ä¸æ‰€å¬é–‹ä¹‹å» 商會è°æ±ºè°ï¼ŒåŽŸå‰‡ä¸Šå°‡å¯ä½œç‚ºæ—¥å¾Œæ¡ˆä»¶å¯©æŸ¥ä¹‹åƒè€ƒã€‚ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 33.85pt;" class="Default"><span style="font-family: 標楷體;"><span style="color: windowtext; font-size: 14pt;">七ã€æœ¬ç½²æ¯å¹´å¾—é‡æ–°æª¢è¨Žè©•ä¼°å°ˆæ¡ˆè«®è©¢è¼”導案件，如產å“未é”é ä¼°æˆæ•ˆã€æˆ–å› å» å•†ç ”ç™¼æš«åœæˆ–終æ¢ï¼Œå¾—åœæ¢å°ˆæ¡ˆè«®è©¢è¼”å°Ž</span><span style="font-size: 14pt;">。</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;"> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;"> </span><span style="font-family: 標楷體; font-size: 14pt;">å…«ã€æ¡ˆä»¶ç®¡ç†ï¼š</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;"> </span><span style="font-family: 標楷體; font-size: 14pt;">專案諮詢輔導案件ä¾ç”¢å“ç ”ç™¼é€²åº¦ï¼Œåˆ†ç‚ºä¸‹åˆ—äºŒé¡žï¼š </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;"> (</span><span style="font-family: 標楷體; font-size: 14pt;">一</span><span style="font-family: arial,sans-serif; font-size: 14pt;">) </span><span style="font-family: 標楷體; font-size: 14pt;">一般輔導案件： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; font-size: 14pt;"> 1. </span><span style="font-family: 標楷體; font-size: 14pt;">產å“尚在</span><span style="font-family: arial,sans-serif; font-size: 14pt;">R&D</span><span style="font-family: 標楷體; font-size: 14pt;">階段ã€æº–備或執行</span><span style="font-family: arial,sans-serif; font-size: 14pt;">Phase I </span><span style="font-family: 標楷體; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; font-size: 14pt;"> II</span><span style="font-family: 標楷體; font-size: 14pt;">臨床試驗階段。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 83pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;"> 2. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">ç”±å» å•†ä¾éœ€æ±‚主動å‘本署請求å¬é–‹</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">Investigational New Drug (</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">以下簡稱</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND) Pre-filing meeting</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">å» å•†æœƒè°ã€‚ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;"> (</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">二</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">) </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">ç©æ¥µè¼”導案件： </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 51.5pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;"> 1. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">產å“進入</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">End of Phase II</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">臨床試驗階段。 </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 83pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;"> 2. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">本署將主動å¬é–‹</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND Pre-filing meeting</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">New Drug Application (</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">以下簡稱</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">NDA) Pre-filing meeting</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">，以å”åŠ©å» å•†æ–¼ç”³è«‹</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">NDA</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">å‰äº†è§£ç›¸é—œç¼ºå¤±ã€‚ </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 2.5pt 0cm 0pt 83pt;" class="Default"><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;"> 3. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">å» å•†ç”³è«‹</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">IND</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">或</span><span style="font-family: arial,sans-serif; color: windowtext; font-size: 14pt;">NDA</span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">後，本署將ä¾æ“šå¯¦éš›å¯©æŸ¥ç‹€æ³ï¼Œä¸»å‹•å¬é–‹å» 商會è°ï¼Œæºé€šæ‡‰è£œä»¶èˆ‡ä¿®æ£è™•ã€‚ </span></p><span style="font-family: arial,sans-serif; color: black; font-size: 14pt;"><br style="page-break-before: always;" clear="all" /></span><p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">è—¥å“專案諮詢輔導è¦é»ž</span> <span style="font-family: 標楷體; color: black; font-size: 14pt;">æµç¨‹åœ–</span> </p><p style="text-justify: inter-ideograph; text-align: justify;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 20pt; margin: 9pt 0cm 0pt 30pt;" class="Default"><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 9pt;">本</span><span style="color: windowtext; font-size: 9pt;">署得組æˆå°ˆæ¡ˆè«®è©¢è¼”導團隊，æˆå“¡åŒ…å«æœ¬ç½²æŒ‡å®šäººå“¡ã€é†«è—¥å“查驗ä¸å¿ƒå¯©æŸ¥äººå“¡ï¼Œå¿…è¦æ™‚邀請本署藥å“è«®è°å°çµ„委員åŠå°ˆå®¶å¸è€…åŠ å…¥ã€‚</span> </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify; margin: 2.5pt 0cm 0pt -6pt;" class="Default"><span style="font-family: 標楷體;"><span style="font-size: 9pt;">本</span><span style="color: windowtext; font-size: 9pt;">署得</span><span style="font-size: 9pt;">ä¾å» å•†ä¹‹ç”³è«‹æˆ–å°±åœ‹å…§æº–å‚™ä¸Šå¸‚æˆ–ç ”ç™¼ä¸ä¹‹æ–°è—¥</span></span><span style="font-family: arial,sans-serif; font-size: 9pt;">(</span><span style="font-family: 標楷體;"><span style="font-size: 9pt;">å«ç”Ÿç‰©è—¥å“</span><span style="font-size: 9pt;">)</span><span style="font-size: 9pt;">進行專案</span><span style="font-size: 9pt;">諮詢輔導案件</span><span style="font-size: 9pt;">è©•é¸ã€‚</span> </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">å» å•†æ˜¯å¦åŒæ„åŠ å…¥æŸ¥é©—ä¸å¿ƒã€Œè—¥ç‰©æ³•è¦ç§‘å¸è«®è©¢è¼”導指標案件</span><span style="font-family: arial,sans-serif; font-size: 9pt;">(IDX)</span><span style="font-family: 標楷體; font-size: 9pt;">ã€ï¼Œæ£å¼æˆç‚ºå°ˆæ¡ˆè«®è©¢è¼”導案件。</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">ä¸åˆ—入諮詢輔導案件 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">ä¸ç¬¦åˆ </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">ç¬¦åˆ </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">就產å“之「創新程度ã€ã€ã€Œè²¢ç»ç¨‹åº¦ã€ã€ã€Œæ—©æ”¶ç¨‹åº¦ã€ã€ã€Œæ»¿è¶³æ³•è¦ç¨‹åº¦ã€ç‰4é …è©•ä¼°æŒ‡æ¨™ï¼Œåˆæ¥è©•é¸ç”³è«‹æ¡ˆã€‚ </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify;" class="Default"><span style="font-family: 標楷體; font-size: 9pt;">專案輔導團隊將<b>æ¯å£</b>èˆ‡å°ˆæ¡ˆå» å•†è¯ç¹‹ï¼Œè©¢å•ç›®å‰ä¹‹ç ”發進度ã€é å®šå·¥ä½œé …ç›®ã€å¾…è§£æ±ºäº‹é …ã€é ä¼°å•é¡Œè§£æ±ºæ™‚é–“ã€æ˜¯å¦æœ‰è°é¡Œéœ€å¾µè©¢æ³•è¦å–®ä½ï¼Œå¿…è¦æ™‚å¬é–‹å» 商會è°ã€‚專案輔導ä¸æ‰€å¬é–‹ä¹‹å» 商會è°æ±ºè°ï¼ŒåŽŸå‰‡ä¸Šå°‡å¯ä½œç‚ºæ—¥å¾Œæ¡ˆä»¶å¯©æŸ¥ä¹‹åƒè€ƒã€‚ </span></p> <p style="text-align: center;"> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">是 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-justify: inter-ideograph; text-align: justify;"><span style="font-family: 標楷體; font-size: 9pt;">å¦ </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">未é”æˆæ•ˆ </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">ä¸åˆ—入諮詢輔導案件 </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">本署<b>æ¯å¹´</b>å¾—é‡æ–°æª¢è¨Žè©•ä¼°å°ˆæ¡ˆè«®è©¢è¼”導案件，如產å“未é”é ä¼°æˆæ•ˆã€æˆ–å› å» å•†ç ”ç™¼æš«åœæˆ–終æ¢ï¼Œå¾—åœæ¢å°ˆæ¡ˆè«®è©¢è¼”導。</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">åœæ¢å°ˆæ¡ˆè«®è©¢è¼”å°Ž </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-family: 標楷體; font-size: 9pt;">ä¾ç”¢å“ç ”ç™¼é€²åº¦åˆ†é¡ž </span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 9pt;">ç©æ¥µè¼”導案件</span></b><b> </b></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">ã€ç”¢å“進入</span><span style="font-size: 9pt;">End of Phase II</span><span style="font-family: 標楷體; font-size: 9pt;">臨床試驗階段。】</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">本<span style="text-decoration: underline;">ç½²</span>主動å¬é–‹</span><span style="font-size: 9pt;"> IND</span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;">NDA Pre-filing meeting</span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">ä¾å¯©æŸ¥ç‹€æ³ï¼Œæœ¬ç½²ä¸»å‹•å¬é–‹</span><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;">NDA</span><span style="font-family: 標楷體; font-size: 9pt;">å» å•†æœƒè°</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;">NDA</span><span style="font-family: 標楷體; font-size: 9pt;">æ£å¼é€ä»¶</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><b><span style="font-family: 標楷體; font-size: 9pt;">一般輔導案件</span></b><b> </b></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">ã€ç”¢å“尚在</span><span style="font-size: 9pt;">R&D</span><span style="font-family: 標楷體; font-size: 9pt;">階段ã€æº–備或執行</span><span style="font-size: 9pt;">Phase I </span><span style="font-family: 標楷體; font-size: 9pt;">或</span><span style="font-size: 9pt;"> II</span><span style="font-family: 標楷體; font-size: 9pt;">臨床試驗階段。】</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">å» å•†ä¾éœ€æ±‚，自行æ出</span> </p> <p style="text-align: center;"><span style="font-size: 9pt;">IND Pre-filing meeting</span></p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">å» å•†ä¾éœ€æ±‚，自行æ出</span> </p> <p style="text-align: center;"><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">å» å•†æœƒè°</span> </p> </div> </td> </tr> </tbody></table><table cellspacing="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="background-color: transparent;border-color: #f0f0f0;"> <div> <p><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">æ£å¼é€ä»¶</span> </p> </div> </td> </tr> </tbody></table></p><p style="text-align: right;"> </p><br clear="all" /><p style="text-align: right;"><span style="padding-bottom: 0cm; padding-left: 0cm; padding-right: 0cm; font-family: 標楷體; color: black; font-size: 14pt; padding-top: 0cm;border: windowtext 1pt solid;">附件 </span></p><p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">è—¥å“專案諮詢輔導案件申請表</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top" rowspan="3"> <p style="text-align: center; line-height: 150%;"><span style="line-height: 150%; font-family: 標楷體; color: black; font-size: 14pt;">一ã€</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center; line-height: 150%;"><span style="line-height: 150%; font-family: 標楷體; color: black; font-size: 14pt;">申請單ä½</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" colspan="5"> <p style="line-height: 150%;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">è² è²¬äºº</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">統一編號</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">地å€</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="3"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">二ã€</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">è¯çµ¡äºº</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">è·ç¨±</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">電話</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">傳真</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="color: black; font-size: 14pt;">E-mail</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="10"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">三ã€</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">案件å稱</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 51.6pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">æ–°è—¥æˆåˆ†</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.8pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 102.5pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">稱é©æ‡‰ç—‡</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 101.85pt; padding-right: 5.4pt; height: 51.6pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">è—¥å“ç ”ç™¼éšŽæ®µ </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">è¨è¨ˆé–‹ç™¼ â–¡ 原型試製 â–¡ 實驗室產å“é©—è‰ </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡<span style="font: 7pt times new roman;"> </span></span><span style="color: black; font-size: 14pt;">IND </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">臨床å‰è³‡æ–™æº–å‚™</span><span style="font-family: 標楷體; color: black; font-size: 14pt;"> â–¡ </span><span style="color: black; font-size: 14pt;">Phase I</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">產å“é©—è‰ </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡<span style="font: 7pt times new roman;"> </span></span><span style="color: black; font-size: 14pt;">Phase II</span> <span style="font-family: 標楷體; color: black; font-size: 14pt;">試é‡ç”¢ â–¡ </span><span style="color: black; font-size: 14pt;">Phase III</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">臨</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">床試驗 </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡<span style="font: 7pt times new roman;"> </span></span><span style="color: black; font-size: 14pt;">NDA</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">查驗登記 (è«‹ä¾å·²å®Œæˆè©¦é©—進行複é¸)</span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" rowspan="4"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">曾有之諮詢或審查相關經驗 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">日期<b> </b></span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">案å </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">案號 </span></p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 69.75pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 163pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="3"> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.4pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">é‡è¦æ€§ </span></p> <p style="text-align: center;"> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">具創新性 </span><span style="color: black; font-size: 14pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡ </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">å…·è²¢ç»æ€§</span> </p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">具有早</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">收性</span><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;"> </span><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡ </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">符åˆæ”¿ç–é¼“å‹µæ–¹å‘ </span></p> <p><span style="font-family: 標楷體; color: black; font-size: 14pt;">(</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">申請者å¯è‡ªè¡Œè©•ä¼°ï¼Œå¯é‡è¤‡å‹¾é¸)</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">是å¦æœ‰æ”¿åºœè¨ˆç•«è£œåŠ© </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡</span><span style="color: black; font-size: 14pt;"> </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">ç„¡</span> </p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">â–¡</span><span style="color: black; font-size: 14pt;"> </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">有，補助來æºæˆ–所屬計畫為_____________________</span><span style="text-decoration: underline;"> </span></p> </td> </tr> <tr style="height: 108.7pt;"> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; height: 108.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">å» å•†é–‹ç™¼åˆ©åŸºç”¢å“說明 </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; height: 108.7pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> </td> </tr> <tr style="height: 57.05pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 46.8pt; padding-right: 5.4pt; height: 57.05pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">四〠</span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 73.15pt; padding-right: 5.4pt; height: 57.05pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p style="text-align: center;"><span style="font-family: 標楷體; color: black; font-size: 14pt;">å°ç”³è«‹æ¡ˆä»¶ä¹‹æœŸè¨±æˆ–é 期é”æˆæ•ˆç›Š </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 306.15pt; padding-right: 5.4pt; height: 57.05pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="5"> </td> </tr> <tr> <td style="background-color: transparent; width: 62px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 98px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 93px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 43px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 137px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 38px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 98px;border-color: #f0f0f0;"></td> </tr> </tbody></table><p style="text-align: center;"> </p><p style="text-justify: inter-ideograph; text-align: justify;"> </p>2013-12-05
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,è—¥ç‰©è£½é€ æ¥è€…檢查辦法法è¦å‘½ä»¤è—¥ç‰©è£½é€ æ¥è€…檢查辦法<table width="566" style="margin: auto auto auto -5.6pt; width: 424.65pt;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 0cm; padding-top: 2.25pt; padding-left: 0cm; padding-right: 12pt; width: 3.06%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 95.88%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">è—¥ç‰©è£½é€ æ¥è€…檢查辦法 </span></p> </td> </tr> </tbody></table><table width="630" style="width: 472.5pt;" border="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="margin: 0cm 0cm 3.75pt; line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 1 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法ä¾è—¥äº‹æ³•ç¬¬ä¸ƒå一æ¢ç¬¬ä¸‰é …è¦å®šè¨‚定之。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 2 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">應ä¾æœ¬è¾¦æ³•å¯¦æ–½æª¢æŸ¥ä¹‹è—¥ç‰©è£½é€ æ¥è€…如下： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€ç¶“營藥å“è£½é€ ã€åŠ 工之æ¥è€…。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€ç¶“營醫療器æè£½é€ ã€è£é…之æ¥è€…。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三ã€å…¶ä»–èˆ‡è—¥ç‰©è£½é€ ã€åŠ 工或è£é…有關之æ¥è€…，包括經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">æ ¸å‡†ç‚ºç ”ç™¼è€Œè£½é€ è—¥ç‰©è€…ã€å…¼ä½œè—¥ç‰©æ¨™ç¤ºåŠèˆ‡åˆ†è£æˆ–包è£è—¥ç‰©æœ‰é—œä¹‹ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">æ¥è€…ç‰ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 3 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…之檢查，分類如下： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€è—¥ç‰©è£½é€ æ¥è€…之新è¨ã€é·ç§»ã€æ“´å»ºã€å¾©æ¥æˆ–å¢žåŠ åŽŸæ–™è—¥ã€åŠ‘åž‹ã€åŠ å·¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">é …ç›®ã€å“é …ä¹‹æª¢æŸ¥ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€è—¥ç‰©è£½é€ æ¥è€…後續追蹤管ç†ä¹‹æª¢æŸ¥ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三ã€å€åŸŸä¾‹è¡Œæ€§æª¢æŸ¥ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å››ã€å…¶ä»–檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …ç¬¬ä¸€æ¬¾ä¹‹åœ‹ç”¢è—¥ç‰©è£½é€ æ¥è€…，其硬體è¨å‚™åŠè¡›ç”Ÿæ¢ä»¶ï¼Œæ‡‰ç¬¦åˆè—¥ç‰©è£½ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">é€ å·¥å» è¨å» 標準第二編åŠå·¥å» 管ç†è¼”導法之è¦å®šï¼Œä¸¦ç”±å·¥æ¥ä¸»ç®¡æ©Ÿé—œåŠç›´ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">轄市或縣 (市) 衛生主管機關檢查之；其軟體è¨å‚™åŠè¡›ç”Ÿæ¢ä»¶ï¼Œæ‡‰ç¬¦åˆè—¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç‰©è£½é€ å·¥å» è¨å» 標準第三編或第四編之è¦å®šï¼Œä¸¦ç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾ç¬¬ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å››æ¢æˆ–第å…æ¢è¦å®šæª¢æŸ¥ä¹‹ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …ç¬¬ä¸€æ¬¾ä¹‹åœ‹å¤–è—¥ç‰©è£½é€ æ¥è€…，應符åˆè—¥ç‰©è£½é€ å·¥å» è¨å» 標準之è¦å®š </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，並由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¾ç¬¬äº”æ¢æˆ–第七æ¢è¦å®šæª¢æŸ¥ä¹‹ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …ç¬¬äºŒæ¬¾ä¹‹æª¢æŸ¥ï¼Œåœ‹ç”¢è—¥ç‰©è£½é€ æ¥è€…ä¾ç¬¬å…«æ¢è¦å®šè¾¦ç†ï¼Œåœ‹å¤–藥物製 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">é€ æ¥è€…ä¾ç¬¬ä¹æ¢è¦å®šè¾¦ç†ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ç‚ºç ”ç™¼è€Œè£½é€ è—¥ç‰©è€…ï¼Œå¦‚æœªç”³è«‹è—¥ç‰©ä¸Šå¸‚è¨±å¯ï¼Œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å¾—ä¸é©ç”¨å‰ä¸‰é …è¦å®šã€‚但其臨床試驗用藥物，應符åˆè—¥ç‰©è£½é€ å·¥å» è¨å» 標 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">準第三編或第四編之è¦å®šï¼Œä¸¦ç”±è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæª¢æŸ¥ä¹‹ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …ç¬¬ä¸‰æ¬¾ä¹‹æª¢æŸ¥ï¼Œä¾ç¬¬å一æ¢è¦å®šè¾¦ç†ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …ç¬¬å››æ¬¾ä¹‹æª¢æŸ¥ï¼Œä¾ç¬¬å二æ¢è¦å®šè¾¦ç†ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 4 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æ–°è¨ã€é·ç§»ã€æ“´å»ºã€å¾©æ¥æˆ–å¢žåŠ åŽŸæ–™è—¥ã€åŠ‘åž‹ã€åŠ å·¥é …ç›®ä¹‹åœ‹ç”¢è—¥å“è£½é€ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æ¥è€…，應繳ç´è²»ç”¨ï¼Œä¸¦å¡«å…·è—¥å“å„ªè‰¯è£½é€ è©•é‘‘ç”³è«‹è¡¨åŠæª¢é™„ä¸‹åˆ—è³‡æ–™ï¼Œå‘ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹æª¢æŸ¥ï¼š </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€é€šéŽç¡¬é«”檢查之è‰æ˜Žæ–‡ä»¶æˆ–å·¥å» ç™»è¨˜è‰æ˜Žæ–‡ä»¶ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€å¡«å…·è£½è—¥å·¥å» åŸºæœ¬è³‡æ–™æŸ¥æ ¸è¡¨ï¼Œä¸¦ä¾æŸ¥æ ¸è¡¨æ‰€è¼‰äº‹é …æª¢é™„å·¥å» åŸºæœ¬è³‡ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">料（Site Master File，以下簡稱 SMF）。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …檢查，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—會åŒç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèµ´å» </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查之。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 5 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三æ¢ç¬¬ä¸€é …第一款之輸入藥å“åœ‹å¤–è£½é€ æ¥è€…，應由我國代ç†å•† (藥商) </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¹³ç´è²»ç”¨ï¼Œä¸¦å¡«å…·ç”³è«‹æ›¸è¡¨åŠä¾æ›¸è¡¨æ‰€è¼‰äº‹é …æª¢é™„è©²åœ‹å¤–è£½é€ æ¥è€…ä¹‹å·¥å» </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">資料 (Plant Master File ，以下簡稱 PMF) ，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查。但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹åœ‹å®¶ï¼Œå…¶è£½é€ æ¥è€…ä¹‹å·¥å» è³‡æ–™ (PMF)</span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，得以該æ¥è€…ä¹‹å·¥å» åŸºæœ¬è³‡æ–™ (SMF) åŠè©²åœ‹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç™¼ä¹‹ç¨½æŸ¥å ± </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">告替代之。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …å·¥å» è³‡æ–™ (PMF) åŠå·¥å» 基本資料 (SMF) ，應經出產國最高衛生主 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">管機關或商會簽è‰ã€‚ä½†å¦‚æª¢é™„å‡ºç”¢åœ‹æœ€é«˜è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‡ºå…·è©²è£½é€ æ¥è€…符 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">åˆç•¶åœ°è—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæˆ–è¼‰æ˜Žè©²è£½é€ æ¥è€…係符åˆç•¶åœ°è—¥å“優良製 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">é€ è¦ç¯„之製售è‰æ˜Žæ£æœ¬è€…，得å…ç°½è‰ï¼›å¦‚出產國係德國者，其è‰æ˜Žæ–‡ä»¶å¾— </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">由德國邦政府衛生主管機關出具，å…å…¶è¯é‚¦æ”¿åºœç°½è‰ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …æª¢æŸ¥å¦‚æœ‰å¯¦æ–½åœ‹å¤–æŸ¥å» ä¹‹å¿…è¦è€…，申請人應å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç¹³ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç´è²»ç”¨ï¼Œä¸¦èˆ‡åœ‹å¤–è£½é€ æ¥è€…é…åˆæª¢æŸ¥è¦æ±‚，備齊相關資料。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 6 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æ–°è¨ã€é·ç§»ã€æ“´å»ºã€å¾©æ¥æˆ–å¢žåŠ é†«ç™‚å™¨æå“é …ä¹‹åœ‹ç”¢é†«ç™‚å™¨æè£½é€ æ¥è€…， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">應繳ç´è²»ç”¨ï¼Œä¸¦å¡«å…·ç”³è«‹æ›¸è¡¨äºŒä»½åŠæª¢é™„下列資料，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">申請檢查： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€å“質手冊。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€å·¥å» 登記è‰æ˜Žæ–‡ä»¶ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三ã€è£½é€ æ¥è—¥å•†è¨±å¯åŸ·ç…§ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 7 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三æ¢ç¬¬ä¸€é …第一款之輸入醫療器æåœ‹å¤–è£½é€ æ¥è€…，應由我國代ç†å•†ï¼ˆè—¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">商）繳ç´è²»ç”¨ï¼Œä¸¦å¡«å…·ç”³è«‹æ›¸è¡¨äºŒä»½åŠæª¢é™„下列資料，å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">關申請檢查： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€è©²è¼¸å…¥é†«ç™‚器æåœ‹å¤–è£½é€ æ¥è€…之å“質系統文件。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€èˆ‡é†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„åŒç‰æ•ˆåŠ›ä¹‹ç¬¦åˆæ€§é©—è‰åˆæ ¼ç™»éŒ„è‰æ›¸ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">三ã€è©²è¼¸å…¥é†«ç™‚器æåœ‹å¤–è£½é€ æ¥è€…ä¹‹å…¨å» é…置圖ã€å„類產å“è£½é€ ä½œæ¥å€åŸŸ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">ã€ä¸»è¦è¨å‚™ã€ç”¢å“è£½é€ æµç¨‹ï¼›å¿…è¦æ™‚，並應標示作æ¥äººå“¡èˆ‡ç‰©æ–™æ¬é‹ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">之通路。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …第一款之å“質系統文件，得先檢附å“質手冊與相關程åºæ›¸åŠæ–‡ä»¶ç¸½è¦½ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">表。但必è¦æ™‚，申請人應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¹‹é€šçŸ¥ï¼Œè£œé€å…¶ä»–å“質系統 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">文件或資料。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç”¢åœ°ç‚ºç¾Žåœ‹ä¹‹è£½é€ æ¥è€…，得以美國最高衛生主管機關出具之製售è‰æ˜Žï¼Œä¸¦ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å…¶å…§å®¹è¼‰æ˜Žè©²è£½é€ æ¥è€…係符åˆç¾Žåœ‹ä¹‹é†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„（Current G-</span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ood Manufacturing Practice</span><span style="font-size: 11.5pt; font-family: 細明體;">ï¼‰è€…ï¼Œæ›¿ä»£ç¬¬ä¸€é …ç¬¬äºŒæ¬¾è³‡æ–™ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">產地為美國ã€ç¾Žå±¬æ³¢å¤šé»Žå„æˆ–é—œå³¶ä¹‹è£½é€ æ¥è€…，於ä¸ç¾Žé†«ç™‚器æ技術åˆä½œ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æ›æ–‡æœ‰æ•ˆæœŸé–“å…§ï¼Œå¾—ä»¥ç¾Žåœ‹æœ€é«˜è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‡ºå…·ä¹‹æŸ¥å» å ±å‘Šæ›¸èˆ‡è£½å”®è‰ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">明åŠèˆ‡é†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„åŒç‰æ•ˆåŠ›ä¹‹ç¬¦åˆæ€§è‰æ›¸ï¼ˆå¦‚ ISO 13485 è‰ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">書），共åŒæ›¿ä»£ç¬¬ä¸€é …第一款至第三款之資料。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">產地為æç›Ÿä¹‹è£½é€ æ¥è€…，於ä¸æ醫療器æ技術åˆä½œæ›æ–‡æœ‰æ•ˆæœŸé–“內，或產 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">åœ°ç‚ºç‘žå£«ä¹‹è£½é€ æ¥è€…，於臺瑞醫療器æ技術åˆä½œæ›æ–‡æœ‰æ•ˆæœŸé–“內，得以經 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¸”與ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„代施 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æŸ¥æ ¸æ©Ÿæ§‹ç°½è¨‚æŸ¥å» å ±å‘Šäº¤æ›æŠ€è¡“åˆä½œæ–¹æ¡ˆä¹‹æ盟醫療器æä»£æ–½æŸ¥æ ¸æ©Ÿæ§‹æ‰€ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‡ºå…·æŸ¥å» å ±å‘Šæ›¸ï¼Œé€£åŒè©²ç”¢è£½åœ‹æœ€é«˜è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‡ºå…·ä¹‹è£½å”®è‰æ˜ŽåŠå‰è¿° </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">èªå¯ä»£æ–½æŸ¥æ ¸æ©Ÿæ§‹å‡ºå…·èˆ‡é†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„åŒç‰æ•ˆåŠ›ä¹‹ç¬¦åˆæ€§è‰æ›¸ï¼ˆ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">如 ISO 13485 è‰æ›¸ï¼‰å…±åŒæ›¿ä»£ç¬¬ä¸€é …第一款至第三款之資料。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …æª¢æŸ¥å¦‚æœ‰å¯¦æ–½åœ‹å¤–æª¢æŸ¥ä¹‹å¿…è¦è€…，申請人應å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç¹³ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç´è²»ç”¨åŠåœ‹å¤–è£½é€ æ¥è€…之å“è³ªæ‰‹å†Šï¼Œä¸¦èˆ‡åœ‹å¤–è£½é€ æ¥è€…é…åˆæª¢æŸ¥è¦æ±‚，備 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">齊相關資料。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 7-1 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">申請檢查符åˆé†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„者，所附資料如有ä¸ç¬¦è¦å®šè€Œå¾—è£œæ£ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">時，申請人應於通知期é™å…§è£œæ£ä¹‹ã€‚補æ£æœŸé™ç‚ºäºŒå€‹æœˆã€‚申請人如未能於 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">期é™å…§è£œæ£è€…，得於補æ£æœŸæ»¿å‰ï¼Œç”³è«‹å»¶æœŸä¸€å€‹æœˆï¼Œä¸”延期以一次為é™ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">申請人如未於期é™å…§è£œæ£æˆ–延期一個月後ä»é€¾æœŸæœªè£œæ£è€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">機關得ä¾ç¾æœ‰è³‡æ–™é€•ç‚ºæª¢æŸ¥åˆ¤å®šã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 8 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三æ¢ç¬¬ä¸€é …第二款之檢查，國產藥å“è£½é€ æ¥è€…æ¯äºŒå¹´æª¢æŸ¥ä¸€æ¬¡ï¼Œä¸¦å¾—視 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">其生產產å“之劑型ã€ä½œæ¥å…§å®¹åŠæ·æ¬¡æª¢æŸ¥ç´€éŒ„，延長一年至二年。國產醫 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">療器æè£½é€ æ¥è€…，æ¯ä¸‰å¹´æª¢æŸ¥ä¸€æ¬¡ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …檢查，æ¥è€…應於è‰æ˜Žæ–‡ä»¶æœ‰æ•ˆæœŸé–“屆滿之å…個月å‰ä¸»å‹•æ出申請。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼å¿…è¦æ™‚或發ç¾è—¥ç‰©æœ‰é‡å¤§å±å®³ä¹‹æƒ…事者，得å¦å¯¦æ–½ä¸ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">定期檢查，並以ä¸é 先通知檢查å°è±¡ç‚ºåŽŸå‰‡ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …åŠå‰é …之檢查，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæª¢æŸ¥è—¥ç‰©è£½é€ æ¥è€…實施藥å“優 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è‰¯è£½é€ è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ç¯„之ç¾æ³ï¼Œä¸¦å¾—通知直轄市或縣（市） </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">衛生主管機關åŠå·¥æ¥ä¸»ç®¡æ©Ÿé—œæ´¾å“¡åƒåŠ 。æ¥è€…應é…åˆæª¢æŸ¥è¦æ±‚，並準用第 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å››æ¢æˆ–第å…æ¢è¦å®šè¾¦ç†ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 9 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">輸入藥å“åœ‹å¤–è£½é€ æ¥è€…後續追蹤管ç†æ¯äºŒå¹´æª¢æŸ¥ä¸€æ¬¡ï¼Œä¸¦å¾—è¦–ç•¶åœ°åœ‹è—¥å“ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è£½é€ ç®¡ç†åˆ¶åº¦åŠæ¨™æº–延長一年至二年；其檢查除書é¢å¯©æŸ¥å¤–，得視其輸入 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">產å“之劑型ã€ä½œæ¥å…§å®¹ã€æ·æ¬¡æª¢æŸ¥ç´€éŒ„åŠç•¶åœ°åœ‹è—¥å“è£½é€ ç®¡ç†åˆ¶åº¦åŠæ¨™æº– </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç‰è¾¦ç†å¯¦åœ°æŸ¥æ ¸ã€‚輸入醫療器æåœ‹å¤–è£½é€ æ¥è€…æ¯ä¸‰å¹´æª¢æŸ¥ä¸€æ¬¡ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …檢查，æ¥è€…應於è‰æ˜Žæ–‡ä»¶æœ‰æ•ˆæœŸé–“屆滿之å…個月å‰ä¸»å‹•æ出申請。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼å¿…è¦æ™‚或發ç¾è—¥ç‰©æœ‰é‡å¤§å±å®³ä¹‹æƒ…事者，得å¦å¯¦æ–½ä¸ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">定期檢查。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ç¬¬ä¸€é …åŠå‰é …之檢查，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæª¢æŸ¥è—¥ç‰©è£½é€ æ¥è€…實施藥å“優 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è‰¯è£½é€ è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ç¯„之ç¾æ³ï¼›æ¥è€…應é…åˆæª¢æŸ¥è¦æ±‚，並準 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">用第五æ¢æˆ–第七æ¢è¦å®šè¾¦ç†ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 10 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…經檢查符åˆç¬¬å››æ¢è‡³ç¬¬ä¹æ¢è¦å®šä¹‹ä¸€è€…，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">關就檢查åˆæ ¼ä¹‹é …ç›®ï¼Œæ ¸ç™¼ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">範之è‰æ˜Žæ–‡ä»¶ã€‚國產åŠè¼¸å…¥è—¥å“è£½é€ æ¥è€…符åˆå„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶æœ‰ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">效期間，得é…åˆç¬¬å…«æ¢ç¬¬ä¸€é …åŠå‰æ¢ç¬¬ä¸€é …ä¹‹æª¢æŸ¥é »çŽ‡å®šä¹‹ï¼›é†«ç™‚å™¨æ製 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">é€ æ¥è€…符åˆå„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶æœ‰æ•ˆæœŸé–“為三年。 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å‰é …è‰æ˜Žæ–‡ä»¶æ ¸ç™¼å¾Œï¼Œå¦‚經主管機關後續檢查發ç¾æœ‰ä¸ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è¦ç¯„或醫療器æå„ªè‰¯è£½é€ è¦ç¯„之情形而未於期é™å…§æ”¹å–„，或經發ç¾æœ‰é‡å¤§ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å±å®³æˆ–é•è¦æƒ…節é‡å¤§ï¼Œæˆ–ç™»è¨˜äº‹é …è®Šæ›´è€Œæœªä¾è¦å®šç”³è«‹è®Šæ›´æˆ–未ç²æ ¸å‡†è®Š </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">更者，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—廢æ¢è©²è‰æ˜Žæ–‡ä»¶ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 11 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">第三æ¢ç¬¬ä¸€é …第三款之檢查，由直轄市或縣 (市) 衛生主管機關會åŒå·¥æ¥ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ä¸»ç®¡æ©Ÿé—œæª¢æŸ¥ç•¶åœ°ä¹‹è—¥ç‰©è£½é€ æ¥è€…；其檢查期間åŠé‡é»žå¦‚下： </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">一ã€æ¯å¹´èˆ‰è¡Œä¸€æ¬¡ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">二ã€æª¢æŸ¥é‡é»žé™¤è—¥ç‰©è£½é€ æ¥è€…之è¨å‚™å¤–ï¼Œä¸¦åŒ…æ‹¬å…¶è£½é€ ã€åŠ å·¥ã€è£é…之作 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">æ¥ç¨‹åºã€å“質管制åŠå…¶æˆå“ã€åŠæˆå“ã€åŽŸæ–™ã€é…件容器ã€åŒ…è£ã€æ¨™ç±¤ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;"> </span><span style="font-size: 11.5pt; font-family: 細明體;">ã€ä»¿å–®èˆ‡å·¥å» æˆ–å ´æ‰€ä¹‹å®‰å…¨ã€æ©Ÿå™¨æŒ‰è£æŽ’列åŠæ“作效率ç‰ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 12 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">其他檢查，由衛生主管機關åŠå·¥æ¥ä¸»ç®¡æ©Ÿé—œä¾ç›¸é—œæ³•ä»¤è¦å®šæˆ–視需è¦ä¾è· </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">權辦ç†ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 13 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">主管機關執行å„é …æª¢æŸ¥æ™‚ï¼Œå¾—è¦–éœ€è¦é‚€è«‹æœ‰é—œæ©Ÿé—œæˆ–專家åƒèˆ‡ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 14 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">檢查人員執行檢查任務時，應出示身分è‰æ˜Žæ–‡ä»¶ï¼›æª¢æŸ¥æ™‚，得索å–ä¸¦å½±å° </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">相關文件；必è¦æ™‚，得å–樣ã€ç…§ç›¸ä¸¦éŒ„音å˜è‰ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">如å—檢查æ¥è€…無故拒絕ã€è¦é¿æˆ–妨礙時，得逕予判定該次檢查çµæžœç‚ºä¸åˆ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æ ¼ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 15 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">è—¥ç‰©è£½é€ æ¥è€…經檢查所見缺失，應ä¾æª¢æŸ¥æ©Ÿé—œæ ¸ç™¼ä¹‹æª¢æŸ¥å ±å‘Šæˆ–有關文件 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">，於期é™å…§æ”¹å–„並檢é€æ”¹å–„å ±å‘Šã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">執行檢查之機關得視å—檢查æ¥è€…之é•è¦æƒ…節，或於å—檢查æ¥è€…逾期未改善 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">æˆ–å…¶æ”¹å–„å ±å‘Šä»æœ‰ç¼ºå¤±æ™‚，ä¾ç›¸é—œæ³•ä»¤è¦å®šè™•ç½°ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 15-1 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">藥商申請醫療器æè£½é€ æ¥è€…應符åˆé†«ç™‚器æå„ªè‰¯è£½é€ è¦ç¯„之è¦å®šï¼›ç¶“檢查 </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">ä¸åˆæ ¼è€…ï¼Œå¾—æ–¼æ ¸å®šä¹‹æ—¥èµ·äºŒå€‹æœˆå…§æ出複評，以一次為é™ã€‚ </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 16 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法之å„é …æ›¸è¡¨ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå®šä¹‹ã€‚ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">å—檢查æ¥è€…應ä¾æ›¸è¡¨æ‰€è¼‰äº‹é …，備齊相關資料；填寫書表åŠæª¢é™„之資料， </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">é™ç”¨ç¹é«”ä¸æ–‡åŠè‹±æ–‡ï¼›å¦‚éžç¹é«”ä¸æ–‡æˆ–英文者，應å¦é™„ç¹é«”ä¸æ–‡æˆ–è‹±æ–‡è¯ </span></p> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本。 </span></p> </td> </tr> <tr> <td valign="top" style="white-space: nowrap; padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 11%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 130%;"><span style="font-size: 11.5pt; font-family: 細明體; line-height: 130%;">第 17 æ¢ </span></p> </td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 2%; background-color: transparent;border-color: #f0f0f0;"></td> <td valign="top" style="padding-bottom: 2.25pt; padding-top: 2.25pt; padding-left: 2.25pt; padding-right: 2.25pt; width: 87%; background-color: transparent;border-color: #f0f0f0;"> <p style="line-height: 18pt;"><span style="font-size: 11.5pt; font-family: 細明體;">本辦法自發布日施行。 </span></p> </td> </tr> </tbody></table>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6077&type=0
化å¸è£½é€ 管制類,è—¥å“安定性,è—¥å“安定性試驗基準行政解釋藥å“安定性試驗基準詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4556&type=0
化å¸è£½é€ 管制類,è—¥å“安定性,è—¥å“安定性試驗基準-生物技術/生物性藥å“之安定性試驗行政解釋藥å“安定性試驗基準-生物技術生物性藥å“之安定性試驗<p style="text-align: center; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif; font-size: 16pt;">è—¥å“安定性試驗基準：生物技術ï¼ç”Ÿç‰©æ€§è—¥å“之安定性試驗</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">一ã€å‰è¨€</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">為確ä¿ç”³è«‹ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“之å“質，推定有效期間，且é…åˆåœ‹éš›é†«è—¥æ³•è¦å”åˆæœƒï¼ˆ</span><span style="background: yellow;">International</span> Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, ICH<span style="font-family: 新細明體,serif;">）之精神，特增訂本文件åšç‚ºè¡›ç”Ÿç½²ã€Œè—¥å“安定性試驗基準ã€ä¹‹è£œå……說明。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">衛生署公告之「藥å“安定性試驗基準ã€é©ç”¨æ–¼ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“ï¼Œç„¶è€Œï¼Œå› ç‚ºç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“具有其特殊性質，所以應以è¨è¨ˆè‰¯å¥½ä¹‹è©¦é©—計畫，è‰å¯¦è©²é¡žè—¥å“æ–¼é 期儲å˜æœŸé–“內的安定性。å°æ–¼æ´»æ€§æˆåˆ†ç‚ºå…¸åž‹çš„蛋白質åŠ</span>/<span style="font-family: 新細明體,serif;">或多胜肽的藥å“而言，其分åçµæ§‹ä¹ƒè‡³ç”Ÿç‰©æ´»æ€§çš„ç¶æŒï¼Œç«¯è³´éžå…±åƒ¹åŠ›åŠå…±åƒ¹åŠ›ï¼Œæ¤é¡žè—¥å“å°ç’°å¢ƒå› å，例如：溫度的變化ã€æ°§åŒ–作用ã€å…‰ç·šã€é›¢åå«é‡ç‰ç‰¹åˆ¥æ•æ„Ÿï¼Œæ˜¯ä»¥ç‚ºç¶æŒæ¤é¡žè—¥å“的生物活性åŠé¿å…退化，通常必需å°å…¶å„²å˜æ¢ä»¶ä½œåš´æ ¼çš„è¦æ±‚。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">安定性的評估需è¦è¤‡é›œçš„分æžæ–¹æ³•ï¼Œå°ç”Ÿç‰©æ´»æ€§çš„分æžæ‡‰æ˜¯å®‰å®šæ€§ç ”究的é‡è¦éƒ¨åˆ†ï¼Œç•¶è—¥å“之純度åŠåˆ†å特徵能用é©ç•¶ä¹‹ç‰©ç†åŒ–å¸ã€ç”ŸåŒ–åŠå…疫化å¸çš„方法分æžæ™‚，以æ¤ç¨®æ–¹æ³•åˆ†æžç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“的分å本質åŠå®šé‡æ¸¬å®šé€€åŒ–è—¥å“，應是安定性試驗計畫的一部分。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å°æ–¼ä¸Šè¿°é—œåˆ‡çš„äº‹é …ï¼Œç”³è«‹è€…æ‡‰æ“¬å®šèƒ½é©ç•¶æ”¯æŒç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“的安定性資料，並考慮會影響藥å“效價ã€ç´”度åŠå“質的許多外部情æ³ã€‚用以支æŒè—¥å“æˆåˆ†ï¼ˆ</span>drug substance<span style="font-family: 新細明體,serif;">）或藥å“（</span>drug product<span style="font-family: 新細明體,serif;">）å¯é”è¦æ±‚的有效期間之原始數據，應ä¾æ“šé•·æœŸã€å¯¦éš›æ™‚é–“ã€å¯¦éš›æ¢ä»¶çš„å®‰å®šæ€§ç ”ç©¶è€Œä¾†ï¼Œæ‰€ä»¥æœ‰å¿…è¦åˆ¶å®šé©ç•¶çš„長期安定性試驗計畫。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">本文件之目的，係æ供申請者在申請查驗登記時，å°æ–¼æ‰€æ‡‰æª¢é€çš„安定性試驗資料æ供指導。且藥å“於申請查驗登記之審查åŠè©•ä¼°éŽç¨‹ä¸ï¼Œç”³è«‹è€…亦應æŒçºŒæ›´æ–°æœ€åˆæª¢é€çš„安定性資料。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">二ã€é©ç”¨ç¯„åœ</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">本文件ä¸é™³è¿°çš„è¦ç¯„é©ç”¨æ–¼ï¼šç‰¹å¾µå®Œæ•´çš„蛋白質åŠå¤šèƒœè‚½ä¹‹è¡ç”Ÿç‰©åŠå…¶è—¥å“，從組織ã€é«”液åŠç´°èƒžåŸ¹é¤Šåˆ†é›¢å‡ºä¾†æˆ–åˆ©ç”¨åŸºå› é‡çµ„æŠ€è¡“è£½é€ ä¹‹æˆåˆ†çš„è¡ç”Ÿç‰©åŠå…¶è—¥å“。所以本文件包å«äº†å¦‚ç´°èƒžæ¿€ç´ ï¼ˆå¹²æ“¾ç´ ã€ä»‹ç™½ç´ ，群è½åˆºæ¿€å› åã€è…«ç˜¤å£žæ»å› åç‰ï¼‰ã€ç´…è¡€çƒç”Ÿæˆç´ ã€è¡€çº–ç¶è›‹ç™½æº¶é…¶åŽŸæ´»åŒ–å› åã€è¡€æ¼¿å› åã€ç”Ÿé•·æ¿€ç´ åŠæˆé•·å› åã€èƒ°å³¶ç´ ã€å–®æ ªæŠ—é«”åŠåŒ…å«å®Œæ•´ç‰¹å¾µçš„蛋白質或多胜肽疫苗ç‰è—¥å“的安定性試驗。æ¤å¤–ï¼Œä¸‹åˆ—ç« ç¯€åˆ—èˆ‰çš„è¦ç¯„，æŸäº›æƒ…æ³ä¸‹ï¼Œä¹Ÿé©ç”¨æ–¼å¦‚傳統疫苗ç‰å…¶ä»–é¡žåž‹çš„è—¥å“。本文件的é©ç”¨ç¯„åœä¸¦ä¸åŒ…å«æŠ—ç”Ÿç´ ã€éŽæ•åŽŸèƒå–物ã€è‚ç´ ã€ç¶ç”Ÿç´ ã€å…¨è¡€æˆ–血液的細胞æˆåˆ†ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">三ã€å°ˆæ¥è¡“語</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">本文件所使用的基本å詞，å¯åƒè€ƒè¡›ç”Ÿç½²å…¬å‘Šä¹‹ã€Œè—¥å“安定性試驗基準ã€ä¹‹ã€Œè¾å½™ã€éƒ¨åˆ†ã€‚å¦å¤–æœ¬æ–‡ä»¶äº¦é™„åŠ ã€Œè¾å½™ã€ï¼Œä»¥åŒ…括使用於生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“ä¸ç‰¹å®šçš„å詞解釋。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å››ã€æ‰¹æ¬¡çš„é¸æ“‡</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（一）藥å“æˆåˆ†</span> <span style="font-family: 新細明體,serif;">（原料藥）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥æ˜¯æ–¼è£½é€ å¾Œï¼Œä½†åœ¨èª¿é…åŠæœ€çµ‚è£½é€ å‰æ‰€å„²å˜çš„å…·è—¥ç†ä½œç”¨çš„活性æˆåˆ†ï¼Œæ‡‰æ供能代表生產è¦æ¨¡ä¹‹è£½é€ åŠå„²å˜æ¢ä»¶ï¼Œè‡³å°‘三批的安定性資料。當原料藥之有效期間為å…個月以上者，於申請查驗登記時，應檢附至少å…個月的安定性資料。有效期間為å…個月以下者，於申請查驗登記時，應æ供之安定性資料，視個案決定。申請時å¯æ供三批試製è¦æ¨¡ä¹‹å®‰å®šæ€§è³‡æ–™ï¼Œä½†æ‡‰æª¢é™„實際生產è¦æ¨¡å‰ä¸‰æ‰¹ä¹‹é•·æœŸå®‰å®šæ€§è©¦é©—計畫書。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">用於安定性試驗計畫的原料藥批次，其å“質è¦èƒ½ä»£è¡¨è‡¨åºŠå‰è©¦é©—åŠè‡¨åºŠè©¦é©—所使用批次的å“質，並代表實際生產è¦æ¨¡è£½é€ çš„å“質。æ¤å¤–，試製è¦æ¨¡è£½é€ 的原料藥應以能代表生產è¦æ¨¡çš„éŽç¨‹åŠå„²å˜æ¢ä»¶åŽ»è£½é€ 。åƒèˆ‡å®‰å®šæ€§è¨ˆç•«çš„原料藥，應儲å˜æ–¼èƒ½é©ç•¶ä»£è¡¨è£½é€ 時實際使用的ä¿å˜å®¹å™¨å…§ï¼Œå¦‚能æ供安定性試驗ä¸ä½¿ç”¨çš„容器，與é 定於生產使用的容器，係相åŒçš„æ料建構åŠåŒæ¨£çš„容器å°è“‹ç³»çµ±ï¼Œå‰‡åŽŸæ–™è—¥ä¹‹å®¹å™¨æ¸›å°æ˜¯å¯æŽ¥å—的。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（二）ä¸é–“產å“</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">於生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“çš„è£½é€ éŽç¨‹ä¸ï¼Œç‰¹å®šä¸é–“物質的å“質åŠç®¡åˆ¶ï¼Œå°æœ€çµ‚產å“çš„è£½é€ ç›¸ç•¶é‡è¦ã€‚ä¸€èˆ¬è€Œè¨€ï¼Œè£½é€ æ¥è€…應鑑別這些ä¸é–“產å“ï¼Œä¸¦å»ºç«‹è‡ªå» çš„æ•¸æ“šåŠè£½ç¨‹é™åˆ¶ï¼Œä»¥ç¢ºä¿å…¶æ–¼ç ”發的製程範åœå…§ä¹‹å®‰å®šæ€§ã€‚雖然å¯ä»¥ä½¿ç”¨è©¦è£½è¦æ¨¡çš„è³‡æ–™ï¼Œä½†è£½é€ æ¥è€…應建立這些資料使用於實際生產è¦æ¨¡çš„é©ç•¶æ€§ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（三）藥å“（最終產å“）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">應æ供至少三批能代表實際生產è¦æ¨¡çš„最終產å“之安定性試驗資料，安定性試驗使用之最終產å“應儘å¯èƒ½ä¾†è‡ªä¸åŒæ‰¹è™Ÿä¹‹åŽŸæ–™è—¥ã€‚有效期間為å…個月以上者，於申請查驗登記時，應檢附至少å…個月的安定性資料。有效期間為å…個月以下者，於申請查驗登記時，應æ供之安定性資料，視個案決定。有效期間應ä¾æ“šæŸ¥é©—登記檢附的實際數據來支æŒï¼Œç”±æ–¼æœ‰æ•ˆæœŸé–“是ä¾æ“šå¯¦éš›æ™‚é–“</span>/<span style="font-family: 新細明體,serif;">實際溫度的數據，所以於審查åŠè©•ä¼°çš„éŽç¨‹ä¸ï¼Œæ‡‰æŒçºŒæ›´æ–°ç”³è«‹æ™‚檢附之安定性試驗資料。用於安定性試驗計畫的最終產å“，其å“質è¦èƒ½ä»£è¡¨è‡¨åºŠå‰è©¦é©—åŠè‡¨åºŠè©¦é©—所使用的å“質。申請查驗登記時，å¯æ供三批試製è¦æ¨¡ä¹‹å®‰å®šæ€§è³‡æ–™ï¼Œä½†æ‡‰æª¢é™„實際生產è¦æ¨¡å‰ä¸‰æ‰¹ä¹‹é•·æœŸå®‰å®šæ€§è©¦é©—計畫書。當實際生產è¦æ ¼è£½é€ çš„è—¥å“ä¸èƒ½ç¬¦åˆä»¥è©¦è£½è¦æ¨¡å»ºç«‹ä¹‹æœ‰æ•ˆæœŸé–“之安定性試驗è¦æ ¼æ™‚，或ä¸èƒ½ä»£è¡¨è‡¨åºŠå‰è©¦é©—åŠè‡¨åºŠè©¦é©—之藥å“時，申請者應採å–é©ç•¶è¡Œå‹•ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（四）樣本é¸æ“‡</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">當藥å“以ä¸åŒçš„å……å¡«é«”ç©ï¼ˆä¾‹å¦‚：</span>1<span style="font-family: 新細明體,serif;">毫å‡ã€</span>2<span style="font-family: 新細明體,serif;">毫å‡ã€æˆ–</span>10<span style="font-family: 新細明體,serif;">毫å‡ï¼‰ã€åŠ‘é‡ï¼ˆä¾‹å¦‚：</span>10<span style="font-family: 新細明體,serif;">å–®ä½ã€</span>20<span style="font-family: 新細明體,serif;">å–®ä½ã€æˆ–</span>50<span style="font-family: 新細明體,serif;">å–®ä½ï¼‰æˆ–é‡é‡ï¼ˆä¾‹å¦‚：</span>1<span style="font-family: 新細明體,serif;">毫克ã€</span>2<span style="font-family: 新細明體,serif;">毫克ã€æˆ–</span>5<span style="font-family: 新細明體,serif;">毫克）銷售時，åƒèˆ‡å®‰å®šæ€§è¨ˆç•«çš„樣本應以矩陣（</span>matrix<span style="font-family: 新細明體,serif;">）系統åŠ</span>/<span style="font-family: 新細明體,serif;">或籃狀（</span>bracketing<span style="font-family: 新細明體,serif;">）的基礎來é¸æ“‡ã€‚矩陣亦å³å®‰å®šæ€§è©¦é©—ç ”ç©¶ä¹‹çµ±è¨ˆè¨è¨ˆï¼Œåœ¨ä¸åŒçš„採樣時間點測試ä¸åŒéƒ¨åˆ†çš„樣本，æ¤æ–¹æ³•åƒ…é©ç”¨æ–¼æœ‰é©ç•¶æ–‡ä»¶è‰æ˜Žï¼Œæ‰€é¸æ“‡æ¸¬è©¦æ¨£æœ¬ä¹‹å®‰å®šæ€§èƒ½ä»£è¡¨æ‰€æœ‰æ¨£æœ¬ä¹‹å®‰å®šæ€§çš„情æ³ã€‚如果相åŒè—¥å“，é¸æ“‡çš„æ¨£æœ¬æœ‰å·®ç•°æ™‚æ‡‰åŠ ä»¥é‘‘åˆ¥ï¼Œä¾‹å¦‚ï¼šåŒ…æ‹¬ä¸åŒçš„批號ã€ä¸åŒçš„強度ã€åŒæ¨£å°è“‹ä½†å°ºå¯¸ä¸åŒã€ä¸åŒçš„容器å°è“‹ç³»çµ±ç‰ã€‚矩陣ä¸èƒ½é©ç”¨æ–¼æ¨£æœ¬å˜åœ¨æœ‰æœƒå½±éŸ¿å®‰å®šæ€§ä¹‹å·®ç•°çš„情æ³ï¼Œä¾‹å¦‚：ä¸åŒçš„強度ã€ä¸åŒçš„容器å°è“‹ç‰ï¼Œæ–¼æ¤ç¨®æƒ…æ³ï¼Œå‰‡ç„¡æ³•ç¢ºèªæ–¼ç›¸åŒçš„儲å˜ç‹€æ³ä¸‹ï¼Œè—¥å“會有相似的å應。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">當相åŒçš„強度åŠç¢ºå¯¦çš„容器å°è“‹ç³»çµ±ï¼Œä½¿ç”¨ä¸‰å€‹ä»¥ä¸Šçš„充填容é‡æ™‚ï¼Œè£½é€ æ¥è€…å¯åªé¸å–最å°åŠæœ€å¤§çš„容器進入安定性計畫ä¸ï¼Œäº¦å³ç±ƒç‹€ï¼ˆ</span>bracketing<span style="font-family: 新細明體,serif;">）試驗。於計畫書的è¨è¨ˆä¸ä½µå…¥ç±ƒç‹€ä¾†å‡å®šæ¥µç«¯æƒ…æ³æ¨£æœ¬çš„安定性能代表ä¸é–“情æ³æ¨£æœ¬çš„安定性。於特定的案例ä¸ï¼Œå¯èƒ½å¿…é ˆæ供資料，以è‰æ˜Žæ¥µç«¯æƒ…æ³æ¨£æœ¬æ‰€å¾—的資料，å¯ä»£è¡¨æ‰€æœ‰çš„樣本。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">五ã€å®‰å®šæ€§è©¦é©—資料</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">整體而言，沒有單一顯示生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“的安定性特徵的分æžæˆ–åƒæ•¸ã€‚é€šå¸¸ï¼Œè£½é€ æ¥è€…應æ出一安定性試驗資料，以ä¿è‰ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“之鑑別ã€ç´”度åŠæ•ˆåƒ¹çš„變化能被測得。申請查驗登記時，申請者應檢附安定性試驗之試驗分æžæ–¹æ³•ç¢ºæ•ˆè³‡æ–™ã€‚安定性應包括何種試驗視藥å“特殊性而定。下列所強調å„é …æ¯‹éœ€å…¨éƒ¨åŒ…å«æ–¼è³‡æ–™ä¸ï¼Œä½†å¯ä»£è¡¨è—¥å“之特性應特別述明，以é©ç•¶åœ°è‰æ˜Žè—¥å“的安定性。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（一）計畫書</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">應包括評估原料藥åŠè—¥å“安定性的詳細計畫書，以支æŒé 定的儲å˜æ¢ä»¶åŠæœ‰æ•ˆæœŸé–“。計畫書ä¸æ‡‰åŒ…括能è‰æ˜Žç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“æ–¼é 定的有效期間內之安定性的所有必需資料，例如：完整定義的è¦æ ¼åŠè©¦é©—間隔。使用的統計方法請åƒç…§ã€Œè—¥å“安定性試驗基準ã€ä¸ä¹‹æ述。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（二）效價</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">當藥å“çš„é 期用途與å¯å®šç¾©åŠå¯æ¸¬é‡çš„生物活性有關時，效價測試應為安定性試驗的一部分。為é”本文件ä¸æ‰€è¿°è—¥å“安定性試驗的目的，效價是藥å“é”到其é 期效應的特定能力，ä¾æ“šæ¸¬é‡è—¥å“的一些特質åŠé©ç•¶çš„定é‡æ–¹æ³•ä¾†æ¸¬å®šã€‚一般而言，ä¸åŒå¯¦é©—室所作的效價試驗，如以相å°æ–¼é©ç•¶å°ç…§æ¨™æº–å“çš„æ–¹å¼è¡¨é”，å³å¯æœ‰æ„義地進行比較，基於æ¤ç›®çš„，試驗應包括å°ç…§æ¨™æº–å“直接或間接與相當於國家或國際標準å“é€²è¡Œæ ¡æ£ä¹‹çµæžœã€‚效價試驗應ä¾è¨ˆç•«æ›¸æ‰€å®šçš„é©ç•¶é–“隔進行，其çµæžœæ‡‰å„˜å¯èƒ½çš„用國家或國際èªå®šçš„標準å“æ ¡æ£éŽçš„生物活性單ä½è¨˜éŒ„。當無國家或國際å°ç…§æ¨™æº–å“å˜åœ¨æ™‚，分æžçµæžœå¯ä»¥ç”¨è‡ªå» 以特性明確的å°ç…§æ¨™æº–å“所得之單ä½è¨˜éŒ„。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">æŸäº›ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“，效價需視活性æˆåˆ†æŽ¥åˆè‡³å¦ä¸€çµ„æˆæˆ–與ä½åŠ‘<span style="background: yellow;">éµ</span>çµè€Œå®šã€‚活性æˆåˆ†è‡ªæŽ¥åˆç‰©æˆ–ä½åŠ‘的載體ä¸åˆ†é›¢æ•ˆæžœï¼Œæ‡‰ä»¥å¯¦éš›æ™‚é–“</span>/<span style="font-family: 新細明體,serif;">å¯¦éš›æº«åº¦ç ”ç©¶ä¾†èª¿æŸ¥ï¼ˆåŒ…æ‹¬é‹é€æ¢ä»¶ï¼‰ã€‚å°æ¤ç¨®è—¥å“çš„è©•ä¼°å¯èƒ½æœ‰äº›å›°é›£ï¼ŒæŸäº›ä¾‹åä¸ï¼Œç”Ÿç‰©æ´»æ€§åŠç‰©åŒ–特徵的體外測試並ä¸å¯¦ç”¨æˆ–æä¾›ä¸æº–確的çµæžœã€‚é©ç•¶çš„方法或使用é©ç•¶çš„替代測試，應考慮克æœé«”外測試的ä¸é©ç•¶æ€§ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（三）純度與分å特徵</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">為é”本文件所述藥å“安定性試驗的目的，純度是一種相å°çš„åè©žã€‚å› é†£åŒ–ä½œç”¨ã€åŽ»é†¯æ°¨ä½œç”¨åŠç•°è³ªæ€§çš„影響，使得生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“的絕å°ç´”度很難測定，所以其純度通常需è¦ç”¨ä¸€ç¨®ä»¥ä¸Šçš„æ–¹æ³•åŠ ä»¥è©•ä¼°ï¼Œä¸”ç´”åº¦å€¼èˆ‡ä½¿ç”¨çš„æ–¹æ³•ç›¸é—œã€‚åŸºæ–¼å®‰å®šæ€§è©¦é©—çš„ç›®çš„ï¼Œç´”åº¦æ¸¬è©¦æ‡‰è‘—é‡æ–¼æ¸¬å®šé€€åŒ–è—¥å“的方法。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">進入安定性試驗之生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“，應記錄其純度ã€é€€åŒ–è—¥å“個別的é‡åŠç¸½é‡ã€‚å¯æŽ¥å—的退化é™é‡ã€æ‡‰å¾—自使用於臨床å‰åŠè‡¨åºŠè©¦é©—的原料藥åŠè—¥å“批號之分æžè³‡æ–™ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">使用相關的物化ã€ç”ŸåŒ–åŠå…疫化å¸çš„分æžæ–¹æ³•ï¼Œæ‡‰èƒ½å°åŽŸæ–™è—¥åŠè—¥å“作詳細的特徵æ述（例如：分å大å°ã€é›»è·ã€å¿Œæ°´æ€§ï¼‰ï¼ŒåŠæº–確åµæ¸¬å‡ºæ–¼å„²å˜æœŸé–“å› åŽ»é†¯æ°¨ä½œç”¨ã€æ°§åŒ–作用ã€ç¡«åŸºæ°§åŒ–ã€å‡é›†æˆ–åˆ†è£‚æ‰€é€ æˆçš„退化改變，例如：有用的方法包括：電泳ã€é«˜åˆ†è¾¨åŠ›è‰²å±¤åˆ†æžåŠå¤šèƒœè‚½åœ–èœç‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">當長期ã€åŠ 速åŠ</span>/<span style="font-family: 新細明體,serif;">或壓力安定性試驗ä¸ï¼Œåµæ¸¬å‡ºæœ‰æ˜Žé¡¯çš„質åŠé‡çš„改變，顯示退化藥å“å½¢æˆï¼Œæ‡‰æ–¼é•·æœŸå®‰å®šæ€§è¨ˆç•«ä¸ï¼Œè€ƒæ…®æ¤é€€åŒ–è—¥å“å¯èƒ½é€ æˆçš„å±å®³ï¼ŒåŠå°å…¶ç‰¹å¾µæè¿°åŠå®šé‡çš„å¿…è¦æ€§ã€‚應æ出並驗è‰å¯æŽ¥å—çš„é™é‡ï¼Œä¸¦è€ƒé‡è‡¨åºŠå‰åŠè‡¨åºŠè©¦é©—使用之藥å“產生的程度。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å°ç„¡æ³•é©ç•¶æ述其特徵的物質或以例行性的分æžæ–¹æ³•ç„¡æ³•æ£ç¢ºåˆ†æžå…¶ç´”度的藥是，申請者應æ出並驗è‰æ›¿ä»£çš„試驗程åºã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（四）其他藥å“特徵</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">於最終容器內的下列藥å“特徵，雖然並éžç‰¹åˆ¥èˆ‡ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“有關，但ä»æ‡‰åŠ 以監視åŠè¨˜éŒ„：</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">è—¥å“å¯è¦‹çš„外觀（溶液</span>/<span style="font-family: 新細明體,serif;">懸浮液的é¡è‰²åŠä¸é€æ˜Žåº¦ã€é¡è‰²ã€è³ªåœ°åŠç²‰æœ«çš„溶解時間）ã€æº¶æ¶²æˆ–粉末或親水性å‡å¡Šé‡çµ„後å¯è¦‹çš„顆粒ã€é…¸é¹¼å€¼åŠç²‰æœ«åŠ<span style="background: yellow;">親</span>水性藥å“的水分程度。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">最少應在é 定儲架期間的開始åŠçµæŸæ™‚實施無èŒæ¸¬è©¦æˆ–替代的測試（例如：容器</span>/<span style="font-family: 新細明體,serif;">å°è“‹çš„完整性測試）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">æ·»åŠ ç‰©ï¼ˆä¾‹å¦‚ï¼šå®‰å®šåŠ‘ã€é˜²è…劑）åŠè³¦å½¢åŠ‘於藥å“註明的期間內å¯èƒ½æœƒé€€åŒ–，如果於åˆæœŸå®‰å®šæ€§è©¦é©—ä¸ï¼Œé¡¯ç¤ºæ¤é¡žç‰©è³ªçš„å應或退化，會å°è—¥å“çš„å“質產生ä¸åˆ©çš„影響時，則應在安定性計畫ä¸å°é€™äº›é …ç›®åŠ ä»¥ç›£è¦–ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">容器</span>/<span style="font-family: 新細明體,serif;">å°è“‹ä¹Ÿæœ‰å¯èƒ½å°è—¥å“é€ æˆä¸åˆ©çš„影響，應å°å…¶è¬¹æ…Žè©•ä¼°ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å…ã€å„²å˜æ¢ä»¶</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（一）溫度</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å› å¤§å¤šæ•¸æœ€çµ‚ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“å¿…é ˆç¢ºå¯¦ç•Œå®šå„²å˜çš„溫度，所以實際時間</span>/<span style="font-family: 新細明體,serif;">實際溫度的安定性試驗，其儲å˜æ¢ä»¶æ‡‰ç‚ºé 定的儲å˜æº«åº¦ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（二）濕度</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“一般å‡ä»¥èƒ½å°æŠ—濕度的容器包è£éŠ·å”®ï¼Œæ‰€ä»¥ç•¶èƒ½è‰æ˜Žé 定的容器（åŠå„²å˜æ¢ä»¶ï¼‰èƒ½æ–¼é«˜æ¿•åº¦åŠä½Žæ¿•åº¦çš„安定性試驗ä¸ï¼Œæ供藥å“è¶³å¤ çš„ä¿è·ï¼Œå‰‡æ–¼ä¸åŒçš„相å°æ¿•åº¦ä¸‹çš„安定性試驗å¯ä»¥çœç•¥ã€‚當未使用能å°æŠ—濕度的容器時，則應æä¾›é©ç•¶çš„安定性資料。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">ï¼ˆä¸‰ï¼‰åŠ é€Ÿèˆ‡å£“åŠ›æ¢ä»¶</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">有效期間應ä¾æ“šå¯¦éš›æ™‚é–“</span>/<span style="font-family: 新細明體,serif;">實際溫度的資料來制定，但建è°æ‡‰é€²è¡ŒåŽŸæ–™è—¥åŠè—¥å“åœ¨åŠ é€ŸåŠå£“力æ¢ä»¶ä¸‹ä¹‹ç ”ç©¶ã€‚æ–¼åŠ é€Ÿæƒ…æ³ä¸‹çš„ç ”ç©¶ï¼Œèƒ½æ供制定有效期間的有用ä½è‰è³‡æ–™ã€æ供藥å“安定性資料以供未來藥å“ç ”ç™¼ï¼ˆä¾‹å¦‚ï¼šè™•æ–¹ã€è£½é€ è¦æ¨¡ç‰è£½é€ 改變時的先期評估）ã€å¹«åŠ©ç¢ºæ•ˆå®‰å®šæ€§è¨ˆç•«çš„分æžæ–¹æ³•æˆ–產生幫助闡明原料藥或藥å“的退化情æ³çš„資料。於壓力情æ³ä¸‹çš„ç ”ç©¶ï¼Œå¯ç”¨æ–¼æ±ºå®šæ„外暴露於éžé 定的æ¢ä»¶ä¸‹ï¼ˆä¾‹å¦‚：é‹é€éŽç¨‹ï¼‰æ™‚，是å¦æœƒå°è—¥å“é€ æˆå±å®³ï¼Œä»¥åŠè©•ä¼°ä½•ç¨®ç‰¹å®šæ¸¬è©¦åƒæ•¸å¯ä½œç‚ºè—¥å“安定性的最佳指標。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">原料藥或藥å“暴露於極端æ¢ä»¶ä¸‹çš„ç ”ç©¶æœ‰åŠ©æ–¼é¡¯ç¤ºé€€åŒ–çš„æ¨¡å¼ï¼Œå¦‚果如æ¤ï¼Œåœ¨é 定的儲å˜æ¢ä»¶ä¸‹ï¼Œæ‡‰å°æ¤ç¨®æ”¹è®Šé€²è¡Œç›£è¦–。雖然在「藥å“安定性試驗基準ã€ä¸ï¼Œæœ‰å°åŠ 速åŠå£“åŠ›ç ”ç©¶åŠ ä»¥æ述，但申請者應注æ„這些æ¢ä»¶å¯èƒ½ä¸é©ç”¨æ–¼ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“，而應以個案來決定儲å˜çš„æ¢ä»¶ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（四）光度</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">應以個案來決定試驗的è¦ç¯„。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（五）容器</span>/<span style="font-family: 新細明體,serif;">å°è“‹</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">調é…好之生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“，å¯èƒ½å› 與容器</span>/<span style="font-family: 新細明體,serif;">å°è“‹çš„相互åæ‡‰ï¼Œè€Œé€ æˆè—¥å“å“質的改變。液狀藥å“（éžå°è“‹çš„安瓿）無法排除æ¤ç¨®äº¤äº’å應時，安定性試驗應包括ä¿æŒæ–¼å轉或水平ä½ç½®ï¼ˆäº¦å³èˆ‡å°è“‹æŽ¥è§¸ï¼‰åŠåž‚ç›´ä½ç½®çš„樣å“，以決定å°è“‹å°è—¥å“å“質的影響。應æä¾›å³å°‡ä¸Šå¸‚之所有ä¸åŒçš„容器</span>/<span style="font-family: 新細明體,serif;">å°è“‹çµ„åˆçš„資料。除了傳統單次使用的å°ç“¶æ‰€å¿…需的標準資料外，申請者應è‰æ˜Žå¤šåŠ‘é‡ç“¶çš„å°è“‹ï¼Œæ–¼æœ€é•·ä¿å˜æœŸé™å…§ï¼Œèƒ½è€å—é‡è¤‡çš„æ’å…¥åŠæŠ½å‡ºï¼Œä»¥ä¿æŒå…¶å®Œæ•´çš„效價ã€ç´”度åŠå“質。並於容器ã€åŒ…è£åŠ</span>/<span style="font-family: 新細明體,serif;">或仿單ä¸è¿°æ˜Žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（å…）冷å‡ä¹¾ç‡¥è—¥å“åœ¨æ‘»åŠ æº¶åŠ‘å¾Œçš„å®‰å®šæ€§</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">冷å‡ä¹¾ç‡¥è—¥å“åœ¨æ‘»åŠ æº¶åŠ‘å¾Œçš„å®‰å®šæ€§ï¼Œæ‡‰è‰æ˜Žå…¶æ¢ä»¶åŠæœ€å¤§çš„有效期間。並於容器ã€åŒ…è£åŠ</span>/<span style="font-family: 新細明體,serif;">或仿單ä¸è¿°æ˜Žã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">七ã€è©¦é©—é–“éš”</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">當é 定的儲架期為一年或少於一年時，實際時間之安定性試驗，於å‰ä¸‰å€‹æœˆæ‡‰ä»¥æ¯æœˆä¸€æ¬¡çš„æ–¹å¼ï¼Œè€Œå¾Œæ‡‰ä»¥æ¯ä¸‰å€‹æœˆä¸€æ¬¡çš„æ–¹å¼å¯¦æ–½ã€‚å°é 定的儲架期為一年以上的藥å“，安定性試驗在第一年應以æ¯ä¸‰å€‹æœˆä¸€æ¬¡ï¼Œç¬¬äºŒå¹´æ‡‰ä»¥æ¯å…個月一次，以後æ¯å¹´ä¸€æ¬¡çš„æ–¹å¼å¯¦æ–½ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">上述的試驗間隔é©ç”¨æ–¼ç”³è«‹æŸ¥é©—ç™»è¨˜çš„éšŽæ®µï¼Œä½†åœ¨æ ¸ç™¼è¨±å¯è‰å¾Œï¼Œå¦‚有資料å¯ç”¨ä»¥è‰æ˜Žé©ç•¶çš„安定性，則å¯é©ç•¶çš„減少測試次數。當已有資料顯示藥å“的安定性無æ時，申請者å¯æ交計畫書，以支æŒæ–¼æ ¸å‡†ä¸Šå¸‚後，延長長期安定性試驗之試驗間隔（例如æ¯ä¹å€‹æœˆå¯¦æ–½ä¸€æ¬¡ï¼‰ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å…«ã€è¦æ ¼</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">雖然生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“易發生失去活性ã€ç‰©ç†åŒ–å¸æ€§è³ªæ”¹è®Šæˆ–儲å˜æœŸé–“的退化，但相關的è¦ç¯„或指引å»å¾ˆå°‘。å°æŸä¸€ç¨®é¡žæˆ–類型的生物技術</span>/<span style="font-family: 新細明體,serif;">生物性藥å“，其最大å¯æŽ¥å—之活性æµå¤±é‡ã€ç‰©ç†åŒ–å¸æ€§è³ªæ”¹è®Šçš„é™é‡æˆ–é 期儲架期é™å…§çš„退化ç‰çš„建è°äº‹é …尚未被制定出來，ä»æ‡‰ä»¥å€‹æ¡ˆä¾†è€ƒé‡ã€‚æ¯å€‹è—¥å“在é 期儲架期é™å…§ï¼Œå‡æ‡‰ç¶æŒå…¶è¦æ ¼æ–¼æ‰€åˆ¶å®šæœ‰é—œå®‰å…¨æ€§ã€ç´”度和效價ç‰ä¹‹é™é‡ç¯„åœå…§ã€‚這些è¦æ ¼åŠé™é‡æ‡‰ä»¥é©ç•¶çš„統計方法分æžè³‡è¨Šè€Œä¾†ã€‚å°æ–¼æ”¾è¡ŒåŠæœ‰æ•ˆæœŸé–“使用ä¸åŒè¦æ ¼æ™‚ï¼Œæ‡‰ç”¨è¶³å¤ çš„è³‡æ–™ä¾†ä½è‰ï¼Œä»¥è‰æ˜Žè—¥å“的臨床功能並未å—到影響。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">ä¹ã€æ¨™ç¤º</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å°å¤§å¤šæ•¸ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性原料藥åŠè—¥å“而言，應確實闡明儲å˜çš„溫度。特定的建è°äº‹é …æ‡‰åŠ ä»¥é™³è¿°ï¼Œå°¤å…¶æ˜¯ç„¡æ³•è€å—冷è—的原料藥åŠè—¥å“。上述的情æ³åŠé©ç•¶çš„é¿å…‰åŠ</span>/<span style="font-family: 新細明體,serif;">或濕度的建è°äº‹é …，應標示於容器ã€åŒ…è£åŠ</span>/<span style="font-family: 新細明體,serif;">或仿單ä¸ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">åã€è¾å½™</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（一）接åˆè—¥å“（</span>Conjugated Product<span style="font-family: 新細明體,serif;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">接åˆè—¥å“走出一種活性æˆåˆ†ï¼ˆä¾‹å¦‚：胜肽ã€é†£é¡žï¼‰ç”¨å…±åƒ¹éµæˆ–éžå…±åƒ¹éµèˆ‡ä¸€è¼‰é«”（例如：蛋白質ã€èƒœè‚½ã€ç„¡æ©Ÿç¤¦ç‰©è³ªï¼‰çµåˆæ‰€çµ„æˆçš„è—¥å“，其目的在改善藥å“的效能或安定性。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（二）退化產å“（</span>Degradation Product<span style="font-family: 新細明體,serif;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">è—¥å“æˆåˆ†ï¼ˆåŽŸæ–™è—¥ï¼‰å› éŽæœŸè€Œå°Žè‡´çµ„æˆçš„改變稱之。æ¤ç¨®è®ŠåŒ–å¯å› åŠ å·¥æˆ–å„²å˜æ‰€é€ æˆï¼ˆä¾‹å¦‚：去醯氨作用ã€æ°§åŒ–ã€å‡é›†ã€è›‹ç™½æ°´è§£ï¼‰ï¼Œå°ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“而言，æŸäº›é€€åŒ–è—¥å“ä»å…·æœ‰æ´»æ€§ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（三）ä¸ç´”物（</span>Impurity<span style="font-family: 新細明體,serif;">）</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">è—¥å“æˆåˆ†ï¼ˆåŽŸæ–™è—¥ï¼‰æˆ–è—¥å“（最終產å“）ä¸éžå®šç¾©ç‚ºè—¥å“æˆåˆ†ã€è³¦å½¢åŠ‘或其他藥å“æ·»åŠ ç‰©ä¹‹åŒ–å¸å¯¦é«”的任何æˆåˆ†ã€‚</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">（四）ä¸é–“產å“（</span>Intermediate<span style="font-family: 新細明體,serif;">）</span><span> </span></p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; margin: 0cm 0cm 9pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å°ç”Ÿç‰©æŠ€è¡“</span>/<span style="font-family: 新細明體,serif;">生物性藥å“而言，ä¸é–“產å“ä¿‚æŒ‡æ–¼è£½é€ éŽç¨‹ä¸ï¼Œéžè—¥å“æˆåˆ†æˆ–è—¥å“ï¼Œä½†å…¶è£½é€ å°è—¥å“æˆåˆ†æˆ–è—¥å“çš„æˆåŠŸè£½é€ éžå¸¸é‡è¦çš„物質。一般而言，ä¸é–“產å“å¿…éœ€åŠ ä»¥å®šé‡åŠåˆ¶å®šè¦æ ¼ï¼Œä½¿åœ¨ç¹¼çºŒè£½é€ éŽç¨‹å‰ï¼Œèƒ½æ±ºå®šæ˜¯å¦æˆåŠŸå®Œæˆè©²è£½é€ æ¥é©Ÿã€‚ä¸é–“產å“包括已進行進一æ¥åˆ†å修飾，或在進一æ¥åŠ å·¥å‰èƒ½é•·æ™‚é–“ä¿å˜çš„物質。</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char;"><span style="font-family: 新細明體,serif;">å一ã€åƒè€ƒæ–‡ç»</span> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char; 19: ;">l. Imitational Conference on Harmonization <span style="font-family: 新細明體,serif;">（</span>1995<span style="font-family: 新細明體,serif;">）</span>. Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products.</p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 23pt; layout-grid-mode: char; 19: ;">2. <span style="font-family: 新細明體,serif;">衛生署</span>89.7.22.<span style="font-family: 新細明體,serif;">衛署藥å—第</span>87041838<span style="font-family: 新細明體,serif;">號公告：「藥å“安定性試驗基準ã€ã€‚</span> </p>2013-12-05
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,è—¥å“å§”è¨—è£½é€ å¯¦æ–½è¦é»žè¡Œæ”¿è§£é‡‹è—¥å“å§”è¨—è£½é€ å¯¦æ–½è¦é»ž<p style="text-align: center;"><span style="font-family: 新細明體,serif;">è—¥å“å§”è¨—è£½é€ å¯¦æ–½è¦é»ž</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">一ã€è¡Œæ”¿é™¢è¡›ç”Ÿç½²ï¼ˆä»¥ä¸‹ç°¡ç¨±æœ¬ç½²ï¼‰ç‚ºä¿ƒé€²è—¥æ¥æ•´é«”發展åŠé…åˆåŠ 強生物技術產æ¥æŽ¨å‹•æ–¹æ¡ˆä¹‹åŸ·è¡Œï¼Œä¸¦è¦ç¯„è—¥å“ä¹‹å§”è¨—è£½é€ ï¼Œç‰¹è¨‚å®šæœ¬è¦é»žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“ä¹‹å§”è¨—è£½é€ æ‡‰ä¾æœ¬è¦é»žåŠå…¶ä»–法令之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æœ¬è¦é»žæ‰€ç¨±ä¹‹å§”è¨—è£½é€ ï¼ŒåŒ…æ‹¬è—¥å“ä¹‹åˆ†æ®µæˆ–å…¨ç¨‹è£½é€ ã€åˆ†è£åŠåŒ…è£ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本è¦é»žæ‰€ç¨±å§”è¨—è£½é€ ï¼Œä¿‚æŒ‡å§”è¨—è€…ä¹‹æŸå–®ä¸€ç”¢å“基於產能ã€ç”¢é‡ã€ç‰¹æ®Šè£½é€ 技術åŠå…¶ä»–å› ç´ ä¹‹è€ƒé‡ï¼Œå°‡ç”¢å“在製程ä¸ä¹‹æŸä¸€éšŽæ®µæˆ–é€£çºŒéšŽæ®µæˆ–å…¨ç¨‹å§”è¨—ä»–å» è£½é€ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å‡¡æŒæœ‰è—¥å“許å¯è‰ä¹‹è—¥å•†ï¼Œæ–¼è©²è¨±å¯è‰æœ‰æ•ˆæœŸé™å…§ï¼Œæˆ–申請藥å“查驗登記之藥商，å‡å¯ä¾æ“šæœ¬è¦é»žï¼Œç¶“æœ¬ç½²æ ¸å‡†å¾Œï¼Œå°‡ç”¢å“委託經評定為已實施優良藥å“è£½é€ æ¨™æº–ä¹‹è—¥å» è£½é€ ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本è¦é»žå°æ–°ç”³è«‹è—¥å“查驗登記准用之。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åˆ†æ®µå§”è¨—è£½é€ ä¹‹è—¥å“製程範åœæ‡‰ä¾æœ¬ç½²èªå®šç‚ºæº–。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è—¥å“å§”è¨—è£½é€ æ‡‰ç”±å§”è¨—è€…å…ˆè¡Œè¦“å¦¥å—å§”è¨—è—¥å» ï¼Œç”±å§”è¨—è€…å¡«å…·ç”³è«‹æ›¸ï¼Œæª¢åŒé›™æ–¹ç°½è¨‚ä¹‹å§”è¨—è£½é€ æ›¸é¢å¥‘ç´„ç‰ç›¸é—œæ–‡ä»¶ï¼Œç”³è«‹æœ¬ç½²æ ¸è¾¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ç¶“æ ¸å‡†å§”è¨—è£½é€ ä¹‹è—¥å“，除法律å¦æœ‰è¦å®šå¤–，其產å“è²¬ä»»æ‡‰ç”±å§”è¨—è€…è² è²¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€ç¶“æ ¸å‡†å§”è¨—è£½é€ ä¹‹è—¥å“其標籤ã€ä»¿å–®åŠåŒ…è£é™¤ä¾è—¥äº‹æ³•æœ‰é—œè¦å®šè¾¦ç†å¤–，並應分別刊載å—å§”è¨—è—¥å» ä¹‹å» åã€åœ°å€åŠå§”託者å稱ã€åœ°å€ï¼Œä¸¦åˆ†åˆ¥æ¨™ç¤ºè£½é€ å» åŠå§”è¨—è£½é€ è€…å—æ¨£ï¼Œç„¡é ˆè¾¦ç†è—¥å“æŸ¥é©—ç™»è¨˜é …ç›®ä¹‹è®Šæ›´ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€ç¶“æ ¸å‡†å§”è¨—è£½é€ ä¹‹è—¥å“許å¯è‰ï¼Œå…¶æœ‰æ•ˆæœŸå±†æ»¿ä¹‹å±•å»¶ï¼Œæ‡‰ç”±è¨±å¯è‰æŒæœ‰äººä¾è—¥äº‹æ³•è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€å§”è¨—è£½é€ å¥‘ç´„æœ‰æ•ˆæœŸé–“å±†æ»¿ä¸å†çºŒç´„æˆ–å› æ•…ä¸é€”解約時，委託者應覓妥其他å—å§”è¨—è—¥å» ï¼Œé‡æ–°ä¾è¦å®šç”³è«‹å§”è¨—è£½é€ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—視作æ¥éœ€è¦ï¼Œå§”託相關公ã€å”會或團體辦ç†ã€‚</span> </p>2013-12-05
臨床試驗類,è—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„行政解釋藥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4557&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤è—¥å“查驗登記審查準則<p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則ä¾è—¥äº‹æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第三åä¹æ¢ç¬¬å››é …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“之查驗登記與許å¯è‰ä¹‹è®Šæ›´ã€ç§»è½‰ã€å±•å»¶ç™»è¨˜åŠæ±¡æ或éºå¤±ä¹‹æ›ç™¼æˆ–補發，ä¾æœ¬æº–則之è¦å®šï¼›æœ¬æº–則未è¦å®šè€…，ä¾å…¶ä»–有關法令åŠä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請å‰æ¢å„類登記，應繳ç´è²»ç”¨ï¼Œä¸¦å¡«å…·ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè¦å®šä¹‹ç”³è«‹æ›¸è¡¨æ ¼å¼åŠæª¢é™„應備資料，é€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …æ‰€ç¨±ä¹‹ç”³è«‹æ›¸è¡¨æ ¼å¼ï¼ŒåŒ…括藥å“查驗登記申請書ã€è®Šæ›´ç™»è¨˜ç”³è«‹æ›¸ã€è¨±å¯è‰æœ‰æ•ˆæœŸé–“展延申請書ã€åˆ‡çµæ›¸ã€å¤–盒仿單標籤é»è²¼è¡¨ã€è‰ç…§é»è²¼è¡¨åŠå…¶ä»–與申請程åºæœ‰é—œä¹‹æ›¸è¡¨æ ¼å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">本準則所稱ä¸æ–‡ï¼Œä¿‚指ç¹é«”ä¸æ–‡ã€‚填寫申請書表或檢附之資料如係ä¸æ–‡è€…，應使用ç¹é«”ä¸æ–‡æˆ–附ç¹é«”ä¸æ–‡è¯æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">西藥</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">通則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« ç”¨è©žå®šç¾©å¦‚ä¸‹ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ–°è—¥ï¼šæŒ‡æœ¬æ³•ç¬¬ä¸ƒæ¢æ‰€ç¨±ä¹‹æ–°è—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¸åè—¥ï¼šæŒ‡èˆ‡åœ‹å…§å·²æ ¸å‡†ä¹‹è—¥å“å…·åŒæˆåˆ†ã€åŒåŠ‘åž‹ã€åŒåŠ‘é‡ã€åŒç™‚效之製劑。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç”Ÿç‰©è—¥å“：指ä¾æ“šå¾®ç”Ÿç‰©å¸ã€å…ç–«å¸å¸ç†è£½é€ 之血清ã€æŠ—æ¯’ç´ ã€ç–«è‹—ã€é¡žæ¯’ç´ åŠèŒæ¶²ç‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸæ–™è—¥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è—¥å“有效æˆåˆ†</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">：指一種經物ç†ã€åŒ–å¸è™•ç†æˆ–生物技術éŽç¨‹è£½é€ 所得具藥ç†ä½œç”¨ä¹‹æ´»æ€§ç‰©æˆ–æˆåˆ†ï¼Œå¸¸ç”¨æ–¼è—¥å“ã€ç”Ÿç‰©è—¥å“或生物技術產å“ä¹‹è£½é€ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ ¸é†«æ”¾å°„性藥å“：指符åˆæœ¬æ³•ç¬¬å…æ¢æ‰€ç¨±è—¥å“之定義，並係以具有放射活度之物質使用於人體內，經體內分佈之後，å¯è¢«ç”¨ä¾†è¨ºæ–·ã€ç›£æ¸¬ã€æ²»ç™‚ã€ç·©è§£ç–¾ç—…或具其他醫療效能之藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±å§”è¨—æ›¸ï¼Œä¿‚æŒ‡è¼¸å…¥è—¥å“ä¹‹åœ‹å¤–è£½é€ å» æˆ–å…¶ç¸½å…¬å¸ã€æˆ–國外許å¯è‰æŒæœ‰è€…所出具之授權登記è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …委託書é™å‡ºå…·æ—¥èµ·ä¸€å¹´å…§æœ‰æ•ˆï¼Œä¸”å…§å®¹æ‡‰è¼‰æ˜Žè£½é€ å» åŠä»£ç†å•†ä¹‹å稱ã€åœ°å€ï¼Œèˆ‡è—¥å“å稱ã€åŠ‘åž‹åŠå«é‡ï¼Œä¸¦å…¶è¨˜è¼‰æ‡‰èˆ‡ç”³è«‹æ›¸ç›¸ç¬¦ã€‚如委託書éžä¸æ–‡æˆ–英文者，應附ä¸æ–‡æˆ–英文è¯æœ¬ã€‚如æŒæœ‰å‡ºç”¢åœ‹è—¥å“è£½é€ è¨±å¯è‰ä¹‹è£½é€ å» æ–¼ä¸è¯æ°‘國境內</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱國內</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¨æœ‰åˆ†å…¬å¸è€…ï¼Œå…¶å§”è¨—æ›¸å¾—ç”±è©²è£½é€ å» ä¹‹ç¸½å…¬å¸æˆ–è¨æ–¼äºžæ´²ä¹‹ç¸½éƒ¨å‡ºå…·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žï¼Œä¿‚指出產國最高衛生主管機關出具之許å¯è£½é€ åŠå‡†åœ¨è©²åœ‹è‡ªç”±è²©è³£ä¹‹è‰æ˜Žæ–‡ä»¶æ£æœ¬ï¼Œä¸”符åˆä¸‹åˆ—è¦å®šè€…：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ‡‰æª¢é™„之è‰æ˜Žæ–‡ä»¶å¦‚éžä¸æ–‡æˆ–英文者，應å¦é™„ä¸æ–‡æˆ–英文è¯æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é™å‡ºå…·æ—¥èµ·äºŒå¹´å…§æœ‰æ•ˆï¼Œä¸¦æ‡‰ç¶“ä¸è¯æ°‘國é§å¤–ä½¿é ˜é¤¨ã€ä»£è¡¨è™•ã€è¾¦äº‹è™•æˆ–外交部授權之é§å¤–機構（以下簡稱我國é§å¤–館處）簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¨˜è¼‰ä¹‹ç”¢å“å稱ã€è£½é€ å» å稱ã€åœ°å€åŠè™•æ–¹å…§å®¹ã€åŠ‘åž‹ã€å«é‡ï¼Œæ‡‰èˆ‡ç”³è«‹æ›¸ç›¸ç¬¦ã€‚其產å“å稱應刊載外銷å“å於許å¯è£½å”®è‰æ˜Žä¸Šï¼›æœªèƒ½åˆŠè¼‰è€…ï¼Œæ‡‰æœ‰åŽŸå» å‡½èªªæ˜Žæœªèƒ½åˆŠè¼‰ä¹‹ç†ç”±åŠå…¶å¤–銷å“å，並說明除å“å外，其餘內容å‡èˆ‡è¨±å¯è£½å”®è‰æ˜Žæ‰€åˆŠè¼‰è€…ç›¸ç¬¦ã€‚å¦‚ä¿‚è† å›ŠåŠ‘è€…ï¼Œé™¤æ‡‰è¼‰æ˜Žå…¶å…§å®¹ç‰©ä¹‹å…¨è™•æ–¹å¤–ï¼Œè»Ÿè† å›Šæ‡‰è¼‰æ˜Žè»Ÿè† å›Šæ®¼ä¹‹å…¨è™•æ–¹ï¼Œç¡¬è† å›Šæ‡‰è¼‰æ˜Žè† å›Šæ®¼ä¹‹è‰²ç´ å稱；其製售è‰æ˜Žç„¡æ³•è¼‰æ˜Žç¡¬è† å›Šæ®¼ä¹‹è‰²ç´ åç¨±è€…ï¼Œæ‡‰ä»¥åŽŸå» å‡½èªªæ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å…¶å…§å®¹æ‡‰è¼‰æ˜Žè©²è—¥å“ä¹‹è£½é€ å» åŠå‡†åœ¨è©²åœ‹è‡ªç”±è²©å”®ï¼Œä¸”è¨˜è¼‰ä¹‹è£½é€ åŠè²©å”®æƒ…形應明確。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …出產國許å¯è£½å”®è‰æ˜Žï¼Œå¾—以下列文件替代之：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹è²©å”®åœ‹æ ¸å‡†è²©å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç”³è«‹ä¹‹è—¥å“係列載於美國藥典藥物資（</span><span style="font-family: calibri;">UnitedStatesPharmacop-</span></p><p><span style="font-family: calibri;"> eia Drug Information</span><span style="font-family: 新細明體,serif;">ï¼›</span><span style="font-family: calibri;">USPDI</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">ã€æˆ–美國食å“藥物管ç†å±€ï¼ˆä»¥ä¸‹ç°¡ç¨±ç¾Žåœ‹</span><span style="font-family: calibri;"> FDA</span><span style="font-family: 新細明體,serif;">）出版之處方藥å“æ ¸å‡†å冊</span><span style="font-family: calibri;"> Approved Prescription Dr-ug Product With Therapeutic Equivalence Evaluations</span><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">OrangeBook</span><span style="font-family: 新細明體,serif;">）者，得影å°åˆŠè¼‰ä¹‹é 數或其網路版或電åæ›¸ç‰ˆï¼Œä¸¦æª¢é™„ç¾Žåœ‹å·žæ”¿åºœè¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç™¼ä¹‹è¨±å¯è£½å”®è‰æ˜Žï¼Œæ›¿ä»£ç¾Žåœ‹</span><span style="font-family: calibri;"> FDA </span><span style="font-family: 新細明體,serif;">出具之許å¯è£½å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“出產國係德國者，其許å¯è£½å”®è‰æ˜Žå¾—由德國邦政府衛生主管機關出具，å…å…¶è¯é‚¦æ”¿åºœç°½ç« 。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥å“出產國係ææ´²è¯ç›Ÿï¼ˆ</span><span style="font-family: calibri;">European Union</span><span style="font-family: 新細明體,serif;">，以下簡稱æ盟）會員國之一者，得以æ盟藥å“å¯©æ ¸æ©Ÿé—œ</span><span style="font-family: calibri;"> European Medicinal Agency</span><span style="font-family: 新細明體,serif;">（以下簡稱</span><span style="font-family: calibri;"> EMA</span><span style="font-family: 新細明體,serif;">ï¼‰å‡ºå…·æ ¸å‡†è£½å”®è‰æ˜Žæ›¿ä»£ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è¼¸å…¥è—¥å“ä¿‚å§”è¨—è£½é€ ä¸”æœªæ–¼å—è¨—è£½é€ å» æ‰€åœ¨åœ‹å®¶ä¸Šå¸‚è€…ï¼Œå¾—ä»¥å§”è¨—è€…æ‰€åœ¨åœ‹å‡ºå…·è‡ªç”±è²©è³£è‰æ˜ŽåŠå—è¨—è£½é€ å» æ‰€åœ¨åœ‹å‡ºå…·è£½é€ è‰æ˜Žæ›¿ä»£ä¹‹ï¼Œæˆ–ä»¥å§”è¨—è€…æ‰€åœ¨åœ‹å‡ºå…·æœ‰è¼‰æ˜Žè£½é€ å» åã€å» å€ä¹‹è‡ªç”±è²©è³£è‰æ˜Žæ›¿ä»£ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …替代文件內容åŠå‡ºç”¢åœ‹æ ¸å‡†è®Šæ›´è‰æ˜Žï¼Œé™¤æœ¬æº–則å¦æœ‰è¦å®šå¤–ï¼Œæº–ç”¨ç¬¬ä¸€é …ç¬¬ä¸€æ¬¾è‡³ç¬¬å››æ¬¾è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±æŽ¡ç”¨è‰æ˜Žï¼Œé™¤æœ¬æº–則å¦æœ‰è¦å®šå¤–，應由採用國之最高衛生主管機關出具，且經我國é§å¤–館處簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …採用è‰æ˜Žï¼ŒæŒ‡å¾·åœ‹ã€ç¾Žåœ‹ã€è‹±åœ‹ã€æ³•åœ‹ã€æ—¥æœ¬ã€ç‘žå£«ã€åŠ 拿大ã€æ¾³æ´²ã€æ¯”利時ã€ç‘žå…¸ç‰å國（以下簡稱å大醫藥先進國家）ä¸ä¹‹ä¸€åœ‹å‡ºå…·ä¹‹æŽ¡ç”¨è‰æ˜Žï¼Œæˆ–</span><span style="font-family: calibri;"> EMA </span><span style="font-family: 新細明體,serif;">出具之採用è‰æ˜Žæ›¿ä»£ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">採用è‰æ˜Žï¼Œå¾—以採用國收載該處方æˆåˆ†ä¹‹ä¸‹åˆ—醫藥å“集（以下簡稱公定書）或其網路版或電åæ›¸ç‰ˆå½±æœ¬ï¼Œèˆ‡æŽ¡ç”¨åœ‹æ ¸å‡†å«è©²æˆåˆ†ä¹‹è™•æ–¹è—¥å“仿單替代，å…由該國最高衛生主管機關出具，並å…經我國é§å¤–館處簽è‰ï¼›å…¶å¼•ç”¨ä¹‹å…¬å®šæ›¸ï¼Œæ‡‰è¼‰æ˜Žç‰ˆæ¬¡ï¼Œä¸¦ä»¥æœ€è¿‘五年內之版本為é™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¾Žåœ‹ï¼š</span><span style="font-family: calibri;">Physicians</span><span style="font-family: 新細明體,serif;">’</span><span style="font-family: calibri;">Desk Reference</span><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">PDR</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è‹±åœ‹ï¼š</span><span style="font-family: calibri;">British National Formulary</span><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">B.N.F.</span><span style="font-family: 新細明體,serif;">）ã€</span><span style="font-family: calibri;">Medicines Compe-</span></p><p><span style="font-family: calibri;"> ndium</span><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">published by Association of British Pharmaceutical I-ndustries</span><span style="font-family: 新細明體,serif;">，</span><span style="font-family: calibri;">ABPI</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ—¥æœ¬ï¼šæ—¥æœ¬é†«è—¥å“集（</span><span style="font-family: calibri;">Drugs in Japan</span><span style="font-family: 新細明體,serif;">）ã€æ—¥æœ¬æœ€è¿‘之新藥。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç‘žå£«ï¼š</span><span style="font-family: calibri;">Arzneimittel-Kompendium der Schweiz </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åŠ 拿大：</span><span style="font-family: calibri;">Compendium of Pharmaceuticals and Specialities</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ³•åœ‹ï¼š</span><span style="font-family: calibri;">Dictionnarie ViDAL</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æ¾³æ´²ï¼š</span><span style="font-family: calibri;">MIM</span><span style="font-family: 新細明體,serif;">’</span><span style="font-family: calibri;">S</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å¾·åœ‹ï¼š</span><span style="font-family: calibri;">Rote Liste</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æ¯”利時：</span><span style="font-family: calibri;">Repertoire Commente des Medicaments </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">åã€ç‘žå…¸ï¼š</span><span style="font-family: calibri;">Farmacevtiska specialiteter i Sverige</span><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">FASS</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±è™•æ–¹ä¾æ“šï¼Œé™¤åˆ¥æœ‰è¦å®šå¤–，以å大醫藥先進國家出版之藥典或公定書為準，並以出版日起五年內之版本為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">檢附處方ä¾æ“šï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼Œä¸¦è¨˜è¼‰æ‰€æ“šæ›¸åã€ç‰ˆæ¬¡ã€å¹´æ¬¡åŠé 數，檢附完整ä¾æ“šä¹‹å½±æœ¬ï¼›å¦‚所附ä¾æ“šéžä¸æ–‡æˆ–英文者，除專有å詞得以英文列出外，應é€å—ç¿»è¯æˆä¸æ–‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å¦‚檢附</span><span style="font-family: calibri;"> USP</span><span style="font-family: 新細明體,serif;">ã€è€…，應åŒæ™‚附</span><span style="font-family: calibri;"> USPDI </span><span style="font-family: 新細明體,serif;">ä¾›å¯©æ ¸ã€‚éžå±¬å…¬å®šæ›¸ä¹‹</span><span style="font-family: calibri;"> ExtraPharmacopoeia </span><span style="font-family: 新細明體,serif;">，僅供åƒè€ƒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è™•æ–¹èˆ‡æ‰€é™„ä¾æ“šæœªç›¡ç›¸ç¬¦è€Œæœ‰è®Šæ›´æ™‚，應附具ç†ç”±æ›¸ï¼Œä¸¦è¦–實際變更情形檢附有關必è¦è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€éŒ 劑ã€è†œè¡£éŒ ã€ç³–è¡£éŒ ï¼Œå¾—ä½¿ç”¨ç›¸åŒè™•æ–¹ä¾æ“šã€‚ä½†è…¸æº¶éŒ ä¸å¾—ä»¥éŒ åŠ‘ã€è†œè¡£éŒ ã€ç³–è¡£éŒ ç‚ºè™•æ–¹ä¾æ“šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è»Ÿè†èˆ‡ä¹³è†ä¹‹è™•æ–¹ä¾æ“šæˆ–採用è‰æ˜Žï¼Œå¦‚éžåˆ—入監視藥å“者，得互用之。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚ä»¥éŒ åŠ‘ç‚ºè™•æ–¹ä¾æ“šæˆ–採用è‰æ˜Žè€…ï¼Œç”³è«‹é›™å±¤éŒ æˆ–åæ¯éŒ 時，應說明製æˆé›™å±¤éŒ 或åæ¯éŒ 之ç†ç”±ï¼Œä¸”ä¸å¾—藉劑型於仿單ã€æ¨™ç±¤ä¸èª‡å¤§ç™‚效。如藉由劑型以é”ç›¸ä¹˜æˆ–åŠ å¤§æ•ˆæžœè€…ï¼Œå» å•†æ–¼æª¢é™„è‡¨åºŠè³‡æ–™ä¸¦ç¶“å¯©æŸ¥æ ¸å‡†å¾Œï¼Œå¾—æ–¼ä»¿å–®ã€æ¨™ç±¤ä¸Šå¢žåˆ—之。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€åœ‹å…§å» 商申請查驗登記所檢附之處方ä¾æ“šï¼Œå¦‚éžå±¬å大醫藥先進國家出版之藥典或公定書者，得以美國</span><span style="font-family: calibri;"> FDA </span><span style="font-family: 新細明體,serif;">之</span><span style="font-family: calibri;"> Orange book </span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;"> USPDI</span><span style="font-family: 新細明體,serif;">替代之。</span> </p><p><span style="font-family: 新細明體,serif;">ç”±åœ‹å…§è‡ªè¡Œç ”ç™¼ä¹‹æ–°è—¥ã€æ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘，å…附處方ä¾æ“šã€‚但應å¦é™„處方è¨è¨ˆç ”究åŠè©²è—¥å“之技術性資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±åŽŸæ–™æª¢é©—è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ï¼Œä¿‚指å„有效æˆåˆ†åŽŸæ–™ä¹‹æª¢é©—è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ï¼›å¦‚係輸入藥å“者，係指其æ¯ä¸€è™•æ–¹æˆåˆ†åŽŸæ–™ï¼ˆåŒ…括製程ä¸åŠ 入輔助原料åŠè‰²ç´ ）之檢驗è¦æ ¼èˆ‡æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">原料檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ï¼Œè¦å®šå¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”³è«‹æŸ¥é©—登記藥å“所用之原料，如ä¾æ“šè—¥å…¸è€…，應ä¾åºè¨»æ˜Žè—¥å…¸å稱ã€å¹´æ¬¡ã€ç‰ˆæ¬¡åŠé 數。但ä¾æ“šä¹‹è—¥å…¸ï¼Œä»¥ä¸è¯è—¥å…¸ã€å大醫藥先進國家出版之藥典ã€æˆ–其他經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŽ¡ç”¨ä¹‹è—¥å…¸ç‚ºé™ï¼›å…¶ç‰ˆæœ¬é™å‡ºç‰ˆæ—¥èµ·äº”年內。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ–°æˆåˆ†æ–°è—¥å¾—ä¾å» è¦ç‚ºä¸»ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æª¢é©—所需之標準å“，應註明係</span><span style="font-family: calibri;"> Primary Standard </span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;"> Working Stan-dard</span><span style="font-family: 新細明體,serif;">。如係</span><span style="font-family: calibri;"> Primary Standard </span><span style="font-family: 新細明體,serif;">者，應註明來æºï¼›å¦‚ä¿‚</span><span style="font-family: calibri;"> Working St-andard </span><span style="font-family: 新細明體,serif;">者，應註明來æºã€æ‰¹è™ŸåŠæ¨™ç¤ºå«é‡ï¼ˆæˆ–力價）ã€æª¢é©—è¦æ ¼ã€æª¢é©—æˆç¸¾æ›¸ã€æ¨™å®šç¨‹åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è‰²ç´ 應有檢驗è¦æ ¼åŠæ–¹æ³•ï¼›é¦™æ–™ç„¡éœ€æª¢é™„檢驗è¦æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ¯ä¸€è™•æ–¹æˆåˆ†åŽŸæ–™ä¹‹æª¢é©—æˆç¸¾æ›¸ï¼Œæ‡‰ç‚ºæ‰€é™„æˆå“批次使用之原料檢驗æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€åŽŸæ–™æ‡‰ä¾è¦æ ¼é€é …檢驗，如有減å…者，應檢附減å…之書é¢ä½œæ¥ç¨‹åºåŠå…¶ä»–å…¨é …æª¢é©—æ‰¹è™Ÿä¹‹æª¢é©—æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æª¢é©—çµæžœå¦‚為數值者，應以數據表示；檢驗方法為比å°æ¨™æº–å“者，得以「åˆæ ¼ã€è¡¨ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ï¼Œä¿‚指藥å“製劑之檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ï¼Œè¦å®šå¦‚下：</span> </p><p><span><span style="font-family: calibri;">一ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif;">申請查驗登記之藥å“如屬藥典藥å“者，應於申請書åŠæ‰€é™„檢驗è¦æ ¼ä¸è¨˜æ˜Žæ‰€ä¾æ“šè—¥å…¸ä¹‹å稱ã€å¹´æ¬¡ã€ç‰ˆæ¬¡åŠé 數；其藥典並以ä¸è¯è—¥å…¸ã€å大醫藥先進國家出版之藥典或其他經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŽ¡ç”¨ä¹‹è—¥å…¸ç‚ºé™ï¼Œä¸”版本é™å‡ºç‰ˆæ—¥èµ·äº”年內。於åŒä¸€å“å下有二種以上酯或鹽類ã€æˆ–å«çµæ™¶æ°´åŠç„¡æ°´ç‰©ä¹‹æˆåˆ†è€…，å‡æ‡‰æ˜Žç¢ºè¨˜è¼‰ç”³è«‹æ¡ˆä»¶ä¿‚採用何種。熱原試驗應以éžæ´»é«”動物替代方å¼å„ªå…ˆã€‚</span> </p><p><span><span style="font-family: calibri;">二ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif;">申請查驗登記藥å“之å„有效æˆåˆ†ï¼Œå‡æ‡‰æ–¼æª¢é©—è¦æ ¼ä¸æ˜Žç¢ºè¨˜è¼‰å…¶å„é …åˆæ ¼ç¯„åœåŠæª¢é©—方法；其鑑別åŠå«é‡æ¸¬å®šï¼Œä¸å¾—僅記載按æŸè—¥å…¸æ“作代之。</span> </p><p><span><span style="font-family: calibri;">三ã€</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體,serif;">å¿…è¦æ™‚，申請人應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¹‹è¦æ±‚，æ出檢驗紀錄，包括所有為確定是å¦ç¬¦åˆæ—¢è¨‚è¦æ ¼åŠæ¨™æº–之檢驗所得數據與下列紀錄：</span> </p><p><span style="font-family: calibri;">（一）</span><span style="font-family: 新細明體,serif;">樣å“之å–樣地點ã€æ•¸é‡ã€æ‰¹è™Ÿæˆ–其他明確之代號ã€å–樣日期ã€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">樣å“化驗完æˆæ—¥æœŸã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（二）所有檢驗方法之ä¾æ“šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（三）æ¯ä¸€æª¢é©—所用樣å“之é‡é‡æˆ–容é‡ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（四）檢驗所需之標準å“，應註明檢驗所需之標準å“，應註明係</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> Primary Standard </span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;"> Working Standard </span><span style="font-family: 新細明體,serif;">。如係</span><span style="font-family: calibri;"> Primary </span></p><p><span style="font-family: calibri;"> Standard </span><span style="font-family: 新細明體,serif;">者，應註明來æºï¼›å¦‚ä¿‚</span><span style="font-family: calibri;"> Working Standard </span><span style="font-family: 新細明體,serif;">者，應註明</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">來æºã€æ‰¹è™ŸåŠæ¨™ç¤ºå«é‡ï¼ˆæˆ–力價）ã€æª¢é©—è¦æ ¼ã€æª¢é©—æˆç¸¾æ›¸ã€æ¨™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">定程åºã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（五）æ¯ä¸€æª¢é©—éŽç¨‹ä¸æ‰€ç”¢ç”Ÿæ•¸æ“šä¹‹å®Œæ•´ç´€éŒ„，包括儀器輸出之圖表</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠå…‰èœç‰ï¼Œå‡æ‡‰æ˜Žç¢ºæ¨™è¨˜ï¼Œé¿å…混淆。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（å…）有關檢驗之所有é‹ç®—紀錄。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（七）檢驗çµæžœé ˆèˆ‡æ—¢è¨‚è¦æ ¼ç›¸æ¯”較而作判定。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（八）æ¯ä¸€æª¢é©—æ“作者之姓ååŠæ—¥æœŸã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（ä¹ï¼‰æ ¡æ ¸è€…ç°½åèªå®šå·²æª¢è¦–原始紀錄之精確性ã€å®‰å…¨æ€§èˆ‡ç¬¦åˆæ—¢è¨‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¦æ ¼ä¹‹è¨˜è¼‰ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€æˆå“檢驗æˆç¸¾æ›¸ï¼Œæº–用å‰æ¢ç¬¬äºŒé …第五款至第七款之è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åˆ†æ®µå§”è¨—è£½é€ è—¥å“æˆå“檢驗試驗之執行，應符åˆè—¥ç‰©å§”è¨—è£½é€ </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠæª¢é©—作æ¥æº–則之è¦å®šï¼Œä¸¦ä»¥èƒ½ç¢ºèªè—¥å“之å“質為原則，ä¸é™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”±åˆ†æ®µå§”è¨—è£½é€ è£½ç¨‹ä¹‹å—è¨—è£½é€ å» åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±æ‰¹æ¬¡è£½é€ ç´€éŒ„ï¼Œä¿‚æŒ‡èˆ‡é€é©—樣å“åŒä¸€æ‰¹ä¹‹æ‰¹æ¬¡è£½é€ 紀錄。但如無法檢é€åŒä¸€æ‰¹æ¬¡æˆ–ç„¡é ˆé€é©—者，得以查驗登記或變更登記申請日å‰äºŒå¹´å…§ä¹‹ä»»ä¸€æ‰¹æ‰¹æ¬¡è£½é€ 紀錄替代。</span> </p><p><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼Œä¿‚æŒ‡ç¬¦åˆè—¥ç‰©è£½é€ å·¥å» è¨å» 標準第三編è¦å®šï¼ˆä»¥ä¸‹ç°¡ç¨±è—¥å“å„ªè‰¯è£½é€ è¦ç¯„ï¼‰ä¹‹è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼Œä¸¦åŒ…æ‹¬æ‰¹æ¬¡è£½é€ ç´€éŒ„ä¹‹ä¸‹æ–™é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±å·²å®Œæˆè®Šæ›´ä¹‹è‰ç…§ï¼ŒåŒ…æ‹¬å·¥å» ç™»è¨˜è‰ã€è—¥å•†è¨±å¯åŸ·ç…§åŠå…¬å¸ç™»è¨˜æˆ–商æ¥ç™»è¨˜ä¹‹è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è‰ç…§é»è²¼è¡¨æ‡‰é»è²¼ä¸‹åˆ—è‰ç…§ä¹‹å½±æœ¬æˆ–照片：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å•†è¨±å¯åŸ·ç…§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å·¥å» 登記è‰ã€‚但輸入藥å“å…附。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å…¬å¸ç™»è¨˜æˆ–商æ¥ç™»è¨˜ä¹‹è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請案件檢附藥å“之化å¸ã€ç‰©ç†æ€§è³ªè³‡æ–™ã€è—¥ç†èˆ‡æ¯’性試驗資料ã€è—¥ç‰©å‹•åŠ›å¸è³‡æ–™ã€ç”Ÿé«”å¯ç”¨çŽ‡ã€è‡¨åºŠä½¿ç”¨æ–‡ç»åŠå…¶ä»–ç ”ç©¶å ±å‘Šï¼Œæ‡‰æ出原始資料，ä¸å¾—以一般敘述性資料ã€æ‘˜è¦æ€§è³‡æ–™æˆ–å€‹æ¡ˆå ±å‘Šæ›¿ä»£ã€‚ç›¸é—œè³‡æ–™ã€æ–‡ç»æˆ–å…¶ä»–ç ”ç©¶å ±å‘Šå¦‚éžä¸æ–‡æˆ–英文者，應å¦é™„ä¸æ–‡æˆ–英文翻è¯åŠç¿»è¯è€…姓å。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“å“å，應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å“åä¸å¾—ä½¿ç”¨ä»–äººè—¥ç‰©å•†æ¨™æˆ–å» å•†å稱。但å–å¾—æ‰€ç”¨å» å•†å稱之商標權者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä»¥è—¥å…¸è¨˜è¼‰ä¹‹å稱ã€å¸åã€é€šä¿—å稱或固有æˆæ–¹å稱為å“åè€…ï¼Œæ‡‰åŠ å† å•†æ¨™ã€å» 商å稱或其他å¯è³‡è¾¨åˆ¥ä¹‹å稱。但外銷專用å“å，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å“åä¸å¾—èˆ‡å…¶ä»–å» å•†è—¥å“å“å相åŒï¼Œæˆ–涉åŠä»¿å†’或影射情事。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å“åä¸å¾—涉有虛å½æˆ–誇大，或使人å°å“å與效能產生ä¸ç•¶è¯æƒ³æˆ–混淆。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¸æ–‡å“åä¸å¾—夾雜外文或數å—。但具直接æ„義者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ä¾æœ¬æ³•æ’¤éŠ·è¨±å¯è‰ä¹‹è—¥å“，其å“åä¸å¾—å†ä½¿ç”¨ï¼›ä¾æœ¬æ³•è¨»éŠ·æˆ–</span> <span style="font-family: 新細明體,serif;">廢æ¢è¨±å¯è‰ä¹‹è—¥å“，二年內其å“åä¸å¾—å†ä½¿ç”¨ã€‚但ä¾ç¬¬ä¸ƒå二æ¢ç¬¬ä¸€é …但書è¦å®šé‡æ–°ç”³è«‹æŸ¥é©—登記ã€åŽŸæœ‰è¨±å¯è‰è®Šæ›´ç‚ºå¤–銷專用許å¯è‰æˆ–外銷專用許å¯è‰ä¹‹è¨»éŠ·æˆ–廢æ¢åŽŸå› 與藥å“之安全或療效無關者，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å¾Œï¼ŒåŒä¸€å» 商得將原å“å使用於åŒæˆåˆ†ã€åŒåŠ‘åž‹ã€åŒåŠ‘é‡ä¸”åŒç™‚效之藥å“，ä¸å—二年內ä¸å¾—å†ä½¿ç”¨ä¹‹é™åˆ¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€åŒä¸€å» 商å°æ–¼ä¸åŒè™•æ–¹ä¹‹è¤‡æ–¹è£½åŠ‘而使用相åŒå“å者，應於ä¸æ–‡å“åä¸ï¼Œä»¥é©ç•¶å—詞明顯å€åˆ†å…¶è—¥å“之ä¸åŒæ•ˆèƒ½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€ä¸å¾—有其他ä¸é©åˆç‚ºè—¥å“å稱之情形。</span> </p><p><span style="font-family: 新細明體,serif;">èªå®šè—¥å“å“å是å¦ç›¸åŒæˆ–近似之標準，ä¾å•†æ¨™ã€å» 商å稱或其他å¯è³‡è¾¨åˆ¥åç¨±ä¹‹é †ä½èªå®šä¹‹ã€‚但å‰é …第三款之èªå®šï¼Œå» 商å稱åŠåŠ‘åž‹ä¸åˆ—入比å°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å·²æ ¸å‡†ä¸Šå¸‚ä¹‹è—¥å“許å¯è‰ï¼Œä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ä¾å‰äºŒé …è¦å®šï¼Œé‡æ–°å¯©æŸ¥æ ¸å®šå…¶è—¥å“å“å。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“製劑包è£åŠç”³è«‹æ›¸åŒ…è£æ¬„之記載，應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ‡‰è¼‰æ˜ŽåŒ…è£æ•¸é‡ã€åŒ…è£æ質åŠåŒ…è£å½¢æ…‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç“¶è£ä¹‹å…§æœæ¶²åŠ‘ã€ç³–漿劑，除營養å£æœæ¶²åŠ‘外，ä¸å¾—使用安瓿è£ï¼Œä¸¦æ‡‰è¨»æ˜Žå®¹é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŒ…è£æ¬„記載之單ä½ï¼Œæ‡‰èˆ‡è™•æ–¹è¨˜è¼‰ä¹‹åŠ‘åž‹å–®ä½ç›¸åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æ¯ç¨®è—¥å“之包è£é™é‡ï¼Œæ‡‰ä¾è—¥å“製劑包è£é™é‡è¡¨ä¹‹è¦å®šè¾¦ç†ï¼›å¦‚有特殊目的者，應在包è£ä¸ŠåŠ 註é™ç”¨ç›®çš„。一般製劑之最å°åŒ…è£ï¼Œä»¥æˆäººäºŒæ—¥æœ€å°ç”¨é‡ç‚ºæº–ï¼›å«å¯å¾…å› ï¼ˆç£·é…¸é¹½ï¼‰ç³–æ¼¿åŠ‘æŒ‡ç¤ºè—¥å“最大單ä½åŒ…è£ä¸å¾—超éŽä¸‰æ—¥ç”¨é‡ï¼›å«éº»é»ƒç´ 或å‡éº»é»ƒç´ ä¹‹éŒ åŠ‘åŠè† 囊劑，其包è£æ質以é‹ç®”ç›’è£ç‚ºé™ï¼Œå¦‚類別屬指示藥å“者，其最大包è£é‡ä¸¦ä»¥æˆäººä¸ƒæ—¥ç”¨é‡ç‚ºé™ï¼›æ„Ÿå†’ã€è§£ç†±éŽ®ç—›ã€å’³å—½æ¶²åŠ‘，其包è£é™é‡ç‚ºæˆäººä¸€æ¬¡é‡è‡³å››åƒæ¯«å‡ã€‚但暈動藥ã€é©…蟲藥ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …所稱藥å“製劑包è£é™é‡è¡¨ï¼Œå¦‚附件一。</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“之包è£å¦‚超éŽåŒ…è£é™é‡è¦å®šè€…，應檢附醫療機構或å¸è¡“團體訂購è‰æ˜Žï¼Œç”³è«‹è®Šæ›´ç™»è¨˜ã€‚但å«éº»é»ƒç´ 或å‡éº»é»ƒç´ 製劑，其類別屬指示藥å“者，ä¸å¾—變更。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請書之申請者商號ã€ä»£è™Ÿã€ä½å€ã€é›»è©±ã€è—¥å•†åŸ·ç…§å—è™Ÿï¼Œèˆ‡è² è²¬äººåŠç®¡ç†æˆ–監製藥師之姓åã€ä½å€åŠè‰æ›¸å—è™Ÿæ¬„ï¼Œæ‡‰è©³å¯¦å¡«æ˜Žä¸¦åŠ è“‹å°ç« 。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …åŠ è“‹ä¹‹å°ç« ，應與其後所有申請案件所用之å°ç« 相åŒï¼›å¦‚有éºå¤±ï¼Œæ‡‰ç”³è«‹å‚™æ¡ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç”³è«‹æ›¸ä¹‹è£½é€ å» å稱ã€ä»£è™ŸåŠå» å€æ¬„ï¼Œå¦‚ä¿‚å§”è¨—è£½é€ ï¼Œæ‡‰å¡«æ˜ŽåŒ…æ‹¬æ‰€æœ‰è£½ç¨‹ä¹‹è£½é€ å» å稱ã€ä»£è™ŸåŠå» å€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請書之原料å稱åŠåˆ†é‡æ¬„，其記載應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è™•æ–¹æ‡‰ä»¥æœ€å°å–®ä½ä¹‹å«é‡ç‚ºæ¨™ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åˆ†é‡é™ä»¥å…¬åˆ¶å¡«å¯«ï¼Œå¢žçŽ‡ä¸å¾—計入。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å«ç”Ÿè—¥æˆåˆ†ä¹‹è¥¿è—¥è£½åŠ‘，其處方ä¸ä¹‹æœ‰æ•ˆæˆåˆ†æŽ’列方å¼ï¼Œçµ±ä¸€ç‚ºåŒ–å¸æˆåˆ†åœ¨å‰ã€ç”Ÿè—¥æˆåˆ†åœ¨å¾Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ³¨å°„劑之處方所用溶劑ã€æº¶è§£è¼”助劑ã€å®‰å®šåŠ‘或其他賦形劑，å‡æ‡‰è©³ç´°è¨˜è¼‰ï¼Œä¸¦å‡æ‡‰é©æ–¼æ³¨å°„用；其處方以最å°å–®ä½å«é‡è¡¨ç¤ºç‚ºåŽŸå‰‡ã€‚但如係乾粉ã€å‡æ™¶æ³¨å°„劑，得以最å°åŒ…è£ä¹‹å«é‡æ¨™ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€é¦™æ–™æ‡‰è¨˜è¼‰å“ååŠåˆ†é‡ï¼›è‘—色劑應詳細記載英文å“ååŠåˆ†é‡ï¼›é˜²è…劑或其他賦形劑，å‡æ‡‰è©³ç´°è¨˜è¼‰å…¶å“ååŠåˆ†é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€äººå·¥ç”˜å‘³åŠ‘如經èªå®šæ–¼é†«ç™‚ä¸Šæœ‰é ˆä½¿ç”¨è€…ï¼Œå¾—å‡†ä½¿ç”¨ã€‚ä½†ä¸å¾—使用於營養液劑。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¦‚ä¿‚è† å›ŠåŠ‘è€…ï¼Œé™¤æ‡‰è¼‰æ˜Žå…¶å…§å®¹ç‰©ä¹‹å…¨è™•æ–¹å¤–ï¼Œè»Ÿè† å›Šæ‡‰è¼‰æ˜Žè»Ÿè† å›Šæ®¼ä¹‹å…¨è™•æ–¹ï¼Œç¡¬è† å›Šæ‡‰è¼‰æ˜Žè† å›Šæ®¼ä¹‹è‰²ç´ å稱。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€åŽŸæ–™è—¥æ‡‰ä¾è—¥å…¸æ”¶è¼‰åŽŸæ–™æˆåˆ†ã€å«é‡ä¹‹æ¨™ç¤ºæ³•è¨˜è¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€è—¥å“æˆåˆ†å¦‚åŒä¸€å“å下有二種以上酯或鹽類ã€æˆ–å«çµæ™¶æ°´åŠç„¡æ°´ç‰©ä¹‹æˆåˆ†è€…，å‡æ‡‰æ˜Žç¢ºè¨˜è¼‰ç”³è«‹æ¡ˆä»¶ä¿‚採用何種。</span> </p><p><span style="font-family: 新細明體,serif;">åã€ä¸»æˆåˆ†ä¹‹åŽŸæ–™ä¾†æºï¼ˆè£½é€ å» ååŠå…¶åœ‹åˆ¥ï¼‰æ‡‰äºˆè¼‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請書之é©æ‡‰ç—‡æ¬„，其記載應以ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å®šä¹‹è—¥å“效能或é©æ‡‰ç—‡å“目資料為準，包括藥å“å†åˆ†é¡žå“é …ã€è—¥å“å†è©•ä¼°çµæžœã€æŒ‡ç¤ºè—¥å“審查基準。</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“效能或é©æ‡‰ç—‡é™¤ä¾å‰é …è¦å®šå¡«æ˜Žå¤–，申請人得å¦åƒè€ƒæ–°è—¥æ–°é©æ‡‰ç—‡åŠå大醫藥先進國家之醫藥å“é›†ï¼Œç°¡æ˜Žå¡«å¯«ã€‚å¦‚ç™‚æ•ˆæœ‰æ‰€å¢žæ¸›ï¼Œä¸¦æ‡‰æª¢é™„æœ‰é—œè³‡æ–™ä»¥ä¾›å¯©æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請書表所附之切çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">甲</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŠåˆ‡çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¹™</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，填寫時應載明具切çµå•†è™Ÿå稱ã€åœ°å€ã€è² 責人姓ååŠåˆ‡çµæ—¥æœŸï¼Œä¸¦å‡åŠ 蓋與申請書相åŒä¹‹å°ç« ã€‚å¦‚ä¿‚å§”è¨—è£½é€ ï¼Œå§”è¨—è€…èˆ‡å—è¨—å» å‡æ‡‰å…·å切çµã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“之標籤ã€ä»¿å–®ã€åŒ…è£ï¼Œæ‡‰ç¬¦åˆæœ¬æ³•ç¬¬ä¸ƒå五æ¢è¦å®šï¼Œä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†äº‹é …刊載。其擬製與刊載之方å¼åŠå…§å®¹ï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼Œä¸”å…¶å—體應易於辨è˜ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä»¿å–®æ‡‰è¼‰æ˜Žä½¿ç”¨é¡žåˆ¥ã€åŒ…è£ã€å„²è—åŠå…¶ä»–ä¾è¦å®šæ‡‰åˆŠè¼‰ä¹‹å¿…è¦äº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¼¸å…¥è—¥å“外盒之標示，應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆä¸€ï¼‰æ‡‰æ–¼åŽŸå» åˆŠè¼‰å“åã€æœ‰æ•ˆæˆåˆ†åŠå«é‡ã€è£½é€ å» æˆ–å…¶å…¬å¸ä¹‹å稱åŠåœ°å€ã€‚ä½†å¤–ç›’æœªåˆŠè¼‰è£½é€ å» ååŠå» å€è€…，應å¦ä»¥å°ç±¤æ¢æ¨™ç¤ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（二）藥商å稱åŠåœ°å€ã€è¨±å¯è‰å—號ã€ä¸æ–‡å“åã€é¡žåˆ¥ï¼Œå¾—以å°ç±¤æ¢æ¨™ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆä¸‰ï¼‰å¦‚ä¿‚å§”è¨—è£½é€ ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…，其外盒之å—è¨—å» å稱ã€åœ°å€ï¼Œå¾—以刊載其所在國別替代之。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç›£è¦–è—¥å“之å¸å藥仿單，應ä¾å·²æ ¸å‡†ä¹‹é¦–å®¶ä»¿å–®æ ¸å®šæ–¹å¼è¨˜è¼‰ï¼›éžç›£è¦–è—¥å“應ä¾åŽŸå» 仿單據實翻è¯ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è²¼æ¨™ç±¤ï¼ˆç±¤æ¢ï¼‰ä½œæ¥ï¼Œè¦–åŒè£½ç¨‹ä¹‹ä¸€éƒ¨åˆ†ï¼Œæ‡‰ä¾è—¥å“å„ªè‰¯è£½é€ è¦ç¯„之作æ¥ç¨‹åºåŸ·è¡Œï¼›è¼¸å…¥è—¥å“æ‡‰æ–¼åŽŸå» è²¼å¦¥ï¼Œæˆ–ä¾è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則之è¦å®šï¼Œæ–¼è¼¸å…¥åœ‹å…§å¾Œå§”託國內符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„ä¹‹è—¥å» ï¼ˆä»¥ä¸‹ç°¡ç¨±</span><span style="font-family: calibri;"> GMP </span><span style="font-family: 新細明體,serif;">è—¥å» ï¼‰æˆ–ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之醫藥物æµä¸å¿ƒåŸ·è¡Œè—¥å“包è£åŠè²¼ç±¤æ¢ä½œæ¥ã€‚ä½†è£½é€ å» ååŠå» å€ä¹‹ç±¤æ¢ï¼Œä»æ‡‰æ–¼åŽŸå» 貼妥，ä¸å¾—於國內委託執行。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è—¥å“外包è£åŠæœ€å°å–®ä½åŒ…è£ï¼ˆç›´æŽ¥åŒ…æ之包è£ï¼‰ï¼Œæ‡‰ä¾æœ¬æ¢è¦å®šï¼Œä»¥ä¸æ–‡åŠè‹±æ–‡æ¨™ç¤ºã€‚但如å—é™æ–¼æœ€å°åŒ…è£ä¹‹é¢ç©è€…，至少應標示ä¸æ–‡å“ååŠå«é‡ã€‚下列å“é …ä¹‹æ¨™ç¤ºï¼Œå¾—è¦–ç‚ºç¬¦åˆæœ¬æ¬¾è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">（一）單次使用之單支單盒包è£ä¹‹æ³¨å°„劑，其外盒已載明ä¸æ–‡è€…。</span> </p><p><span style="font-family: 新細明體,serif;">（二）以原包è£çµ¦è—¥æˆ–販售之藥å“，於給藥或販售時ä¸å–®ç¨å°‡å¤–盒拆開，其外盒已載明ä¸æ–‡è€…。</span> </p><p><span style="font-family: 新細明體,serif;">（三）ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ 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¼ä¸å¾—å°æ–¼é›»è…¦å—體七號å—。</span> </p><p><span style="font-family: 新細明體,serif;">åã€å¸‚售藥å“å¾—åƒ…æ”¾ç½®ç¶“å¯©æŸ¥æ ¸å®šä¹‹ä¸æ–‡ä»¿å–®ã€‚但如市售藥å“åŒæ™‚放置ä¸ã€å¤–æ–‡ä»¿å–®è€…ï¼Œå¤–æ–‡ä»¿å–®å…§å®¹é ˆèˆ‡æ ¸å®šæœ¬ä¹‹ä¸æ–‡ä»¿å–®å…§å®¹ç›¸ç¬¦ï¼Œå» 商得ä¾æ ¸å®šä¹‹ä¸æ–‡ä»¿å–®è‡ªè¡Œä¿®æ£å…¶å¤–文仿單內容。</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€ä»¿å–®ã€æ¨™ç±¤ã€åŒ…è£ä¸å¾—刊å°æ¶‰åŠçŒ¥è¤»ã€æœ‰å‚·é¢¨åŒ–或誇大效能之圖案或文å—。</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€å¦‚於仿單ã€æ¨™ç±¤æˆ–包è£ä¸ŠåˆŠè¼‰ç¶“銷商å稱時，其上刊載經銷商å稱之å—é«”ä¸å¾—大於藥商（許å¯è‰æŒæœ‰è€…）å稱之å—體，並應檢附經銷商之藥商許å¯åŸ·ç…§å½±æœ¬ä¾›åƒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€ä¸æ–‡å“å之å—é«”ä¸å¾—å°æ–¼å¤–æ–‡å—體，並應清晰å¯è¾¨ï¼Œä¸”得以單一ä¸æ–‡å“åå—體高度ä¸å°æ–¼å–®ä¸€å¤–æ–‡å—æ¯ä¹‹é«˜åº¦ç‚ºæ¯”å°æ¨™æº–。</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€æˆè—¥ä¹‹æ¨™ç±¤åŠåŒ…è£ä¸Šï¼Œæ‡‰ä¾å…¶é¡žåˆ¥ï¼ŒåŠ å°æ˜Žé¡¯å¤§è™Ÿã€Œæˆè—¥ã€æˆ–「乙類æˆè—¥ã€ï¼Œå…¶å—體並以æ£æ¥·ç‚ºåŽŸå‰‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€å¦‚åŒä¸€å¼µè¨±å¯è‰è—¥å“之有效æˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡åŠç”¨é€”å‡ç›¸åŒï¼Œå…¶ä¸å…·ä»»ä½•è—¥ç†ä½œç”¨é¦™æ–™ã€è‰²ç´ ã€çŸ¯å‘³åŠ‘之外觀或形狀變更，ä¸å½±éŸ¿è—¥å“å“質åŠæ°‘眾用藥安全者，得以賦形劑變更方å¼å¢žåŠ 組æˆã€‚但其藥å“標籤ã€ä»¿å–®åŠå¤–盒包è£æ‡‰æœ‰é©ç•¶æ–‡å—敘述，以明顯å€åˆ¥ï¼Œè‡³å…¶åœ–案ã€é¡è‰²å¾—é…åˆæ–‡å—敘述有ä¸åŒçµ„æˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€é‹ç®”ç›’è£ä¹‹æ¯ä¸€ç‰‡é‹ç®”紙上，å‡æ‡‰åˆŠå°è—¥å“å稱且應以ä¸æ–‡ç‚ºä¸»ï¼›ä¸¦å¾—刊å°å…¶å» ååŠè¨±å¯è‰å—號。下列å“é …å¾—è¦–ç‚ºç¬¦åˆæœ¬æ¬¾è¦å®šï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（一）é‹ç®”å¡‘è† ç‰‡ä¹‹æœ€å°åŒ…è£ï¼Œå…¶æ¯ç‰‡é‹ç®”紙上å‡å·²åˆŠå°ï¼ˆå«å°å¦¥æˆ–åŠ è²¼ï¼‰ä¸æ–‡è—¥å“å稱者。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（二）以原包è£çµ¦è—¥æˆ–販售之藥å“，於給藥或販售時ä¸å–®ç¨å°‡å¤–盒拆開，其外盒已載明ä¸æ–‡è€…。</span> </p><p><span style="font-family: 新細明體,serif;">å七ã€è—¥å“之標籤或包è£ï¼Œæ‡‰ä¾ä¸‹åˆ—æ–¹å¼ä¹‹ä¸€ï¼ŒåˆŠè¼‰æ‰¹è™Ÿã€è£½é€ 日期ã€æœ‰æ•ˆæœŸé–“ã€ä¿å˜æœŸé™ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼ˆä¸€ï¼‰æ‰¹è™Ÿèˆ‡è£½é€ æ—¥æœŸåŠæœ‰æ•ˆæœŸé–“。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（二）批號與ä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼ˆä¸‰ï¼‰æ‰¹è™Ÿèˆ‡è£½é€ æ—¥æœŸåŠä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…«ã€ä¾å‰æ¬¾è¦å®šåˆŠè¼‰è£½é€ 日期ã€ä¿å˜æœŸé™æ™‚，應以年ã€æœˆã€æ—¥æ¨™æ˜Žï¼Œä¸”è£½é€ æ—¥æœŸã€æœ‰æ•ˆæœŸé–“ã€ä¿å˜æœŸé™ï¼Œä¸¦æ‡‰ä»¥æ¶ˆè²»è€…易於辨è˜æˆ–判斷之方å¼åˆŠè¼‰ã€‚但有效期間在二年以上者，其ä¿å˜æœŸé™å¾—僅標示年ã€æœˆï¼Œä¸¦æŽ¨å®šç‚ºç•¶æœˆä¹‹æœˆåº•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åä¹ã€ä»¥å¡‘è† ç‚ºåŒ…è£å®¹å™¨ä¹‹å¤§åž‹è¼¸æ³¨æ¶²ï¼Œæ‡‰æ–¼å®¹å™¨ä¸Šæ¨™ç¤ºå…¶èˆ‡è—¥å“接觸之æ質å稱。</span> </p><p><span style="font-family: 新細明體,serif;">擬製藥å“仿單ã€æ¨™ç±¤ã€å¤–ç›’ã€é‹ç®”åŠå…¶ä»–å„種標示æ料圖樣，應å¦ç¬¦åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹é ˆåŠ 刊注æ„äº‹é …å“ç›®ã€è—¥å“å†è©•ä¼°çµæžœã€æŒ‡ç¤ºè—¥å“審查基準ã€è—¥å“å†åˆ†é¡žå“é …ã€é†«ç™‚è—¥å“ä»¿å–®åˆŠè¼‰äº‹é …æ¨™æº–åŒ–ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">管制藥å“之標籤åŠåŒ…è£æ‡‰åŠ åˆŠäº‹é …ï¼Œé™¤æº–ç”¨å‰äºŒé …之è¦å®šå¤–，應å¦ä¾ç®¡åˆ¶è—¥å“管ç†æ¢ä¾‹åŠå…¶ç›¸é—œæ³•ä»¤è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ï¼Œæ‡‰é»è²¼æˆ–附仿單ã€æ¨™ç±¤ã€å¤–ç›’ã€é‹ç®”åŠå…¶ä»–標示æ料之已å°å¦¥å¯¦é«”æˆ–æ“¬ç¨¿ã€‚é ˆæª¢é€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ä¹‹è®Šæ›´åŠæŸ¥é©—登記案，於申請時，得檢é€åŒ…æ之å°åˆ·å¯¦é«”或擬稿；é‹ç®”實體得以彩色照片替代之。</span> </p><p><span style="font-family: 新細明體,serif;">æŸ¥é©—ç™»è¨˜ç”³è«‹æ¡ˆæ–¼é ˜è‰æ™‚，應檢附藥å“外觀åŠä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€æ ¸å®šä¹‹æ¨™ç±¤ã€ä»¿å–®ã€åŒ…è£ä¹‹é›»å檔。變更登記申請案如涉åŠè—¥å“外觀ã€æ¨™ç±¤ã€ä»¿å–®æˆ–包è£ä¹‹è®Šæ›´è€…，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€æ ¸å®šä¹‹äº‹é …，檢附變更後之藥å“外觀ã€æ¨™ç±¤ã€ä»¿å–®ã€åŒ…è£åŠç›¸é—œé›»å檔。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“製劑確效作æ¥ä¹‹å¯¦æ–½ï¼Œè¦å®šå¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”³è«‹æŸ¥é©—登記時，得先行檢齊申請藥å“之分æžæ–¹æ³•ç¢ºæ•ˆä½œæ¥å ±å‘Šæ›¸åŠé—œéµæ€§è£½ç¨‹ç¢ºæ•ˆè¨ˆç•«æ›¸ã€‚ä½†æ ¸å‡†å¾Œï¼Œæ‡‰åŸ·è¡Œé€£çºŒä¸‰æ‰¹ä¹‹è£½ç¨‹ç¢ºæ•ˆï¼Œä¿Ÿå…¶çµæžœç¬¦åˆè¦æ ¼å¾Œï¼Œå§‹å¾—上巿。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“確效作æ¥æ‡‰é”到確ä¿è—¥å“之有效性åŠå®‰å…¨æ€§ï¼Œä¸¦ç¬¦åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹è—¥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“確效作æ¥ä¹‹å¯¦æ–½é …目與時程è¦å®šå¦‚下：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">國產藥å“è£½é€ å» æ‡‰æ–¼æ°‘åœ‹å…«åä¹å¹´å二月三å一日å‰ï¼Œé ˜æœ‰è¼¸å…¥è—¥å“許å¯è‰ä¹‹å» 商應於民國ä¹å一年å…月åæ—¥å‰ï¼Œæª¢é™„其藥å“è£½é€ å» ä¹‹æ”¯æ´ç³»çµ±ã€å„€å™¨ã€è¨å‚™ç¢ºæ•ˆèˆ‡è©²å» 至少一種以上產å“之關éµæ€§è£½ç¨‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«è£½ç¨‹ä¹‹æ¸…潔確效</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŠåˆ†æžæ–¹æ³•ç¢ºæ•ˆä½œæ¥æ›¸é¢è³‡æ–™ï¼Œé€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‚™ã€‚å¦‚æœªæª¢é™„è³‡æ–™æˆ–ç¶“å¯©æ ¸ä¸é€šéŽè€…，除ä¾æ³•å…¬å¸ƒè©²è£½é€ å» åŠå…¶åœ¨æˆ‘國境內之所有藥å“許å¯è‰å單且令é™æœŸæ”¹å–„外，ä¸å‡†è©²å» è—¥å“新案查驗登記。如未於期é™æ”¹å–„者，ä¸å‡†å±•å»¶è—¥å“許å¯è‰ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">國產藥å“è£½é€ å» æ‡‰æ–¼æ°‘åœ‹ä¹å一年å…月三åæ—¥å‰ï¼Œé ˜æœ‰è¼¸å…¥è—¥å“許å¯è‰ä¹‹å» 商應於民國ä¹å二年å二月åæ—¥å‰ï¼Œå®Œæˆå„è—¥å“é—œéµæ€§è£½ç¨‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«è£½ç¨‹æ¸…潔確效</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">與分æžæ–¹æ³•ç¢ºæ•ˆä½œæ¥ä¹‹å¯¦æ–½åŠé€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‚™ä¹‹ç¨‹åºã€‚å¦‚æœªæª¢é™„è³‡æ–™æˆ–ç¶“å¯©æ ¸ä¸é€šéŽè€…，準用å‰ç›®è¦å®šè™•ç†ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">國產藥å“è£½é€ å» æ‡‰æ–¼æ°‘åœ‹ä¹å三年å…月三åæ—¥å‰ï¼Œé ˜æœ‰è¼¸å…¥è—¥å“許å¯è‰ä¹‹å» 商應於民國ä¹å四年å二月åæ—¥å‰ï¼Œå®Œæˆå„è—¥å“å…¨é¢ç¢ºæ•ˆä½œæ¥ä¹‹å¯¦æ–½åŠé€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‚™ä¹‹ç¨‹åºã€‚å¦‚æœªæª¢é™„è³‡æ–™æˆ–ç¶“å¯©æ ¸ä¸é€šéŽè€…，準用第一目è¦å®šè™•ç†ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">國產藥å“自民國ä¹å一年七月一日起，輸入藥å“自民國ä¹å二年å二月å一日起，æŒæœ‰è¨±å¯è‰è€Œä¸ç”¢è£½ã€ä¸è¼¸å…¥è²©å”®è€…，得ä¸åŸ·è¡Œç¢ºæ•ˆä½œæ¥ã€‚但輸入藥å“應檢附其藥å“許å¯è‰ï¼Œåˆ‡çµå¾…備齊確效作æ¥æ›¸é¢è³‡æ–™ï¼Œç¶“å¯©æ ¸é€šéŽå§‹å¾—輸入該藥å“販售，並於許å¯è‰æ£é¢åŠ 蓋本è‰æœªä¾æœ¬ç½²å…¬å‘Šäº‹é …è¦å®šæª¢é½Šè³‡æ–™ä¸å¾—è¼¸å…¥è²©å”®ä¹‹ç« æˆ³è€…ï¼Œå¾—ä¸åŸ·è¡Œç¢ºæ•ˆä½œæ¥è€Œå‡†å…¶è¨±å¯è‰å±•å»¶ï¼›å…¶å¾Œå¦‚æª¢é½Šè³‡æ–™ï¼Œç¶“å¯©æ ¸é€šéŽå¾Œï¼Œå¾—於其許å¯è‰å†åŠ 蓋本è‰æ¥å·²ä¾æœ¬ç½²å…¬å‘Šäº‹é …æª¢é½Šè³‡æ–™å‡†äºˆè¼¸å…¥è²©å”®ä¹‹ç« æˆ³ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">如有未執行確效作æ¥è€Œç”¢è£½æˆ–輸入販售藥å“者，ä¾æœ¬æ³•è¦å®šè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“查驗登記或變更登記執行之國內臨床試驗åŠæ‡‰æª¢é™„資料，è¦å®šå¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€</span> <span style="font-family: 新細明體,serif;">å» å•†åŸ·è¡Œåœ‹å…§è‡¨åºŠè©¦é©—ï¼Œæ‡‰ç¬¦åˆè—¥å“優良臨床試驗準則之è¦å®šï¼Œä¸¦ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹è‡¨åºŠè©¦é©—ç”³è«‹é ˆçŸ¥åŠéŠœæŽ¥æ€§è©¦é©—基準辦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å» 商進行臨床試驗å‰ï¼Œæ‡‰æ出藥å“臨床試驗計畫，詳實填載臨床試驗內容摘è¦è¡¨åŠè—¥å“臨床試驗申請書，é€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¿Ÿä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥åŒæ„並發給åŒæ„è©¦é©—é€²è¡Œå‡½å¾Œï¼Œå» å•†æ‡‰ä¾å¯©æŸ¥æ„è¦‹æ‰€è¼‰äº‹é …ï¼Œé€²è¡Œè‡¨åºŠè©¦é©—ï¼Œä¸¦æ–¼è©¦é©—å®Œæˆå¾Œï¼Œå°‡è©¦é©—å ±å‘Šçµæžœé€äº¤å‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å‰æ¬¾è©¦é©—å ±å‘Šçµæžœæœªç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥ä¸¦ç™¼çµ¦åŒæ„å ±å‘Šå‚™æŸ¥å‡½ä¹‹å‰ï¼Œå…¶æŸ¥é©—登記或變更登記申請案ä¸äºˆæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請案件檢附之國外臨床資料，應具備å°ç…§çµ„比較或雙盲è¨è¨ˆï¼Œä¸å¾—以一般敘述性資料ã€æ‘˜è¦æ€§è³‡æ–™æˆ–å€‹æ¡ˆå ±å‘Šæ›¿ä»£ã€‚å¦‚ä¿‚åœ‹å…§è‡¨åºŠè©¦é©—ï¼Œæ‡‰æª¢é™„ä¹‹æŠ€è¡“æ€§è³‡æ–™æº–ç”¨å‰é …è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22-1 </span><span style="font-family: 新細明體,serif;">æ¢</span> <span style="font-family: 新細明體,serif;">下列藥å“應申請銜接性試驗評估：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ–°æˆåˆ†æ–°è—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å…¶ä»–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šæ‡‰ç”³è«‹éŠœæŽ¥æ€§è©¦é©—評估之藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …以外之藥å“ï¼Œå» å•†å¾—è‡ªè¡Œæ±ºå®šæ˜¯å¦ç”³è«‹éŠœæŽ¥æ€§è©¦é©—評估。如未申請銜接性試驗評估而逕行申請查驗登記，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥èªæœ‰å¿…è¦è€…，ä»æ‡‰åŸ·è¡ŒéŠœæŽ¥æ€§è©¦é©—。</span> </p><p><span style="font-family: 新細明體,serif;">申請銜接性試驗評估，應填具銜接性試驗評估查檢表，並檢附藥å“之完整臨床試驗數據資料（</span><span style="font-family: calibri;">complete clinical data package</span><span style="font-family: 新細明體,serif;">），且宜å«äºžæ´²äººç¨®è³‡æ–™ã€‚銜接性試驗評估，得於查驗登記å‰æ出申請ã€æˆ–與查驗登記申請案åŒæ™‚申請。</span> </p><p><span style="font-family: 新細明體,serif;">經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè©•ä¼°èªå®šå¾—å…除銜接性試驗者，其查驗登記申請案，得å…附銜接性試驗資料。但其藥å“之療效與安全性，ä»æ‡‰æœ‰å……足之臨床試驗資料為ä¾æ“šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如經評估èªå®šä¸å¾—å…除銜接性試驗者，申請人應ä¾è©•ä¼°çµæžœï¼Œæ“¬å®šé©ç•¶ä¹‹éŠœæŽ¥æ€§è©¦é©—計畫書é€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥ã€‚俟審查åŒæ„後，申請人應執行銜接性試驗，並於試驗完æˆå¾Œï¼Œå°‡è©¦é©—å ±å‘ŠåŠç›¸é—œè³‡æ–™é€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">於國內完æˆéŠœæŽ¥æ€§è©¦é©—ä¸¦ç¶“æœ¬ç½²æ ¸å‡†ä¹‹æ–°è—¥ï¼Œè‡ªç™¼è‰æ—¥èµ·äº”å¹´å…§ï¼Œå‡¡è£½é€ æˆ–è¼¸å…¥ç›¸åŒæˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡ä¹‹å¸åè—¥å» å•†ï¼Œé™¤ä¾ç¾è¡Œè¦å®šæª¢é™„資料外，應å¦æª¢é™„èˆ‡ç”³è«‹æ–°è—¥æŸ¥é©—ç™»è¨˜ä¸”ç¶“æœ¬ç½²é¦–å…ˆæ ¸ç™¼è¨±å¯è‰å» 商相åŒæ¨™æº–ä¹‹åœ‹å…§éŠœæŽ¥æ€§è©¦é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請查驗登記或變更登記之藥å“å¦‚ä¿‚å§”è¨—è£½é€ æˆ–å§”è¨—æª¢é©—è€…ï¼Œé™¤æ‡‰ç¬¦åˆè—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則之è¦å®šå¤–，並應ä¾ç¬¬å…åå››æ¢åŠç¬¬å…åå…æ¢è¦å®šå‚™é½Šç›¸é—œè³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« è¦å®šä¹‹å„類申請案件，除別有è¦å®šå¤–，其審查以書é¢å¯©æ ¸èˆ‡è—¥å“é€é©—作æ¥ä½µè¡Œã€‚如書é¢å¯©æ ¸é€šéŽè€…，申請人å³æ‡‰ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥è¾¦ç†é ˜è‰æ‰‹çºŒï¼›å¦‚檢驗è¦æ ¼å¯©æ ¸é€šéŽè€…，申請人å³æ‡‰ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥è¾¦ç†é€é©—手續。</span> </p><p><span style="font-family: 新細明體,serif;">下列申請案，除經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¿…è¦é€é©—者外，得以書é¢å¯©æ ¸è€Œå…é€é©—樣å“：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æŸ¥é©—登記：</span> </p><p><span style="font-family: 新細明體,serif;">（一）列屬æˆè—¥ï¼ˆå«ä¹™é¡žæˆè—¥ï¼‰ä¹‹è£½åŠ‘。</span> </p><p><span style="font-family: 新細明體,serif;">（二）符åˆå«ç¶ç”Ÿç´ 產å“èªå®šåŸºæº–表之ç¶ç”Ÿç´ 製劑。</span> </p><p><span style="font-family: 新細明體,serif;">（三）å¸å藥。</span> </p><p><span style="font-family: 新細明體,serif;">（四）新藥。</span> </p><p><span style="font-family: 新細明體,serif;">（五）符åˆæŒ‡ç¤ºè—¥å“審查基準之製劑。</span> </p><p><span style="font-family: 新細明體,serif;">（å…）一般原料藥。</span> </p><p><span style="font-family: 新細明體,serif;">（七）外銷專用之製劑åŠåŽŸæ–™è—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆå…«ï¼‰æ ¸é†«æ”¾å°„æ€§è—¥å“。</span> </p><p><span style="font-family: 新細明體,serif;">（ä¹ï¼‰éŽæ•åŽŸè—¥å“。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …採書é¢å¯©æ ¸ä¹‹è—¥å“ï¼Œç”³è«‹äººé ˆåŠ é€æ¨£å“掃æ檔或彩色圖片供審查。必è¦æ™‚，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ï¼Œæä¾›å°ç…§æ¨™æº–å“，以利比å°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請案件有下列情形之一者，ä¸äºˆæ ¸å‡†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”³è«‹äººè³‡æ ¼ä¸åˆæˆ–è£½é€ è¨å‚™ä¸ç¬¦ï¼ŒåŒ…括其軟硬體è¨å‚™åŠç›¸é—œåŠ‘åž‹è¨å‚™ä¸ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„或未ä¾è¦å®šæ出符åˆè©²è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æœªä¾è¦å®šç¹³ç´è²»ç”¨æˆ–檢附之資料ä¸å……足或與申請案件內容ä¸ç¬¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç”³è«‹ä¹‹è—¥å“，主治效能ä¸æ˜Žç¢ºæˆ–無顯著療效ã€æˆ–未通éŽè—¥å“å†è©•ä¼°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç”³è«‹ä¹‹è—¥å“有嚴é‡å‰¯ä½œç”¨æˆ–具安全疑慮。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç”³è«‹ä¹‹è£½åŠ‘所å«æ¯’劇或管制藥å“ä¸ç¬¦è¦å®šä¹‹åŠ‘é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ç”³è«‹ä¹‹è—¥å“å«æœ‰æœªç¶“æ ¸å‡†ä½¿ç”¨ä¹‹è‘—è‰²åŠ‘ã€é˜²è…劑ã€æŠ—氧化劑。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ç”³è«‹å«æœ‰ç¦æ¢ä½¿ç”¨ä¹‹æˆåˆ†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€ç”³è«‹ä¹‹è—¥å“，處方ã€è£½æ³•æˆ–劑型ä¸é©ç•¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å£æœæ¶²è£½åŠ‘æˆåˆ†éžç‡Ÿé¤Šä¿å¥ï¼Œæˆ–å«æœ‰</span><span style="font-family: calibri;">Caffeine </span><span style="font-family: 新細明體,serif;">類之æˆåˆ†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€æ¿€ç´ </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括蛋白åŒåŒ–è·çˆ¾è’™ã€é¡žå›ºé†‡é¡ž</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€èƒƒè…¸è—¥ã€é©…蟲劑ã€éŽ®æšˆåŠ‘åŠå…·æŠ—ç¡çœ ã€è§£ç†±ã€éŽ®ç—›ã€éŽ®å’³ã€è¢ªç—°æˆ–其他具醫療效能之製劑，以å£æœæ¶²ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€èƒºåŸºé…¸é¡žåŠå¤šç¨®ç¶ç”Ÿç´ 類營養劑之å«é†‡ç¸½é‡è¶…éŽ</span><span style="font-family: calibri;">8%W/V</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€å«å¯å¾…å› </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">磷酸鹽</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之糖漿劑，å«è”—ç³–é‡æœªæ»¿ç™¾åˆ†äº”å五</span><span style="font-family: calibri;"> W/V </span><span style="font-family: 新細明體,serif;">者；或å¯å¾…å› ç³–æ¼¿è£½åŠ‘å«é‡æ¯ä¸€ç™¾æ¯«å‡æœªæ»¿ä¸€å…¬å…‹è€Œåˆ—屬於指示用藥，其å¯å¾…å› å«é‡ä¸ç¬¦ä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">一日最大é…åˆé‡ï¼Œæ„Ÿå†’糖漿劑ä¹æ¯«å…‹ï¼ŒéŽ®å’³ã€è¢ªç—°ç³–漿劑å八毫克。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">如與</span><span style="font-family: calibri;"> Ephedrine Hydrochloride</span><span style="font-family: 新細明體,serif;">ã€</span><span style="font-family: calibri;">dl-Methylephedrine Hydroc-</span></p><p><span style="font-family: calibri;"> hloride </span><span style="font-family: 新細明體,serif;">é…åˆæ™‚，應減é‡ç™¾åˆ†ä¹‹äºŒå。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æˆäººæ¯æ¬¡æœç”¨é‡æ‡‰ç‚ºäº”毫å‡ä»¥ä¸Šï¼Œè™•æ–¹å–®ä½å«é‡æ‡‰é…åˆèª¿æ•´ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€å«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“åŠæ¯’è—¥ã€åŠ‡è—¥ä¹‹ä¸è¥¿è—¥æ··åˆè£½åŠ‘。</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€æª¢é€ä¹‹æª¢é©—è¦æ ¼æˆ–資料文ç»ä¸é©ç•¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€æœªæ–¼è¦å®šæœŸé™å…§è¾¦ç†é ˜è‰æˆ–é€é©—手續，或é€é©—之藥å“經檢驗與申請資料ä¸ç¬¦æˆ–å…¶ä»–åŽŸå› ä¸åˆæ ¼è€…。</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€æœªä¾æ ¸å®šäº‹é …刊載ã€ä¿®æ£æˆ–變更藥å“之包è£ã€æ¨™ç±¤æˆ–仿單。</span> </p><p><span style="font-family: 新細明體,serif;">å七ã€å…¶ä»–ä¸ç¬¦æœ¬æº–則或有關法令è¦å®šï¼Œæˆ–ä¸ç¬¦ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …之情形。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請案件如未ä¾è¦å®šç¹³ç´è²»ç”¨ã€æœªå¡«å…·ç”³è«‹æ›¸è¡¨ã€æœªå‚™é½Šè³‡æ–™æˆ–有其他ä¸ç¬¦æœ¬æº–則è¦å®šä¹‹æƒ…形而得補æ£æ™‚，申請人應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ä¹‹æœŸé™å…§è£œæ£ã€‚補æ£æœŸé™ç‚ºäºŒå€‹æœˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請人如未能於期é™å…§è£œæ£è€…，得於補æ£æœŸæ»¿å‰ï¼Œä»¥æ›¸é¢æ•˜æ˜Žç†ç”±ç”³è«‹å»¶æœŸï¼›å…¶å»¶æœŸæœŸé™ï¼Œè‡ªè£œæ£æœŸæ»¿ç¿Œæ—¥èµ·ç®—一個月，且延期以一次為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請人如未於期é™å…§è£œæ£æˆ–延期一個月後ä»é€¾æœŸæœªè£œæ£è€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ä¾ç¾æœ‰è³‡æ–™é€•ç‚ºå¯©æŸ¥æ ¸é§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請人如接ç²é ˜è‰é€šçŸ¥è€…，除ä¾è¦å®šè¾¦ç†è—¥å“é€é©—æ‰‹çºŒå¤–ï¼Œæ‡‰æ–¼é ˜è‰æœŸé™å…§ç¹³ç´è²»ç”¨ï¼Œä¾ä¸‹åˆ—程åºè¾¦ç†é ˜è‰æ‰‹çºŒï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æª¢é™„ä¾æ ¸å®šè‰æœ¬å°å¦¥ä¹‹æ¨™ç±¤ã€ä»¿å–®ã€åŒ…è£å„二份。但新藥應檢附三份；輸入藥å“除市售å“包è£æ£æœ¬å¤–，ä¸æ–‡ä»¿å–®èˆ‡å°ç±¤æ¢é ˆä¾æŽ’版å°åˆ·æ–¹å¼å°å¦¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æª¢é™„已蓋用申請人åŠå…¶è² 責人å°ç« ä¹‹é ˜è‰é€šçŸ¥å‡½æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æª¢é‚„原附之標籤ã€ä»¿å–®ã€å¤–包è£æ ¸å®šè‰æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æª¢é‚„原附之藥å“查驗登記申請書影本。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æª¢é‚„原附之藥å“許å¯è‰å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é ˜è‰æœŸé™ç‚ºä¸‰å€‹æœˆã€‚如申請人於è¦å®šæœŸé™å…§è¾¦ç†é ˜è‰æ‰‹çºŒï¼Œæ‰€æª¢é™„之標籤ã€ä»¿å–®ã€åŒ…è£æˆ–其他相關物å“è³‡æ–™æœ‰éŒ¯èª¤è€Œé ˆé‡æ–°æ›´æ£åˆŠå°è€…，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ä¹‹æœŸé™å…§æ›´æ£ï¼Œä¸¦æ–¼æ›´æ£å¾Œå§‹å¾—é ˜è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“è®Šæ›´ç™»è¨˜ç”³è«‹æ¡ˆå¦‚ç¶“å¯©æŸ¥æ ¸å‡†è€…ï¼Œé™¤è—¥å“許å¯è‰ä¿‚污æ或éºå¤±äºˆä»¥æ›ç™¼æˆ–è£œç™¼å¤–ï¼Œå…¶é¤˜è®Šæ›´äº‹é …ï¼Œç”±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ–¼åŽŸè¨±å¯è‰åŠ è¨»è®Šæ›´ç™»è¨˜äº‹é …ã€æ—¥æœŸåŠåŠ è“‹ç« æˆ³å¾Œç™¼é‚„ä¹‹ã€‚ä½†å¦‚æ›ç™¼æ–°è‰è€…，應å¦ç¹³ç´è²»ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å¦‚ç”³è«‹äººé ˜å¾—è—¥å“許å¯è‰å¾Œï¼Œæœªä¾è¦å®šè¾¦ç†é€é©—手續或é€é©—樣å“經檢驗與申請資料ä¸ç¬¦æˆ–å…¶ä»–åŽŸå› ä¸åˆæ ¼è€…，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ï¼Œç¹³å›žè—¥å“許å¯è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請人如接ç²é€é©—通知者，應於通知之é€é©—期é™å…§ï¼Œç¹³ç´è²»ç”¨ä¸¦æª¢é™„下列樣å“åŠè³‡æ–™ï¼Œé€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæª¢é©—：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥ç‰©æ¨£å“ä¸‰ä»½ï¼›æœ¬æ¬¾æ‰€ç¨±ä¸€ä»½ï¼Œä¿‚æŒ‡è¶³å¤ ä¸€æ¬¡æª¢é©—æ•¸é‡ç‚ºä¸€ä»½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¦–檢驗需è¦ï¼Œæä¾›å°ç…§æ¨™æº–å“é©é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥ç‰©æ¨£å“檢驗éžé€è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ä¹‹æª¢é©—é …ç›®æ”¶è²»æ¨™æº–è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ¨£å“掃æ檔或彩色圖片。</span> </p><p><span style="font-family: 新細明體,serif;">監視期間之藥å“查驗登記申請案件，應ä¾ä¸‹åˆ—程åºè¾¦ç†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å¦‚其申請查驗登記所附之書é¢è³‡æ–™é½Šå…¨è€…，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ç”³è«‹äººæª¢é€æ¨£å“辦ç†æª¢é©—。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é€é©—樣å“經檢驗åˆæ ¼ï¼Œå¦‚其生體相ç‰æ€§è©¦é©—å ±å‘Šæˆ–è‡¨åºŠè©¦é©—å ±å‘Šå°šæœªå‡†å‚™æŸ¥è€…ï¼Œä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé™¤ç™¼å‡½é€šçŸ¥å¤–，並將原檢é€ç•™å˜æŸ¥é©—登記資料，以彌å°æ–¹å¼é€é‚„åŽŸç”³è«‹å» å•†ï¼Œç”³è«‹äººæ‡‰è² ä»£è¡Œä¿ç®¡è²¬ä»»ä¸”ä¸å¾—ä»»æ„自行拆å°ã€‚但如經檢驗èªå®šä¸åˆæ ¼è€…，ä¾æœ¬æ³•æœ‰é—œè¦å®šè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç”³è«‹äººæŽ¥ç²ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥å…¶è—¥å“生體相ç‰æ€§è©¦é©—å ±å‘Šæˆ–è‡¨åºŠè©¦é©—å ±å‘Šå‡†äºˆå‚™æŸ¥å¾Œï¼Œæ‡‰å°‡åŽŸæª¢é‚„å½Œå°è³‡æ–™åŠè©²é€šçŸ¥å‡½å½±æœ¬é€å›žä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¼Œä»¥å®Œæˆå¾ŒçºŒä½œæ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">凡有é‡æ–°æª¢é©—案件，申請人應å†ç¹³ç´è²»ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”³è«‹äººå¦‚æœªé ˜è‰å‰ï¼Œå³è¾¦ç†é€é©—手續者，其後ä¸å¾—以書é¢å¯©æ ¸æœªç²é€šéŽç‚ºç”±ï¼Œè¦æ±‚退還檢驗費åŠé€é©—樣å“。</span> </p><p><span style="font-family: 新細明體,serif;">申請人如尚未辦ç†é€é©—手續或é€é©—樣å“之檢驗尚未完æˆå‰ï¼Œå³é ˜å¾—è—¥å“許å¯è‰è€…並將相關藥å“上市銷售者，應確實é€æ‰¹å°‡è£½é€ 日期ã€æ‰¹è™Ÿã€éŠ·å”®å°è±¡åŠæ•¸é‡åˆ—表，æ¯éš”å日分別å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œåŠå…¶æ‰€åœ¨åœ°ä¹‹ç›´è½„市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå ±å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形，如申請人未ä¾è¦å®šè¾¦ç†é€é©—手續或é€é©—樣å“經檢驗與申請資料ä¸ç¬¦æˆ–å…¶ä»–åŽŸå› ä¸åˆæ ¼ï¼Œæ‡‰æ–¼æ”¶å—通知後立å³åœæ¢è£½å”®ç›¸é—œè—¥å“並繳回藥å“許å¯è‰ï¼Œä¸”ä¾æœ¬æ³•æœ‰é—œè¦å®šè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入藥å“查驗登記所需檢附樣å“ã€æ•¸é‡èˆ‡é€šé—œä½œæ¥è¦å®šå¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å‡¡æŒä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç™¼ä¹‹é€šçŸ¥å» 商é€é©—書函通關，原則上以該é€é©—書函上載明之藥物樣å“åŠå°ç…§æ¨™æº–å“之數é‡ç‚ºæº–。但為顧åŠåŒ…è£å®Œæ•´æ€§ï¼Œå¾—商請海關視實際單一完整包è£é…Œé‡æ”¾è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¼¸å‡ºã€è¼¸å…¥ç®¡åˆ¶è—¥å“（å«è©¦è£½ç®¡åˆ¶è—¥å“原料藥輸入）之相關åŒæ„文件，應ä¾ç®¡åˆ¶è—¥å“管ç†æ¢ä¾‹åŠå…¶æ–½è¡Œç´°å‰‡ä¹‹è¦å®šï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç”³è«‹ã€‚éžåˆ—屬管制藥å“分級åŠå“é …ï¼Œæ‡‰å‡ºç”¢åœ‹è¦æ±‚應申請我國輸入許å¯æ–‡ä»¶è€…，亦åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入藥å“è®Šæ›´ç™»è¨˜å¦‚é ˆé€é©—時，其樣å“ã€æ•¸é‡èˆ‡é€šé—œä½œæ¥ï¼Œæº–用å‰é …è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å·²é ˜æœ‰è¨±å¯è‰ä¹‹è—¥å“，如未通éŽç™‚效åŠå®‰å…¨æ€§è©•ä¼°ã€æˆ–列為應å†è©•ä¼°ä¹‹è™•æ–¹è€…，ä¾ä¸‹åˆ—è¦å®šè™•ç†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸåˆ—為評估未通éŽï¼Œå¦‚æ出臨床資料申復，經å†è©•ä¼°çµæžœä»ç¶æŒåŽŸè°å®šæ¡ˆè€…，其藥å“許å¯è‰æœ‰æ•ˆæœŸé–“屆滿時，ä¸å‡†å±•å»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŽŸåˆ—為應å†è©•ä¼°ä¹‹è™•æ–¹ï¼Œå¦‚æŒæœ‰è¨±å¯è‰ä¹‹å» 商æ出臨床資料é€å¯©ï¼Œç¶“è©•ä¼°çµæžœåˆ—為評估未通éŽè€…，其藥å“許å¯è‰æœ‰æ•ˆæœŸé–“屆滿時，ä¸å‡†å±•å»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŽŸåˆ—為評估未通éŽã€æˆ–應å†è©•ä¼°ä¹‹è™•æ–¹ï¼Œå¦‚檢附完整之臨床資料，經å†è©•ä¼°é€šéŽè€…，其藥å“許å¯è‰å¾—准變更ã€å±•å»¶ã€‚如æ出之臨床資料ä¸å®Œæ•´æˆ–未æå‡ºä»»ä½•è³‡æ–™ç”³å¾©ä¹‹å» å•†ï¼Œå…¶åŽŸé ˜ä¹‹è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“屆滿時，ä¸å‡†å±•å»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸåˆ—為評估未通éŽã€æˆ–應å†è©•ä¼°ä¹‹è™•æ–¹ï¼ŒæŒæœ‰ç›¸é—œè™•æ–¹è—¥å“許å¯è‰ä¹‹å» 商，於申復期間內或é€å¯©å†è©•ä¼°è³‡æ–™å‰ï¼Œå…¶è¨±å¯è‰ä»å±¬æœ‰æ•ˆã€‚但如已逾申復期é™ï¼Œç„¡ä»»ä½•å» 商æ出資料或申復者，該相關處方藥å“之許å¯è‰æœ‰æ•ˆæœŸé–“屆滿時，ä¸å‡†å±•å»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">查驗登記</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“æŸ¥é©—ç™»è¨˜ï¼Œå…¶è£½é€ å» ä¹‹è»Ÿç¡¬é«”è¨å‚™åŠç›¸é—œåŠ‘åž‹è¨å‚™ï¼Œæ‡‰ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„，並æ出符åˆè©²è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€‚å¦‚ä¿‚åˆ†æ®µå§”è¨—è£½é€ è€…ï¼Œå…¶è£½é€ å» æ‡‰åŒ…æ‹¬åˆ†æ®µå§”è¨—è£½é€ ä¸æ‰€æœ‰è£½ç¨‹æ¶‰åŠä¹‹å—è¨—è£½é€ å» ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ›¾æ ¸å‡†ç›¸åŒæœ‰æ•ˆæˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡ä¹‹è—¥å“許å¯è‰ï¼Œå¦‚其廢æ¢æˆ–è¨»éŠ·ä¹‹åŽŸå› èˆ‡è—¥å“療效安全性有關者，日後首家申請案應ä¾æ–°æˆåˆ†æ–°è—¥è¦å®šè¾¦ç†æŸ¥é©—登記；如其廢æ¢æˆ–è¨»éŠ·ä¹‹åŽŸå› èˆ‡è—¥å“療效安全性無關者，日後首家申請案得ä¾å¸åè—¥è¦å®šè¾¦ç†æŸ¥é©—登記。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請人如在åŒä¸€æœˆä»½å…§ç”³è«‹è—¥å“查驗登記四件以上者，應事先æ出專案申請，說明ç†ç”±ä¸¦æª¢é™„è£½é€ å» æœ‰é—œè³‡æ–™ï¼ŒåŒ…æ‹¬è—¥å“è£½é€ ã€å“質管制部門之è¨å‚™åŠå°ˆæ¥æŠ€è¡“人員ç‰è³‡æ–™ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥æˆ–派員實地檢視其å“質管制ã€ç”Ÿç”¢ç´€éŒ„ã€æ¨£å“è£½é€ éŽç¨‹åŠè—¥å“監製者é§å» 情形，以確èªå…¶ç¬¦åˆå¯¦éš›ä¸¦æœ‰è£½é€ 能力。</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å» å¦‚åˆ†åˆ¥ä¾ç¬¬äºŒå一æ¢ç¬¬ä¸‰æ¬¾æ™‚程è¦å®šå®Œæˆç¢ºæ•ˆä½œæ¥è€…，æ¯æœˆå¾—申請藥å“查驗登記三件或一年三åå…件。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 35 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請查驗登記之藥å“如係製劑者，其劑型應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŒä¸€å“å有二種以上劑型者，應分別申請查驗登記；åŒä¸€åŠ‘型，其製劑之濃度或單ä½å«é‡ä¸åŒè€…，亦應分別申請。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¹¾ç²‰æ³¨å°„劑ä¸åŒå…§å®¹é‡ï¼Œå¾—以一案申請。但其注射液濃度ä¸åŒè€…，應分別申請。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¹¾ç²‰æ³¨å°„劑如其肌肉注射與éœè„ˆæ³¨å°„所附之溶液ä¸åŒè€…，應分別申請。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è£½è—¥å·¥å» 之劑型未經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè©•é‘‘通éŽè€…，ä¸å¾—ç”³è«‹è©²åŠ‘åž‹è£½åŠ‘ä¹‹æŸ¥é©—ç™»è¨˜ã€‚ä½†å…¶å·¥å» åŠ‘åž‹ç¶“è©•é‘‘é€šéŽè»Ÿè†åŠ‘者，得申請乳è†åŠ‘ã€å‡è† 劑之查驗登記；經評鑑通éŽç³–è¡£éŒ ã€è†œè¡£éŒ è€…ï¼Œå¾—ç”³è«‹éŒ åŠ‘ã€å…§æœé¡†ç²’劑ã€å…§æœæ•£åŠ‘之查驗登記；經評鑑通éŽéŒ 劑者，得申請內æœé¡†ç²’劑ã€å…§æœæ•£åŠ‘之查驗登記。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 36 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”³è«‹æŸ¥é©—ç™»è¨˜é ˆåŸ·è¡Œä¹‹è—¥å“安定性試驗，è¦å®šå¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŸ·è¡Œå®‰å®šæ€§è©¦é©—ï¼Œæ‡‰ç ”ç©¶å‡ºè—¥å“退化曲線，據以推定有效期間，確ä¿è—¥å“使用時之有效性åŠå®‰å…¨æ€§ï¼Œä¸¦ç¬¦åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹è—¥å“安定性試驗基準。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŸ·è¡Œå®‰å®šæ€§è©¦é©—，應æ出安定性試驗書é¢ä½œæ¥ç¨‹åºåŠå…¶å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç‚ºç¢ºèªå®‰å®šæ€§è©¦é©—之充足與完整，申請人應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¹‹é€šçŸ¥ï¼Œè£œå……其他相關或必è¦è³‡æ–™ã€‚但藥å“æŸ¥é©—ç™»è¨˜ç”³è«‹æ¡ˆä»¶ï¼Œæœ‰é—œå®‰å®šæ€§è©¦é©—å ±å‘Šä¹‹åŽŸå§‹æ•¸æ“šç´€éŒ„å¾—å…é€å¯©è€Œç•™å» 商備查。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åˆ†æ®µå§”è¨—è£½é€ ä¹‹è—¥å“，其安定性試驗之執行，以能確èªè—¥å“å“質為原則，ä¸é™ç”±åˆ†æ®µå§”è¨—è£½é€ è£½ç¨‹ä¹‹å—è¨—è£½é€ å» åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 37 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”³è«‹æŸ¥é©—ç™»è¨˜é ˆåŸ·è¡Œç”Ÿé«”å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—之藥å“範åœã€å“ç›®ã€å°ç…§å“ã€è©¦é©—原則ã€æ–½è¡ŒæœŸé–“ã€æ›¿ä»£åŽŸå‰‡åŠå…¶ä»–æœ‰é—œè©¦é©—ä¹‹äº‹é …ï¼Œæ‡‰ä¾è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則之è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">執行生體å¯ç”¨çŽ‡æˆ–生體相ç‰æ€§è©¦é©—，應填具ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€å®šä¹‹è—¥å“生體相ç‰æ€§è©¦é©—計畫書申請表ã€è—¥å“生體相ç‰æ€§è©¦é©—å ±å‘Šæ›¸ç”³è«‹è¡¨ã€è—¥å“生體å¯ç”¨çŽ‡è©¦é©—計畫書申請表ã€è—¥å“生體å¯ç”¨çŽ‡è©¦é©—å ±å‘Šæ›¸ç”³è«‹è¡¨ã€æº¶é›¢çŽ‡æ›²ç·šæ¯”å°å ±å‘Šç”³è«‹è¡¨ï¼Œä¸¦ä¾æ›¸è¡¨æ‰€è¼‰äº‹é …備齊相關資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請新æˆåˆ†æ–°è—¥æŸ¥é©—登記，得å…附出產國許å¯è£½å”®è‰æ˜ŽåŠæŽ¡ç”¨è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …申請，如檢附出產國許å¯è£½å”®è‰æ˜ŽåŠæŽ¡ç”¨è‰æ˜Žè€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—視實際情æ³ï¼Œèª¿æ•´å¯©æŸ¥æµç¨‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請新療效複方ã€æ–°ä½¿ç”¨é€”徑ã€æ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘查驗登記，未附出產國許å¯è£½å”®è‰æ˜Žè€…ï¼Œæ‡‰æ–¼é ˜è‰å‰è£œé½Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">出產國許å¯è£½å”®è‰æ˜Žå¦‚係屬å大醫藥先進國者出具，視為已檢附å大醫藥先進國家ä¸ä¸€åœ‹ä¹‹æŽ¡ç”¨è‰æ˜Žã€‚申請者檢é€ä¹‹æŽ¡ç”¨è‰æ˜Žï¼ŒåˆŠè¼‰ä¹‹ç”¢å“è£½é€ å» å稱ã€åœ°å€åŠè™•æ–¹å…§å®¹ã€åŠ‘åž‹ã€å«é‡ï¼Œèˆ‡ç”³è«‹ä¹‹æ–°è—¥ç›¸åŒè€…，視為已檢附出產國許å¯è£½å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38-1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請新æˆåˆ†æ–°è—¥æŸ¥é©—登記，除ä¾ç¬¬ä¸‰åä¹æ¢è¦å®šå¤–，å¦æ‡‰æ供下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç ”發階段在我國進行第一期（</span><span style="font-family: calibri;">Phase I</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">åŠèˆ‡åœ‹å¤–åŒæ¥é€²è¡Œç¬¬ä¸‰æœŸæ¨žç´æ€§è‡¨åºŠè©¦é©—（</span><span style="font-family: calibri;">Phase III Pivotal Trial</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">，或與國外åŒæ¥åœ¨æˆ‘國</span> <span style="font-family: 新細明體,serif;">進行第二期臨床試驗（</span><span style="font-family: calibri;">Phase II</span><span style="font-family: 新細明體,serif;">）åŠç¬¬ä¸‰æœŸæ¨žç´æ€§è‡¨åºŠè©¦é©—（</span><span style="font-family: calibri;">PhaseIII Pivotal Trial</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¸Šå¸‚後風險管ç†è¨ˆç•«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¯¦æ–½åœ‹å¤–æŸ¥æ ¸ä¹‹å¿…è¦è€…，應é…åˆå…¶æŸ¥æ ¸è¦æ±‚，且備齊相關資料。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …第一款試驗之çµæžœï¼Œæ‡‰ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥é€šéŽï¼Œè©¦é©—è¨è¨ˆæ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è©¦é©—性質屬第一期（</span><span style="font-family: calibri;">Phase I</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">，如藥動å¸è©¦é©—（</span><span style="font-family: calibri;">PK study</span><span style="font-family: 新細明體,serif;">）或藥效å¸è©¦é©—（</span><span style="font-family: calibri;">PD study</span><span style="font-family: 新細明體,serif;">）ç‰ï¼Œæˆ‘國å¯è©•ä¼°ä¹‹å—試者人數至少å人為原則。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¬¬äºŒæœŸï¼ˆ</span><span style="font-family: calibri;">Phase II</span><span style="font-family: 新細明體,serif;">）之臨床試驗，我國å¯è©•ä¼°ä¹‹å—試者人數至少二å人為原則。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¬¬ä¸‰æœŸæ¨žç´æ€§è‡¨åºŠè©¦é©—（</span><span style="font-family: calibri;">Phase III Pivotal Trial</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">，我國å¯è©•ä¼°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之å—試者人數至少八å人為原則，且足以顯示我國與國外試驗çµæžœç›¸ä¼¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å‰ä¸‰æ¬¾æˆ–其他å°è—¥å“å“質安全ã€ç™‚æ•ˆæœ‰é¡¯è‘—æ”¹é€²ï¼Œæˆ–é€ ç¦æˆ‘國民眾ã€æˆ–特殊情æ³ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šè€…，得視實際情æ³èª¿æ•´åŸ·è¡Œè©¦é©—數目åŠå—試者人數。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38-2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請新æˆåˆ†æ–°è—¥æŸ¥é©—登記，檢附å大醫藥先進國家ä¸ä¹‹ä¸€åœ‹æŽ¡ç”¨è‰æ˜Žè€…，除ä¾ç¬¬ä¸‰åä¹æ¢è¦å®šå¤–，å¦æ‡‰æä¾›å¯è‰æ˜Žå°åœ‹äººç”¨è—¥ä¹‹å®‰å…¨æ€§ã€æœ‰æ•ˆæ€§å…·è‡¨åºŠä¸Šã€çµ±è¨ˆå¸ä¸Šæœ‰æ„義之臨床試驗，且其試驗çµæžœï¼Œæ‡‰ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥é€šéŽã€‚å¿…è¦æ™‚，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—å¦è¦æ±‚檢附上市後風險管ç†è¨ˆç•«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …臨床試驗，應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åœ¨æˆ‘國執行之臨床試驗，其試驗性質屬第一期（</span><span style="font-family: calibri;">Phase I</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">，如藥動å¸è©¦é©—（</span><span style="font-family: calibri;">PK study</span><span style="font-family: 新細明體,serif;">）或藥效å¸è©¦é©—（</span><span style="font-family: calibri;">PD study</span><span style="font-family: 新細明體,serif;">）ç‰ï¼Œå¯è©•ä¼°ä¹‹å—試者人數至少å人為原則。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¤šåœ‹å¤šä¸å¿ƒä¹‹ç¬¬äºŒæœŸè‡¨åºŠè©¦é©—（</span><span style="font-family: calibri;">Phase II study</span><span style="font-family: 新細明體,serif;">），我國å¯è©•ä¼°ä¹‹å—試者人數至少二å人為原則，或我國å—試者人數å 總人數百分之å以上。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¤šåœ‹å¤šä¸å¿ƒä¹‹ç¬¬ä¸‰æœŸè‡¨åºŠè©¦é©—（</span><span style="font-family: calibri;">Phase III study</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">，我國å¯è©•ä¼°ä¹‹å—試者人數至少八å人為原則，或我國å—試者人數å 總人數百分之å以上。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æœ‰å大醫藥先進國家之一åƒèˆ‡ä¹‹å¤šåœ‹å¤šä¸å¿ƒç¬¬ä¸‰æœŸè‡¨åºŠè©¦é©—（</span><span style="font-family: calibri;">PhaseIII study</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">ï¼Œä¸”å…¶è©¦é©—å ±å‘Šå°‡å‘美國</span><span style="font-family: calibri;"> FDA </span><span style="font-family: 新細明體,serif;">或æ盟</span><span style="font-family: calibri;"> EMA </span></p><p><span style="font-family: 新細明體,serif;">申請查驗登記之臨床資料，並符åˆä¸‹åˆ—æ¢ä»¶ä¹‹ä¸€è€…：</span> </p><p><span style="font-family: 新細明體,serif;">（一）單次試驗總å—試者人數二百人（å«ï¼‰ä»¥ä¸Šï¼Œæˆ‘國å¯è©•ä¼°ä¹‹å—試者人數至少三å人為原則，或我國å—試者比例å 總人數百分之五以上。</span> </p><p><span style="font-family: 新細明體,serif;">（二）單次試驗總å—試者人數二百人以下，我國å¯è©•ä¼°ä¹‹å—試者人數至少å人為原則。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å…¶ä»–å°è—¥å“å“質安全ã€ç™‚æ•ˆæœ‰é¡¯è‘—æ”¹é€²ï¼Œæˆ–é€ ç¦æˆ‘國民眾ã€æˆ–特殊情æ³ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šè€…，得視實際情æ³ï¼Œèª¿æ•´å‰å››æ¬¾åŸ·è¡Œè©¦é©—數目åŠå—試者人數。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38-3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾å‰äºŒæ¢è¦å®šé€²è¡Œä¹‹è‡¨åºŠè©¦é©—çµæžœï¼Œç¶“申請ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…，得å…除或替代銜接性試驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38-4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請新æˆåˆ†æ–°è—¥æŸ¥é©—登記，如檢附å大醫藥先進國家二國以上之採用è‰æ˜Žè€…，除ä¾ç¬¬ä¸‰åä¹æ¢è¦å®šå¤–，ä»éœ€ä¾ç¬¬äºŒå二æ¢ä¹‹ä¸€è¦å®šè¾¦ç†ã€‚å¿…è¦æ™‚，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—è¦æ±‚檢附上市後風險管ç†è¨ˆç•«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 39 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請新藥ã€æ–°åŠ‘åž‹ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘查驗登記應檢附資料，è¦å®šå¦‚附件二åŠé™„件三。</span> </p><p><span style="font-family: 新細明體,serif;">新劑型ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡è£½åŠ‘ï¼Œæº–ç”¨æœ¬ç« æ–°è—¥ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請å¸å藥查驗登記應檢附資料，è¦å®šå¦‚附件四åŠé™„件五。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 41 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請生物藥å“查驗登記應檢附資料，è¦å®šå¦‚附件å…åŠé™„件七。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 42 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請原料藥查驗登記應檢附資料，è¦å®šå¦‚附件八åŠé™„件ä¹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 43 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”³è«‹æ ¸é†«æ”¾å°„æ€§è—¥å“查驗登記應檢附資料，è¦å®šå¦‚附件ååŠé™„件å一。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …申請應符åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹æ ¸é†«æ”¾å°„性藥臨床試驗基準åŠæ ¸é†«æ”¾å°„性藥å“審查基準。</span> </p><p><span style="font-family: 新細明體,serif;">新劑型ã€æ–°åŠ‘é‡ä¹‹æ ¸é†«æ”¾å°„性藥å“ï¼Œæº–ç”¨æœ¬ç« æ–°è—¥ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 44 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請外銷專用許å¯è‰æŸ¥é©—登記，應檢附藥å“查驗登記申請書æ£å‰¯æœ¬ã€åˆ‡çµæ›¸ï¼ˆç”²ï¼‰ã€åˆ‡çµæ›¸ï¼ˆä¹™ï¼‰ã€å¤–銷專用切çµæ›¸ã€ä»¿å–®æ¨™ç±¤é»è²¼è¡¨äºŒä»½ã€è‰ç…§é»è²¼è¡¨ã€æœ‰æ•ˆæˆåˆ†æª¢é©—è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸ã€æˆå“檢驗è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸ã€ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€‚å…¶è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼ˆåŒ…æ‹¬æ‰¹æ¬¡ç´€éŒ„ä¸ä¹‹ä¸‹æ–™é‡ï¼‰ã€æ‰¹æ¬¡è£½é€ 紀錄ã€è³¦å½¢åŠ‘檢驗è¦æ ¼èˆ‡æ–¹æ³•åŠæˆç¸¾æ›¸ã€å®‰å®šæ€§è©¦é©—資料ã€åˆ†æžæ–¹æ³•ç¢ºæ•ˆè³‡æ–™ã€é—œéµæ€§è£½ç¨‹ç¢ºæ•ˆè³‡æ–™ç‰ï¼Œæ‡‰ç•™å» 商備查。如經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªæœ‰å¿…è¦è€…，申請人並應é…åˆé€é©—樣å“。</span> </p><p><span style="font-family: 新細明體,serif;">申請外銷專用許å¯è‰æŸ¥é©—登記，如係輸入åŠæˆå“æ–¼åœ‹å…§è£½é€ æˆæˆå“å†å¤–銷，且æŒæœ‰å«è©²åŠæˆå“之輸入許å¯è‰è€…，除é©ç”¨å‰é …è¦å®šå¤–，應å¦é™„委託書æ£æœ¬ï¼Œè¼‰æ˜ŽæŽˆæ¬Šç”³è«‹äººæ–¼åœ‹å…§ç™»è¨˜åŠå¤–銷他國販賣。如未æŒæœ‰å«è©²åŠæˆå“之輸入許å¯è‰è€…，並應å†åŠ 附å«è©²åŠæˆå“之出產國許å¯è£½å”®è‰æ˜Žæˆ–è£½é€ è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">ç™»è¨˜äº‹é …ä¹‹è®Šæ›´</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 45 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“ç™»è¨˜äº‹é …è®Šæ›´ï¼Œå¦‚ä¾è¦å®šæ‡‰åŸ·è¡Œå®‰å®šæ€§è©¦é©—者，其安定性試驗之執行åŠæ‡‰æª¢é€è³‡æ–™å¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“å„é …è®Šæ›´ï¼Œä¾è¦å®šé ˆæª¢é™„å®‰å®šæ€§è©¦é©—å ±å‘Šè³‡æ–™è€…ï¼Œå‡æ‡‰ä¾è—¥å“安定性試驗基準之è¦å®šï¼Œä»¥è®Šæ›´å¾Œä¹‹è—¥å“一批，執行å…å€‹æœˆä¹‹åŠ é€Ÿè©¦é©—åŠé”宣稱效期之長期試驗安定性試驗。申請變更登記時，應檢é€è‡³å°‘ä¸‰å€‹æœˆä¹‹åŠ é€Ÿå®‰å®šæ€§è³‡æ–™ï¼Œå…¶é¤˜åŠ é€Ÿè©¦é©—åŠé•·æœŸè©¦é©—çµæžœèˆ‡å®‰å®šæ€§è©¦é©—之書é¢ä½œæ¥è³‡æ–™åŠå¯¦é©—數據ç‰ï¼Œæ‡‰ç•™å» 商備查。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“有效期間變更者，應以市售å“三批執行包括é”有效期間之長期試驗，並經統計分æžã€‚但其原許å¯è‰ä¿‚於民國ä¹å年一月一日å‰æ出藥å“查驗登記申請者，得自行決定ä¾è—¥å“安定性試驗基準執行儲å˜è©¦é©—或長期試驗。æ·å¹´å®‰å®šæ€§è©¦é©—之書é¢ä½œæ¥è³‡æ–™èˆ‡å¯¦é©—數據åŠå…¶ä»–ç›¸é—œè³‡æ–™æ‡‰ç•™å» å•†å‚™æŸ¥ï¼Œç„¡éœ€å†ç”³è«‹è®Šæ›´ç™»è¨˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è¦å®šç•™å» 商備查之資料，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥æ供時，申請人應å³æå‡ºç›¸é—œè³‡æ–™ä»¥ä¾›æŸ¥æ ¸ã€‚å¦‚ç¶“æŸ¥æ ¸ç™¼ç¾æœ‰ä¸å¯¦è€…，申請人應回收市售藥å“，並ä¾æœ¬æ³•æœ‰é—œè¦å®šè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 46 </span><span style="font-family: 新細明體,serif;">æ¢</span> <span style="font-family: 新細明體,serif;">申請變更登記之藥å“，如其查驗登記時已執行生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—者，其後辦ç†è®Šæ›´ç™»è¨˜ä¹‹è¦å®šå¦‚下：</span> </p><p><span style="font-family: calibri;">一ã€</span><span style="font-family: 新細明體,serif;">主è¦æ”¹è®ŠåŠæ¬¡è¦æ”¹è®Šä¹‹å®šç¾©ï¼Œä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …è¦</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">定èªå®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€è£½åŠ‘如涉åŠè£½é€ 變更者，應檢附資料如下：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（一）屬主è¦æ”¹è®Šè€…，應檢附生體相ç‰æ€§è©¦é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（二）屬次è¦æ”¹è®Šè€…，應檢附溶離率曲線比å°å ±å‘Šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€è£½åŠ‘如涉åŠè£½é€ å ´æ‰€è®Šæ›´è€…ï¼Œæ‡‰æª¢é™„è³‡æ–™å¦‚ä¸‹ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（一）é…方與製程比å°ï¼ŒåŒ…括原料來æºã€è¦æ ¼åŠè£½é€ è¨å‚™ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（二）溶離率曲線比å°è³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（三）如經判定屬主è¦æ”¹è®Šæˆ–資料ä¸è¶³è€…，應å¦æª¢é€ç”Ÿé«”相ç‰æ€§è©¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€ç”³è«‹è®Šæ›´ä¹‹è—¥å“，如涉åŠé…方與製程之多é‡æ”¹è®Šè€…，ä¾å…¶å„別</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之變更範åœè¾¦ç†ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">五ã€æ‰€æœ‰ç”Ÿé«”相ç‰æ€§è©¦é©—，å‡å¾—以生體å¯ç”¨çŽ‡é€£åŒè‡¨åºŠè©¦é©—å ±å‘Šæ›¿</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">代之。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…ã€åŸ·è¡Œä¹‹ç”Ÿé«”å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—，應符åˆè—¥å“生體å¯ç”¨çŽ‡</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則之è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å·²æ ¸å‡†ä¸Šå¸‚ä¹‹è—¥å“ï¼Œå» å•†è‡ªè¡Œç”³è«‹åŸ·è¡Œç”Ÿé«”ç›¸ç‰æ€§è©¦é©—ä¸¦å…¶å ±å‘Šç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æ ¸é€šéŽï¼Œå¦‚其後涉åŠè£½é€ èˆ‡å…¶å ´æ‰€ä¹‹è®Šæ›´è€…ï¼Œæº–ç”¨å‰é …è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">供生體å¯ç”¨çŽ‡æˆ–生體相ç‰æ€§è©¦é©—之藥å“批é‡ï¼Œä»¥æœ€ä½Žä¸å¾—少於一è¬é¡†ç‚ºåŽŸå‰‡ï¼Œå¦‚有特殊情æ³ï¼Œä¸åœ¨æ¤é™ã€‚但ä»ä¸å¾—低於生產批é‡ä¹‹å分之一。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 47 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入藥å“è®Šæ›´ç™»è¨˜é ˆæª¢é™„ä¹‹åŽŸå» è®Šæ›´é€šçŸ¥å‡½ï¼Œæ‡‰ç”±åŽŸç™»è¨˜è£½é€ å» æˆ–å…¶ç¸½å…¬å¸ã€æˆ–國外許å¯è‰æŒæœ‰è€…出具è‰æ˜Žå‡½æ£æœ¬ï¼Œä¸¦é™å‡ºå…·æ—¥èµ·ä¸€å¹´å…§æœ‰æ•ˆï¼Œä¸”å…¶æ‰€è¼‰ä¹‹å» åã€å» å€å‡æ‡‰èˆ‡åŽŸæ ¸å®šç›¸ç¬¦ï¼Œä¸å¾—以關係ä¼æ¥ã€ä»£ç†å•†ã€ç¶“銷商出具，或æŒé›»å ±ã€å ±åƒ¹å–®æˆ–電傳資料替代。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 48 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“製劑之仿單ã€æ¨™ç±¤ã€åŒ…è£è®Šæ›´ï¼Œç¬¦åˆä¸‹åˆ—情形之一者，得自行變更。</span> </p><p><span style="font-family: 新細明體,serif;">但其變更應符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„，於書é¢ä½œæ¥ç¨‹åºè©³å¯¦ä¿®æ£ä¸¦ä½œç´€éŒ„ï¼Œä¸”éœ€ç•™å» å•†å‚™æŸ¥ï¼Œä¸¦å…¶å¸‚å”®å“應ä¾æœ‰é—œæ³•ä»¤è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸæ ¸å‡†æ–‡å—內容未變更者，包括如下：</span> </p><p><span style="font-family: 新細明體,serif;">（一）僅標籤ã€ä»¿å–®ã€å¤–盒圖樣或色澤之變更。但ä¸å¾—有涉åŠçŒ¥è¤»ã€æœ‰å‚·é¢¨åŒ–或誤導效能之圖樣。</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆäºŒï¼‰å› åŒ…è£æ•¸é‡ä¸åŒè€Œä¾æ¯”例縮å°æˆ–æ”¾å¤§åŽŸæ ¸å‡†ä¹‹åœ–æ–‡ï¼Œæˆ–æ›´æ”¹åŽŸæ ¸å‡†åœ–æ–‡ä½ç½®ä¹‹ç‰ˆé¢ç§»å‹•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆä¸‰ï¼‰åŽŸæ ¸å‡†æ–‡å—之å—體更改。但其å“å英文å—é«”ä¸å¾—大於ä¸æ–‡å—體。</span> </p><p><span style="font-family: 新細明體,serif;">（四）ä¼æ¥è˜åˆ¥ç³»çµ±ï¼ˆ</span><span style="font-family: calibri;">CIS</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">ã€é˜²å½æ¨™ç±¤ä¹‹åŠ å°æˆ–更改。</span> </p><p><span style="font-family: 新細明體,serif;">（五）由標籤é»è²¼æ”¹ç‚ºå¤–ç›’å°åˆ·æˆ–å¢žåŠ å¤–ç›’è€…ã€‚ä½†å…¶æ–‡å—ã€åœ–樣之è¨è¨ˆæ‡‰èˆ‡åŽŸæ ¸å‡†æ¨™ç±¤ç›¸åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（å…）åŒä¸€æ³¨å°„劑ä¸åŒåŒ…è£é‡ä¹‹æ¨™ç±¤å¤–盒，得以相åŒåœ–樣ã€æ–‡å—而ä¸åŒè‰²ç³»ä¹‹æ¨™ç±¤å¤–盒，以資å€åˆ†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ–‡å—內容雖有變更，但ä¸æ¶‰åŠè—¥å“å“質ã€ç”¨è—¥å®‰å…¨è€…：</span> </p><p><span style="font-family: 新細明體,serif;">（一）增å°æˆ–變更æ¢ç¢¼ã€å¥ä¿ä»£ç¢¼ã€è˜åˆ¥ä»£ç¢¼ã€</span><span style="font-family: calibri;">GMP </span><span style="font-family: 新細明體,serif;">è—¥å» ä¹‹</span><span style="font-family: calibri;"> GMP </span><span style="font-family: 新細明體,serif;">å—樣ã€ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ç™»è¨˜ä¹‹è‘—作權登記å—號或公å¸å•†æ¨™ã€è¨»å†Šå•†æ¨™å—號或專利è‰æ›¸å—號。</span> </p><p><span style="font-family: 新細明體,serif;">（二）防å½å°ˆç·šä¹‹åŠ å°æˆ–更改。指示藥å“åŠæˆè—¥å¢žå°æˆ–變更建è°å”®åƒ¹æˆ–消費者æœå‹™å°ˆç·šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（三）經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è®Šæ›´è—¥å•†å稱ã€è£½é€ å» å稱或地å€ï¼Œèˆ‡å¢žå°æˆ–變更電話ã€å‚³çœŸã€é€£çµ¡è™•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（四）增å°æˆ–變更經銷商å稱ã€åœ°å€ã€‚但經銷商å稱之å—é«”ä¸å¾—大於藥商（許å¯è‰æŒæœ‰è€…）å稱之å—體，且經商應具有藥商許å¯åŸ·ç…§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ï¼ˆäº”ï¼‰å¢žåŠ å°å£æ¨™ç¤ºï¼ˆå¤–盒）或更改其標示，包括價ä½æ¨™ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（å…）輸出藥å“，ä¾å¤–銷國之è¦æ±‚於標籤ã€ä»¿å–®ä¸Šå¢žåˆ—é …ç›®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（七）為藥å“å¸‚å ´å€éš”æ‰€éœ€ï¼Œæ–¼åŽŸæ ¸å®šåŒ…è£ä¸ŠåŠ 註本藥é™ç”±æŸé†«é™¢ä½¿ç”¨ã€æˆ–é™ä¾›é†«é™¢ç”¨ï¼Œä¸å¾—轉售åŠå…¶ä»–é©ç•¶è¾å¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（八）英文å“ååŠ è¨»ä¹‹å» å增刪或變更。</span> </p><p><span style="font-family: 新細明體,serif;">（ä¹ï¼‰è™•æ–¹ä¹‹å–®ä½æ¨™ç¤ºæ–¹å¼æ›´æ”¹ï¼Œç¬¦åˆä¸è¯è—¥å…¸è€…。</span> </p><p><span style="font-family: 新細明體,serif;">（å）於ä¸å½±éŸ¿åŽŸè¨‚貯è—法情形下，å°æ•´åˆå…¶è²¯è—法之用詞改變。但其用詞應ä¾ä¸è¯è—¥å…¸ç”¨è©žè¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç‚ºç¶è·è—¥å“å“質åŠç”¨è—¥å®‰å…¨ï¼Œè€ŒåŠ 註使用方法之文å—內容變更者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 49 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å·²é ˜æœ‰è¨±å¯è‰ä¹‹è—¥å“，如原列屬於指示藥或其後列屬於指示藥å“審查基準之類別者，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …è¦å®šè¾¦ç†ã€‚逾期未辦ç†è€…，ä¾æœ¬æ³•æœ‰é—œè¦å®šè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 50 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“ä¸ã€è‹±æ–‡å“å變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¦‚係國產藥å“之ä¸ã€è‹±æ–‡å“å或輸入藥å“之ä¸æ–‡å“å變更，應å¦é™„切çµæ›¸ï¼ˆç”²ï¼‰ï¼›å¦‚æŒæœ‰ç¶“濟部智慧財產局商標註冊è‰æˆ–æ ¸å‡†å¯©å®šæ›¸è€…ï¼Œå¾—é™„å…¶å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係輸入藥å“之英文å“å變更，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½èˆ‡å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 51 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“類別變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å®‰å…¨æ€§è©¦é©—ã€è‡¨åºŠæ–‡ç»åŠå大醫藥先進國家藥典或醫藥å“集收載情形。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係輸入藥å“，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œè©•ä¼°æ‡‰è®Šæ›´é¡žåˆ¥è€…，得å…附å‰é …第三款åŠç¬¬å››æ¬¾è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如涉åŠé ˆæ›è‰è€…，應å¦é™„查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 52 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“åŠ‘åž‹ä¹‹è®Šæ›´ï¼Œä»¥éŒ åŠ‘ã€ç³–è¡£éŒ ã€è†œè¡£éŒ 之間或乳è†åŠ‘ã€è»Ÿè†åŠ‘之間互為變更，或符åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ›¾æ ¸å‡†ç›¸åŒæœ‰æ•ˆæˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡ä¹‹å¤–用å‡è† 劑與乳è†åŠ‘ã€è»Ÿè†åŠ‘之間互為變更為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請å‰é …劑型變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è£½é€ 管制標準書，或與æˆå“åŒæ‰¹æ¬¡ä¹‹æ‰¹æ¬¡è£½é€ 紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å®‰å®šæ€§è©¦é©—資料。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚係國產藥å“，應å¦é™„æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€åˆ‡çµæ›¸ï¼ˆç”²ï¼‰åŠå·¥å» 登記è‰å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚係輸入藥å“，應å¦é™„該批次使用之原料與æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€åŽŸå» 變更通知函åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 53 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“之有效æˆåˆ†ä¸å¾—ä»»æ„變更，如有變更，應é‡æ–°ç”³è«‹æŸ¥é©—登記。但如符åˆä¸‹åˆ—情形之一，得以申請處方變更登記之方å¼è¾¦ç†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸè¨±å¯è‰æœªåˆ—鹽類之ç¶ç”Ÿç´ è£½åŠ‘ï¼Œåƒ…åŠ è¨»é¹½é¡žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æŠ—ç”Ÿç´ é¡žè£½åŠ‘åŽŸç‚ºé‡é‡æ¨™ç¤ºï¼Œæ”¹ç‚ºä»¥åŠ›åƒ¹æ¨™ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šè™•æ–¹æˆåˆ†ç¦ç”¨æˆ–å®‰å…¨å ªè™žï¼Œæ‡‰ä¿®æ£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係輸入藥å“，應å¦é™„å…¶åŽŸå» ä¹‹è£½é€ æ–¹æ³•ã€æª¢é©—方法ã€è¦æ ¼ã€å®‰å®šæ€§æˆ–è—¥å“å†è©•ä¼°ï¼Œç¶“由出產國最高衛生主管機關出具è‰æ˜Žæ‡‰è®Šæ›´è™•æ–¹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請藥å“處方變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è£½é€ 管制標準書，或與æˆå“åŒæ‰¹æ¬¡ä¹‹æ‰¹æ¬¡è£½é€ 紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å®‰å®šæ€§è©¦é©—資料。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åˆ‡çµæ›¸ï¼ˆç”²ï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚係國產藥å“，應å¦é™„æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¦‚係輸入藥å“，應å¦é™„該批次使用之原料與æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€åŽŸå» 變更通知函åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“有下列情形之一，應é‡æ–°ç”³è«‹æŸ¥é©—登記，ä¸å¾—以申請處方變更登記之方å¼è¾¦ç†ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŒä¸€æˆåˆ†ä¸åŒå«é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŽŸè£½é€ å» ä¸å†è£½é€ åŽŸæ ¸å®šè—¥å“，而以新產å“替代原登記藥å“，且å“åã€è™•æ–¹å‡èˆ‡åŽŸæ ¸å®šä¸åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 54 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“é©æ‡‰ç—‡è®Šæ›´ç™»è¨˜ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ‰€å®£ç¨±é©æ‡‰ç—‡ä¹‹è©³ç´°è‡¨åºŠæ–‡ç»å ±å‘ŠäºŒä»½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係國產藥å“，應å¦é™„å«å…¶æ–°é©æ‡‰ç—‡ä¹‹å…¬å®šæ›¸ä¾æ“šã€‚如係輸入藥å“，應å¦é™„經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯åœ‹å®¶æ‰€æ ¸å‡†è©²é©æ‡‰ç—‡ä¹‹è‰æ˜Žï¼Œè©²è‰æ˜Žä¸¦æ‡‰ç¶“我國é§å¤–館處簽è‰ï¼›å¦‚未能於申請時檢附者，得先檢附åå¤§é†«è—¥å…ˆé€²åœ‹å®¶æœ€é«˜è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ‰€æ ¸ç™¼ä¹‹æ ¸å‡†å‡½å½±æœ¬åŠæ ¸å‡†ä»¿å–®ï¼Œä¸¦æ–¼ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å‰è£œé½Šè©²è‰æ˜ŽåŠç°½è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ¨™ç±¤ã€ä¸æ–‡ä»¿å–®ã€å¤–ç›’ã€é‹ç®”片實體或彩色照片或其擬稿å„二份；如係輸入藥å“，應å¦é™„外文仿單二份。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è¼¸å…¥è—¥å“應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å¦‚é¦–å®¶ç”³è«‹å¢žåŠ æ–°é©æ‡‰ç—‡ä¹‹å» 商於國內執行臨床試驗並所附資料能è‰å¯¦è©²æ–°é©æ‡‰ç—‡ä¹‹ç™‚效åŠå®‰å…¨æ€§è€…，得å…附å‰é …第四款資料。</span> </p><p><span style="font-family: 新細明體,serif;">é¦–å®¶ç”³è«‹å¢žåŠ æ–°é©æ‡‰ç—‡ï¼ˆå«è®Šæ›´é©æ‡‰ç—‡åŠæ–°å¢žé©æ‡‰ç—‡ï¼‰ä¹‹å» 商，得自行決定是å¦åŸ·è¡Œåœ‹å…§è‡¨åºŠè©¦é©—。如有執行國內臨床試驗並所附資料能è‰å¯¦è©²æ–°é©æ‡‰ç—‡ä¹‹ç™‚效åŠå®‰å…¨æ€§è€…，自其ç²å‡†å¢žåŠ æ–°é©æ‡‰ç—‡ä¹‹æ—¥èµ·äº”年內，其他申請相åŒæˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡è¨±å¯è‰ä¹‹æŸ¥é©—登記宣稱具有該é©æ‡‰ç—‡ã€æˆ–已有相åŒæˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡è¨±å¯è‰ç”³è«‹å¢žåŠ 該é©æ‡‰ç—‡ä¹‹å» 商，應ä¾ç¬¬ä¸€é …第一款ã€ç¬¬äºŒæ¬¾åŠç¬¬äº”款至第七款è¦å®šæª¢é™„資料，並應å¦é™„èˆ‡é¦–å®¶å» å•†ç›¸åŒæ¨™æº–ä¹‹åœ‹å…§è‡¨åºŠè©¦é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如首家ç²å‡†å¢žåŠ æ–°é©æ‡‰ç—‡ï¼ˆå«è®Šæ›´é©æ‡‰ç—‡åŠæ–°å¢žé©æ‡‰ç—‡ï¼‰ä¹‹å» 商未執行國內臨床試驗或雖有執行國內臨床試驗但其ç²å‡†å¢žåŠ æ–°é©æ‡‰ç—‡ä¹‹æ—¥å·²é€¾äº”年者，其他申請相åŒæˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡è¨±å¯è‰ä¹‹æŸ¥é©—登記宣稱具有該é©æ‡‰ç—‡æˆ–已有相åŒæˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡è¨±å¯è‰ç”³è«‹å¢žåŠ 該é©æ‡‰ç—‡ä¹‹å» 商，應ä¾ç¬¬ä¸€é …第一款ã€ç¬¬äºŒæ¬¾åŠç¬¬äº”款至第七款è¦å®šæª¢é™„資料。</span> </p><p><span style="font-family: 新細明體,serif;">ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹çµ±ä¸€é©æ‡‰ç—‡è€Œè‡ªè¡Œä¿®è¨‚標仿單者，於申請é©æ‡‰ç—‡è®Šæ›´ç™»è¨˜æ™‚，應檢附藥å“變更登記申請書åŠè—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 55 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“用法用é‡è®Šæ›´ç™»è¨˜ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£ã€åé¢å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ‰€å®£ç¨±ç”¨æ³•ç”¨é‡ä¹‹è©³ç´°è‡¨åºŠæ–‡ç»å ±å‘ŠäºŒä»½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ¨™ç±¤ã€ä¸æ–‡ä»¿å–®ã€å¤–ç›’ã€é‹ç®”片實體或彩色照片或其擬稿å„二份；如係輸入藥å“，應å¦é™„外文仿單二份。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å…¬å®šæ›¸å½±æœ¬æˆ–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹æ ¸å‡†ç”¨æ³•ç”¨é‡ä¹‹è‰æ˜Žä¸”經我國é§å¤–館處簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¦‚係輸入藥å“，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è®Šæ›´å‰ã€å¾Œä¹‹ç”¨æ³•ç”¨é‡å°ç…§è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 56 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“賦形劑變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¦‚賦形劑變更足以影響藥å“特性者，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ï¼Œå°‡è—¥å“é€é©—並附檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸å„二份ã€å®‰å…¨æ€§ä¹‹è³‡æ–™ã€ç”Ÿé«”相ç‰æ€§è©¦é©—資料åŠå®‰å®šæ€§è©¦é©—資料。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“許å¯è‰å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係輸入藥å“，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">已執行生體相ç‰æ€§è©¦é©—之製劑申請å‰é …變更登記時，應å¦ä¾ç¬¬å››åå…æ¢è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如藥å“之有效æˆåˆ†ã€åŠ‘åž‹ã€åŠ‘é‡ã€ç”¨é€”å‡ç›¸åŒï¼Œå…¶ä¸å…·ä»»ä½•è—¥ç†ä½œç”¨é¦™æ–™ã€è‰²ç´ ã€çŸ¯å‘³åŠ‘之外觀或形狀變更，ä¸å½±éŸ¿è—¥å“å“質åŠæ°‘眾用藥安全者，得以賦形劑變更方å¼ï¼Œæª¢é€è³‡æ–™å¢žåŠ 上述組æˆã€‚但其藥å“標籤ã€ä»¿å–®åŠå¤–盒包è£æ‡‰æœ‰é©ç•¶æ–‡å—敘述，以明顯å€åˆ¥ï¼Œè‡³å…¶åœ–案ã€é¡è‰²å¾—é…åˆæ–‡å—敘述有ä¸åŒçµ„æˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 57 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“檢驗è¦æ ¼ã€æ–¹æ³•ã€å¤–觀變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£ã€åé¢å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è®Šæ›´å¾Œä¹‹è—¥å“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸å„二份，並說明新舊二è¦æ ¼ä¹‹å·®ç•°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係輸入藥å“，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“之檢驗è¦æ ¼ã€æ–¹æ³•å¦‚ä¿‚ä¾æ“šè—¥å…¸æ›´æ–°è€…，應於變更登記申請書ä¸è¨˜æ˜Žæ‰€ä¾æ“šè—¥å…¸ä¹‹å稱ã€å¹´æ¬¡ã€ç‰ˆæ¬¡åŠé 數；其藥典並以ä¸è¯è—¥å…¸ã€å大醫藥先進國家出版之藥典或其他經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŽ¡ç”¨ä¹‹è—¥å…¸ç‚ºé™ï¼Œä¸”版本é™å‡ºç‰ˆæ—¥èµ·äº”年內，並得å…附å‰é …第三款資料。但詳細資料åŠåŽŸå§‹æ•¸æ“šæ‡‰ç•™å» 商備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 58 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“直接包è£æ質變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å®‰å®šæ€§è©¦é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係注射劑，應å¦é™„æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ï¼›å¦‚以注射é‡ç’æˆ–å¡‘è† è»Ÿè¢‹ç‚ºå®¹å™¨è€…ï¼Œä¸¦æ‡‰é™„è©²å®¹å™¨ä¹‹æª¢é©—è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚係國產注射劑，應å¦é™„處方ä¾æ“šå½±æœ¬ã€‚如未能æ出處方ä¾æ“šè€…，應檢附包è£æ質安全性資料，並ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥è¾¦ç†é€é©—手續。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚係輸入藥å“，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¦‚ä¿‚æ³¨å°„åŠ‘å¢žåŠ è»Ÿè¢‹åŒ…è£ï¼Œæ‡‰å¦é™„è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸æˆ–èˆ‡æˆå“åŒæ‰¹æ¬¡ä¹‹æ‰¹æ¬¡è£½é€ 紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 59 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請注射液充填é‡ä¹‹è®Šæ›´ï¼Œä»¥å–®ä½å«é‡ä¸è®ŠåŠå®¹å™¨æ質ä¸è®Šç‚ºé™ï¼Œå…¶è®Šæ›´ç™»è¨˜æ‡‰æª¢é™„資料如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¦‚係國產藥å“，應å¦é™„用法用é‡ä¾æ“šå½±æœ¬ï¼›å¦‚係輸入藥å“，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚ä¿‚å……å¡«é‡è®Šå°è€…，應å¦é™„安定性試驗資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 60 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商å稱變更如ä¸æ¶‰åŠæ¬Šåˆ©ç§»è½‰è€…，申請變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“許å¯è‰æ¸…冊。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å·²å®Œæˆè®Šæ›´ä¹‹è‰ç…§å½±æœ¬å„ä¸€ä»½ã€‚ä½†å…¨å» å§”è¨—è£½é€ è€…å…é™„å·¥å» ç™»è¨˜è‰ï¼›å¦‚係輸入藥å“之藥商，得僅附變更後之藥商許å¯åŸ·ç…§å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¾å‰é …è¦å®šç”³è«‹è®Šæ›´ç™»è¨˜æ™‚，得將所有藥å“許å¯è‰ä¸€æ¬¡å ±å‚™ã€‚ä½†å¦‚æœªèƒ½ä¸€æ¬¡å ±å‚™è€…ï¼Œå…¶æ–¼åˆ†æ¬¡å ±å‚™æ™‚ï¼Œæ‡‰è¨»æ˜Žç¬¬ä¸€æ¬¡å ±å‚™æ ¸å‡†å‡½ä¹‹æ–‡è™Ÿæˆ–æª¢é™„å…¶æ ¸å‡†å‡½å½±æœ¬ï¼Œå…附藥商許å¯åŸ·ç…§å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å¦‚åœ‹å¤–è—¥å» åˆä½µï¼Œè‡´å…¶åŽŸè¨ç«‹æ–¼åœ‹å…§ä¹‹ä¸åŒåˆ†å…¬å¸æˆ–代ç†å•†é‡æ–°æ”¹çµ„åˆä½µä¸”變更藥商å稱者，應ä¾ä¸‹åˆ—è¦å®šè¾¦ç†è®Šæ›´ç™»è¨˜ï¼Œå¦‚涉åŠæ¬Šåˆ©ç§»è½‰è€…，並應由讓與人åŠå—讓人共åŒæ出申請：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è®Šæ›´ç™»è¨˜ç”³è«‹æ›¸ï¼›å…¶æ‡‰ç”±åˆä½µä¹‹è—¥å•†å…±åŒå…·åæ出，載明申請藥商åç¨±è®Šæ›´ç™»è¨˜ï¼Œä¿‚å› åœ‹å¤–è—¥å» åˆä½µã€‚但如藥商經改組後，原藥商å稱消滅者，得僅由更å後之新藥商æ出申請。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åœ‹å¤–è—¥å» åˆä½µä¹‹è®Šæ›´é€šçŸ¥å‡½ï¼Œä¸¦æ‡‰ç”±åœ‹å¤–è£½é€ å» æˆ–å…¶ç¸½å…¬å¸ã€æˆ–國外許å¯è‰æŒæœ‰è€…出具或有關主管機關出具之官方è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åˆä½µå¾Œä¹‹åœ‹å¤–è£½é€ å» æˆ–å…¶ç¸½å…¬å¸ã€æˆ–國外許å¯è‰æŒæœ‰è€…出具之</span> <span style="font-family: 新細明體,serif;">委託書æ£æœ¬ï¼Œä¸¦ç¶“我國é§å¤–館處簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åˆä½µå‰å¾Œè—¥å•†ä¹‹è—¥å•†è¨±å¯åŸ·ç…§å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åˆä½µå¾Œä¹‹è—¥å•†åŠå…¶è² 責人出具之切çµæ›¸ï¼Œè¼‰æ˜Žå°æ‰€æœ‰è—¥å“切çµä¾æ³•è¼¸å…¥è²©è³£ï¼Œä¸¦é¡˜è² 全責；å¦åŠ å…·å°åŒä¸€è£½é€ å» ç„¡ç›¸åŒè™•æ–¹ä¹‹åˆ‡çµæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚變更å‰ä¹‹è—¥å•†å·²æŒæœ‰è—¥å“許å¯è‰è€…，應å¦é™„è—¥å“許å¯è‰æ£æœ¬åŠåŽŸæŒæœ‰ä¹‹è¼¸å…¥è—¥å“許å¯è‰æ¸…冊，並以一件申請案辦妥全部許å¯è‰è®Šæ›´ç‚ºåŽŸå‰‡ã€‚å…¶è®Šæ›´ç™»è¨˜ç”³è«‹æ¡ˆå¦‚ç¶“æ ¸å‡†ï¼Œç”³è«‹äººæ‡‰è‡ªè¡Œè®Šæ›´æ‰€æœ‰è—¥å“標籤ã€ä»¿å–®ã€å¤–ç›’ã€é‹ç®”片ç‰ä¹‹è—¥å•†å稱，必è¦æ™‚應æ出備查。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¦‚變更å‰ä¹‹è—¥å•†æœ‰æŸ¥é©—登記申請案ä»åœ¨å¯©æŸ¥ä¸è€…，應å¦é‡æ–°å¡«å…·è—¥å“查驗登記申請書æ£ã€å‰¯æœ¬ï¼Œè¼‰æ˜Žåˆä½µä¹‹è—¥å•†å稱。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 61 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ å» åç¨±è®Šæ›´ï¼Œå» å€ä¸è®Šè€…，應檢附下列資料，申請變更登記：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“許å¯è‰æ¸…冊。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係國內藥å“è£½é€ å» ï¼Œæ‡‰å¦é™„已完æˆè®Šæ›´ä¹‹è‰ç…§å½±æœ¬å„一份。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚係輸入藥å“ä¹‹è£½é€ å» ï¼Œæ‡‰å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹æœ€é«˜è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‡ºå…·ä¹‹è£½é€ å» å稱變更è‰æ˜Žæ–‡ä»¶ï¼Œä¸¦æ‡‰ç¶“我國é§å¤–館處簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如輸入藥å“ä¹‹åœ‹å¤–è£½é€ å» å» å€ä¸è®Šï¼Œè£½é€ å» å…¬å¸å稱或國外許å¯è‰æŒæœ‰è€…å稱變更，而ä¸æ¶‰åŠæ¬Šåˆ©ç§»è½‰è€…，應檢附下列資料，申請變更登記：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“許å¯è‰æ¸…冊。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸå» 變更通知函。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 62 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“è£½é€ å» åœ°å€è®Šæ›´è€…，應ä¾ä¸‹åˆ—è¦å®šï¼Œç”³è«‹è®Šæ›´ç™»è¨˜ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åœ°å€è®Šæ›´å¦‚ä¿‚å› é–€ç‰Œæ•´ç·¨è€…ï¼Œæ‡‰æª¢é™„ä¸‹åˆ—è³‡æ–™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">（一）藥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">（二）藥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（三）如係國產藥å“ä¹‹è£½é€ å» ï¼Œæ‡‰å¦é™„è—¥å“許å¯è‰æ¸…冊ã€å·²å®Œæˆè®Šæ›´ä¹‹è‰ç…§å½±æœ¬åŠæˆ¶æ”¿æ©Ÿé—œå‡ºå…·ä¹‹é–€ç‰Œæ•´ç·¨è‰æ˜Žæ–‡ä»¶å„一份。</span> </p><p><span style="font-family: 新細明體,serif;">（四）如係輸入藥å“ä¹‹åœ‹å¤–è£½é€ å» ï¼Œæ‡‰å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½èˆ‡å‡º</span> <span style="font-family: 新細明體,serif;">產國戶政機關或有關機關出具之è‰æ˜Žæ–‡ä»¶ï¼Œå…¶è‰æ˜Žæ–‡ä»¶ä¸¦æ‡‰ç¶“我國é§å¤–館處簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¦‚ä¿‚é·å» 或產地變更者，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">（一）藥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">（二）藥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（三）如係國產藥å“è£½é€ å» ï¼Œæ‡‰å¦é™„è—¥å“許å¯è‰æ¸…冊ã€å·²å®Œæˆè®Šæ›´ä¹‹è‰ç…§å½±æœ¬å„一份åŠé·å» 後å–得符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（四）如係輸入藥å“ä¹‹åœ‹å¤–è£½é€ å» ï¼Œæ‡‰å¦é™„委託書ã€åŽŸå» 變更通知函æ£æœ¬ã€å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸æˆ–èˆ‡æˆå“åŒæ‰¹æ¬¡ä¹‹æ‰¹æ¬¡è£½é€ 紀錄ã€è©²æ‰¹æ¬¡ä½¿ç”¨ä¹‹</span> <span style="font-family: 新細明體,serif;">原料與æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€å®‰å®šæ€§è©¦é©—資料。如符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶æŒæœ‰è€…éžç”³è«‹äººæ™‚ï¼Œå¾—ä»¥åŽŸå» æŽˆæ¬Šå‡½æˆ–æŒæœ‰è‰æ˜Žæ–‡ä»¶ä¹‹åœ‹å…§è—¥å•†æŽˆæ¬Šå‡½ï¼Œä¸¦è¼‰æ˜Žå…¶è‰æ˜Žæ–‡ä»¶ä¹‹æ ¸å‡†æ–‡è™Ÿæ›¿ä»£ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（五）已執行生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—之藥å“，應ä¾ç¬¬å››åå…æ¢è¦å®šæª¢é™„相關資料。</span> </p><p><span style="font-family: 新細明體,serif;">（å…）如涉åŠé ˆæ›è‰è€…，應å¦é™„查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如輸入藥å“ä¹‹åœ‹å¤–è£½é€ å» å» å€ä¸è®Šï¼Œè£½é€ å» å…¬å¸åœ°å€æˆ–國外許å¯è‰æŒæœ‰è€…地å€è®Šæ›´ï¼Œè€Œä¸æ¶‰åŠæ¬Šåˆ©ç§»è½‰è€…，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“許å¯è‰æ¸…冊。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸå» 變更通知函。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 63 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“之仿單ã€æ¨™ç±¤ã€å¤–ç›’ã€é‹ç®”è®Šæ›´æˆ–æ ¸å®šæœ¬éºå¤±è£œç™¼ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£ã€åé¢å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚ä½†ç”³è«‹æ ¸å®šæœ¬éºå¤±è£œç™¼è€…，å…附。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ¨™ç±¤ã€ä»¿å–®ã€å¤–ç›’ã€é‹ç®”片實體或其彩色照片或擬稿å„二份；如仿單有變更者，應於ä¸ã€å¤–文仿單擬稿標示變更處。輸入藥å“並應å¦é™„外文仿單åŠä¸æ–‡ä»¿å–®æ“¬ç¨¿ï¼Œå…¶ä¸æ–‡ä»¿å–®æ“¬ç¨¿æ‡‰ä¾æ–°ç‰ˆå¤–文仿單內容詳實翻è¯ã€‚如僅係仿單變更，其他包æ未變更者，得僅é€ä»¿å–®ï¼Œç„¡é ˆæª¢é€å…¶ä»–包æ。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚係申請éºå¤±è£œç™¼è€…，應å¦é™„éºå¤±åˆ‡çµæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è¼¸å…¥è—¥å“應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚ä½†ç”³è«‹æ ¸å®šæœ¬éºå¤±è£œç™¼è€…，å…附。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 64 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“å§”è¨—è£½é€ ç™»è¨˜ï¼Œæ‡‰ç¬¦åˆè—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則之è¦å®šï¼Œä¸¦æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å§”è¨—è£½é€ ç”³è«‹å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å§”è¨—è£½é€ å¥‘ç´„æ›¸å½±æœ¬ï¼Œå…¶å…§å®¹æ‡‰èªªæ˜Žå§”è¨—è£½é€ ç®¡ç†ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è—¥å“許å¯è‰æ¸…å†Šï¼Œå…¶å…§å®¹æ‡‰ä»¥åŠ‘åž‹åˆ†é¡žã€‚ä½†å–®å¼µå§”è¨—è£½é€ è€…ï¼Œå…附。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€èªªæ˜Žè£½ç¨‹ä¹‹åˆ†æ®µå§”è¨—è£½é€ æƒ…å½¢ä¹‹è³‡æ–™ã€‚ä½†å…¨ç¨‹å§”è¨—è£½é€ è€…ï¼Œå…附。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è£½ç¨‹ç®¡åˆ¶æ¨™æº–書。但國產藥å“如尚ä¸è£½é€ 者，得å…é™„è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼ŒæƒŸæ‡‰æ–¼è¨±å¯è‰åŠ 註「ä¸å¾—è£½é€ ã€ä¹‹å—æ¨£ã€‚å¦‚å» å•†å…¶å¾Œæ“¬å¯¦éš›ç”Ÿç”¢è©²è—¥å“者，應檢é€è£½é€ 管制標準書，經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æ ¸å¾Œï¼Œå§‹å¾—è£½é€ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å§”託者之藥商許å¯åŸ·ç…§å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å—è¨—å» ä¹‹å·¥å» ç™»è¨˜è‰åŠè—¥å•†è£½é€ æ¥è¨±å¯åŸ·ç…§å½±æœ¬å„一份。但輸入藥å“ä¹‹å§”è¨—è£½é€ ï¼Œå¾—æª¢é™„å—è¨—è£½é€ å» ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬æ›¿ä»£ä¹‹ï¼›å¦‚è‰æ˜Žæ–‡ä»¶ä¹‹æŒæœ‰è€…éžç”³è«‹äººæ™‚ï¼Œå¾—ä»¥åŽŸå» æŽˆæ¬Šå‡½æˆ–æŒæœ‰è‰æ˜Žæ–‡ä»¶ä¹‹åœ‹å…§è—¥å•†æŽˆæ¬Šå‡½ï¼Œä¸¦è¼‰æ˜Žå…¶è‰æ˜Žæ–‡ä»¶ä¹‹æ ¸å‡†æ–‡è™Ÿæ›¿ä»£ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€å—è¨—å» å‡ºå…·ä¹‹å—託藥å“æˆå“檢驗è¦æ ¼åŠæ–¹æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€èˆ‡å‰å—è¨—è£½é€ å» è§£ç´„æ›¸ã€‚ä½†é¦–æ¬¡ç”³è«‹å§”è¨—è£½é€ è€…ï¼Œå…附。</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€è¼¸å…¥è—¥å“å§”è¨—è£½é€ ï¼Œæ‡‰å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å§”è¨—è£½é€ ä¹‹è—¥å“如已執行生體相ç‰æ€§è©¦é©—者，應å¦ä¾æœ‰é—œè¦å®šæª¢é™„資料。</span> </p><p><span style="font-family: 新細明體,serif;">ç”³è«‹ç¬¬ä¸€é …ç™»è¨˜ä¹‹è¨±å¯è‰æ›è‰ï¼Œä»¥æ–¼åŽŸè‰åŠ 註而ä¸æ›è‰æ–¹å¼ç‚ºåŽŸå‰‡ã€‚ä½†å¦‚ç”³è«‹è®Šæ›´ä¹‹æ¡ˆä»¶ï¼Œç¶“æ ¸å®šéœ€ç”±è¼¸å…¥è¨±å¯è‰æ”¹åˆ—è£½é€ è¨±å¯è‰è€…，應予æ›è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">有å‰é …ä½†æ›¸æƒ…å½¢è€…ï¼Œé™¤æ‡‰å¡«å…·å§”è¨—è£½é€ æª¢é™„è³‡æ–™æŸ¥æª¢è¡¨ä¸¦ä¾æ›¸è¡¨æ‰€è¼‰äº‹é …檢附資料外，應å¦é™„查驗登記申請書åŠåˆ‡çµæ›¸ï¼ˆç”²ï¼‰å„一份。</span> </p><p><span style="font-family: 新細明體,serif;">申請人於其申請案ç²å‡†å¾Œï¼Œæ‡‰è‡ªè¡Œè®Šæ›´å…¶è—¥å“標籤ã€ä»¿å–®ã€å¤–ç›’ã€é‹ç®”片ç‰ï¼Œå¿…è¦æ™‚應æ出備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 65 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請國產藥å“å§”è¨—è£½é€ å¾Œæ”¶å›žè‡ªè£½ç™»è¨˜ï¼Œæ‡‰æª¢é™„ä¸‹åˆ—è³‡æ–™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ”¶å›žè‡ªè£½ç”³è«‹å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€èˆ‡å‰å—è¨—è£½é€ å» è§£ç´„æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åˆ‡çµæ›¸ï¼ˆç”²ï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å·²å®Œæˆè®Šæ›´ä¹‹è‰ç…§å½±æœ¬å„一份。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸æˆ–è©¦è£½æ‰¹æ¬¡è£½é€ ç´€éŒ„ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å¦‚申請人原éž</span><span style="font-family: calibri;"> GMP </span><span style="font-family: 新細明體,serif;">è—¥å» è€…ï¼Œæ‡‰å¦é™„符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 66 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“委託檢驗，應符åˆè—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則之è¦å®šï¼Œä¸¦æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å§”託檢驗申請函。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å§”託檢驗申請表。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å§”託檢驗契約書影本，其內容應列明委託檢驗範åœä¹‹ç›¸é—œäº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å§”託者與å—託者訂定之委託檢驗作æ¥è¨ˆåŠƒæ›¸åŠæ¨™æº–作æ¥ç¨‹åºï¼ˆå«æŽ¡æ¨£æ–¹æ³•ã€æ¨£æœ¬ä¿å˜æ–¹æ³•ã€é‹é€ç§»äº¤æ¢ä»¶ç‰ï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å§”è¨—é …ç›®ä¹‹æª¢é©—è¦æ ¼åŠæ–¹æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—視實際需è¦ï¼Œå°å—託者進行ç¾å ´æŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 67 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請外銷專用之國產藥å“è®Šæ›´æˆ–å¢žåŠ å¤–éŠ·å°ˆç”¨ç›´æŽ¥åŒ…è£æ質ã€åŒ…è£é™é‡ã€æ¨™ç±¤ã€ä»¿å–®ã€å¤–ç›’ã€è—¥å“å稱ã€é©æ‡‰ç—‡ã€è³¦å½¢åŠ‘ã€æª¢é©—è¦æ ¼ã€æ–¹æ³•ã€å¤–觀者，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¦‚申請藥å“å稱ã€é©æ‡‰ç—‡ã€ç›´æŽ¥åŒ…è£æ質ã€åŒ…è£é™é‡ä¹‹è®Šæ›´è€…，應檢附藥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¦‚申請標仿單外盒ã€è³¦å½¢åŠ‘ã€æª¢é©—è¦æ ¼ã€æ–¹æ³•ã€å¤–è§€è®Šæ›´æˆ–å¢žåŠ è€…ï¼Œæ‡‰æª¢é™„è—¥å“許å¯è‰æ£ã€åé¢å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¤–銷專用切çµæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚係仿單ã€æ¨™ç±¤ã€å¤–ç›’ã€é‹ç®”之變更者，應檢附仿單ã€æ¨™ç±¤ã€å¤–ç›’ã€é‹ç®”擬稿å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚係檢驗è¦æ ¼ã€æ–¹æ³•ã€å¤–觀之變更者，應說明新舊二è¦æ ¼ä¹‹å·®ç•°ã€‚å¦è®Šæ›´å¾Œä¹‹è—¥å“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ï¼Œæ‡‰ç•™å» 商備查。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 68 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“貯å˜æ¢ä»¶è®Šæ›´ç™»è¨˜ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å®‰å®šæ€§è©¦é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¼¸å…¥è—¥å“應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 69 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請æµè¡Œæ€§æ„Ÿå†’ç–«è‹—ç—…æ¯’æ ªè®Šæ›´ç™»è¨˜ï¼Œæ‡‰æª¢é™„ä¸‹åˆ—è³‡æ–™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è®Šæ›´å¾Œè—¥å“之æˆåˆ†ã€è£½ç¨‹ã€åŽŸæ–™èˆ‡æˆå“檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥å“å®‰å®šæ€§è©¦é©—å ±å‘Šã€‚ä½†é€ä»¶ç”³è«‹æ™‚ï¼Œå¦‚è®Šæ›´ç—…æ¯’æ ªå¾Œä¹‹è—¥å“å®‰å®šæ€§è©¦é©—å ±å‘Šå°šæœªå®Œæˆè€…，得先檢附變更å‰ä¹‹è—¥å“å®‰å®šæ€§è©¦é©—å ±å‘Šï¼Œä¿Ÿæ–°ç—…æ¯’æ ªè—¥å“å®‰å®šæ€§è©¦é©—å ±å‘Šå®Œæˆå¾Œï¼Œé€äº¤å¯©æŸ¥æ ¸å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ–°ç—…æ¯’æ ªä¹‹ç›¸é—œè‡¨åºŠæ–‡ç»è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œåŽŸæ ¸å‡†ä¹‹å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è®Šæ›´å¾Œè—¥å“之標籤ã€ä»¿å–®åŠå¤–盒擬稿二份。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å¦‚係輸入藥å“，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€‚但出產國許å¯è£½å”®è‰æ˜Žï¼Œå¾—æ–¼é€ä»¶ç”³è«‹æ™‚å…ˆæª¢é™„å½±æœ¬ï¼Œæ ¸å‡†å‰ï¼Œæ‡‰é™„æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">許å¯è‰ä¹‹ç§»è½‰èˆ‡æ›ç™¼åŠè£œç™¼</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 70 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">國產藥å“許å¯è‰ç§»è½‰åŠè¼¸å…¥è—¥å“之代ç†æ¬Šç§»è½‰ç™»è¨˜ï¼Œæ‡‰ç”±è®“與人åŠå—讓人共åŒç”³è«‹ï¼Œä¸¦æª¢é™„下列資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€é›™æ–¹å…·å之藥å“變更登記申請書。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€ç§»è½‰ä¹‹è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€ç§»è½‰ä¹‹è—¥å“許å¯è‰æ¸…冊，其內容應包括許å¯è‰å—號ã€è™•æ–¹ã€åŠ‘</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é‡ã€åŠ‘型。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€å—讓人å°ç§»è½‰è—¥å“è² è²¬ä¹‹åˆ‡çµæ›¸ï¼›ç”³è«‹åœ‹ç”¢è—¥å“許å¯è‰ç§»è½‰ï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸¦æ‡‰åŠ å…·å°ç§»è½‰è—¥å“無相åŒè™•æ–¹ä¹‹åˆ‡çµæ›¸ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">五ã€ç”³è«‹åœ‹ç”¢è—¥å“許å¯è‰ç§»è½‰ç™»è¨˜ï¼Œæ‡‰å¦é™„下列資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（一）讓與人åŠå—è®“äººæ‰€åœ¨åœ°ä¹‹ç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">准移轉文件影本。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（二）å—讓人ç¾æœ‰è—¥å“許å¯è‰æ¸…冊，其內容應包括許å¯è‰å—號ã€è™•</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ–¹ã€åŠ‘é‡ã€åŠ‘型。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（三）切çµæ›¸ï¼ˆç”²ï¼‰ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（四）已完æˆè®Šæ›´ä¹‹è‰ç…§å½±æœ¬å„一份。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼ˆäº”ï¼‰è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ã€‚ä½†å¦‚ç”¢å“å°šä¸è£½é€ 者，得å…é™„è£½é€ ç®¡åˆ¶æ¨™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">準書，惟應於許å¯è‰åŠ 註「ä¸å¾—è£½é€ ã€ä¹‹å—æ¨£ã€‚å¦‚å» å•†å…¶å¾Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">擬實際生產該藥å“者，應檢é€è£½é€ 管制標準書，經ä¸å¤®è¡›ç”Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸»ç®¡æ©Ÿé—œå¯©æ ¸å¾Œï¼Œå§‹å¾—è£½é€ ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…ã€ç”³è«‹è¼¸å…¥è—¥å“之代ç†æ¬Šç§»è½‰ç™»è¨˜ï¼Œæ‡‰å¦é™„下列資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（一）讓與人與å—讓人之藥商許å¯åŸ·ç…§å½±æœ¬ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（二）雙方讓渡書æ£æœ¬ï¼Œä¸¦åŠ 蓋讓與人åŠå—讓人雙方原å°é‘‘。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼ˆä¸‰ï¼‰åŽŸå» å§”è¨—æ›¸æ£æœ¬ï¼Œè©³è¿°çµ‚æ¢è®“與人之代ç†æ¬Šï¼Œæ”¹ç”±å—讓人å–</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">得代ç†æ¬Šï¼Œèˆ‡é›™æ–¹åœ°å€åŠç§»è½‰è—¥å“之å“å；其委託書並應經</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">我國é§å¤–館處簽è‰ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（四）å°ç§»è½‰è—¥å“åŒä¸€è£½é€ å» ç„¡ç›¸åŒè™•æ–¹ä¹‹åˆ‡çµæ›¸ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">（五）申請國產藥å“許å¯è‰ç§»è½‰ç™»è¨˜ï¼Œå¦‚移轉藥å“許å¯è‰ä¹‹å“å有</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠ å† å» åä¸”æœªç¶“è¢«åŠ å† å» åä¹‹å» å•†æŽˆæ¬Šè€…ï¼Œæ‡‰åŒæ™‚辦ç†è—¥å“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“å變更登記；已執行生體相ç‰æ€§è©¦é©—之藥å“，並應ä¾è—¥å“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則辦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 71 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“許å¯è‰éºå¤±æˆ–污æ，申請補發或æ›ç™¼ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£ã€åé¢å½±æœ¬ã€‚但申請許å¯è‰æ±¡ææ›ç™¼è€…，應附許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥å“許å¯è‰éºå¤±åˆ‡çµæ›¸ã€‚但申請許å¯è‰æ±¡ææ›ç™¼è€…，å…附。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚係國產藥å“，應å¦é™„åŽŸæ ¸å‡†ä¹‹æ¨™ä»¿å–®æ ¸å®šæœ¬ä¸€ä»½åŠå¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨äºŒä»½ã€‚但原許å¯è‰å¦‚係衛署藥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">æˆ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">製å—者，å…附。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚係輸入藥å“，應å¦é™„åŽŸå» å§”è¨—æ›¸æ£æœ¬ï¼Œä¸¦ç¶“我國é§å¤–館處簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">許å¯è‰ä¹‹å±•å»¶ç™»è¨˜</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 72 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“之展延，應於期滿å‰å…個月內申請。逾期者，應é‡æ–°ç”³è«‹æŸ¥é©—登記，ä¸å—ç†å…¶å±•å»¶ç”³è«‹ã€‚但於原許å¯è‰æœ‰æ•ˆæœŸé–“屆滿後å…個月內é‡æ–°ç”³è«‹æŸ¥é©—登記者，得準用第七å三æ¢è¦å®šä¸¦æª¢é™„查驗登記申請書æ£æœ¬ï¼Œç°¡åŒ–其申請程åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請藥å“許å¯è‰å±•å»¶ç™»è¨˜ï¼Œå¦‚需åŒæ™‚辦ç†è®Šæ›´è€…，應與其他展延案分開申請。</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“欄ä½å¦‚å·²è“‹æ»¿å±•å»¶ç« æˆ³è€…ï¼Œæ‡‰å¦é™„è—¥å“查驗登記申請書æ£æœ¬ï¼Œä»¥æ†‘æ›ç™¼æ–°è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 73 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請藥å“許å¯è‰å±•å»¶ç™»è¨˜ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¶“ç”³è«‹äººæ‰€åœ¨åœ°ä¹‹ç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç« ä¹‹è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“展延申請書。如藥å“ä¿‚å§”è¨—è£½é€ è€…ï¼Œæ‡‰ç”±è—¥å“許å¯è‰æ‰€æœ‰äººæå‡ºç”³è«‹ï¼Œä¸¦ç”±å…¶æ‰€åœ¨åœ°ä¹‹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç« ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¦‚國產藥å“ä¿‚å§”è¨—è£½é€ è€…ï¼Œæ‡‰å¦é™„å§”è¨—è£½é€ å¥‘ç´„æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係輸入藥å“，應å¦é™„出產國許å¯è£½å”®è‰æ˜Žæ£æœ¬ã€åŽŸå» 委託書æ£æœ¬åŠè¼¸å…¥è—¥å“ä¹‹åœ‹å¤–è£½é€ å» ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€‚如符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之è‰æ˜Žæ–‡ä»¶æŒæœ‰è€…éžç”³è«‹äººæ™‚ï¼Œå¾—ä»¥åŽŸå» æŽˆæ¬Šå‡½æˆ–æŒæœ‰è‰æ˜Žæ–‡ä»¶ä¹‹åœ‹å…§è—¥å•†æŽˆæ¬Šå‡½ï¼Œä¸¦è¼‰æ˜Žå…¶è‰æ˜Žæ–‡ä»¶ä¹‹æ ¸å‡†æ–‡è™Ÿæ›¿ä»£ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">輸入藥å“許å¯è‰ä¹‹å±•å»¶ç™»è¨˜ï¼Œå¦‚其藥å“未曾檢é€å®‰å®šæ€§è©¦é©—資料經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‡†äºˆå‚™æŸ¥è€…，申請展延時應å¦é™„安定性試驗資料，包括安定性試驗之書é¢ä½œæ¥è³‡æ–™åŠå¯¦é©—數據。</span> </p><p><span style="font-family: 新細明體,serif;">申請生物藥å“許å¯è‰å±•å»¶ï¼Œæ‡‰å¦é™„æˆå“檢驗è¦æ ¼ã€æ–¹æ³•èˆ‡æª¢é©—æˆç¸¾æ›¸åŠå¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">ä¸è—¥</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">通則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 74 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æœ¬ç« æ‰€ç¨±æª¢é©—è¦æ ¼ï¼Œä»¥å°ç£å‚³çµ±è—¥å…¸æˆ–ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šä¹‹å…¶ä»–å„åœ‹è—¥å…¸æˆ–å…¬å‘Šäº‹é …ç‚ºæº–ï¼Œè—¥å…¸ä¸¦ä»¥æœ€æ–°ç‰ˆæœ¬æˆ–å‰ä¸€ç‰ˆæœ¬ç‚ºé™ã€‚但å°ç£å‚³çµ±è—¥å…¸æœªæ”¶è¼‰æˆ–éžå±¬ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …è€…ï¼Œè£½é€ åŠè¼¸å…¥æ¥è€…應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šä¹‹å…¶ä»–å„國藥典或視需è¦è‡ªè¡Œåˆ¶è¨‚之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 75 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥ä¹‹è™•æ–¹ä¾æ“šæ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä»¥ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹åŸºæº–方為處方ä¾æ“šï¼Œå…¶åŠ‘åž‹ã€è™•æ–¹å…§å®¹ï¼Œæ‡‰èˆ‡åŸºæº–方所載者相åŒã€‚但出典ä¸åŒè€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å›ºæœ‰å…¸ç±æ‰€è¼‰ä¹‹è™•æ–¹ï¼Œå¾—為處方ä¾æ“šã€‚æœ¬ç« æ‰€ç¨±å›ºæœ‰å…¸ç±ï¼Œä¿‚指醫宗金鑑ã€é†«æ–¹é›†è§£ã€æœ¬è‰ç¶±ç›®ã€æœ¬è‰æ‹¾éºã€æœ¬è‰å‚™è¦ã€ä¸åœ‹é†«å¸å¤§è¾å…¸åŠä¸åœ‹è—¥å¸å¤§è¾å…¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä»¥å…§æ”¿éƒ¨æ ¸ç™¼æˆ–其後經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ›ç™¼ä¹‹éžå±¬å›ºæœ‰å…¸ç±æ”¶è¼‰ä¹‹è—¥å“許å¯è‰ï¼Œä¸å¾—為處方ä¾æ“šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€éžå±¬å‰æ¬¾æ‰€åˆ—之其他典ç±ï¼Œèˆ‡å…¶ä»–藥商藥å“許å¯è‰ä¹‹è™•æ–¹ï¼Œå¾—為åƒè€ƒä¾æ“šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç”³è«‹å¤–銷專用許å¯è‰ï¼Œå¾—以輸入國藥典ã€åŸºæº–方或其訂單è¦æ±‚為åƒè€ƒä¾æ“šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è™•æ–¹ä¾æ“šä¹‹åŠ‘åž‹ï¼Œæ‡‰èˆ‡æ“¬è£½é€ ã€è¼¸å…¥è€…相符，如為湯劑或應為煎煮者</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">如煮散</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，ä¸å®œä½œç‚ºå‚³çµ±ä¸¸åŠ‘ã€æ•£åŠ‘。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å«æœ‰èŒ¶è‘‰ä¹‹æ„Ÿå†’</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">咳嗽</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">製劑，除別有è¦å®šå¤–ï¼Œå…¶ä¸€æ—¥èŒ¶è‘‰ä¹‹æœ€å¤§æ·»åŠ é‡ç‚ºä¸‰é»žä¸ƒäº”公克。</span> </p><p><span style="font-family: 新細明體,serif;">檢附處方ä¾æ“šï¼Œæ‡‰è¨˜è¼‰æ‰€æ“šä¹‹åƒè€ƒè¨±å¯è‰å—號或書åã€ç‰ˆæ¬¡åŠé 數，並應附ä¾æ“šå½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 76 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥å“å應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å–®æ–¹è£½åŠ‘，以ä¸è—¥æååŠ å† å» åã€å“牌或註冊商標ã€èˆ‡åŠ‘åž‹å稱為原則。但如需以商å“ååŠ å† å» åã€å“牌或註冊商標ã€èˆ‡åŠ‘åž‹å稱者，應於å“åæœ«è™•ä»¥æ‹¬è™ŸåŠ è¨»ä¸è—¥æå稱。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¤‡æ–¹è£½åŠ‘，以使用原典æˆæ–¹åç¨±åŠ å† å» åã€å“牌或註冊商標ã€èˆ‡åŠ‘åž‹å稱為原則。如需以商å“ååŠ å† å» åã€å“牌或註冊商標ã€èˆ‡åŠ‘åž‹å稱者，應於å“åæœ«è™•ä»¥æ‹¬è™ŸåŠ è¨»åŽŸå…¸æˆæ–¹å稱。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“å“å應å«å» å。但如已å–得商標註冊è‰ï¼Œæ–¼ç”³è«‹æŸ¥é©—登記時，檢附商標註冊è‰å½±æœ¬è€…，得å…å«å» å；如係商標授權使用者，並應檢附商標使用授權書。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å“åä¸å¾—ä½¿ç”¨ä»–äººè—¥ç‰©å•†æ¨™æˆ–å» å。但å–å¾—æ‰€ç”¨å» å之商標權者，ä¸åœ¨æ¤é™ã€‚å¦‚ä¿‚å§”è¨—è£½é€ ï¼Œå…¶å“ååŠ å† å» å者，應檢附å—è¨—å» å‡ºå…·ä¹‹å» ååŒæ„使用書。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å•†å“å</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è—¥å“å“åé™¤å» ååŠåŠ‘åž‹å稱之部分</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸å¾—與其他藥商藥å“之商å“å相åŒæˆ–近似，且ä¸å¾—涉åŠä»¿å†’或影射情事。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å“å分ä¸æ–‡ã€å¤–æ–‡äºŒé …ï¼Œæ¯é …æ‡‰æ“¬å®šä¸€è‡³ä¸‰ç¨®ï¼Œä¾›å¯©æ ¸å–æ¨ã€‚外文å“å，以ä¸æ–‡éŸ³è¯ç‚ºåŽŸå‰‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å“åä¸å¾—涉有虛å½æˆ–誇大藥å“效能åŠå®‰å…¨ï¼Œæˆ–使人å°å“å與效能產生ä¸ç•¶è¯æƒ³ã€æ··æ·†æˆ–助長藥物濫用之虞。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å“å如涉åŠç™‚效者，應與效能åŠé©æ‡‰ç—‡é…åˆï¼Œå¿…è¦æ™‚，並應æ</span> <span style="font-family: 新細明體,serif;">供臨床療效評估çµæžœä½è‰ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€ä¸æ–‡å“åä¸å¾—夾雜外文ã€æ•¸å—。但具直接æ„義者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€å¦‚新申請案擬使用申請人原有藥å“許å¯è‰ä¹‹å“ååŠ è¨»å…¶ä»–å—æ¨£è€…ï¼Œæ‰€åŠ è¨»ä¹‹å—樣，ä¸å¾—使人å°åŽŸå“åèˆ‡åŠ è¨»å—樣之å“å有ä¸ç•¶è¯æƒ³æˆ–混淆。</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€åŒä¸€è™•æ–¹ä¾æ“šä½œæˆå¤§å°ä¸¸ã€å¤§å°éŒ 或大å°è† 囊者，其所用å“å應相åŒï¼ŒæƒŸæ‡‰æ–¼å“åæœ«è™•ä»¥æ‹¬è™ŸåŠ è¨»å¯è³‡è¾¨åˆ¥ä¹‹å稱；å«ç›¸åŒè™•æ–¹æˆåˆ†ä¹‹ä¸åŒåŠ‘åž‹è—¥å“許å¯è‰ï¼Œå…¶å“åå¾—ä¸ç›¸åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€åŒè—¥å•†ä¹‹ä¸åŒè™•æ–¹ä¸å¾—使用相åŒå•†å“å。</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€ä¸å¾—有其他ä¸é©åˆç‚ºè—¥å“å“å之情形。</span> </p><p><span style="font-family: 新細明體,serif;">申請許å¯è‰ç§»è½‰ç™»è¨˜æˆ–å“å變更者，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ä¾å‰é …è¦å®šï¼Œé‡æ–°å¯©æŸ¥æ ¸å®šå…¶è—¥å“å“å。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 77 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">查驗登記申請書之包è£æ¬„，應載明包è£æ•¸é‡ã€åŒ…è£æ質åŠåŒ…è£å½¢æ…‹ï¼›å…¶åŒ…è£æ•¸é‡æ‰€è¼‰ä¹‹åŒ…è£æœ€å°å–®ä½ï¼Œæ‡‰èˆ‡è—¥å“查驗登記申請書之劑型單ä½ç›¸åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æ¯ç¨®è—¥å“之單ä½åŒ…è£æœ€å¤§é™é‡ï¼ŒéŒ 劑ã€ä¸¸åŠ‘ã€è† 囊劑為一åƒç²’以下，粉劑ã€æ•£åŠ‘ã€é¡†ç²’劑ã€è† 劑ã€æ²¹è†åŠ‘ã€ç¡¬è†åŠ‘為一åƒå…¬å…‹ä»¥ä¸‹ï¼Œå…§æœæ¶²åŠ‘ã€å¤–用液劑ã€è†æ»‹åŠ‘ã€é…’劑ã€éœ²åŠ‘為一åƒå…¬æ’®ä»¥ä¸‹ï¼Œç¢Žç‰‡åŠ‘為一åƒåŒ…ä»¥ä¸‹ï¼Œè—¥è† å¸ƒåŠ‘ç‚ºä¸€åƒç‰‡ä»¥ä¸‹ï¼›æœ€å°åŒ…è£å‡ä»¥ä¸€æ¬¡ç”¨é‡ç‚ºé™ã€‚但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å®šæœ‰æ¡ˆè€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥å“包è£å¦‚符åˆç¬¬äºŒé …è¦å®šè€…ï¼Œå» å•†å¾—é…åˆå¸‚å ´éœ€è¦ï¼Œè‡ªè¡Œèª¿æ•´ï¼Œå…申請變更登記。但超éŽç¬¬äºŒé …é™é‡è¦å®šä¹‹åŒ…è£ï¼Œä»æ‡‰ä¾è¦å®šæª¢é™„醫療機構或å¸è¡“團體訂購è‰æ˜Žï¼Œç”³è«‹è®Šæ›´ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è—¥è† å¸ƒä¹‹åŒ…è£æ¨™ç¤ºï¼Œä»¥ä¸å«å¸ƒé‡ç‚ºåŽŸå‰‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 78 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">填載查驗登記申請書之原料å稱åŠåˆ†é‡æ¬„，應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸæ–™å稱應以ä¸æ–‡æ¨™ç¤ºï¼Œä¸è—¥æ應以本è‰ç¶±ç›®ã€å°ç£å‚³çµ±è—¥å…¸æˆ–其他經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå¯ä¹‹è—¥å…¸æˆ–醫藥å“集所載者為準。並以公制單ä½å¡«è¼‰åŽŸæ–™å«é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŽŸæ–™å稱åŠåˆ†é‡ï¼Œæ‡‰ä¾å›ã€è‡£ã€ä½ã€ä½¿åŠè³¦å½¢åŠ‘ä¹‹é †åºå¡«æ˜Žå…¨è™•æ–¹ï¼Œä¸¦å‡æ‡‰è©³ç´°è¨˜è¼‰å…¶å稱åŠåˆ†é‡ã€‚屬ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹åŸºæº–方者，應ä¾åŸºæº–æ–¹ä¹‹é †åºå¡«è¼‰ã€‚如以é»è²¼æ–¹å¼ï¼Œä¸¦æ‡‰åŠ è“‹è² è²¬äººåŠç›£è£½è€…å°ç« 。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å‚³çµ±éŒ ã€ä¸¸ã€è† 囊ç‰è£½åŠ‘，應以最å°å–®ä½æ¨™ç¤ºå„原料分é‡ä¹‹å«é‡ï¼›å‚³çµ±ç²‰ã€æ•£ã€é¡†ç²’ã€è† ã€æ²¹è†ã€ç¡¬è†ã€è—¥è† 布ç‰è£½åŠ‘，應以æ¯å…¬å…‹æ¨™ç¤ºå„原料分é‡ä¹‹å«é‡ï¼›æ¶²ã€è†æ»‹ã€é…’劑ã€éœ²åŠ‘ç‰è£½åŠ‘，應以æ¯å…¬æ’®æ¨™ç¤ºå„原料分é‡ä¹‹å«é‡ï¼›ç¢Žç‰‡åŠ‘，應以一包為單ä½æ¨™ç¤ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€èƒå–濃縮製劑，屬單方製劑應以一公克為單ä½æ¨™ç¤ºï¼Œå±¬è¤‡æ–¹è£½åŠ‘應以一日用é‡ç‚ºå–®ä½æ¨™ç¤ºã€‚ä½†æ¿ƒç¸®éŒ ã€ä¸¸ã€è† 囊ç‰è£½åŠ‘，應以最å°å–®ä½æ¨™ç¤ºå„原料分é‡ä¹‹å«é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚ä¿‚è† å›ŠåŠ‘è€…ï¼Œé™¤æ‡‰è¼‰æ˜Žå…¶å…§å®¹ç‰©ä¹‹å…¨è™•æ–¹å¤–ï¼Œè»Ÿè† å›Šæ‡‰è¼‰æ˜Žè»Ÿè† å›Šæ®¼ä¹‹å…¨è™•æ–¹ï¼Œç¡¬è† å›Šæ‡‰åˆ†åˆ¥è¼‰æ˜Žè† å›Šæ®¼è“‹ã€é«”ä¹‹è‰²ç´ å稱åŠå«é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">填載查驗登記申請書之效能或é©æ‡‰ç—‡æ¬„，應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å¦‚ä¿‚ä¾æ“šä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹åŸºæº–方者，所載應與基準方相åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¦‚ä¿‚ä¾æ“šå›ºæœ‰å…¸ç±è€…，所載應與典ç±ç›¸ç¬¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¦‚ä¿‚ä¾æ“šå…¶ä»–藥商之藥å“許å¯è‰è€…，所載應與其相符。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係完æˆè‡¨åºŠè©¦é©—，應ä¾æ ¸å‚™ä¹‹è‡¨åºŠè©¦é©—å ±å‘Šæ“¬å®šæ•ˆèƒ½æˆ–é©æ‡‰ç—‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 80 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">填載查驗登記申請書之用法用é‡æ¬„，應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç”¨æ³•ã€ç”¨é‡ä¹‹è¨˜è¼‰ï¼Œæ‡‰ç¬¦åˆåŽŸè™•æ–¹åˆ†é‡æ¯”例使用為原則；濃縮劑型åŠå…§æœæ¶²åŠ‘ä¸è—¥ä¹‹æ¯æ—¥æœç”¨é‡ï¼Œæ‡‰ç¶“æ›ç®—後與一日飲片é‡ç›¸åŒï¼Œä¸¦ä»¥åˆ†äºŒè‡³ä¸‰æ¬¡æœç”¨ç‚ºåŽŸå‰‡ã€‚ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘ŠåŸºæº–方之èƒå–濃縮製劑åŠå…§æœæ¶²åŠ‘，æ¯æ—¥æœç”¨é‡æ‡‰èˆ‡ç¶“æ›ç®—後之基準方一日飲片é‡ç›¸åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å°å…’用é‡ï¼Œä»¥å…«è‡³å五æ²æœæˆäººä¸‰åˆ†ä¹‹äºŒé‡ã€äº”至七æ²æœæˆäººäºŒåˆ†ä¹‹ä¸€é‡ã€äºŒè‡³å››æ²æœæˆäººä¸‰åˆ†ä¹‹ä¸€é‡ç‚ºåŽŸå‰‡ï¼Œæˆ–標示兒童ä¾å¹´é½¡éžæ¸›ä¹‹ã€‚但嬰幼兒應由醫師診治æœè—¥ï¼Œæˆè—¥ä¸å¾—å°äºŒæ²ä»¥ä¸‹å¬°å¹¼å…’標示用法ã€ç”¨é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 81 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥ä¹‹æ¨™ç±¤ã€ä»¿å–®ã€åŒ…è£ï¼Œæ‡‰ç¬¦åˆæœ¬æ³•ç¬¬ä¸ƒå五æ¢è¦å®šï¼Œä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†äº‹é …刊載。其擬製與刊載之方å¼åŠå…§å®¹ï¼Œæ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼Œä¸”å…¶å—體應易於辨è˜ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä»¿å–®æ‡‰è¼‰æ˜Žå„²è—åŠå…¶ä»–ä¾è¦å®šæ‡‰åˆŠè¼‰ä¹‹å¿…è¦äº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä»¿å–®è¨˜è¼‰äº‹é …以ä¸è¶…出效能åŠé©æ‡‰ç—‡ç‚ºåŽŸå‰‡ï¼Œè¤‡æ–¹è£½åŠ‘以å„有效æˆåˆ†æ··åˆä½¿ç”¨ä¹‹ä¸»è¦è—¥ç†ä½œç”¨ç‚ºç¯„åœï¼Œä¸å¾—有誇大å—樣。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä»¿å–®æ‡‰è©³å¯¦åˆŠè¼‰ç¦å¿Œã€è¦èªžã€å‰¯ä½œç”¨åŠæ³¨æ„äº‹é …ï¼Œä¸¦æ‡‰ä½¿ç”¨ç´…å—æˆ–åŠ å°ç´…框或使用粗黑異體å—，以引起使用者特別注æ„。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä»¥å•†å“ååŠ å† å» åã€å“牌或註冊商標ã€èˆ‡åŠ‘åž‹å稱為å“å之單方製劑，與以商å“ååŠ å† å» åã€å“牌或註冊商標ã€èˆ‡åŠ‘åž‹å稱為å“å之複方製劑，應於仿單之å“åå¾ŒåŠ è¨»åŽŸå…¸æˆæ–¹å稱。如無仿單者，應標示於標籤或外盒。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¸æ–‡ä»¿å–®ä¹‹å—體大å°è¦æ ¼ï¼Œé™¤å¦æœ‰è¦å®šå¤–，ä¸å¾—å°æ–¼é›»è…¦å—體七號å—。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ä»¿å–®ã€æ¨™ç±¤ã€åŒ…è£ä¸å¾—刊å°æ¶‰åŠçŒ¥è¤»ã€æœ‰å‚·é¢¨åŒ–或誇大效能ã€é©æ‡‰ç—‡ä¹‹åœ–案或文å—。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å¦‚於仿單ã€æ¨™ç±¤ã€åŒ…è£ä¸ŠåˆŠè¼‰ç¶“銷商å稱時，其上刊載經銷商å稱之å—é«”ä¸å¾—大於藥商</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">許å¯è‰æŒæœ‰è€…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å稱之å—體，並應檢附經銷商之藥商許å¯åŸ·ç…§å½±æœ¬ä¾›åƒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€ä¸æ–‡å“å之å—é«”ä¸å¾—å°æ–¼å¤–æ–‡å—體，並應清晰å¯è¾¨ï¼Œä¸”得以單一ä¸æ–‡å“åå—體高度ä¸å°æ–¼å–®ä¸€å¤–æ–‡å—æ¯ä¹‹é«˜åº¦ç‚ºæ¯”å°æ¨™æº–。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€è—¥å“å稱å—體大å°ï¼Œæ¯å€‹å—ä¸å¾—å°æ–¼å¦ä¸€å€‹å—一å€ä»¥ä¸Šã€‚ä½†å» å</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å“牌ã€è¨»å†Šå•†æ¨™</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€åŠ‘åž‹ååŠå•†å“å</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è—¥å“å“åé™¤å» ååŠåŠ‘åž‹å之部分</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">é–“ä¸åˆ—入比å°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€æˆè—¥ä¹‹æ¨™ç±¤åŠåŒ…è£ä¸Šï¼Œæ‡‰ä¾å…¶é¡žåˆ¥ï¼ŒåŠ å°æ˜Žé¡¯å¤§è™Ÿã€Œæˆè—¥ã€æˆ–「乙類æˆè—¥ã€ï¼Œå…¶å—體並以æ£æ¥·ç‚ºåŽŸå‰‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€å¤–用製劑之標籤åŠåŒ…è£ä¸Šï¼Œæ‡‰åŠ å°ã€Œå¤–用ã€ï¼Œä¸¦ä½¿ç”¨ç´…å—æˆ–åŠ å°ç´…框。</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€é‹ç®”ç›’è£ä¹‹æ¯ä¸€ç‰‡é‹ç®”紙上，å‡æ‡‰åˆŠå°è—¥å“å“åã€å» ååŠè¨±å¯è‰å—號。</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€è—¥å“之標籤或包è£ï¼Œæ‡‰ä¾ä¸‹åˆ—æ–¹å¼ä¹‹ä¸€ï¼ŒåˆŠè¼‰æ‰¹è™Ÿã€è£½é€ 日期ã€æœ‰æ•ˆæœŸé–“ã€ä¿å˜æœŸé™ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‰¹è™Ÿèˆ‡è£½é€ æ—¥æœŸåŠæœ‰æ•ˆæœŸé–“。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">批號與ä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‰¹è™Ÿèˆ‡è£½é€ æ—¥æœŸåŠä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€ä¾å‰æ¬¾è¦å®šåˆŠè¼‰è£½é€ 日期ã€ä¿å˜æœŸé™æ™‚，應以年ã€æœˆã€æ—¥æ¨™æ˜Žï¼Œä¸”è£½é€ æ—¥æœŸã€æœ‰æ•ˆæœŸé–“ã€ä¿å˜æœŸé™ï¼Œä¸¦æ‡‰ä»¥æ¶ˆè²»è€…易於辨è˜æˆ–判斷之方å¼åˆŠè¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€è¼¸å…¥è—¥å“之藥商å稱åŠåœ°å€ã€è¨±å¯è‰å—號ã€ä¸æ–‡å“åã€é¡žåˆ¥ï¼Œå¾—以å°ç±¤æ¢æ¨™ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€è²¼æ¨™ç±¤</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">籤æ¢</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">作æ¥ï¼Œè¦–åŒè£½ç¨‹ä¹‹ä¸€éƒ¨åˆ†ï¼Œæ‡‰ä¾è—¥å“å„ªè‰¯è£½é€ è¦ç¯„之作æ¥ç¨‹åºåŸ·è¡Œï¼›è¼¸å…¥è—¥å“æ‡‰æ–¼åŽŸå» è²¼å¦¥ï¼Œæˆ–ä¾è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–則之è¦å®šï¼Œæ–¼è¼¸å…¥åœ‹å…§å¾Œå§”託國內</span><span style="font-family: calibri;"> GMP </span><span style="font-family: 新細明體,serif;">è—¥å» æˆ–ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„之醫藥物æµä¸å¿ƒåŸ·è¡Œè—¥å“包è£åŠè²¼ç±¤æ¢ä½œæ¥ã€‚ä½†è£½é€ å» ååŠå» å€ä¹‹ç±¤æ¢ï¼Œä»æ‡‰æ–¼åŽŸå» 貼妥，ä¸å¾—於國內委託執行。</span> </p><p><span style="font-family: 新細明體,serif;">外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ï¼Œæ‡‰é»è²¼æˆ–附仿單ã€æ¨™ç±¤ã€å¤–ç›’ã€é‹ç®”åŠå…¶ä»–標示æ料之已å°å¦¥å¯¦é«”或擬稿。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 82 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請人如接ç²é ˜è‰é€šçŸ¥è€…ï¼Œæ‡‰æ–¼é ˜è‰æœŸé™</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三個月</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">內繳ç´è²»ç”¨ï¼Œä¾ä¸‹åˆ—程åºè¾¦ç†é ˜è‰æ‰‹çºŒï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æª¢é™„ä¾æ ¸å®šè‰æœ¬å°å¦¥ä¹‹å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。但新藥應檢附三份；輸入藥å“除市售å“包è£æ£æœ¬å¤–，ä¸æ–‡ä»¿å–®èˆ‡å°ç±¤æ¢æ‡‰ä¾æŽ’版å°åˆ·æ–¹å¼å°å¦¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æª¢é‚„原附外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ä¹‹æ ¸å®šè‰æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æª¢é‚„原附之藥å“許å¯è‰å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如申請人於è¦å®šæœŸé™å…§è¾¦ç†é ˜è‰æ‰‹çºŒï¼Œæ‰€æª¢é™„之標籤ã€ä»¿å–®ã€åŒ…è£æˆ–其他相關物å“è³‡æ–™æœ‰éŒ¯èª¤è€Œé ˆé‡æ–°æ›´æ£åˆŠå°è€…，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ä¹‹æœŸé™å…§æ›´æ£ï¼Œä¸¦æ–¼æ›´æ£å¾Œå§‹å¾—é ˜è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如申請人收å—é ˜è‰é€šçŸ¥å¾Œï¼Œå†æ¬¡ç”³è«‹è®Šæ›´è€…ï¼Œé ˆé‡æ–°ç¹³ç´è®Šæ›´å¯©æŸ¥è²»è¾¦ç†è®Šæ›´ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å¦‚ç”³è«‹äººé ˜å¾—è—¥å“許å¯è‰å¾Œï¼Œæœªä¾è¦å®šè¾¦ç†é€é©—手續或é€é©—樣å“經檢驗與申請資料ä¸ç¬¦æˆ–å…¶ä»–åŽŸå› ä¸åˆæ ¼è€…，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ï¼Œç¹³å›žè—¥å“許å¯è‰ï¼Œä¸¦ä¾æœ¬æ³•æœ‰é—œè¦å®šè™•ç½°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 83 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請人如接ç²é€é©—通知者，應於通知之é€é©—期é™å…§ï¼Œç¹³ç´è²»ç”¨ä¸¦æª¢é™„下列樣å“åŠè³‡æ–™ï¼Œä¾è¦å®šé€é©—。é€é©—期é™ï¼Œåœ‹ç”¢ä¸è—¥ç‚ºä¸‰å日，輸入ä¸è—¥ç‚ºä¸‰å€‹æœˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥ç‰©æ¨£å“三份åŠåŽŸè—¥æï¼›æœ¬æ¬¾æ‰€ç¨±ä¸€ä»½ï¼Œä¿‚æŒ‡è¶³å¤ ä¸€æ¬¡æª¢é©—æ•¸é‡ç‚ºä¸€ä»½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¦–檢驗需è¦ï¼Œæä¾›å°ç…§æ¨™æº–å“é©é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥ç‰©æ¨£å“檢驗éžé€è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">凡有é‡æ–°æª¢é©—案件，申請人應å†ç¹³ç´è²»ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請人é€é©—é ˆéµå®ˆä¹‹ç›¸é—œäº‹é …，準用第二åä¹æ¢è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 84 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入ä¸è—¥æŸ¥é©—登記所需檢附樣å“ã€æ•¸é‡èˆ‡é€šé—œä½œæ¥è¦å®šç‚ºï¼šå‡¡æŒä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç™¼ä¹‹é€šçŸ¥è—¥å•†é€é©—書函通關，原則上以該é€é©—書函上載明之藥物樣å“ã€åŽŸè—¥æåŠå°ç…§æ¨™æº–å“之數é‡ç‚ºæº–。但為顧åŠåŒ…è£å®Œæ•´æ€§ï¼Œå¾—商請海關視實際單一完整包è£é…Œé‡æ”¾è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請輸入ä¸è—¥è®Šæ›´ç™»è¨˜å¦‚é ˆé€é©—時，其樣å“ã€æ•¸é‡èˆ‡é€šé—œä½œæ¥ï¼Œæº–用å‰é …è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 85 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請案件如未ä¾è¦å®šç¹³ç´è²»ç”¨ã€æœªå¡«å…·ç”³è«‹æ›¸è¡¨ã€æœªå‚™é½Šè³‡æ–™æˆ–有其他ä¸ç¬¦æœ¬æº–則è¦å®šä¹‹æƒ…形而得補æ£æ™‚，申請人應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé€šçŸ¥ä¹‹æœŸé™å…§è£œæ£ã€‚補æ£æœŸé™ç‚ºä¸‰å€‹æœˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請人如未能於期é™å…§è£œæ£è€…，得於補æ£æœŸæ»¿å‰ï¼Œä»¥æ›¸é¢æ•˜æ˜Žç†ç”±ç”³è«‹å»¶æœŸï¼›å…¶å»¶æœŸæœŸé™ï¼Œè‡ªè£œæ£æœŸæ»¿ç¿Œæ—¥èµ·ç®—一個月，且延期以一次為é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">申請人如未於期é™å…§è£œæ£æˆ–延期一個月後ä»é€¾æœŸæœªè£œæ£è€…，ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ä¾ç¾æœ‰è³‡æ–™é€•ç‚ºå¯©æŸ¥æ ¸é§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 86 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">èƒå–濃縮製劑之審查基準如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ¿ƒç¸®è£½åŠ‘以åˆä½µç…Žç…®ç‚ºåŽŸå‰‡ã€‚但原方為傳統丸ã€æ•£è€…ï¼Œå¾—åˆ†åˆ¥ç…Žç…®ï¼›é˜¿è† ã€èŠ’ç¡ã€é£´ç³–åŠå…¶ä»–ä¸å®œåŠ 入煎煮之ä¸è—¥ï¼Œä¸å¾—åˆä½µç…Žç…®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç…Žç…®æ‰€æŠ½å‡ºä¹‹æµ¸è†ï¼Œé™¤å¾—以ä¸è¯è—¥å…¸æ”¶è¼‰ä¹‹ä¹³ç³–ã€æ¾±ç²‰ç‰æˆ–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ä¹‹é©ç•¶è£½åŠ‘輔助劑ã€æˆ–ä¸å½±éŸ¿è—¥æ•ˆä¹‹è³¦å½¢åŠ‘ç‰ç‚ºè³¦å½¢åŠ‘予以調製外，如原方ä¾æ“šç‚ºå‚³çµ±ä¸¸ã€éžç…®æ•£ä¹‹å‚³çµ±æ•£ã€æˆ–其他特殊情形經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è€…，得以ä¸è—¥åŽŸæœ«èª¿è£½ä¹‹ã€‚但其微生物é™é‡ï¼Œæ‡‰æº–用賦形劑之è¦å®šã€‚èƒå–濃縮製劑微生物ã€é‡é‡‘屬ã€è¾²è—¥æ®˜ç•™ä¹‹é™é‡ï¼Œæ‡‰ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ¿ƒç¸®è£½åŠ‘之乾浸è†èˆ‡è³¦å½¢åŠ‘比例，以一比一為原則，以一比三為上é™ã€‚如有特殊情æ³è€…，申請人應檢附相關資料供審查。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç”³è«‹æ›¸ä¹‹ç”Ÿè—¥èˆ‡æµ¸è†æ¯”例å€æ•¸ï¼Œæ‡‰åƒé…Œå¯¦éš›ç”Ÿç”¢æƒ…形訂定。但實際生產之生藥與浸è†æ¯”例å€æ•¸ä¸å¾—超éŽç”³è«‹å€¼ä¸Šä¸‹ä¹‹ç™¾åˆ†ä¹‹å五。</span> </p><p><span style="font-family: 新細明體,serif;">濃縮製劑之指標æˆåˆ†å®šé‡æ³•ã€è¦æ ¼ä¹‹åˆ¶è¨‚åŠæ‡‰æª¢é™„資料，應ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …之è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 87 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">使用瀕臨絕種野生動æ¤ç‰©åœ‹éš›è²¿æ˜“公約附錄二所列之ä¿è‚²é¡žç‰©ç¨®ä½œç‚ºä¸è—¥æ者，應附來æºè‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 88 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請書表所附之切çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">甲</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŠåˆ‡çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¹™</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，填寫時應載明具切çµå•†è™Ÿå稱ã€åœ°å€ã€è² 責人姓ååŠåˆ‡çµæ—¥æœŸï¼Œä¸¦å‡åŠ 蓋與申請書相åŒä¹‹å°ç« ã€‚å¦‚ä¿‚å§”è¨—è£½é€ ï¼Œå§”è¨—è€…èˆ‡å—è¨—å» å‡æ‡‰å…·å切çµã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 89 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥æŸ¥é©—登記或變更登記執行之國內臨床試驗åŠæ‡‰æª¢é™„資料，è¦å®šå¦‚下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å•†åŸ·è¡Œåœ‹å…§è‡¨åºŠè©¦é©—，應符åˆè—¥å“優良臨床試驗準則之è¦å®šï¼Œä¸¦ä¾ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å•†é€²è¡Œè‡¨åºŠè©¦é©—å‰ï¼Œæ‡‰æ出藥å“臨床試驗計畫，詳實填載臨床試驗內容摘è¦è¡¨ã€è—¥å“臨床試驗申請書åŠä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹æŠ€è¡“性資料，é€äº¤ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¿Ÿä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥åŒæ„並發給åŒæ„試驗進行函後，藥商應ä¾å¯©æŸ¥æ„è¦‹æ‰€è¼‰äº‹é …ï¼Œé€²è¡Œè‡¨åºŠè©¦é©—ï¼Œä¸¦æ–¼è©¦é©—å®Œæˆå¾Œï¼Œå°‡è©¦é©—å ±å‘Šçµæžœé€äº¤å‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç™¼çµ¦åŒæ„試驗進行函後，如有變更，應申請變更。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è©¦é©—å ±å‘Šçµæžœæœªç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥ä¸¦ç™¼çµ¦åŒæ„å ±å‘Šå‚™æŸ¥å‡½ä¹‹å‰ï¼Œå…¶æŸ¥é©—登記或變更登記申請案ä¸äºˆæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 90 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é™¤æœ¬ç« åˆ¥æœ‰è¦å®šå¤–，委託書ã€å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žã€æ‰¹æ¬¡è£½é€ ç´€éŒ„èˆ‡è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ã€å·²å®Œæˆè®Šæ›´ä¹‹è‰ç…§èˆ‡è‰ç…§é»è²¼è¡¨ã€æª¢é™„之文ç»è³‡æ–™èˆ‡ç ”ç©¶å ±å‘Šã€è—¥å“查驗登記申請書之申請者欄ã€å§”è¨—è£½é€ èˆ‡å§”è¨—æª¢é©—ï¼Œåˆ†åˆ¥æº–ç”¨ç¬¬äº”æ¢ã€ç¬¬å…æ¢ã€ç¬¬å一æ¢ã€ç¬¬å二æ¢ã€ç¬¬å三æ¢ã€ç¬¬åå…æ¢ç¬¬ä¸€é …åŠç¬¬ä¸‰é …ã€ç¬¬äºŒå三æ¢ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è—¥ç”³è«‹æ¡ˆä»¶ï¼Œå¦‚有第二å五æ¢è¦å®šæƒ…形之一者，或é‡è¤‡ç”³è«‹åŒè™•æ–¹ä¾æ“šä¹‹åŒåŠ‘型且éžä½œæˆå¤§å°ä¸¸ã€å¤§å°éŒ 或大å°è† 囊者，ä¸äºˆæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">ä¸è—¥æŸ¥é©—登記</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 91 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥æŸ¥é©—ç™»è¨˜ï¼Œå…¶è£½é€ å» ä¹‹è»Ÿç¡¬é«”è¨å‚™åŠç›¸é—œåŠ‘åž‹è¨å‚™ï¼Œæ‡‰ç¬¦åˆè—¥ç‰©è£½é€ å·¥å» è¨å» 標準，並æ出符åˆè©²æ¨™æº–之è‰æ˜Žæ–‡ä»¶å½±æœ¬ã€‚å¦‚ä¿‚åˆ†æ®µå§”è¨—è£½é€ è€…ï¼Œå…¶è£½é€ å» æ‡‰åŒ…æ‹¬åˆ†æ®µå§”è¨—è£½é€ ä¸æ‰€æœ‰è£½ç¨‹æ¶‰åŠä¹‹å—è¨—è£½é€ å» ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 92 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請國產ä¸è—¥æŸ¥é©—登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åˆ‡çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">甲</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¹™</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å„一份。如åŒæ™‚申請外銷專用å“å或外銷專用許å¯è‰æŸ¥é©—登記者，並應附外銷專用切çµæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨äºŒä»½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è‰ç…§é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è™•æ–¹ä¾æ“šå½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ‰¹æ¬¡è£½é€ 紀錄影本。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æˆå“檢驗è¦æ ¼ã€æˆå“檢驗方法ã€æˆå“一般檢查紀錄表ã€æˆå“檢驗æˆç¸¾æ›¸åŠè–„層層æžæª¢é©—çµæžœå½©è‰²ç…§ç‰‡æˆ–圖片é»è²¼æœ¬å„äºŒä»½ï¼›å…¶æª¢é©—é …ç›®åŠè¦æ ¼ï¼Œæ‡‰ç¬¦åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å®‰å®šæ€§è©¦é©—書é¢ä½œæ¥ç¨‹åºåŠå…¶å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æœªç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ä¹‹æ”¶è¼‰æ–¼å›ºæœ‰å…¸ç±ä¹‹è™•æ–¹è€…，單方製劑應檢附一種ã€è¤‡æ–¹è£½åŠ‘應檢附二種指標æˆåˆ†ä¹‹é«˜æ•ˆæ¶²ç›¸å±¤æžæª¢é©—方法åŠåœ–èœã€‚但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šæœ‰çª’礙難行者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€ç”³è«‹ä»¥å…¶ä»–藥商藥å“許å¯è‰ç‚ºä¾æ“šä¹‹æ¡ˆä»¶ï¼Œæ‡‰å¦é™„與該藥å“ç¶“æ ¸å‡†æ™‚æ‰€æ出之相åŒè©¦é©—æˆ–æª¢é©—é …ç›®è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 93 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請輸入ä¸è—¥æŸ¥é©—登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å§”託書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žæ£æœ¬åŠä¸æ–‡è¯æœ¬å„一份。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åˆ‡çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">甲</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¹™</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å„一份。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è‰ç…§é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è™•æ–¹ä¾æ“šå½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€èˆ‡é€é©—樣å“åŒæ‰¹ä¹‹å®Œæ•´æ‰¹æ¬¡è£½é€ 紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€ä¸æ–‡æˆ–英文之檢驗è¦æ ¼åŠæª¢é©—方法二份，包括原料åŠæˆå“之資料，並應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應載明æ¯ä¸€è™•æ–¹æˆåˆ†åŽŸæ–™</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«è£½ç¨‹ä¸åŠ 入輔助原料</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之檢驗è¦æ ¼åŠæ–¹æ³•ï¼›å¦‚ä¾è—¥å…¸è™•æ–¹è€…，應檢附藥典影本。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">賦形劑應有檢驗è¦æ ¼åŠæ–¹æ³•ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æª¢é©—é …ç›®åŠè¦æ ¼ï¼Œæ‡‰ç¬¦åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€æª¢é©—æˆç¸¾æ›¸ï¼ŒåŒ…括原料åŠæˆå“之資料二份，並應符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應載明批號ã€æª¢é©—日期ã€å“å，並應有檢驗人員åŠè² 責人員之簽å。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ¯ä¸€è™•æ–¹æˆåˆ†åŽŸæ–™</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«è£½ç¨‹ä¸åŠ 入輔助原料</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之檢驗æˆç¸¾æ›¸ï¼Œæ‡‰ç‚ºæ‰€é™„æˆå“批次使用之原料檢驗æˆç¸¾æ›¸ï¼Œä¸¦åŽŸæ–™åŠæˆå“應ä¾è¦æ ¼é€é …檢驗。</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€å®‰å®šæ€§è©¦é©—書é¢ä½œæ¥ç¨‹åºåŠå…¶å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€æœªç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ä¹‹æ”¶è¼‰æ–¼å›ºæœ‰å…¸ç±ä¹‹è™•æ–¹è€…，單方製劑應檢附一種ã€è¤‡æ–¹è£½åŠ‘應檢附二種處方內藥æ之指標æˆåˆ†ä¹‹é«˜æ•ˆæ¶²ç›¸å±¤æžæª¢é©—方法åŠåœ–èœã€‚但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šæœ‰çª’礙難行者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€ç”³è«‹ä»¥å…¶ä»–藥商藥å“許å¯è‰ç‚ºä¾æ“šä¹‹æ¡ˆä»¶ï¼Œæ‡‰å¦é™„與該藥å“ç¶“æ ¸å‡†æ™‚æ‰€æ出之相åŒè©¦é©—æˆ–æª¢é©—é …ç›®è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 94 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥ä¹‹æ–°è—¥æŸ¥é©—登記，應檢附查驗登記申請書資料一套ã€åœ‹å…§è‡¨åºŠè©¦é©—å ±å‘ŠåŠä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šè¦å®šä¹‹æŠ€è¡“性資料，é€äº¤å¯©æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 95 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請åŒåŠ‘åž‹ä¸åŒå«é‡ä¹‹è—¥å“許å¯è‰ï¼Œæ‡‰å¦æ出申請。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 96 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥商如在åŒä¸€æœˆä»½å…§ç”³è«‹æŸ¥é©—登記複方二件ã€å–®æ–¹å…件ã€æˆ–複方一件且單方三件以上者，應事先æ出專案申請，說明ç†ç”±ä¸¦æª¢é™„è£½é€ å» æœ‰é—œè³‡æ–™ï¼ŒåŒ…æ‹¬è—¥å“è£½é€ ã€å“質管制部門之è¨å‚™åŠå°ˆæ¥æŠ€è¡“人員ç‰è³‡æ–™ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥æˆ–派員實地檢視其å“質管制ã€ç”Ÿç”¢ç´€éŒ„ã€æ¨£å“è£½é€ éŽç¨‹åŠè—¥å“監製者é§å» 情形，以確èªå…¶ç¬¦åˆå¯¦éš›ä¸¦æœ‰è£½é€ 能力。</span> </p><p><span style="font-family: 新細明體,serif;">æ–°è¨è—¥å» 之查驗登記申請案件，得優先審查；新èƒå–æ¿ƒç¸®è£½åŠ‘è£½é€ å» ä¹‹è¤‡æ–¹è£½åŠ‘å¾—å°ˆæ¡ˆç”³è«‹å…±ä¸€ç™¾ä»¶ï¼Œå–®æ–¹è£½åŠ‘å¾—å°ˆæ¡ˆç”³è«‹å…±äº”å件，ä¸å—å‰é …件數è¦å®šä¹‹é™åˆ¶ã€‚但æ¯æ¬¡å°ˆæ¡ˆåƒ…得申請二å四件。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">ä¸è—¥ç™»è¨˜äº‹é …之變更</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 97 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥ç™»è¨˜äº‹é …ä¹‹è®Šæ›´ï¼Œå¦‚ä¿‚å§”è¨—è£½é€ è€…ï¼Œæ‡‰æª¢é™„é›™æ–¹å…·å之藥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 98 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥ä¹‹ä¸ã€è‹±æ–‡å“å變更登記，應檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“æŸ¥é©—ç™»è¨˜ç”³è«‹æ›¸ã€‚ä½†è£½é€ å» ä¿‚</span><span style="font-family: calibri;">GMP</span><span style="font-family: 新細明體,serif;">è—¥å» è€…ï¼Œå…附。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚係國產ä¸è—¥ä¹‹ä¸ã€è‹±æ–‡å“å或輸入ä¸è—¥ä¹‹ä¸æ–‡å“å變更，應å¦é™„切çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">甲</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">；如æŒæœ‰ç¶“濟部智慧財產局商標註冊è‰æˆ–æ ¸å‡†å¯©å®šæ›¸è€…ï¼Œå¾—é™„å…¶å½±æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚係輸入ä¸è—¥ä¹‹ä¸ã€è‹±æ–‡å“å變更，應å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žæ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚係申請外銷專用許å¯è‰å“å變更，或申請外銷專用之ä¸è‹±æ–‡å“å新增或變更者，應å¦é™„外銷專用切çµæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 99 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥åŠ‘型之變更，以ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå·²å…¬å‘ŠåŸºæº–方之濃縮散變更為濃縮顆粒者åŠæ¿ƒç¸®é¡†ç²’劑變更為濃縮散劑者為é™ã€‚其餘變更劑型，應é‡æ–°ç”³è«‹æŸ¥é©—登記。</span> </p><p><span style="font-family: 新細明體,serif;">申請ä¸è—¥åŠ‘型變更登記，應é€é©—樣å“並檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åˆ‡çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">甲</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è‰ç…§é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€æ‰¹æ¬¡è£½é€ 紀錄影本。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€æˆå“檢驗è¦æ ¼ã€æˆå“檢驗方法ã€æˆå“一般檢查紀錄表ã€æˆå“檢驗æˆç¸¾æ›¸åŠè–„層層æžæª¢é©—çµæžœå½©è‰²ç…§ç‰‡æˆ–圖片é»è²¼æœ¬å„äºŒä»½ï¼›å…¶æª¢é©—é …ç›®åŠè¦æ ¼ï¼Œæ‡‰ç¬¦åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€å®‰å®šæ€§è©¦é©—書é¢ä½œæ¥ç¨‹åºåŠå ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€å¦‚係輸入ä¸è—¥ï¼Œæ‡‰å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žæ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 100 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥è³¦å½¢åŠ‘變更登記，應é€é©—樣å“並檢附下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ‰¹æ¬¡è£½é€ 紀錄影本。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æˆå“檢驗è¦æ ¼ã€æˆå“檢驗方法ã€æˆå“一般檢查紀錄表ã€æˆå“檢驗æˆç¸¾æ›¸åŠè–„層層æžæª¢é©—çµæžœå½©è‰²ç…§ç‰‡æˆ–圖片é»è²¼æœ¬å„äºŒä»½ï¼›å…¶æª¢é©—é …ç›®åŠè¦æ ¼ï¼Œæ‡‰ç¬¦åˆä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šäº‹é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å®‰å®šæ€§è©¦é©—書é¢ä½œæ¥ç¨‹åºåŠå…¶å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è®Šæ›´è³¦å½¢åŠ‘之檢驗è¦æ ¼ã€æ–¹æ³•åŠæª¢é©—æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å¦‚係輸入ä¸è—¥ï¼Œæ‡‰å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žæ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 101 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥ä¹‹è™•æ–¹è®Šæ›´ï¼Œå¦‚係有效æˆåˆ†è®Šæ›´è€…，應é‡æ–°ç”³è«‹æŸ¥é©—ç™»è¨˜ç‚ºåŽŸå‰‡ã€‚ä½†åˆªé™¤ç¡ƒç ‚ã€ä¿è‚²é¡žè—¥æ，或ä¾åŸºæº–方申請處方，或其他有關處方ç‰æ¯”例之變更者，得準用å‰æ¢è¦å®šï¼Œä»¥ç”³è«‹è³¦å½¢åŠ‘變更登記之方å¼è¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 102 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥ä¹‹é©æ‡‰ç—‡ã€æ•ˆèƒ½ã€ç”¨æ³•ç”¨é‡è®Šæ›´ç™»è¨˜ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚但申請變更用法用é‡è€…，應附影本，å…附æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è®Šæ›´ä¹‹ä¾æ“šå½±æœ¬ï¼Œä¸¦è©³è¿°è®Šæ›´ä¹‹ç†ç”±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å¦‚涉åŠä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘ŠåŸºæº–方之變更者，應ä¾æœ‰é—œå…¬å‘Šè¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 103 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請ä¸è—¥é¡žåˆ¥ã€è‰åˆ¥è®Šæ›´ç™»è¨˜ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è—¥å“變更登記申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è®Šæ›´ä¹‹ä¾æ“šå½±æœ¬ï¼Œä¸¦è©³è¿°è®Šæ›´ä¹‹ç†ç”±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">國產ä¸è—¥è£½åŠ‘之標籤ã€ä»¿å–®ã€åŒ…è£è®Šæ›´ï¼Œç¬¦åˆä¸‹åˆ—情形之一者，得自行變更。但其變更應符åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„，於書é¢ä½œæ¥ç¨‹åºè©³å¯¦ä¿®æ£ä¸¦ä½œç´€éŒ„ï¼Œä¸”éœ€ç•™å» å‚™æŸ¥ï¼Œä¸¦å…¶å¸‚å”®å“應ä¾æœ‰é—œæ³•ä»¤è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸæ ¸å‡†æ–‡å—內容未變更者，包括如下：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">僅標籤ã€ä»¿å–®ã€å¤–盒圖樣或色澤之變更。但ä¸å¾—有涉åŠçŒ¥è¤»ã€æœ‰å‚·é¢¨åŒ–或誤導效能之圖樣。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å› åŒ…è£æ•¸é‡ä¸åŒè€Œä¾æ¯”例縮å°æˆ–æ”¾å¤§åŽŸæ ¸å‡†ä¹‹åœ–æ–‡ï¼Œæˆ–æ›´æ”¹åŽŸæ ¸å‡†åœ–æ–‡ä½ç½®ä¹‹ç‰ˆé¢ç§»å‹•ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŽŸæ ¸å‡†æ–‡å—之å—體更改。但其å“å英文å—é«”ä¸å¾—大於ä¸æ–‡å—體。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¼æ¥è˜åˆ¥</span><span style="font-family: calibri;"> CIS </span><span style="font-family: 新細明體,serif;">ä¹‹åŠ å°æˆ–更改。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">由標籤é»è²¼æ”¹ç‚ºç›´æŽ¥å°æ–¼å¤–包è£æˆ–å¢žåŠ å¤–ç›’è€…ã€‚ä½†å…¶æ–‡å—ã€åœ–樣之è¨è¨ˆæ‡‰èˆ‡æ¨™ç±¤ç›¸åŒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ–‡å—內容雖有變更，但ä¸æ¶‰åŠè—¥å“å“質ã€ç”¨è—¥å®‰å…¨è€…：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">增å°æˆ–變更æ¢ç¢¼ã€å¥ä¿ä»£ç¢¼ã€è˜åˆ¥ä»£ç¢¼ã€</span><span style="font-family: calibri;">GMP </span><span style="font-family: 新細明體,serif;">è—¥å» ä¹‹</span><span style="font-family: calibri;"> GMP </span><span style="font-family: 新細明體,serif;">å—樣ã€è™•æ–¹ä¸åŽŸæ–™ä¹‹å¤–æ–‡åã€ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ç™»è¨˜ä¹‹è‘—作權登記å—號或公å¸å•†æ¨™ã€è¨»å†Šå•†æ¨™å—號或專利è‰æ›¸å—號。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">增å°æˆ–變更建è°å”®åƒ¹æˆ–消費者æœå‹™å°ˆç·šã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è®Šæ›´è—¥å•†å稱或地å€ï¼Œèˆ‡å¢žå°æˆ–變更電話ã€å‚³çœŸã€é€£çµ¡è™•ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">增å°æˆ–變更經銷商å稱ã€åœ°å€ã€‚但經銷商å稱之å—é«”ä¸å¾—大於藥商</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">許å¯è‰æŒæœ‰è€…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å稱之å—體，且經銷商應具有藥商許å¯åŸ·ç…§ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å¢žåŠ å°å£æ¨™ç¤º</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">外盒</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">或更改其標示，包括價ä½æ¨™ç¤ºã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">輸出藥å“，ä¾å¤–銷國之è¦æ±‚於標籤ã€ä»¿å–®ä¸Šå¢žåˆ—é …ç›®ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為藥å“å¸‚å ´å€éš”æ‰€éœ€ï¼Œæ–¼åŽŸæ ¸å®šåŒ…è£ä¸ŠåŠ 註本藥é™ç”±æŸé†«é™¢ä½¿ç”¨ã€æˆ–é™ä¾›é†«é™¢ç”¨ï¼Œä¸å¾—轉售åŠå…¶ä»–é©ç•¶è¾å¥ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">英文å“ååŠ è¨»ä¹‹å» å增刪或變更。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¹</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">處方之單ä½æ¨™ç¤ºæ–¹å¼æ›´æ”¹ï¼Œç¬¦åˆå°ç£å‚³çµ±è—¥å…¸è€…。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ–¼ä¸å½±éŸ¿åŽŸè¨‚貯è—法情形下，å°æ•´åˆå…¶è²¯è—法之用詞改變。但其用詞應ä¾ä¸è¯è—¥å…¸ç”¨è©žè¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç‚ºç¶è·è—¥å“å“質åŠç”¨è—¥å®‰å…¨ï¼Œè€ŒåŠ 註使用方法之文å—內容變更者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 105 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥åŒ…è£è®Šæ›´ï¼Œé™¤ç¬¦åˆå‰æ¢å¾—自行變更外，其餘變更應ä¾ä¸‹åˆ—è¦å®šç”³è«‹è®Šæ›´ç™»è¨˜ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŒ…è£æ質ä¸è®Šæ›´è€…，申請變更包è£é™é‡ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“變更登記申請書。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŒ…è£ä¹‹æè³ªä¹‹è®Šæ›´ï¼Œå¦‚èˆ‡åŽŸæ ¸å‡†ä¹‹åŒ…è£æ質ä¸åŒè€…，應檢附下列資料：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“變更登記申請書。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">安定性試驗書é¢ä½œæ¥ç¨‹åºåŠå…¶å ±å‘Šã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‰¹æ¬¡è£½é€ ç´€éŒ„ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …包è£æ質之變更，如涉åŠæ¨™ç±¤ã€ä»¿å–®ã€å¤–ç›’è®Šæ›´è€…ï¼Œä¸¦æ‡‰åŠ å…·ä¸‹åˆ—è³‡æ–™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å¤–ç›’ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">包è£ä¹‹è®Šæ›´ï¼Œæ‡‰ç¬¦åˆç¬¬ä¸ƒå七æ¢ç¬¬äºŒé …è‡³ç¬¬å››é …ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如係輸入ä¸è—¥ï¼Œæ‡‰å¦é™„åŽŸå» è®Šæ›´é€šçŸ¥å‡½åŠå‡ºç”¢åœ‹è¨±å¯è£½å”®è‰æ˜Žæ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 106 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥ä¹‹å§”è¨—è£½é€ ç™»è¨˜åŠå§”è¨—è£½é€ å¾Œæ”¶å›žè‡ªè£½ç™»è¨˜ï¼Œæ‡‰é™„åˆ‡çµæ›¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">甲</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，並分別準用第å…åå››æ¢åŠç¬¬å…å五æ¢ä¹‹è¦å®šã€‚但第å…åå››æ¢ç¬¬ä¸€é …ç¬¬ä¸ƒæ¬¾è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸åŠç¬¬å款資料ã€ç¬¬å…å五æ¢ç¬¬ä¸ƒæ¬¾åŠç¬¬å…«æ¬¾è³‡æ–™å…é™„ï¼ŒæƒŸæ‡‰ç•™å» å‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è—¥ä¹‹å§”託檢驗，準用第å…åå…æ¢è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 107 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥è¨±å¯è‰ç™»è¨˜äº‹é …ä¹‹è®Šæ›´ï¼ŒåŒ…æ‹¬åŽŸå» è®Šæ›´é€šçŸ¥å‡½ã€æª¢é©—è¦æ ¼åŠæ–¹æ³•è®Šæ›´ã€è—¥å•†</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«è£½é€ å» </span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之å稱或地å€è®Šæ›´ã€è—¥å“之標仿單外盒與é‹ç®”ç´™</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">袋</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">變更åŠæ ¸å®šæœ¬éºå¤±è£œç™¼ï¼Œåˆ†åˆ¥æº–用第四å七æ¢ã€ç¬¬äº”å七æ¢åŠç¬¬å…åæ¢è‡³ç¬¬å…å三æ¢ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">ä¸è—¥è¨±å¯è‰ä¹‹ç§»è½‰èˆ‡æ›ç™¼åŠè£œç™¼</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 108 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥è¨±å¯è‰ä¹‹ç§»è½‰ç™»è¨˜ã€éºå¤±è£œç™¼èˆ‡æ±¡ææ›ç™¼ï¼Œåˆ†åˆ¥æº–用第七åæ¢åŠç¬¬ä¸ƒå一æ¢ä¹‹è¦å®šã€‚但第七åæ¢ç¬¬ä¸€é …ç¬¬äº”æ¬¾ç¬¬äº”ç›®ä¹‹è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸å…é™„ï¼ŒæƒŸæ‡‰ç•™å» å‚™æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">ä¸è—¥è¨±å¯è‰ä¹‹å±•å»¶ç™»è¨˜</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 109 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è—¥è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“之展延，應於期滿å‰ä¸‰å€‹æœˆå…§ç”³è«‹ã€‚申請展延登記，如需åŒæ™‚辦ç†è®Šæ›´è€…，應與其他展延案分開申請。</span> </p><p><span style="font-family: 新細明體,serif;">申請ä¸è—¥ä¹‹è—¥å“許å¯è‰å±•å»¶ç™»è¨˜ï¼Œæ‡‰æª¢é™„下列資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¶“申請人所在地之直轄市或縣</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">市</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸ç« ä¹‹è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“展延申請書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¦‚è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“欄ä½å·²è“‹æ»¿å±•å»¶ç« 戳，應å¦é™„è—¥å“查驗登記申請書æ£æœ¬ï¼Œä»¥æ†‘æ›ç™¼æ–°è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¦‚申請展延之藥å“ï¼Œä¿‚å±¬å…§æ”¿éƒ¨æ ¸ç™¼ä¹‹è—¥å“許å¯è‰è€…，å…繳審查費，惟應å¦é™„下列資料：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“變更登記申請書。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŽŸæ ¸å‡†ä¸¦è“‹æœ‰ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œé¨Žç¸«ç« 之外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">外盒ã€ä»¿å–®ã€æ¨™ç±¤é»è²¼è¡¨å„二份。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¦‚申請展延之藥å“，係屬ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹è©•ä¼°è—¥å“æˆ–éœ€åŠ å¼·ç®¡ç†ä¹‹è—¥å“者，應ä¾å…¬å‘Šè¦å®šæª¢é™„有關資料。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ä»¥å…§æ”¿éƒ¨æ ¸ç™¼æˆ–其後經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ›ç™¼ä¹‹éžå±¬å›ºæœ‰å…¸ç±æ”¶è¼‰ä¹‹è—¥å“許å¯è‰ï¼Œè‡ªæ°‘國ä¹å四年三月一日起，該許å¯è‰æ–¼å±•å»¶æ™‚，應å¦é™„處方內藥æ之二種指標æˆåˆ†ä¹‹é«˜æ•ˆæ¶²ç›¸å±¤æžæª¢é©—方法åŠåœ–èœã€‚但經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œèªå®šæœ‰çª’礙難行者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è‡ªæ°‘國ä¹å四年三月一日起，應å¦é™„å…¶è£½é€ å» ä¹‹è»Ÿç¡¬é«”è¨å‚™åŠç›¸é—œåŠ‘åž‹è¨å‚™ç¬¦åˆè—¥ç‰©è£½é€ å·¥å» è¨å» 標準之è‰æ˜Žæ–‡ä»¶å½±æœ¬ï¼›æˆ–在ä¹å四年二月二åå…«æ—¥å‰æª¢é™„ä¸‹åˆ—è³‡æ–™ï¼Œç¶“æŸ¥æ ¸é€šéŽå¾Œï¼Œæ–¹å¾—展延至ä¹å四年ä¹æœˆä¸‰åæ—¥æ¢ï¼Œä¸¦ä¾ä¸Šé–‹è¦å®šè¾¦ç†ï¼Œå¦‚ä¿‚åˆ†æ®µå§”è¨—è£½é€ è€…ï¼Œå…¶è£½é€ å» æ‡‰åŒ…æ‹¬åˆ†æ®µå§”è¨—è£½é€ ä¸æ‰€æœ‰è£½ç¨‹æ¶‰åŠä¹‹å—è¨—è£½é€ å» ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€æ–°å»ºå» 房：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">建照執照。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">建築ã€æ°´é›»åŠç©ºèª¿å·¥ç¨‹åˆç´„書。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">建築物使用執行</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">完工後</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">施工照片。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">切çµæå‡ºè»Ÿé«”æŸ¥å» æ—¥æœŸã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€æ”¹å»ºå» 房：準用å‰é …è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€å»ºç‰©ç¯„åœå…§ä¿®ç¹•ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">建築ã€æ°´é›»åŠç©ºèª¿å·¥ç¨‹åˆç´„書。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">施工照片。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">切çµæå‡ºè»Ÿé«”æŸ¥å» æ—¥æœŸã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 110 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=71&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=72&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6081&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記法è¦å‘½ä»¤è—¥å“查驗登記審查準則─人用血漿製劑之查驗登記<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱之「人用血漿製劑ã€ï¼Œä¿‚指將多袋人血漿混åˆ</span><span style="font-family: calibri;"> (pooling)</span><span style="font-family: 新細明體,serif;">ã€åˆ†å±¤</span><span style="font-family: calibri;"> (Fractionation) </span><span style="font-family: 新細明體,serif;">精製而得之治療性產å“。於æŸäº›æƒ…æ³ä¸‹ï¼Œäº¦å¯ç¯©æª¢å‡ºå«é«˜åŠ›åƒ¹ç‰¹å®šæŠ—體之人血漿，混åˆå¾Œåˆ†å±¤ç²¾è£½è€Œå¾—。人血漿之收集å¯ç”±è¡€æ¼¿åˆ†é›¢è¡“或由全血經離心而得。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人用血漿製劑應檢附之資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¡€æ¼¿åŽŸæ–™ä¾†æºä¹‹ç®¡åˆ¶ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¡€æ¼¿åŽŸæ–™è¦æ ¼ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç”¢å“è£½é€ åŠç´”化éŽç¨‹</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç—…毒去活化</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">去除確效資料</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è¡€æ¼¿è£½åŠ‘è—¥å“技術性資料：</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è¡€æ¼¿è£½åŠ‘çš„è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å®‰å®šæ€§è³‡æ–™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è—¥ç†åŠæ¯’性試驗資料</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€è‡¨åºŠä½¿ç”¨æ–‡ç»</span> </p><p><span style="font-family: 新細明體,serif;">一○ã€å…¶ä»–</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">血漿原料來æºä¹‹ç®¡åˆ¶ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¡€æ¼¿åŽŸæ–™ä¾†æºæ¸…單：血漿原料係指「原料血漿</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">分離術血漿</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€åŠã€Œå›žæ”¶è¡€æ¼¿ã€ç‰ç”¨æ–¼è£½é€ 血漿製劑之原料。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血漿原料之è¦æ ¼æ‡‰ç¬¦åˆä¸è¯è—¥å…¸ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ç”¨ä¾†è£½é€ è¡€æ¼¿è£½åŠ‘ä¹‹äººè¡€æ¼¿ä¾†æºè’集機構</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如：國內之æè¡€ä¸å¿ƒæˆ–ç¶“æ ¸å‡†ä¹‹åœ‹å¤–æ©Ÿæ§‹ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，應有血漿管制標準書</span><span style="font-family: calibri;"> (Plasma Master F-ile)</span><span style="font-family: 新細明體,serif;">。內容應明確敘述其來æºèˆ‡ç®¡åˆ¶ï¼ŒåŒ…括æ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¾›</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血者之篩é¸ã€åŽŸæ–™ä¸ç—…原標誌之檢驗ã€é‹é€æ–¹å¼ã€å„²å˜æº«åº¦åŠä¸åˆæ ¼è¡€æ¼¿ä¹‹è™•ç†æ–¹å¼ç‰ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血漿來æºå°‡ä¾ç–¾ç—…之發生ã€å¥åº·ä¹‹è¦æ±‚åŠç›£è¦–作æ¥ç³»çµ±ä¹‹å®Œå–„，é©æ™‚åšå¿…è¦ä¹‹ç®¡åˆ¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€æ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¾›</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">血者åŠè¡€æ¼¿æ··åˆæ¶²</span><span style="font-family: calibri;"> (Plasma Pool) </span><span style="font-family: 新細明體,serif;">以</span><span style="font-family: calibri;"> anti - HIV 1/2 </span><span style="font-family: 新細明體,serif;">ã€</span> </p><p><span style="font-family: calibri;"> anti-HCV </span><span style="font-family: 新細明體,serif;">åŠ</span><span style="font-family: calibri;"> HBsAg </span><span style="font-family: 新細明體,serif;">之篩檢çµæžœæ‡‰ç‚ºé™°æ€§å應。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¡€æ¼¿æ··åˆæ¶²æ‡‰æœ‰ä»¥æ ¸é…¸æ“´å¢žæŠ€è¡“</span><span style="font-family: calibri;"> (Nucleic acid amplification te-</span></p><p><span style="font-family: calibri;"> chnology;NAT) </span><span style="font-family: 新細明體,serif;">檢測，至少應有å°</span><span style="font-family: calibri;"> HCV </span><span style="font-family: 新細明體,serif;">之</span><span style="font-family: calibri;"> RNA </span><span style="font-family: 新細明體,serif;">çš„</span><span style="font-family: calibri;"> NAT </span><span style="font-family: 新細明體,serif;">檢驗為陰性的çµæžœå ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€</span><span style="font-family: calibri;">NAT </span><span style="font-family: 新細明體,serif;">的檢測方法：若</span><span style="font-family: calibri;"> NAT </span><span style="font-family: 新細明體,serif;">檢測方法尚未於我國å–得許å¯è‰ï¼Œç”³è«‹å» 商應將其檢驗è¦æ ¼ã€æ–¹æ³•åŠéˆæ•åº¦ç‰ï¼Œä¾è¼¸è¡€ç”¨è¨ºæ–·è©¦åŠ‘查驗登記之è¦æ±‚，檢附相關資料供審查評估。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€</span><span style="font-family: calibri;">NAT </span><span style="font-family: 新細明體,serif;">篩檢試驗：行政院衛生署將åƒè€ƒå…¶ä»–國家之è¦å®šï¼Œå…¬å‘Šæ–°å¢žä¹‹ç¯©æª¢é …ç›®åŠè¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å°æ–¼è¡€æ¼¿åŽŸæ–™æ‡‰æœ‰å¯å›žæº¯ä¹‹è¿½è¹¤ç´€éŒ„</span><span style="font-family: calibri;"> (Traceability) </span><span style="font-family: 新細明體,serif;">，å°æ–¼ä¾›è¡€è€…之å¥åº·åŠå—血者之ä¸è‰¯å應，應åŠæ™‚é€šå ±ä¸¦æŽ¡å–å¿…è¦ä¹‹ä½œæ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">血漿製劑之原料ã€è¦æ ¼ã€æ¨™æº–å“ã€è©¦åŠ‘ã€ææ–™åŠå‹•ç‰©æ€§åŽŸæ–™ã€è©¦åŠ‘åŠæˆåˆ†çš„管制：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¡€æ¼¿åŽŸæ–™æ‡‰æª¢é™„åŽŸå» åŠåŽŸç”¢åœ‹è¦æ±‚的血漿原料è¦æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŽŸæ–™ä¹‹æ´»æ€§ï¼šæ‡‰æ•˜è¿°ä»¥è£½é€ å» å°ç…§æ¨™æº–å“</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">標準批次或試驗批次</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">測定產å“效價ï¼ç”Ÿç‰©æ´»æ€§ä¹‹ç”Ÿç‰©å¸è©¦é©—，包括所使用之方法與標準å“，åŠè©²è©¦é©—之變異性以åŠå¯æŽ¥å—之範åœã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å°ç…§æ¨™æº–å“ï¼è¡€æ¸…組：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å°ç…§æ¨™æº–å“：如使用國際å°ç…§æ¨™æº–å“ï¼Œé ˆæª¢é™„è©²æ¨™æº–å“之è¦æ ¼èˆ‡åˆ†æžæˆç¸¾æ›¸ã€‚若無å°ç…§æ¨™æº–å“，å¯è‡ªè¡Œå»ºç«‹å» 內一級å°ç…§æ¨™æº–å“ã€‚ä½†é ˆæª¢é™„è©²å°ç…§æ¨™æº–å“之製備標準作æ¥ç¨‹åºã€ç‰¹æ€§ã€è¦æ ¼ã€åˆ†æžæˆç¸¾æ›¸åŠå®‰å®šæ€§æ•¸æ“šã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å» å…§å·¥ä½œæ¨™æº–å“ï¼šå» å…§å·¥ä½œæ¨™æº–å“é ˆæª¢é™„å…¶è£½å‚™ã€ç‰¹æ€§ã€è¦æ ¼ã€è©¦é©—åŠçµæžœã€‚äº¦æ‡‰æª¢é™„è©²å» å…§å·¥ä½œæ¨™æº–å“以å‰è¿°å°ç…§æ¨™æº–å“æ‰€æ ¡æ£ä¹‹æ•¸æ“šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è©¦åŠ‘åŠæ料之管制</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰è¡¨åˆ—æ‰€æœ‰ä½¿ç”¨æ–¼è¡€æ¼¿è£½åŠ‘è£½é€ ä¹‹ç‰¹æ®Šè©¦è—¥å’Œæ料，如緩è¡æ¶²ã€è¡€æ¸…ã€æŠ—ç”Ÿç´ ã€å–®æ ªæŠ—體與ä¿è—劑之測試方法與其相關è¦æ ¼ã€‚å°æ–¼è³¼è²·ä¹‹åŽŸæ–™æ‡‰æœ‰ä¾›æ‡‰å•†ä¹‹åˆ†æžè‰æ˜ŽåŠè‡ªå®¶æª¢å®šçµæžœã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æŸäº›æƒ…æ³ä¸‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å¦‚ä½¿ç”¨å–®æ ªæŠ—é«”æ–¼è£½é€ æ™‚</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應詳述其製備éŽç¨‹åŠç‰¹æ€§ã€‚若人類組織被用於å¸æ”¶æˆ–å¸é™„作用，則應敘述æ贈者之åˆé©æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å‹•ç‰©æ€§åŽŸæ–™ã€è©¦åŠ‘åŠæˆåˆ†çš„管制：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è‹¥æ–¼è£½é€ éŽç¨‹ä¸æœ‰ä½¿ç”¨ç”±å‹•ç‰©ä¾†æºå–得之原料時，需è‰æ˜Žå…¶ä¸å«å¤–來物質，如牛海綿狀腦病變</span><span style="font-family: calibri;"> (Bovine Spongiform Encephalopathy, BSE) </span><span style="font-family: 新細明體,serif;">物質，與其他動物病毒。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">若有使用由動物來æºå–å¾—ä¹‹åŽŸæ–™æ–¼è£½é€ éŽç¨‹ä¸ï¼Œæ‡‰ä¾å¯¦éš›éœ€è¦è¼‰æ˜Žï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">動物來æºåŠä½¿ç”¨ç·£ç”±</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">å…疫方法</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">å» å…§é£¼é¤Š</span><span style="font-family: calibri;"> (in-house) </span><span style="font-family: 新細明體,serif;">動物之管制</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">外來物質之篩é¸èˆ‡æª¢ç–«æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">ç¸é†«ç›£ç£</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">採血éŽç¨‹</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">è£½é€ ç”¨å‹•ç‰©ä¹‹é£¼é¤Šå ´æ‰€åŠå…¶ç’°å¢ƒæ¢ä»¶</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產å“è£½é€ åŠç´”化éŽç¨‹ï¼šå°æ–¼è¡€æ¼¿è£½åŠ‘è£½é€ éŽç¨‹ä¸ä¹‹åˆ†å±¤ã€ç´”化ç‰æ¥é©Ÿæ‡‰æœ‰å®Œæ•´ä¹‹æ•˜è¿°ã€‚並檢附書é¢ä½œæ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é¸æ“‡æ–¹æ³•ä¹‹åˆç†æ€§</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è£½é€ æˆ–å†è£½</span><span style="font-family: calibri;"> (reprocessing) </span><span style="font-family: 新細明體,serif;">éŽç¨‹</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">å°æ–¼ç”¢å“å†è£½æˆ–其相關方法的完整確效資料</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">å°æ–¼æ‰¹æ¬¡ä¹‹å…¨éƒ¨æˆ–部份產å“å†è£½ä¹‹å®¹è¨±æ¢ä»¶</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">純化éŽç¨‹</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">製程ä¸ä¹‹éŽæ¿¾æ–¹æ³•ï¼Œæ‡‰æ供資料åŠæ•¸æ“š</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŽ»é™¤ï¼ä¸æ´»åŒ–感染性病原之製程åŠå»¢æ£„物之ä¸æ´»åŒ–æ¥é©Ÿ</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ»…èŒåŠç„¡èŒæ“作éŽç¨‹ï¼šæ‡‰ç„¡å¾®ç”Ÿç‰©ä¹‹æ±¡æŸ“</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">確ä¿å…§å®¹ç‰©ä¸å—污染或交å‰æ±¡æŸ“的方法</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">製程ä¸å¾®ç”Ÿç‰©è² è·é‡èˆ‡å…§æ¯’ç´ çš„é™åº¦</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">病毒去活化ï¼åŽ»é™¤ç¢ºæ•ˆè³‡æ–™ï¼šäººä¾†æºä¹‹è¡€æ¼¿è£½åŠ‘於製程ä¸é ˆåŠ 入經確效之病毒去除ï¼ä¸æ´»åŒ–之驟。病毒之去活化ï¼åŽ»é™¤ç¢ºæ•ˆè³‡æ–™æ‡‰èƒ½å°‡å€‹åˆ¥ä¹‹æ¨™æº–病毒</span><span style="font-family: calibri;"> (Model virus) </span><span style="font-family: 新細明體,serif;">減少至</span><span style="font-family: calibri;"> 1/10,000 </span><span style="font-family: 新細明體,serif;">以下。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">血漿製劑產å“之è¦æ ¼èˆ‡åˆ†æžæ–¹æ³•ç‰æŠ€è¡“性資料：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€çµ„æˆï¼šæ‡‰è©³è¿°è¡€æ¼¿è£½åŠ‘最終æˆå“之組æˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è£½é€ 與包è£ï¼šæ‡‰è©³è¿°è¡€æ¼¿è£½åŠ‘最終æˆå“ä¹‹è£½é€ æ—¥æœŸã€æœ‰æ•ˆæœŸé™ã€æ¨™ä»¿å–®åŠåŒ…è£è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æª¢é©—è¦æ ¼åŠæª¢é©—方法：應具備該製劑之鑑別ã€å®‰å®šæ€§èˆ‡è£½é€ 一致性ç‰åˆ†æžæ–¹æ³•èˆ‡æ¸¬è©¦çµæžœ</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應檢附批次紀錄放行試驗之è¦æ ¼åŠåˆ†æžæ–¹æ³•ï¼Œæœ‰æ•ˆæœŸé™ä¹‹åˆ¶å®šåŠç®¡åˆ¶è¦æ ¼ï¼Œä»¥ç¢ºä¿å…¶é‘‘別ã€ç´”度ã€å¼·åº¦æˆ–效價åŠæ‰¹æ¬¡é–“之一致性。若為éžå…¬å®šæ›¸ä¹‹æª¢é©—方法，應予確效以è‰å¯¦å…¶åˆé©æ€§ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰å…·å‚™æ‰¹æ¬¡æ”¾è¡Œè¨ˆç•«æ›¸ï¼Œé ˆåŒ…å«è©²ç”¢å“具代表性批次之è¦æ ¼ç¯„åœã€‚è¦æ ¼å¯åŒ…å«</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸ä¾·é™</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物化å¸ç´”度ã€å®‰å…¨æ€§ã€å¤–觀ã€</span><span style="font-family: calibri;">pH </span><span style="font-family: 新細明體,serif;">值ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å«æ¿•åº¦ã€è³¦å½¢åŠ‘ã€å…§æ¯’ç´ èˆ‡ç„¡èŒæ€§ç‰ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應敘述產å“包è£ä¸æ‰€é™„之æ料，例如稀釋液或注射é‡ç’。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應充分詳述試驗方法與åˆæ ¼æ¨™æº–，包å«æŠ½æ¨£è¨ˆç•«åŠåˆ†æžæ–¹æ³•ä¹‹æº–確度與精密度。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">物ç†åŒ–å¸è©¦é©—：ä¾å¯¦éš›éœ€è¦é¸æ“‡ä¸‹åˆ—或其他é©ç•¶é …目分æžä¹‹ï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">效價試驗</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">色層分æž</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">電泳，如：硫酸å二酯鈉èšä¸™çƒ¯é†¯èƒºè† 體電泳</span><span style="font-family: calibri;"> (SDS-PAGE)</span></p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">å…疫墨點分æž</span><span style="font-family: calibri;"> (Immunoblot Analysis)</span></p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æµå¼ç´°èƒžå„€åˆ†æž</span><span style="font-family: calibri;"> (Flow Cytometer Analysis)</span></p><p><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">é…µç´ çµåˆå…疫分æž</span><span style="font-family: calibri;"> (ELISA)</span></p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸ç´”物：應具備ä¸ç´”物包括蛋白質是å¦è®Šç•°</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如斷裂ã€èšé›†ã€åŽ»èƒºèˆ‡æ°§åŒ–</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">與其他ä¸ç´”物或殘留物</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如製程ä¸è©¦åŠ‘åŠç´°èƒžåŸ¹é¤Šæˆåˆ†</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">之分æžè³‡æ–™ã€‚應鑑è˜å¯èƒ½å˜åœ¨ä¹‹å…¶ä»–活性血漿æˆåˆ†ï¼Œä¸¦è¨‚定å„種ä¸ç´”物è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">賦形劑：å°æ–¼äººé¡žæˆ–動物來æºä¹‹éžæ´»æ€§æˆåˆ†ï¼Œæ‡‰å…·å‚™åˆ†æžæˆç¸¾æ›¸ï¼Œæˆ–其他足以è‰æ˜Žå…¶ä¸å«å¤–來污染物者。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">容器與å°è“‹ï¼šæ‡‰æœ‰è£½ç¨‹ä¸æ‰€ç”¨ä¹‹å®¹å™¨èˆ‡å°è“‹å°æ–¼åŽŸæ–™åŠç”¢å“之åˆé©æ€§è©•ä¼°æ¸¬è©¦ï¼Œå¦‚å¸é™„ã€å¯æ»²å‡ºç‰©ã€ç”Ÿç‰©æ¸¬è©¦ç‰ã€‚並應有儲</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å˜æœŸé™ä¸å®¹å™¨åŠå°è“‹å®Œæ•´æ€§ä¹‹è‰æ˜ŽåŠä¾›æ‡‰å•†è³‡è¨Šã€‚若容器或å°è“‹ç³»çµ±å·²ç²è¨±å¯ï¼Œæ‡‰å…·å‚™è¨±å¯è‰æ˜Žä¾›åƒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æª¢é©—æˆç¸¾æ›¸ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應註明批號ã€æª¢é©—日期ã€æª¢é©—人員åŠè² 責人簽å</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應包括所有原料åŠæˆå“之檢驗æˆç¸¾æ›¸</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應ä¾è¦æ ¼é€é …檢驗</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">原料檢驗æˆç¸¾æ›¸æ‡‰ç‚ºæ‰€é™„æˆå“批次使用之原料檢驗æˆç¸¾æ›¸</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">檢驗çµæžœç‚ºæ•¸å€¼è€…應以數據表示，檢驗方法為比å°æ¨™æº–å“者å¯ä»¥ã€Œ</span><span style="font-family: calibri;">Pass</span><span style="font-family: 新細明體,serif;">ã€è¡¨ç¤º</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ–¹æ³•ç¢ºæ•ˆï¼šæ‡‰å…·å‚™æ–¹æ³•ç¢ºæ•ˆèˆ‡æ•¸æ“šåˆ†æžã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¡€æ¼¿è£½åŠ‘çš„è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼šæ‡‰é™„ç”±åŽŸæ–™è£½æˆæ¯ä¸€çµ„æˆä»½</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åŠæˆå“</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">的製程åŠè£½ç¨‹ç®¡åˆ¶æ¨™æº–書</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ‡‰åŒ…括在分è£å‰ä¹‹è£½é€ éŽç¨‹å„階段å‡é©æ™‚å–樣ã€åŒ–驗的管制標準書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å®Œæˆåˆ†è£å‰ä¹‹å„é …è©¦é©—</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體,serif;">包括單一血袋ã€æ··åˆè¡€æ¼¿</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體,serif;">純化後之產物，分è£å‰æº¶æ¶²åŠæœ€çµ‚產å“ç‰å„éšŽæ®µä¹‹è©¦é©—é …ç›®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å®Œæ•´æ‰¹æ¬¡è£½é€ 紀錄或製程管制標準書</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">應與所é€ä¹‹æˆå“為åŒæ‰¹æ¬¡</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">：應有å„æ‰¹æ¬¡è£½é€ èˆ‡æ¸¬è©¦ä¹‹å®Œæ•´ç´€éŒ„ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應註明æ¯æ‰¹ç”¢é‡ã€ä¸‹æ–™é‡</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰è¨»æ˜Žè£½é€ æ–¹æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">原料混åˆæ¬¡åºã€æ™‚é–“ã€åŠ 熱…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŠå®Œæ•´è£½é€ éŽç¨‹ï¼ç®¡åˆ¶é …ç›®åŠç¯„åœ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«æ°´é‡æ¸¬å®šã€</span><span style="font-family: calibri;">pH</span><span style="font-family: 新細明體,serif;">ã€å……填釅</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">抽樣方法</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å¦‚æŠ½æ¨£é »çŽ‡ã€æŠ½æ¨£é‡</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安定性資料：應敘述產å“之安定性以訂定其儲è—æ¢ä»¶èˆ‡æœ‰æ•ˆæœŸé™ï¼Œå¿…è¦æ™‚應有åŠè£½å“或調é…原液在特定儲å˜æˆ–é‹é€æ¢ä»¶ä¸‹ä¹‹å®‰å®šæ€§åŠå…¶ç¢ºæ•ˆè³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å®‰å®šæ€§è©¦é©—å ±å‘Šæ‡‰ä¾è¡Œæ”¿é™¢è¡›ç”Ÿç½²å…¬å‘Šä¹‹ã€Œè—¥å“安定性試驗準則ã€å…§å®¹ç¢ºå¯¦åŸ·è¡Œï¼Œä¸¦æª¢é™„實驗方法ã€çµ±è¨ˆåˆ†æžåŠå®šé‡åˆ†æžæ–¹æ³•çš„確效ç‰è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç†åŠæ¯’性試驗資料</span> </p><p><span style="font-family: 新細明體,serif;">血漿製劑至少應æ供單一劑é‡ä¹‹æ¯’性試驗資料，以說明其安全性。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床使用文ç»</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¡€æ¼¿è£½åŠ‘應æ供國外臨床文ç»ä»¥èªªæ˜Žè©²ç”¢å“之製程與é…æ–¹ç‰è‡¨åºŠå®‰å…¨æ€§è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€èˆ‡ç¶“æ ¸å‡†ä¹‹è¡€æ¼¿è£½åŠ‘ä¹‹çµ„æˆã€é©æ‡‰ç—‡åŠç‰¹æ€§ç‰æœ‰é¡¯è‘—ä¸åŒæ™‚，ä»æ‡‰åŸ·è¡Œåœ‹å…§è‡¨åºŠè©¦é©—。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¡€æ¼¿è£½åŠ‘之藥å“許å¯è‰æŒæœ‰è€…應執行藥å“上市後ä¸è‰¯ä½œç”¨ç›£è¦–，並定期æ供該藥å“之監視資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">其他</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¼¸å…¥æˆ–è£½é€ ä¹‹è¡€æ¼¿è£½åŠ‘ï¼Œæ‡‰ç”³è«‹æª¢é©—å°ç·˜å¾Œï¼Œå§‹å¾—銷售。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¡€æ¼¿è£½åŠ‘之藥å“許å¯è‰æŒæœ‰è€…ï¼Œé ˆæ–¼æ¯å¹´ä¸‰æœˆä¸€æ—¥å‰æª¢é€å‰ä¸€å¹´å…ƒæœˆä¸€æ—¥èµ·è‡³å二月å…一日æ¢ä¹‹å„å“ç›®ã€æ‰¹è™Ÿè¡€æ¼¿è£½åŠ‘è¼¸å…¥æˆ–è£½é€ æ•¸é‡åŠé‹éŠ·ç´€éŒ„至署備查。逾期未辦ç†è€…，許å¯è‰æŒæœ‰è—¥å•†æš«ä¸å‡†ç”³è«‹è¡€æ¼¿è£½åŠ‘類查驗登記。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è¡€æ¼¿è£½åŠ‘之回收計劃書：血漿製劑之藥å“許å¯è‰æŒæœ‰è€…應訂定回收作æ¥è¨ˆç•«æ›¸ï¼Œä»¥å› 應å±å®³è—¥ç‰©ä¹‹å›žæ”¶ï¼Œå…¶å…§å®¹åŒ…括下列å„é …è³‡æ–™ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“之å“å</span><span style="font-family: calibri;">.</span></p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“之批號或åºè™Ÿç‰è˜åˆ¥è³‡æ–™èˆ‡ç·¨è™Ÿã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è—¥å“å›žæ”¶ä¹‹åŽŸå› åŠå…¶å¯èƒ½ç”¢ç”Ÿä¹‹å±éšªã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åœæ¢éŠ·å”®è©²è—¥å“之指示åŠå…¶ä»–應執行的動作。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¡€æ¼¿è£½åŠ‘之é©æ‡‰ç—‡åŠä»¿å–®æ‡‰åŠ åˆŠä¹‹äº‹é …</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">肌肉注射用人å…疫血清çƒè›‹ç™½</span><span style="font-family: calibri;"> (Immunoglobulin Human) </span><span style="font-family: 新細明體,serif;">之é©æ‡‰ç—‡ç‚ºã€Œå…疫血清çƒè›‹ç™½ç¼ºä¹ç—‡ã€</span><span style="font-family: calibri;">A </span><span style="font-family: 新細明體,serif;">åž‹è‚ç‚Žçš„é 防ã€éº»ç–¹çš„é 防和治療ã€ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">人血清白蛋白</span><span style="font-family: calibri;"> (Albumin Human) </span><span style="font-family: 新細明體,serif;">之é©æ‡‰ç—‡æ‡‰ç‚ºã€Œä½Žè›‹ç™½è¡€ç—‡ã€ä¼‘å…‹ã€ç‡’å‚·ã€ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">以人血為來æºä¹‹è¡€æ¼¿è£½åŠ‘，係自人類血漿分離而得之產å“，為使病患充分了解使用之風險與利益，特è¦å®šè©²é¡žè£½åŠ‘之外盒，應以ä¸æ–‡æ¨™ç¤ºã€Œè«‹èˆ‡ä½ 的醫師討論使用æ¤ç”¢å“之風險與利益ã€ï¼Œå…¶ä¸æ–‡ä»¿å–®æ‡‰åŠ 刊下列注æ„äº‹é …ï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">å‡è¡€å› åæ‡‰åŠ åˆŠï¼š</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">注æ„äº‹é …ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本å“係由人類血漿製得，自人類血漿所製得之產å“，å¯èƒ½å˜åœ¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è‘—æŸäº›æ„ŸæŸ“æºï¼Œä¾‹å¦‚致病性之病毒；藉由篩檢血漿之æ血者，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">檢驗æŸäº›ç¾æœ‰ç—…毒感染æºï¼Œå†ç¶“由去活化åŠï¼Œæˆ–去除æŸäº›ç—…毒</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，å³å¯é™ä½Žæ¤ç”¢å“傳染感染æºä¹‹å±éšªæ€§ã€‚惟縱然採å–上述措施</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，æ¤é¡žç”¢å“ä»æœ‰å¯èƒ½å‚³æŸ“疾病。æŸäº›ç—…毒，例如</span><span style="font-family: calibri;"> parvovirus</span></p><p><span style="font-family: calibri;"> B19 </span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">åž‹è‚炎病毒，特別難去除或去活化。</span><span style="font-family: calibri;">Parvovirus B</span></p><p><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">å°å•å©¦æˆ–å…ç–«ä¸å…¨çš„人影響較嚴é‡ã€‚由於ä»æœ‰å¯èƒ½å˜åœ¨æŸ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">些未知的感染æºï¼Œå› æ¤ï¼Œæ‰€æœ‰æ„ŸæŸ“病人，å‡æ‡‰ç›´æŽ¥å‘診療醫師</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠè£½é€ å» æˆ–ä»£ç†å•†å ±å‘Šã€‚è«‹èˆ‡ä½ çš„é†«å¸«è¨Žè«–ä½¿ç”¨æ¤ç”¢å“之風險</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠåˆ©ç›Šã€‚</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">è¦èªžï¼š</span> </p><p><span style="font-family: calibri;"> Parvovirus B19 </span><span style="font-family: 新細明體,serif;">之感染症狀為發燒ã€æ˜ç¡ã€ç™¼å¯’åŠæµé¼»æ°´ï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">接著大約二週後會產生發疹åŠé—œç¯€ç—›ã€‚</span><span style="font-family: calibri;">A </span><span style="font-family: 新細明體,serif;">åž‹è‚炎則包å«å¹¾å¤©è‡³</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一週之食慾ä¸æŒ¯ã€å€¦æ€ åŠç™¼ç‡’，接著å™å¿ƒã€å˜”ååŠè‚šå痛。深</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">色尿åŠé¢è‰²ç•¥é»ƒäº¦ç‚ºä¸€èˆ¬ç—‡ç‹€ï¼Œå¦‚果這些症狀產生，請å‘醫生</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">諮詢。</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">å…¶å®ƒè¡€æ¼¿è£½åŠ‘æ‡‰åŠ åˆŠï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本å“係由自人類血漿所製得之產å“，å¯èƒ½å˜åœ¨è‘—æŸäº›æ„ŸæŸ“æºï¼Œä¾‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">如致病性之病毒。藉由篩檢血漿之æ血者，檢驗æŸäº›ç¾æœ‰ç—…毒感</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">染æºï¼Œå†ç¶“由去活化åŠï¼¼æˆ–去除æŸäº›ç—…毒，å³å¯é™ä½Žæ¤ç”¢å“傳染</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">感染æºä¹‹å±éšªæ€§ã€‚惟縱然採å–上述措施，æ¤é¡žç”¢å“ä»æœ‰å¯èƒ½å˜åœ¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æŸäº›æœªçŸ¥çš„感染æºã€‚å› æ¤ï¼Œæ‰€æœ‰æ„ŸæŸ“病人，å‡æ‡‰ç›´æŽ¥å‘診療醫師</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠè£½é€ å» æˆ–ä»£ç†å•†å ±å‘Šã€‚è«‹èˆ‡ä½ çš„é†«å¸«è¨Žè«–ä½¿ç”¨æ¤ç”¢å“之風險åŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">利益。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»ï¼š</span> </p><p><span style="font-family: calibri;"> 1 For the submission of chemistry, manufacturing and co-</span></p><p><span style="font-family: calibri;"> ntrol and establishment description information for h-</span></p><p><span style="font-family: calibri;"> uman plasma-derived biological products, animal plasma</span></p><p><span style="font-family: calibri;"> or serum-derived products. CBER/FDA/HHS Feb 1999.</span></p><p><span style="font-family: calibri;"> 2 Manufacture of medicinal products derived from human</span></p><p><span style="font-family: calibri;"> blood or human plasma. European Commission March, 2000</span></p><p><span style="font-family: calibri;"> . ENTR/III/5717/99-en</span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05
查驗登記類,è—¥å“查驗登記審查準則,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記法è¦å‘½ä»¤è—¥å“查驗登記審查準則一éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記詳如附件2013-12-05
查驗登記類,è—¥å“查驗登記審查準則,生物性體外診斷試劑之查驗登記法è¦å‘½ä»¤è—¥å“查驗登記審查準則ï¼ç”Ÿç‰©æ€§é«”外診斷試劑之查驗登記<p><span style="font-family: 新細明體,serif;">ç‚ºäº†åŠ å¼·ç”Ÿç‰©æ€§é«”å¤–è¨ºæ–·è©¦åŠ‘çš„ç®¡ç†ï¼Œé 防和é¿å…經由輸血傳æ’的疾病，</span> </p><p><span style="font-family: 新細明體,serif;">確ä¿ç”Ÿç‰©æ€§é«”外診斷試劑的å“質åŠå®‰å…¨ï¼Œçˆ°ä¾æ“šè—¥äº‹æ³•ç¬¬å››å二æ¢ï¼Œåˆ¶å®š</span> </p><p><span style="font-family: 新細明體,serif;">「藥å“查驗登記審查準則ï¼ç”Ÿç‰©æ€§é«”外診斷試劑之查驗登記ã€ã€‚本準則é©</span> </p><p><span style="font-family: 新細明體,serif;">用於生物性體外診斷試劑查驗登記，å°æ–¼åŽŸæ–™ã€è£½ç¨‹ç®¡ç†ä»¥åŠç”¢å“之å“質</span> </p><p><span style="font-family: 新細明體,serif;">ã€å®‰å…¨çš„è¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">第一æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">體外診斷藥物係指用來診斷疾病或在判定治療å‰ã€æ²»ç™‚ä¸ã€é 防</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疾病或疾病復發ç‰å¥åº·ç‹€æ³æ‰€ç”¨ä¹‹ç”Ÿç‰©è—¥å“ã€é†«ç™‚器æ或其他工</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…·</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如：電腦軟體ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。本基準所稱之「生物性體外診斷試劑ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，主è¦æŒ‡ä»»ä½•ç”¨ä¾†ç¯©é¸ä¾›è¡€è€…è¡€æºåŠå…¶åˆé©æ€§</span><span style="font-family: calibri;"> (donor suitabi-</span></p><p><span style="font-family: calibri;"> lity) </span><span style="font-family: 新細明體,serif;">ã€æ¸¬è©¦ç—…毒之感染，或是決定輸血之é…åˆæ€§</span><span style="font-family: calibri;"> (transfusi-</span></p><p><span style="font-family: calibri;"> on compatibility) </span><span style="font-family: 新細明體,serif;">ç‰è¡›ç”Ÿç½²ä»¥è—¥å“列管之體外診斷試劑而訂定</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之化å¸ã€è£½é€ åŠç®¡åˆ¶ç‰ä¹‹ç›¸é—œè¦ç¯„。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç›®å‰éœ€è¾¦ç†è—¥å“查驗登記之生物性體外診斷試劑有</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è‚炎檢驗試劑</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">人類å…疫缺ä¹ç—…毒檢</span><span style="font-family: calibri;">.</span><span style="font-family: 新細明體,serif;">驗試劑</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">人類嗜</span><span style="font-family: calibri;"> T </span><span style="font-family: 新細明體,serif;">æ·‹å·´çƒç—…毒檢驗試劑</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) Anti-A</span><span style="font-family: 新細明體,serif;">，</span><span style="font-family: calibri;">Anti-B </span><span style="font-family: 新細明體,serif;">血型分類試劑。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">行政院衛生署將é©æ™‚æª¢è¨Žé ˆè¾¦ç†æŸ¥é©—登記之生物性體外診斷</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試劑å“é …ï¼Œå¦è¡Œå…¬å‘Šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">上述體外診斷試劑之管ç†é©ç”¨è—¥äº‹æ³•ä¹‹è—¥å“管ç†ï¼›éžå±¬ä¸Šè¿°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››é¡žè©¦åŠ‘çš„é«”å¤–è¨ºæ–·è©¦åŠ‘ï¼Œåˆ—å±¬ã€Œæš«æ¯‹é ˆè¾¦ç†æŸ¥é©—登記之醫</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">療器æã€ï¼Œå…¶æ¨™ç¤ºä»æ‡‰ä¾è—¥äº‹æ³•ç¬¬ä¸ƒå五æ¢è¦å®šäº‹é …刊載。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åˆ—å±¬æš«æ¯‹é ˆè¾¦ç†æŸ¥é©—登記之醫療器æï¼Œå…¶è£½é€ ã€è²©è³£ç‰ä»æ‡‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾è—¥äº‹æ³•ä¸å°é†«ç™‚器æ相關之è¦å®šç®¡ç†ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">需辦ç†è—¥å“æŸ¥é©—ç™»è¨˜ä¹‹é«”å¤–è¨ºæ–·è©¦åŠ‘è£½é€ å» æ‡‰ç¬¦åˆã€Œè—¥å“優</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è‰¯è£½é€ è¦ç¯„ã€ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">第二æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物性體外診斷試劑應檢附之資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原料與åŠè£½å“之è¦æ ¼èˆ‡åˆ†æžæ–¹æ³•ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產å“è£½é€ åŠç´”化éŽç¨‹ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產å“之è¦æ ¼èˆ‡æŠ€è¡“性資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½ç¨‹ç®¡åˆ¶æˆ–æ‰¹æ¬¡è£½é€ ç´€éŒ„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安定性資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床試驗：</span> </p><p><span style="font-family: 新細明體,serif;">第三æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原料與åŠè£½å“之è¦æ ¼èˆ‡åˆ†æžæ–¹æ³•ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原料與åŠè£½å“æ‡‰æª¢é™„åŽŸå» è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">特性æè¿°ï¼ç”¨ä»¥è£½é€ 體外診斷試劑最終形å¼çš„任何原料與</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠè£½å“å‡æ‡‰æœ‰æ˜Žç¢ºä¹‹æ•˜è¿°ï¼ŒåŒ…括化å¸æ§‹é€ ã€ä¸€ç´šå’Œæ¬¡å–®ä½</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çµæ§‹</span><span style="font-family: calibri;"> (primary and subunit structure)</span><span style="font-family: 新細明體,serif;">ã€åˆ†åé‡ã€åˆ†å</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¼ã€å稱ã€æŠ—體種類ï¼äºžåž‹</span><span style="font-family: calibri;"> (antibody class / subcla-</span></p><p><span style="font-family: calibri;"> ss) </span><span style="font-family: 新細明體,serif;">，åŠé‡å°å…¶ç‰¹æ€§é€²è¡Œé‘‘別ã€æ•ˆåƒ¹ã€ç‰¹ç•°æ€§ã€ç´”度ã€å®‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">定性ã€ä¸€è‡´æ€§ç‰ä¹‹åˆ†æžæ¸¬è©¦çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">物ç†åŒ–å¸è©¦é©—</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">ä¾å¯¦éš›éœ€è¦é¸æ“‡ä¸‹åˆ—é©ç•¶é …目分æžä¹‹ï¼š</span> </p><p><span style="font-family: calibri;"> a.</span><span style="font-family: 新細明體,serif;">胺基酸分æžï¼›</span><span style="font-family: calibri;">b.</span><span style="font-family: 新細明體,serif;">氮端與碳端之胺基酸åºåˆ—ï¼›</span><span style="font-family: calibri;">c.</span><span style="font-family: 新細明體,serif;">完整</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">胺基酸åºåˆ—ï¼›</span><span style="font-family: calibri;">d.</span><span style="font-family: 新細明體,serif;">èƒœî ½åœ–èœï¼é…µç´ 水解圖èœï¼›</span><span style="font-family: calibri;">e.</span><span style="font-family: 新細明體,serif;">雙硫éµ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éµçµçš„測定；</span><span style="font-family: calibri;">f. SDS-PAGE (</span><span style="font-family: 新細明體,serif;">包括還原åŠéžé‚„原æ¢ä»¶</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">ï¼›</span><span style="font-family: calibri;">g.</span><span style="font-family: 新細明體,serif;">ç‰é›»é»žèšç„¦é›»æ³³ï¼›</span><span style="font-family: calibri;">h.</span><span style="font-family: 新細明體,serif;">傳統與高效液相層æžï¼Œå¦‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">逆相</span><span style="font-family: calibri;"> (reverse-phase)</span><span style="font-family: 新細明體,serif;">ã€åˆ†å篩</span><span style="font-family: calibri;"> (size exclusion)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€é›¢å交æ›</span><span style="font-family: calibri;"> (ion -exchange) </span><span style="font-family: 新細明體,serif;">ç‰ï¼›</span><span style="font-family: calibri;">i </span><span style="font-family: 新細明體,serif;">質èœå„€åœ–èœï¼›</span> </p><p><span style="font-family: calibri;"> j.</span><span style="font-family: 新細明體,serif;">測定蛋白質之去胺基</span><span style="font-family: calibri;"> (deaminated) </span><span style="font-family: 新細明體,serif;">ã€è¢«æ°§åŒ–</span><span style="font-family: calibri;"> (o-</span></p><p><span style="font-family: calibri;"> xidized)</span><span style="font-family: 新細明體,serif;">ã€æ–·è£‚</span><span style="font-family: calibri;"> (clipped) </span><span style="font-family: 新細明體,serif;">å’Œèšé›†</span><span style="font-family: calibri;"> (aggregated)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å½¢å¼æˆ–其他變異物，如胺基酸置æ›</span><span style="font-family: calibri;"> (substitutions</span></p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">ã€ä½µæŽ¥</span><span style="font-family: calibri;"> (adducts) </span><span style="font-family: 新細明體,serif;">ï¼è¡ç”Ÿç‰©ï¼›</span><span style="font-family: calibri;">k.</span><span style="font-family: 新細明體,serif;">測定éžå°ˆä¸€æ€§å®¿</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">主蛋白ã€</span><span style="font-family: calibri;">DNA</span><span style="font-family: 新細明體,serif;">與試劑之殘餘é‡ï¼›</span><span style="font-family: calibri;">l. </span><span style="font-family: 新細明體,serif;">å…疫化å¸åˆ†æžï¼›</span><span style="font-family: calibri;">m.</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è² è·èŒèˆ‡å…§æ¯’ç´ ä¹‹å®šé‡ï¼›</span><span style="font-family: calibri;">n.</span><span style="font-family: 新細明體,serif;">抗體ä¸å’Œå應；</span><span style="font-family: calibri;">o.</span><span style="font-family: 新細明體,serif;">å‡è¡€å</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應；</span><span style="font-family: calibri;">p.</span><span style="font-family: 新細明體,serif;">抑制å‡è¡€å應試驗；</span><span style="font-family: calibri;">q.</span><span style="font-family: 新細明體,serif;">抗體氮å«é‡</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">å°æ–¼è½‰è¯å¾Œä¿®é£¾ä½œç”¨</span><span style="font-family: calibri;"> (post-translational modifi-</span></p><p><span style="font-family: calibri;"> cation) </span><span style="font-family: 新細明體,serif;">，如醣化作用，以åŠèˆ‡å…¶ä»–物質如蛋白質ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é…µç´ ã€æ”¾å°„æ€§æ ¸ç¨®æˆ–åŒ–å¸è—¥å“ç‰å½¢æˆè¡ç”Ÿç‰©è³ªï¼Œå…¶ç‰©</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç†åŒ–å¸ç‰¹æ€§ä¹Ÿæ‡‰äºˆä»¥æ•˜è¿°ï¼ŒåŒ…括è¡ç”Ÿæˆ–çµåˆä¹‹ç¨‹åº¦ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">未修飾原料之å«é‡ã€æ¸¸é›¢ç‰©è³ª</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¾‹å¦‚é…µç´ ã€è›‹ç™½è³ªã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ”¾å°„æ€§æ ¸ç¨®ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之去除ã€ä»¥åŠç¶“修飾原料之安定性。</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">所有的測試方法應有完整的敘述以åŠçµæžœï¼ŒåŒ…括色層</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">分æžåœ–ã€</span><span style="font-family: calibri;">SDS-PAGE </span><span style="font-family: 新細明體,serif;">æˆ–è† é«”é›»æ³³çš„åŽŸå§‹ç…§ç‰‡ã€å…‰èœç‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之資料。</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">原料之活性</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應敘述並æä¾›æ¯ä¸€ç¨®åŽŸæ–™ä»¥é«”外</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å¿…è¦æ™‚活體</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">測試效</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">價ã€ç‰¹ç•°æ€§ã€æ´»æ€§çµæžœåŠç›¸é—œè¦æ ¼ã€‚所使用之æ¯ä¸€ç¨®åˆ†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æžæ‡‰äºˆæ•˜è¿°ï¼ŒåŒ…括所用的方法與標準å“ã€è©¦é©—éŽç¨‹ã€çµ„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">間與組內分æžçš„變異性ã€ç·šæ€§åˆ†æžåŠå¯æŽ¥å—之範åœã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¦æ ¼èˆ‡åˆ†æžæ–¹æ³•ï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">原料與åŠè£½å“之è¦æ ¼åŠæ¸¬è©¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應詳述放行測試</span><span style="font-family: calibri;"> (release testing) </span><span style="font-family: 新細明體,serif;">之è¦æ ¼åŠåˆ†æžæ–¹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法ã€æœ‰æ•ˆæœŸé™ä¹‹åˆ¶å®šã€é‹é€æ¢ä»¶åŠåŽŸæ–™èˆ‡åŠè£½å“之鑑別</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€ç´”度ã€å¼·åº¦åŠï¼æˆ–效價ã€ç‰¹ç•°æ€§ã€æ‰¹æ¬¡é–“一致性ç‰è¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ ¼èˆ‡æª¢é©—æ–¹æ³•ã€‚è‹¥ç‚ºéžå…¬å®šæ›¸ä¹‹æª¢é©—方法，應予確效以</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è‰å¯¦å…¶åˆé©æ€§ã€‚</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">ä¸ç´”物</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¿…è¦æ™‚應æä¾›ä¸ç´”物包括原料與åŠè£½å“蛋白質是å¦è®Šç•°</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如斷裂ã€èšé›†ã€åŽ»èƒºèˆ‡æ°§åŒ–</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">與其他ä¸ç´”物</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如製程</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸è©¦åŠ‘和細胞培養æˆåˆ†ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之分æžè³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°ç…§æ¨™æº–å“ï¼è¡€æ¸…組：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å°ç…§æ¨™æº–å“：如使用國際å°ç…§æ¨™æº–å“ï¼Œé ˆæª¢é™„è©²æ¨™æº–å“之</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¦æ ¼èˆ‡åˆ†æžæˆç¸¾æ›¸ã€‚若無å°ç…§æ¨™æº–å“，å¯è‡ªè¡Œå»ºç«‹å» 內一</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç´šå°ç…§æ¨™æº–å“</span><span style="font-family: calibri;"> (in-house, primary reference standard</span></p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">ï¼Œä½†é ˆæª¢é™„è©²æ¨™æº–å“之特性ã€è¦æ ¼èˆ‡åˆ†æžæˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å» å…§å·¥ä½œæ¨™æº–å“ï¼šå» å…§å·¥ä½œå°ç…§æ¨™æº–å“</span><span style="font-family: calibri;"> (working refer-</span></p><p><span style="font-family: calibri;"> ence standards) </span><span style="font-family: 新細明體,serif;">é ˆæª¢é™„å…¶è£½å‚™ã€ç‰¹æ€§ã€è¦æ ¼ã€æ¸¬è©¦ã€æ›´</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">新與分æžæˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第四æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產å“è£½é€ åŠç´”化éŽç¨‹ï¼šå°æ–¼ç”Ÿç‰©æ€§é«”外診斷試劑製程ä¸ä¹‹ç®¡åˆ¶æ‡‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有完整之敘述。並檢附書é¢ä½œæ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原料：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰è¡¨åˆ—æ‰€æœ‰ä½¿ç”¨æ–¼è£½é€ åŽŸæ–™èˆ‡åŠè£½å“æˆä»½ä¹‹å稱ã€æ¸¬è©¦æ–¹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法與è¦æ ¼ï¼Œæˆ–å…¶åƒè€ƒæ–‡ç»ã€‚å°æ–¼è³¼è²·ä¹‹åŽŸæ–™ï¼Œæ‡‰æœ‰ä¾›æ‡‰å•†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之分æžè‰æ˜Žèˆ‡è‡ªå®¶æª¢å®šçµæžœã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰è¡¨åˆ—æ‰€æœ‰ä½¿ç”¨æ–¼è£½é€ åŽŸæ–™èˆ‡åŠè£½å“之特殊試劑與æ料，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">如培養基ã€ç¨€é‡‹æ¶²ã€æŸ“劑ã€è©¦åŠ‘ã€ç·©è¡æ¶²ã€è¡€æ¸…ã€æŠ—ç”Ÿç´ </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€å–®æ ªæŠ—é«”ã€ä¿è—劑之測試方法ã€æ¸¬è©¦çµæžœèˆ‡å…¶ç›¸é—œä¹‹è¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ ¼ã€‚æŸäº›æƒ…æ³ä¸‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å¦‚ä½¿ç”¨èƒœî ½æˆ–å–®æ ªæŠ—é«”ç‚ºè£½é€ åŽŸæ–™èˆ‡åŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製å“時</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å‰‡é ˆè©³è¿°å…¶è£½å‚™éŽç¨‹åŠç‰¹æ€§ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">動物性原料ã€è©¦åŠ‘åŠæˆåˆ†çš„ç®¡åˆ¶ï¼šè‹¥æ–¼è£½é€ éŽç¨‹ä¸æœ‰ä½¿ç”¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">由動物來æºå–得之原料時，需è‰æ˜Žå…¶ä¸å«å¤–來物質，如牛</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">海綿狀腦病變</span><span style="font-family: calibri;"> (Bovine Spongiform Encephalopathy, B-</span></p><p><span style="font-family: calibri;"> SE) </span><span style="font-family: 新細明體,serif;">物質，與其他動物病毒。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æµç¨‹åœ–</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ‡‰æœ‰ä¸€ä»½å®Œæ•´è£½é€ éŽç¨‹ä¹‹æµç¨‹åœ–åŠå…¶æ述。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製程：製程ä¸ï¼Œä¾å…¶æ料來æºä¹‹ä¸åŒï¼Œæ‡‰æœ‰å„相關之資料。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">動物來æº</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°æ–¼åœ¨è£½é€ éŽç¨‹ä¸æ‰€ä½¿ç”¨çš„å‹•ç‰©ï¼Œå¦‚ç”¨ä¾†è£½é€ è…¹æ°´çš„è€é¼ </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€ç”¢ç”Ÿè¡€æ¸…抗體的兔åã€æˆ–æ˜¯åŸºå› è½‰æ®–å‹•ç‰©ï¼Œæ‡‰ä¾å¯¦éš›éœ€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¦è¼‰æ˜Žï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">所使用之動物來æºå’Œç¨®é¡ž</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è‹¥ç‚ºåŸºå› è½‰æ®–å‹•ç‰©ï¼Œå‰‡é ˆåŒ…</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å«å…¶è£½å‚™åŽŸç†åŠåŸºå› 安定性</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">外來物質的篩é¸èˆ‡æª¢ç–«æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">動物飼養之控管</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">ç¸é†«ç›£ç£</span> </p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">å°æ–¼ç‰›è£½å“é ˆè¨»æ˜Žå…¶åœ°å€ä¾†æºåŠåœ°é»ž</span> </p><p><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">所使用å…疫原之</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">å…疫原性</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">特異性</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">純度</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">ç„¡èŒæ€§</span> </p><p><span style="font-family: calibri;"> (5) </span><span style="font-family: 新細明體,serif;">安定性</span> </p><p><span style="font-family: calibri;"> (6) </span><span style="font-family: 新細明體,serif;">å…疫接種方å¼ã€åŠ‘é‡åŠæ™‚程</span> </p><p><span style="font-family: calibri;"> (7) </span><span style="font-family: 新細明體,serif;">ä½åŠ‘</span> </p><p><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">所收集之原料：é‡è¦ç‰©è³ªçš„敘述</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">收集方法ã€é«”ç©ã€å®¹å™¨èˆ‡æ™‚程</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">製程æ¥é©Ÿèˆ‡çµ„æˆä¹‹æ•˜è¿°</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">è©¦é©—é …ç›®</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">力價</span><span style="font-family: calibri;"> (titer) </span><span style="font-family: 新細明體,serif;">ï¼æ•ˆåƒ¹</span><span style="font-family: calibri;"> (potency) </span><span style="font-family: 新細明體,serif;">ã€è¦ª</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">和性ã€ç‰¹ç•°æ€§ã€éˆæ•åº¦ã€è² è·èŒã€å®‰å®šæ€§</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">貯è—æ¢ä»¶</span> </p><p><span style="font-family: calibri;"> (5) </span><span style="font-family: 新細明體,serif;">其他å°æ–¼åŽŸæ–™ã€è£½ç¨‹æˆ–用途之特別敘述</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">人來æºï¼šå°æ–¼åœ¨è£½é€ éŽç¨‹ä¸æ‰€ä½¿ç”¨æ料為人來æºæ™‚，應ä¾</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">實際需è¦è¼‰æ˜Žï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">供血者之åˆé©æ€§ï¼æŽ¥å—標準</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">收集方法ã€é«”ç©å’Œå®¹å™¨</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">使用之抗å‡è¡€åŠ‘</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">é‡è¦çµ„æˆä¹‹æ•˜è¿°</span> </p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æˆåˆ†ä¹‹è™•ç†</span> </p><p><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¸¬è©¦é …ç›®</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">感染性疾病標記試驗</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">力價</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">效價</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">親和性</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">特異性</span> </p><p><span style="font-family: calibri;"> (5) </span><span style="font-family: 新細明體,serif;">éˆæ•åº¦</span> </p><p><span style="font-family: calibri;"> (6) </span><span style="font-family: 新細明體,serif;">è² è·èŒ</span> </p><p><span style="font-family: calibri;"> (7) </span><span style="font-family: 新細明體,serif;">安定性</span> </p><p><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">純化與ä¸æ´»åŒ–æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">貯è—æ¢ä»¶</span> </p><p><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">病毒ä¸æ´»åŒ–æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">å…疫注射劑é‡èˆ‡æ™‚程</span> </p><p><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">其他å°æ–¼åŽŸæ–™ã€è£½ç¨‹æˆ–用途之特別敘述</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">細胞來æºï¼šå°æ–¼æ‰€ä½¿ç”¨æ料為細胞來æºå¦‚å–®æ ªæŠ—é«”æˆ–é‡çµ„</span> </p><p><span style="font-family: calibri;"> DNA </span><span style="font-family: 新細明體,serif;">技術時，應ä¾å¯¦éš›éœ€è¦è¼‰æ˜Žï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">細胞來æºèˆ‡ç¨®é¡ž</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">ç´°èƒžä¹‹åŸºå› åž‹èˆ‡è¡¨ç¾åž‹</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¯ç´°èƒžæ ªä¹‹ç‰¹æ€§</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">å–®æ ªé¸æ®–æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">ä¸æœ½åŒ–</span><span style="font-family: calibri;"> (immortalization) </span><span style="font-family: 新細明體,serif;">之æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">監控與測試æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">åŸºå› æ§‹ç¯‰ä¹‹ç‰¹æ€§</span> </p><p><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">載體之特性</span> </p><p><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">細胞庫之建立ã€ç‰¹æ€§ã€ç¶æŒã€èˆ‡å®‰å®šæ€§</span> </p><p><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">細胞培養æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">收集æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">純化與ä¸æ´»åŒ–æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">下游製程æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">其他å°æ–¼åŽŸæ–™ã€è£½ç¨‹æˆ–用途之特別敘述</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åˆæˆä¾†æºï¼šå°æ–¼æ‰€ä½¿ç”¨çš„æ料為åˆæˆä¾†æºå¦‚åˆæˆèƒœî ½ï¼Œæ ¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">î ºé…¸ç‰ï¼Œå‰‡æ‡‰åŒ…å«å…¶ç´”化之æ¥é©Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第五æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製程管制</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製程ä¸ä¹‹ç®¡åˆ¶</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為確ä¿æœ€çµ‚æˆå“符åˆæ•ˆèƒ½è¦æ ¼</span><span style="font-family: calibri;"> (functional requirement)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，應有製程ä¸ç®¡åˆ¶ä¹‹ç›£æŽ§èˆ‡æ¸¬è©¦ç‰ï¼ŒåŒ…括固相被覆</span><span style="font-family: calibri;"> (solid-</span></p><p><span style="font-family: calibri;"> phase coating) </span><span style="font-family: 新細明體,serif;">之完整性</span><span style="font-family: calibri;"> (integrity) </span><span style="font-family: 新細明體,serif;">ã€æ¨™ç¤ºæ–¼æŠ—é«”ï¼</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">抗原çµåˆç‰©ä¸Šé…µç´ 之純度與效價。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製程確效：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å®œæœ‰è£½ç¨‹ç¢ºæ•ˆä¹‹ç ”ç©¶èˆ‡å…¶çµæžœã€‚如製程變更或生產è¦æ¨¡æ”¾å¤§</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">以åŠè£½é€ æ¥é©Ÿä¸æœ‰æ‰€æ”¹è®Šï¼Œå‰‡å…¶è£½ç¨‹é ˆé‡æ–°è©•ä¼°ä¹‹ã€‚為確ä¿</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾‹è¡Œä¹‹è£½é€ ï¼Œæ‡‰æ–¼è£½ç¨‹ä¸æŒ‡å‡ºé—œéµæ€§åƒæ•¸ï¼Œä½œç‚ºå…¶ç®¡åˆ¶é»žã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å®œé€²è¡Œç¢ºæ•ˆç ”ç©¶ä¹‹è£½ç¨‹ï¼ŒåŒ…æ‹¬ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">細胞生長與收集éŽç¨‹</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">純化éŽç¨‹</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸æ´»åŒ–或去除感染性病原之製程</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å°æ–¼æ¨™ç¤ºé ˆç„¡èŒæˆ–使用ä¿è—åŠ‘ä¹‹åŽŸæ–™ï¼Œé ˆè‰æ˜Žåœ¨å…¶æ˜“å—å¾®</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物污染的製程具有é©ç•¶ä¹‹ç®¡åˆ¶æŽªæ–½</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">固相被覆éŽç¨‹</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">çµåˆ</span><span style="font-family: calibri;"> (conjugation) </span><span style="font-family: 新細明體,serif;">éŽç¨‹</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">效價之調整</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">其他</span> </p><p><span style="font-family: 新細明體,serif;">第å…æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產å“之è¦æ ¼èˆ‡æŠ€è¡“性資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">組æˆï¼šæ‡‰æ•˜è¿°æ‰€æœ‰ç”¨æ–¼æˆå“è£½é€ ä¹‹çµ„æˆèªªæ˜Žï¼ŒåŒ…括數é‡ã€æ¯”</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">率或é…æ–¹ç‰ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ èˆ‡åŒ…è£ï¼šæ‡‰è©³è¿°ç”Ÿç‰©æ€§é«”外診斷試劑最終æˆå“ä¹‹è£½é€ æ—¥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">期ã€æœ‰æ•ˆæœŸé™ã€æ¨™ä»¿å–®åŠåŒ…è£è³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應完整敘述å„種調é…åŽŸæ¶²ä¹‹è£½é€ æµç¨‹ï¼ŒåŒ…括其éžç„¡èŒæ“作</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€æ»…èŒä½œæ¥ã€ç„¡èŒæ“作ã€è£ç“¶ï¼å……å¡«ã€å†·å‡ä¹¾ç‡¥ã€æ¨™ç¤ºèˆ‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">包è£ç‰ä¹‹æ¥é©Ÿã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">仿單標籤粘貼表應附外文仿單åŠä¸æ–‡è¯ç¨¿å„二份。å¦é™„試</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">劑åŠè©¦åŠ‘使用儀器之實體相片或任何å¯èªªæ˜Žå¯¦é«”åŠå„€å™¨ä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">目錄。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">檢驗è¦æ ¼åŠæª¢é©—方法：應敘述å°æœ€çµ‚æˆå“之外觀鑑別ã€ç´”度</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€å¼·åº¦åŠï¼æˆ–效價ã€éˆæ•åº¦ç‰¹ç•°æ€§èˆ‡æ‰¹æ¬¡é–“一致性之檢驗方</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法和è¦æ ¼åŠè¡›ç”Ÿç‰©é™åº¦ç®¡åˆ¶ä¸¦æ‡‰ä¾å¯¦éš›éœ€è¦è¼‰æ˜Žï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">監測最終æˆå“之抽樣æ¥é©Ÿã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">宜å°éžå…¬å®šæ›¸æª¢é©—方法之系統åˆé©æ€§ç¢ºæ•ˆè³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">宜以公定書檢驗方法確èªç‰¹æ®Šä¸æ´»åŒ–æˆä»½ä¸å…·å¹²æ“¾æ€§ä¹‹ç¢º</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ•ˆç ”ç©¶çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">至少連續三批åˆæ ¼åŽŸæ–™æ‰€ä½œä¹‹å» 內測試分æžçµæžœã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">敘述並æ供最終æˆå“之體外測å¼æ•ˆåƒ¹ã€ç‰¹ç•°æ€§ã€æ´»æ€§ä¹‹çµ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æžœåŠè¦æ ¼ï¼›å¿…è¦æ™‚應æ供其他</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如：活體</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">資料。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">容器與å°è“‹ï¼šæ‡‰ä½¿ç”¨å°æˆå“å…·åˆé©æ€§ä¹‹å®¹å™¨å’Œå°è“‹ï¼Œä¸¦æä¾›</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åˆé©æ€§å’Œç”Ÿç‰©æ¸¬è©¦è³‡æ–™ï¼Œä»¥åŠå®¹å™¨èˆ‡å°è“‹æ–¼æˆå“有效期é™å…§</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">完整性之è‰æ˜Žã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">微生物：若為無èŒè£½å“，則應有無èŒè£½ç¨‹ç¢ºæ•ˆè³‡æ–™ï¼Œè‹¥ç‚ºå¾®</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物管制之æˆå“，則應符åˆç›¸é—œä¹‹è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ‰¹æ¬¡è£½é€ è¨˜éŒ„ï¼šæ‡‰æœ‰å„æ‰¹æ¬¡è£½é€ èˆ‡æ¸¬è©¦ä¹‹å®Œæ•´ç´€éŒ„ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">檢驗æˆç¸¾æ›¸ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應註明批號ã€æª¢é©—日期ã€æª¢é©—人員åŠè² 責人簽å。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應包括所有原料åŠæˆå“之檢驗æˆç¸¾æ›¸ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應ä¾è¦æ ¼é€é …檢驗。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">原料檢驗æˆç¸¾æ›¸æ‡‰ç‚ºæ‰€é™„æˆå“批次使用之原料檢驗æˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">績書。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">檢驗çµæžœç‚ºæ•¸å€¼è€…應以數據表示，檢驗方法為比å°æ¨™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">準å“者å¯ä»¥ã€Œ</span><span style="font-family: calibri;">Pass</span><span style="font-family: 新細明體,serif;">ã€è¡¨ç¤ºã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">方法確效：æ供必è¦ä¹‹æ–¹æ³•ç¢ºæ•ˆèˆ‡æ•¸æ“šåˆ†æžã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">第七æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安定性資料：應敘述æˆå“之安定性試驗çµæžœä»¥è¨‚定其貯è—æ¢ä»¶èˆ‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有效期é™ï¼ŒåŒæ™‚應有åŠè£½å“</span><span style="font-family: calibri;"> (intermediate fluids) </span><span style="font-family: 新細明體,serif;">或調é…原</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">液</span><span style="font-family: calibri;"> (formulated bulk) </span><span style="font-family: 新細明體,serif;">在特定貯è—或é‹é€æ¢ä»¶ä¸‹ä¹‹å®‰å®šæ€§è³‡æ–™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€‚å®‰å®šæ€§è©¦é©—å ±å‘Šæ‡‰ä¾è¡Œæ”¿é™¢è¡›ç”Ÿç½²å…¬å‘Šä¹‹ã€Œè—¥å“安定性試驗基</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">準ã€å…§å®¹ç¢ºå¯¦åŸ·è¡Œï¼Œä¸¦æª¢é™„實驗方法ã€çµ±è¨ˆåˆ†æžåŠå®šé‡åˆ†æžæ–¹æ³•</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">的確效ç‰è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第八æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床試驗：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應檢附有關產å“å†ç¾æ€§</span><span style="font-family: calibri;"> (reproducibility)</span><span style="font-family: 新細明體,serif;">ã€æ•æ„Ÿæ€§</span><span style="font-family: calibri;"> (sen-</span></p><p><span style="font-family: calibri;"> sitivity) </span><span style="font-family: 新細明體,serif;">ã€ç‰¹ç•°æ€§</span><span style="font-family: calibri;"> (specificity)</span><span style="font-family: 新細明體,serif;">ã€äº¤äº’å應</span><span style="font-family: calibri;"> (cross r-</span></p><p><span style="font-family: calibri;"> eaction) </span><span style="font-family: 新細明體,serif;">ç‰ç”¢å“效能評估資料以利審查。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試劑ä¾ç”¢å“用途ä¸åŒåˆ†ç‚ºä¾›ç¯©é¸ä½¿ç”¨è€…</span><span style="font-family: calibri;"> (screening kits)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠä¾›ç¢ºèªä½¿ç”¨è€…</span><span style="font-family: calibri;"> (supplementary kits </span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;"> confirmatory</span></p><p><span style="font-family: calibri;"> kits) </span><span style="font-family: 新細明體,serif;">兩類。其供篩é¸ä½¿ç”¨è€…å¾—é™ç”±é†«ç™‚é™¢æ‰€æˆ–ç ”ç©¶æ©Ÿæ§‹ä½¿</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">用，供確èªä½¿ç”¨è€…則é™ç”±æœ¬ç½²æŒ‡å®šæ•™å¸é†«é™¢åŠæœ‰é—œå–®ä½ä½¿ç”¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">國內臨床試驗之原則：除人類å…疫缺ä¹ç—…毒檢驗試劑åŠäººé¡ž</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—œ</span><span style="font-family: calibri;"> T </span><span style="font-family: 新細明體,serif;">æ·‹å·´çƒç—…毒檢驗試劑外，è‚炎檢驗試劑åŠå…¶ä»–新檢驗</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">方法ã€åŽŸç†ä¹‹è©¦åŠ‘除檢附產å“效能評估資料，需å¦ä¾ä¸‹åˆ—原</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">則執行國內臨床試驗：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰ç”±å» å¤–çš„ç ”ç©¶å–®ä½é€²è¡Œã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ‡‰èˆ‡å·²æ ¸å‡†ä¸Šå¸‚ä¹‹ç”¢å“比較。如兩者有æ§ç•°ç™¼ç”Ÿï¼Œå‰‡æ‡‰ä»¥</span> </p><p><span style="font-family: calibri;"> Western blot</span><span style="font-family: 新細明體,serif;">ã€è‡¨åºŠè¨ºæ–·ç‰å…¶ä»–確èªè©¦é©—來è‰å¯¦ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">臨床試驗之è¨è¨ˆèˆ‡çµæžœæ‡‰èƒ½é¡¯ç¤ºæˆ–è‰æ˜Žç”¢å“的一致性。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">衛生署將評估åŠå…¬å‘Šå¾—執行國內生物性體外診斷試劑臨床</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗之單ä½ï¼Œç›®å‰æš«ä»¥è¡Œæ”¿é™¢è¡›ç”Ÿç½²ç–¾ç—…管制局ã€ä¸è¯è¡€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">液基金會å°åŒ—æè¡€ä¸å¿ƒåŠå€åŸŸé†«é™¢ä»¥ä¸Šç‰ç´šä¹‹é†«é™¢ï¼Œç”±ä¸Š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">列單ä½æ“‡ä¸‰å–®ä½é€²è¡Œã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ç„¡åŒé¡žç”¢å“å¯ä¾›æ¯”å°æ¸¬è©¦ä¹‹è©¦åŠ‘，ä»æ‡‰æ–¼åœ‹å…§é€²è¡Œ</span><span style="font-family: calibri;"> 600</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä»½ä»¥ä¸Šæª¢é«”ä¹‹è‡¨åºŠè©¦é©—ï¼Œä¸¦å…ˆæ“¬å®šè©³ç´°ç ”ç©¶è¨ˆç•«æ›¸é€ç½²æ ¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">備。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人類å…疫缺ä¹ç—…毒抗體檢驗試劑之è¦æ±‚﹕</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">本類試劑於申辦輸入藥å“查驗登記時，應檢附美ã€æ—¥ã€åŠ </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€è‹±ã€æ¯”ã€å¾·ã€ç‘žã€æ³•ã€æ¾³ã€ç‘žå…¸ç‰å國ä¸ä¸€åœ‹ä¹‹æŽ¡ç”¨è‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">明，始准辦ç†ç™»è¨˜ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">éˆæ•åº¦ï¹•</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">ä¾åŽŸå» 臨床診斷試驗çµæžœç‚ºå¯©æŸ¥åŸºæº–。上述臨床診斷試</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—çµæžœå°šæ‡‰åŒ…括與å¦ä¸€ç¶“å‰è¿°å國ä¸è‡³å°‘ä¸€åœ‹æ ¸å‡†ä½¿ç”¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之上市產å“比å°ä¹‹è©¦é©—çµæžœï¼Œä¸”應包å«</span><span style="font-family: calibri;"> HIV-1 subtype</span></p><p><span style="font-family: calibri;"> O </span><span style="font-family: 新細明體,serif;">å…例以上之檢體測試çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">åœ‹å…§é–‹ç™¼ä¹‹è£½åŠ‘ï¼Œå› åœ‹å…§å¾Œå¤©å…疫缺ä¹ç—‡å€™ç¾¤</span><span style="font-family: calibri;"> (AIDS)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">病例有é™ï¼Œæœ¬ç½²è¦–製劑發展éŽç¨‹åŠéˆæ•åº¦æ¸¬å®šä¹‹æ–¹æ³•äºˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">以個案審定。必è¦æ™‚å¾—è¦æ±‚å» å•†æ–¼åœ‹å¤–é€²è¡Œæ¯”å°è©¦é©—。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">篩檢用試劑原則上ä»æ‡‰åŒ…å«</span><span style="font-family: calibri;">HIV-1 subtype O </span><span style="font-family: 新細明體,serif;">å…例以上</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之檢體測試çµæžœï¼Œæˆ–æ‡‰åŠ å…¥</span><span style="font-family: calibri;">subtype O </span><span style="font-family: 新細明體,serif;">抗原於試劑製程</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¨è¨ˆä¸ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">特異性﹕</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">ä¾åŽŸå» 臨床診斷試驗çµæžœç‚ºå¯©æŸ¥åŸºæº–，上述臨床診斷試</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—çµæžœå°šæ‡‰åŒ…括與å¦ä¸€ç¶“å‰è¿°å國ä¸è‡³å°‘ä¸€åœ‹æ ¸å‡†ä½¿ç”¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之上市產å“比å°ä¹‹è©¦é©—çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">åœ‹å…§é–‹ç™¼ä¹‹è£½åŠ‘ï¼Œå› åœ‹å…§å¾Œå¤©å…疫缺ä¹ç—‡å€™ç¾¤</span><span style="font-family: calibri;"> (AIDS)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">病例有é™ï¼Œæœ¬ç½²è¦–製劑發展éŽç¨‹åŠç‰¹ç•°æ€§æ¸¬å®šä¹‹æ–¹æ³•äºˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">以個案審定。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è‚炎檢驗試劑之è¦æ±‚﹕</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">éˆæ•åº¦ï¹•</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">除</span><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">åž‹è‚炎表é¢æŠ—原檢驗試劑外，其餘å„類試劑之éˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ•åº¦çš†ä»¥åŽŸå» 臨床診斷試驗çµæžœç‚ºå¯©æŸ¥åŠæª¢é©—基準，上</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">述臨床診斷試驗çµæžœå°šæ‡‰åŒ…括與å¦ä¸€å€‹æ¥ç¶“æ ¸å‡†ä¹‹åœ‹å…§</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產å“æˆ–åŽŸé–‹ç™¼å» ä¸Šå¸‚ç”¢å“比å°ä¹‹è©¦é©—çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 2 B </span><span style="font-family: 新細明體,serif;">åž‹è‚炎表é¢æŠ—原檢驗試劑之éˆæ•åº¦</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以能測出æ¯æ¯«å‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">血清å«è‹¥å¹²</span><span style="font-family: calibri;"> ng </span><span style="font-family: 新細明體,serif;">之</span><span style="font-family: calibri;"> HBsAg ad </span><span style="font-family: 新細明體,serif;">亞型為準</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">標準：</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">逆å‘被動血çƒå‡é›†æ³•</span><span style="font-family: calibri;"> (Reverse Passive Haemagglu-</span></p><p><span style="font-family: calibri;"> tination Assay</span><span style="font-family: 新細明體,serif;">，簡稱</span><span style="font-family: calibri;">RPHA) </span><span style="font-family: 新細明體,serif;">其檢驗éˆæ•åº¦æ‡‰ã€Œå°‘æ–¼</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">或ç‰æ–¼</span><span style="font-family: calibri;"> 10ng/ml HBsAg ad </span><span style="font-family: 新細明體,serif;">亞型ã€ã€‚</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">é…µç´ å…疫法</span><span style="font-family: calibri;"> (Enzyme ImmunoAssay</span><span style="font-family: 新細明體,serif;">，簡稱</span><span style="font-family: calibri;"> EIA) </span><span style="font-family: 新細明體,serif;">其檢</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—éˆæ•åº¦æ‡‰ã€Œå°‘於或ç‰æ–¼</span><span style="font-family: calibri;"> lng/ml HBsAg ad </span><span style="font-family: 新細明體,serif;">亞型ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">其他任何方法之產å“，其éˆæ•åº¦æ‡‰ç¬¦åˆå‰è¿°ä¹‹è¦è¶³ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">特異性﹕</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">ä»¥åŽŸå» è‡¨åºŠè©¦é©—çµæžœç‚ºå¯©æŸ¥åŸºæº–，上述臨床診斷試驗çµ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">果尚應包括與å¦ä¸€å€‹æ¥ç¶“æ ¸å‡†ä¹‹åœ‹å…§ç”¢å“æˆ–åŽŸé–‹ç™¼å» ä¸Š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">市產å“比å°ä¹‹è©¦é©—çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">特異性資料需包括於國內測試å…百份以上檢體之臨床診</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">斷試驗çµæžœ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">應由本署疾病管制局ã€ä¸è¯è¡€æ¶²åŸºé‡‘會å°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">北æè¡€ä¸å¿ƒåŠå€åŸŸé†«é™¢ä»¥ä¸Šç‰ç´šä¹‹é†«é™¢é¸æ“‡ä¸‰å–®ä½ï¼Œæ¯</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å–®ä½å„測試二百份以上檢體</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，其與任一上市之åŒé¡žç”¢</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“比å°ä¹‹ç‰¹ç•°æ€§èª¤å·®ä¸å¾—大於百分之二。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) B </span><span style="font-family: 新細明體,serif;">åž‹è‚ç‚Ž</span><span style="font-family: calibri;"> e </span><span style="font-family: 新細明體,serif;">抗原ä¸å¾—以逆å‘被動血çƒå‡é›†æ³•æ¸¬è©¦ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人類嗜</span><span style="font-family: calibri;"> T </span><span style="font-family: 新細明體,serif;">æ·‹å·´çƒç—…毒</span><span style="font-family: calibri;"> (Human T Lymphotropic Virus) </span><span style="font-family: 新細明體,serif;">檢</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">驗試劑è¦æ±‚：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">éˆæ•åº¦ï¼šä¾åŽŸå» 臨床試驗çµæžœç‚ºå¯©æŸ¥åŸºæº–。國內開發之製</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">劑，本署將視製劑發展éŽç¨‹åŠéˆæ•åº¦æ¸¬å®šä¹‹æ–¹æ³•äºˆä»¥å€‹æ¡ˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審定，必è¦æ™‚å¾—è¦æ±‚å» å•†æ–¼åœ‹å¤–é€²è¡Œæ¯”å°è©¦é©—。本類試劑</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請查驗登記案件除按照查驗登記è¦å®šæª¢é€ç›¸é—œè³‡æ–™å¤–，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應åŒæ™‚檢é€è©¦åŠ‘è£½é€ éŽç¨‹ä»¥åˆ©å¯©æ ¸ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">特異性：ä¾åŽŸå» 臨床診斷試驗çµæžœç‚ºå¯©æŸ¥åŸºæº–，國內開發</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之製劑，本署將視製劑發展éŽç¨‹åŠç‰¹ç•°æ€§æ¸¬å®šä¹‹æ–¹æ³•äºˆä»¥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">個案審定。</span> </p><p><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»ï¼š</span> </p><p><span style="font-family: calibri;">1 </span><span style="font-family: 新細明體,serif;">ä¸è¯è—¥å…¸ç¬¬äº”版，附錄肆ã€è£½åŠ‘通則åŠä¸€èˆ¬è¦å®š</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物性體外診</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">斷試劑</span> </p><p><span style="font-family: calibri;">2 Guidance for Industry</span><span style="font-family: 新細明體,serif;">：</span><span style="font-family: calibri;">Content and Format of Chemistry, Manuf-</span></p><p><span style="font-family: calibri;"> acturing and Controls Information and Esteblishment Descripti-</span></p><p><span style="font-family: calibri;"> on Information for a Biological In Vitro Diagnostic Product </span><span style="font-family: 新細明體,serif;">，</span> </p><p><span style="font-family: calibri;"> FDA / CBER</span><span style="font-family: 新細明體,serif;">，</span><span style="font-family: calibri;">Mar. 1999 </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">3 Guideline for the Manufacture of In Vitro Diagnostic Products</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，</span><span style="font-family: calibri;">FDA / CDRH</span><span style="font-family: 新細明體,serif;">，</span><span style="font-family: calibri;">Jan. 1994 </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">4 Requirement for Immunoassay Kits</span><span style="font-family: 新細明體,serif;">，</span><span style="font-family: calibri;"> WHO Technical Report Series</span></p><p><span style="font-family: calibri;"> , No.658, 1981. p.206-242</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">5 84.11.6. </span><span style="font-family: 新細明體,serif;">衛署藥å—第</span><span style="font-family: calibri;"> 84070084 </span><span style="font-family: 新細明體,serif;">號公告。</span> </p><p><span style="font-family: calibri;">6 76.11.9 </span><span style="font-family: 新細明體,serif;">衛署藥å—第</span><span style="font-family: calibri;"> 700534 </span><span style="font-family: 新細明體,serif;">號公告。</span> </p><p><span style="font-family: calibri;">7 86.10.29 </span><span style="font-family: 新細明體,serif;">衛署藥å—第</span><span style="font-family: calibri;"> 86063358 </span><span style="font-family: 新細明體,serif;">號公告。</span> </p><p><span style="font-family: calibri;"> </span></p>2013-12-05
查驗登記類,è—¥å“查驗登記審查準則,生物相似性藥å“之查驗登記法è¦å‘½ä»¤è—¥å“查驗登記審查準則ï¼ç”Ÿç‰©ç›¸ä¼¼æ€§è—¥å“之查驗登記詳如附件2013-12-05
查驗登記類,è—¥å“查驗登記審查準則,ç–«è‹—é¡žè—¥å“之查驗登記法è¦å‘½ä»¤è—¥å“查驗登記審查準則ï¼ç–«è‹—é¡žè—¥å“之查驗登記<p><span style="font-family: 新細明體,serif;">ç‚ºäº†åŠ å¼·ç–«è‹—é¡žè—¥å“的管ç†ï¼Œç¢ºä¿ç–«è‹—é¡žè—¥å“çš„å“質åŠå®‰å…¨ï¼Œçˆ°ä¾æ“šè—¥äº‹</span> </p><p><span style="font-family: 新細明體,serif;">法第四å二æ¢åŠä¸ƒåå››æ¢ï¼Œåˆ¶å®šã€Œè—¥å“查驗登記審查準則ï¼ç–«è‹—è—¥å“之查</span> </p><p><span style="font-family: 新細明體,serif;">驗登記ã€ã€‚本基準é©ç”¨æ–¼ç–«è‹—é¡žè—¥å“查驗登記åŠæª¢é©—å°ç·˜æ™‚之å“質åŠå®‰å…¨</span> </p><p><span style="font-family: 新細明體,serif;">çš„è¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">第一æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本基準所稱之「疫苗類藥å“ã€ï¼Œä¿‚指由å…疫抗原組æˆçš„è—¥å“，經</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">由人體投與後å¯åˆºæ¿€å…疫系統，å°ç–¾ç—…或感染æºç”¢ç”Ÿé 防ã€æ”¹å–„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">或治療的效果。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">「疫苗ã€çš„組æˆåŒ…括經減毒處ç†çš„æ´»èŒã€ç—…毒或寄生蟲；去</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">活化的生物有機體；經處ç†çš„活細胞；或天然ï¼ç´”化的å…ç–«</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括於宿主細胞ä¸è£½é€ ä¹‹åŸºå› é‡çµ„æˆä»½ã€å…±åƒ¹çµåˆç‰©ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åˆæˆæŠ—原ã€èšæ ¸î ºé…¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如質體ã€åŽ»æ°§æ ¸é†£æ ¸é…¸ç–«è‹—</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">；表ç¾</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">特定異種å…疫原之載體細胞ã€æˆ–帶有å…疫原之細胞。包括上</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">述多種疫苗的組åˆã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">「疫苗類藥å“ã€å¯åŒ…括其他體內診斷用之抗原ã€å¾®ç”Ÿç‰©è›‹ç™½</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">質或細èŒæ¯’ç´ </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如：肉毒桿èŒæ¯’ç´ </span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æˆåˆ†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第二æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“應檢附之資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥的定義åŠåŒ–å¸ã€è£½é€ 與管制的è¦æ±‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žåŽŸæ–™è—¥ä¹‹è£½é€ æ–¹æ³•</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥之製程管制資料</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥製程一致性資料</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥之è¦æ ¼</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥之å†è£½</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“之組æˆèˆ‡ç‰¹æ€§</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“ä¹‹è£½é€ æ¥è€…與è¨å‚™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¹</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“ä¹‹è£½é€ æ–¹æ³•</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一○</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“之è¦æ ¼</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">容器與å°è“‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">微生物之管制</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安定性</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一四</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç†åŠæ¯’性試驗資料</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物動力å¸è³‡æ–™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一å…</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床使用文ç»</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一七</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物藥å“之藥å“å„ªè‰¯è£½é€ è¦ç¯„åŠç¢ºæ•ˆè³‡æ–™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一八</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">檢驗å°ç·˜</span> </p><p><span style="font-family: 新細明體,serif;">第三æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥的定義åŠåŒ–å¸ã€è£½é€ 與管制的è¦æ±‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">「疫苗類原料藥ã€å®šç¾©ç‚ºå°šæœªé…方調製的疫苗類活性æˆåˆ†ï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¯ç‚ºç´°èŒç´°èƒžã€ç—…毒</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">活病毒ã€æ¸›æ¯’病毒ã€æ»ç—…毒</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">或寄生</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">蟲；由細胞ä¸åˆ†é›¢</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">或經å†ç´”化</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">的蛋白質；活體細胞分泌</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">或經å†ç´”化</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">的抗原以åŠç¶“ç”±åŸºå› é‡çµ„或åˆæˆçš„醣類ã€è›‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç™½è³ªæˆ–å¤šèƒœî ½æŠ—åŽŸã€èšæ ¸î ºé…¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¾‹å¦‚è³ªé«”æˆ–åŽ»æ°§æ ¸é†£æ ¸é…¸</span><span style="font-family: calibri;"> (</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ＤＮＡ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ç–«è‹—</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">或çµåˆä»¥ä¸Šçš„物質。「混åˆç–«è‹—</span><span style="font-family: calibri;"> (combina-</span></p><p><span style="font-family: calibri;"> tion vaccine) </span><span style="font-family: 新細明體,serif;">ã€å‰‡æ‡‰èªªæ˜Žå…¶æŽ¡æ”¶éŽç¨‹åŠèˆ‡å…¶ä»–抗原çµåˆåŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">調é…çš„å„種活性物質。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥化å¸ã€è£½é€ 與管制的è¦æ±‚：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥ä¹‹è£½é€ ï¼Œç„¡è«–æ˜¯ç™¼é…µã€åŸ¹é¤Šã€åˆ†é›¢ã€æˆ–åˆæˆï¼Œé€šå¸¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">都是從原料藥生產開始，經éŽä¸é–“物質的製備ã€ç‰¹æ€§é‘‘定</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€ä»¥åŠç´”化而製æˆåŽŸæ–™è—¥ã€‚生物性原料藥的å“質åŠç´”度ä¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">能僅ä¾å¾ŒçºŒçš„測試來èªå®šï¼Œè€Œéœ€ä¾è³´è£½é€ åŠåˆæˆéŽç¨‹ä¸çš„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">管制方能é”æˆã€‚宜執行下列措施以é”æˆæ£ç¢ºçš„管制åŠæœ€å°‘</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">程度的ä¸ç´”物：</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">種æºç”Ÿç‰©åŠè©¦åŠ‘ç‰èµ·å§‹æ料的é©ç•¶å“質與純度。</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">ä¸é–“ç‰©è³ªåŠ å·¥éŽç¨‹ä¸çš„管制的制定與é‹ç”¨ã€‚</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">一致éµå®ˆç¶“ç¢ºæ•ˆçš„åŠ å·¥éŽç¨‹ã€‚</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">é©ç•¶çš„藥物最終</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">放行</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">管制測試。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原料藥的組æˆèˆ‡ç‰¹æ€§ï¼šæ‡‰æ供原料藥的說明åŠç‰¹æ€§èªªæ˜Žã€‚å°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ··åˆç–«è‹—，å¯åƒè€ƒå·²æ ¸å‡†çš„許å¯è‰ç”³è«‹æ›¸ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">原料藥的說明：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應包括</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸‹åˆ—é …ç›®ï¼šåŽŸæ–™è—¥çš„ç”Ÿç‰©ç¨®å</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é¸å®šçš„èŒæ ªæˆ–èŒè½</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">或化å¸å稱，包括已建立的å稱。å°</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括微生物細胞</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">製æˆçš„原料藥的細胞來æºã€ç´°èƒžéƒ¨åˆ†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">或已純化抗原的活性æˆåˆ†åŠåˆæˆåŽŸæ–™è—¥çš„物ç†åŠåŒ–å¸æ€§è³ª</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">äº¦æ‡‰åŠ ä»¥èªªæ˜Žã€‚æœ‰é—œåŽŸæ–™è—¥çš„åŒ–å¸ä¿®é£¾æˆ–接åˆä½œç”¨æ‡‰è©³ç´°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">說明，åŒæ™‚應æä¾›å˜æ–¼åŽŸæ–™è—¥å…§æ‰€æœ‰éžæ´»æ€§ç‰©è³ªçš„表單。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">原料藥的特性：</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">應æ供原料藥的特性ã€ç´”度ã€å®‰å®šæ€§å’Œè£½ç¨‹ä¸€è‡´æ€§çš„測</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試。測試çµæžœæ‡‰åŒ…æ‹¬è«¸å¦‚æ ¼å¼æ•¸æ“šã€è‰²èœæˆ–å…‰èœçš„清楚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">影本ã€è† 體或å…ç–«å¸é™„的照片ã€ç´°èƒžè¨ˆé‡åˆ†æžçš„實際圖</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">表ã€æˆ–其他é©ç•¶æ ¼å¼çš„實際數據。數據應經完善整ç†ä¸¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å……åˆ†åŠ è¨»æŒ‡æ¨™ä»¥åˆ©æ–¹ä¾¿å¯©æŸ¥ã€‚å®šé‡åˆ†æžçš„çµæžœæ‡‰ç”¨å¯¦éš›</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">的數據表示，而ä¸å¯ç”¨ä¸€èˆ¬çš„「åˆæ ¼ã€æˆ–「ä¸åˆæ ¼ã€è¡¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">示。</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">原料藥的物ç†åŒ–å¸ç‰¹æ€§è³‡æ–™ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一般而言，物ç†åŒ–å¸ç‰¹æ€§é‘‘定應包括</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">下列</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å„é …ï¼š</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">紫外線ï¼å¯è¦‹å…‰æˆ–質èœå„€</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">胺基酸分æž</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">èƒºåŸºé…¸æˆ–æ ¸î ºé…¸åºåˆ—分æž</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">醣類之測定，é©ç•¶çš„話，å†åŠ 上åºåˆ—分æž</span> </p><p><span style="font-family: calibri;"> (5) </span><span style="font-family: 新細明體,serif;">èƒœî ½åœ–èœ</span> </p><p><span style="font-family: calibri;"> (6) </span><span style="font-family: 新細明體,serif;">雙硫éµä½ç½®çš„決定</span> </p><p><span style="font-family: calibri;"> (7) </span><span style="font-family: 新細明體,serif;">å二基硫酸鈉─èšä¸™é†¯æ°¨å‡è† 電泳</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">還原態與éžé‚„原</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ…‹</span><span style="font-family: calibri;">) (Sodium Dodecyl Sulfate-Polyacrylamide G-</span></p><p><span style="font-family: calibri;"> el Electrophoresis, SDS-PAGE)</span></p><p><span style="font-family: calibri;"> (8) </span><span style="font-family: 新細明體,serif;">一ç¶æˆ–二ç¶</span><span style="font-family: calibri;"> (1D </span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;"> 2D) </span><span style="font-family: 新細明體,serif;">ç‰é›»ä½ç„¦èšé›»æ³³åˆ†æž</span> </p><p><span style="font-family: calibri;"> (9) </span><span style="font-family: 新細明體,serif;">高壓液體層æžæ³•</span><span style="font-family: calibri;"> (HPLC) </span><span style="font-family: 新細明體,serif;">ã€æ°£ç›¸å±¤æžæ³•</span><span style="font-family: calibri;"> (GC) </span><span style="font-family: 新細明體,serif;">ã€æ¶²ç›¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">層æžæ³•</span><span style="font-family: calibri;"> (LC) </span><span style="font-family: 新細明體,serif;">ã€æˆ–薄層光èœåˆ†æž</span><span style="font-family: calibri;"> (thin layer chro-</span></p><p><span style="font-family: calibri;"> matography) </span><span style="font-family: 新細明體,serif;">ç‰å„種光èœåˆ†æžæ³•</span> </p><p><span style="font-family: calibri;"> (10) </span><span style="font-family: 新細明體,serif;">æ ¸ç£å…±æŒ¯å…‰èœåˆ†æž</span> </p><p><span style="font-family: calibri;"> (11) </span><span style="font-family: 新細明體,serif;">用以åµæ¸¬åŒ…括去氨基ã€æ°§åŒ–ã€åŠ å·¥åŠå‡é›†ç‰åž‹å¼çš„相</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">關蛋白質ã€èƒºåŸºé…¸å–代ã€æŽ¥åˆåŠè¡ç”Ÿç‰è®Šå½¢åŠè«¸å¦‚ç¡«</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">氫基試劑ã€å°¿ç´ ã€æ®˜é¤˜çš„宿主蛋白質ã€æ®˜é¤˜çš„åŽ»æ°§æ ¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é†£æ ¸é…¸åŠå…§æ¯’ç´ ç‰åŠ å·¥éŽç¨‹ä¹‹æ±¡æŸ“物所實施的分æžæ–¹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法</span> </p><p><span style="font-family: calibri;"> (12) </span><span style="font-family: 新細明體,serif;">與其他藥å“çµåˆçš„ç”¢ç‰©ï¼Œå¦‚å¤šæŠ—åŽŸèƒœî ½</span><span style="font-family: calibri;"> (multiple a</span></p><p><span style="font-family: calibri;"> ntigen peptides; MAP) </span><span style="font-family: 新細明體,serif;">或經進一æ¥åŒ–å¸æˆ–é…µç´ ä¿®é£¾</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">的原料藥，應æä¾›é¡å¤–的物ç†åŒ–å¸ç‰¹æ€§è³‡æ–™ã€‚包括產</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“çµåˆæˆ–共軛éµçµçš„程度，未修飾產物的é‡ï¼Œæ¸¸é›¢ç‰©</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">的移除</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¾‹å¦‚æ¯’ç´ ã€æ”¾å°„æ€§æ ¸é…¸ã€é€£æŽ¥ç‰©ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，åŠä¿®</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">飾後產物的安定性</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">生物活性：</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">應æ出原料藥的效價和活性之敘述與çµæžœã€‚應æ供有</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">關疫苗的進一æ¥ç‰¹æ€§è³‡æ–™åŒ…括</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">下列å„é …</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">：</span> </p><p><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">蛋白質西方墨點分æž</span><span style="font-family: calibri;"> (Western blot analysis)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æˆ–é…µç´ é€£çµå…ç–«å¸é™„分æžæ³•</span><span style="font-family: calibri;"> (enzyme-linked imm-</span></p><p><span style="font-family: calibri;"> unosorbent assay</span><span style="font-family: 新細明體,serif;">ï¼›</span><span style="font-family: calibri;">ELISA) </span><span style="font-family: 新細明體,serif;">ç‰é‘‘別測試</span> </p><p><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">細胞計é‡åˆ†æž</span> </p><p><span style="font-family: calibri;"> C </span><span style="font-family: 新細明體,serif;">é©ç•¶çš„神經毒性測試</span> </p><p><span style="font-family: calibri;"> D </span><span style="font-family: 新細明體,serif;">血清分型</span> </p><p><span style="font-family: calibri;"> E </span><span style="font-family: 新細明體,serif;">電泳分型</span><span style="font-family: calibri;"> (Electrophoretic Typing)</span></p><p><span style="font-family: calibri;"> F </span><span style="font-family: 新細明體,serif;">ä¸æ´»åŒ–試驗</span> </p><p><span style="font-family: calibri;"> G </span><span style="font-family: 新細明體,serif;">ä¸å’Œåˆ†æž</span> </p><p><span style="font-family: calibri;"> H </span><span style="font-family: 新細明體,serif;">效價試驗</span><span style="font-family: calibri;"> (Titrations)</span></p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">應æ供原料藥之效價åŠæ´»æ€§è‰æ˜Ž</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾è£½é€ æ¥è€…之åƒè€ƒæ¨™æº–組或其他相關標準執行相關的</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">體內åŠé«”外生物活性測試</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">生物鑑定</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，並æ供測試</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çš„çµæžœã€‚應å°æ¯ç¨®ç”Ÿç‰©é‘‘定的è¦æ ¼ã€å°ç…§æ¨™æº–å“ã€æ¸¬</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試方法的確效åŠå¯æŽ¥å—誤差範åœä½œå®Œæ•´çš„說明，åŒæ™‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">也應包括於å…疫化å¸æˆ–血清å¸åˆ†æžä¸æ‰€ä½¿ç”¨ç‰¹å®šæŠ—é«”</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">的鑑定。</span> </p><p><span style="font-family: 新細明體,serif;">第四æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žåŽŸæ–™è—¥ä¹‹è£½é€ æ–¹æ³•ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ‡‰èªªæ˜ŽåŽŸæ–™è—¥è£½é€ åŠç®¡åˆ¶çš„éŽç¨‹ï¼Œä»¥è‰æ˜Žæ£ç¢ºçš„å“質管制，åŠèƒ½</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é é˜²å¤–ä¾†å› åå¯èƒ½é€ æˆçš„污染。並æ供相關的標準æ“作éŽç¨‹</span><span style="font-family: calibri;"> (S-</span></p><p><span style="font-family: calibri;"> OP) </span><span style="font-family: 新細明體,serif;">資料。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原料藥</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應æä¾›ç”¨æ–¼åŽŸæ–™è—¥è£½é€ çš„æ料表單</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">培養基ã€ç·©è¡æ¶²ã€å¤š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">èƒœî ½åˆæˆç”¨ä¹‹æ¨¹è„‚，化å¸ç‰©è³ªã€è‰²å±¤åˆ†æžç”¨ç®¡æŸ±ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，æ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">料的測試與產å“è¦æ ¼ã€æˆ–相關基準ç‰åƒè€ƒæ–‡ç»ã€‚商å“化的</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ料，應有供應商的產å“è¦æ ¼åŠåˆ†æžçµæžœ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è£½é€ æ¨™æº–</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">明書。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應說明原料藥純化或製程ä¸ä½¿ç”¨çš„å–®æ ªæŠ—é«”ã€é…µç´ åŠå…¶ä»–</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">蛋白質ç‰è©¦åŠ‘ã€ç‰¹æ®ŠèƒºåŸºé…¸åŠå…¶è¡ç”Ÿç‰©ã€æˆ–醣脂ç‰ä¾†æºï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">包括供應商之è‰æ˜Žæ›¸ã€ç‰¹ç•°æ€§åŠä¾†æºç‰è³‡æ–™ã€‚應æ供細胞</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生長之原料藥，例如：血清ã€èƒ°è›‹ç™½î ¸ç‰å¤–ä¾†å› å的測試</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çµæžœã€‚應å°å„種æˆåˆ†çš„用途作說明。</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ‡‰è¡¨åˆ—æ‰€æœ‰ä½¿ç”¨æ–¼è£½é€ åŽŸæ–™è—¥èˆ‡åŠè£½å“æˆä»½ä¹‹å稱ã€æ¸¬</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試方法與è¦æ ¼ï¼Œæˆ–å…¶åƒè€ƒæ–‡ç»ã€‚å°æ–¼å•†æ¥åŒ–之原料藥，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應有供應商之分æžè‰æ˜Žèˆ‡è‡ªå®¶æª¢å®šçµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ‡‰è¡¨åˆ—æ‰€æœ‰ä½¿ç”¨æ–¼è£½é€ åŽŸæ–™è—¥èˆ‡åŠè£½å“之特殊試劑與æ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">料，如培養基ã€ç·©è¡æ¶²ã€è¡€æ¸…ã€æŠ—ç”Ÿç´ ã€å–®æ ªæŠ—é«”ã€é˜²</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è…劑。在æŸäº›æƒ…形，如輔助性之生技產å“使用於原料藥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¹‹è£½é€ éŽç¨‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¾‹å¦‚å–®æ ªæŠ—é«”ä½¿ç”¨æ–¼è¦ªå’Œæ€§è‰²å±¤åˆ†æž</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應詳述其製備éŽç¨‹åŠç‰¹æ€§ã€‚</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">動物性原料藥ã€è©¦åŠ‘åŠæˆåˆ†çš„ç®¡åˆ¶ï¼šè‹¥æ–¼è£½é€ éŽç¨‹ä¸æœ‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">使用由動物來æºå–得之原料藥時，需è‰æ˜Žå…¶ä¸å«å¤–來物</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">質，如牛海綿狀腦病變</span><span style="font-family: calibri;"> Bovine Spongiform Encephal-</span></p><p><span style="font-family: calibri;"> opathy (BSE) </span><span style="font-family: 新細明體,serif;">物質，與其他動物病毒。</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">申請時應有ä¸å«æœ‰å¤–來物之確效資料或証明。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æµç¨‹åœ–ï¼šæ‡‰æœ‰ä¸€ä»½å®Œæ•´è£½é€ éŽç¨‹ä¹‹æµç¨‹åœ–，åŒæ™‚應表列其製</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¨‹ç®¡åˆ¶èˆ‡è©¦é©—é …ç›®ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製程：製程ä¸ï¼Œä¾å…¶æ料來æºä¹‹ä¸åŒï¼Œæ‡‰æœ‰å„相關之資料。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">動物來æº</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括禽類之å—ç²¾åµ</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”¨æ–¼å¾®ç”Ÿç‰©ç”Ÿé•·æˆ–è£½é€ é‡çµ„蛋白質，åŠç”¨ä½œç–«è‹—的動物性</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">來æºï¼Œæ‡‰è¦–疫苗特性æä¾›</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">下列å„é …è³‡æ–™ï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">動物的物種與年齡</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">動物的å¥åº·ç‹€æ³ï¼Œä¾‹å¦‚：無特定的病原èŒ</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">外來物質的篩é¸èˆ‡æª¢ç–«éŽç¨‹</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">動物飼養之控管，例如：é©ç•¶çš„動物隔離éŽç¨‹</span> </p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">ç¸é†«ç›£ç£åŠå¯¦é©—室監視</span> </p><p><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">動物é 防接種的說明</span> </p><p><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">å°æŽ¡æ”¶çš„組織åŠæŽ¡ç”¨æ–¹æ³•çš„說明</span> </p><p><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">å°æ–¼ç‰›è£½å“é ˆè¨»æ˜Žå…¶åœ°å€ä¾†æºåŠåœ°é»ž</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">病毒來æº</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°ç”¨æ–¼ç–«è‹—è£½é€ çš„ç—…æ¯’ç¨®æºä½œè©³ç´°çš„說明，æ供的資料應</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">包括</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">下列å„é …ï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">病毒的起æº</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">病毒èŒæ ªçš„èœç³»è³‡æ–™</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">種批系統</span><span style="font-family: calibri;"> (Seed Lot System) </span><span style="font-family: 新細明體,serif;">的詳細資料</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">ç¶æŒç—…毒種æºçš„培養技術</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">細胞來æº</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">細胞種批系統</span><span style="font-family: calibri;"> (Cell Seed Lot System) </span><span style="font-family: 新細明體,serif;">：應æ供有關微</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物細胞ã€å‹•ç‰©ä¾†æº</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">昆蟲類ã€äººé¡žåŠå…¶ä»–哺乳類</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之細</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">èƒžæˆ–ç´°èƒžæ ªä¹‹ç´°èƒžå—質資料。</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">微生物細胞</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">應å°å¾®ç”Ÿç‰©çš„物種ã€èŒæ ªã€å·²çŸ¥çš„表ç¾åž‹ç‰¹æ€§åŠåŸºå› </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">型特性作說明。用於疫苗原料藥的微生物細胞åŠè¡ç”Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">物包括：整個細胞的疫苗</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">æ´»èŒæˆ–æ»èŒ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€å¤©ç„¶çš„溶</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">èŒç”¢ç‰©æˆ–已純化的å…疫原ã€é‡çµ„çš„åŽ»æ°§æ ¸é†£æ ¸é…¸è£½å“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€æŽ¥åˆç‰©è³ªåŠè³ªé«”åŽ»æ°§æ ¸é†£æ ¸é…¸ç–«è‹—ã€‚</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">應æä¾›è£½é€ ç”¨å„種èŒæ ªçš„æ·å²åŠç‰¹æ€§é‘‘定，並å°èŒæ ª</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">作完整的說明，包括：</span> </p><p><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">單離的起æº</span> </p><p><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">物種</span> </p><p><span style="font-family: calibri;"> C </span><span style="font-family: 新細明體,serif;">生物化å¸ç‰¹æ€§</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">發酵ç‰</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> D </span><span style="font-family: 新細明體,serif;">èŒæ ªé‘‘別特性鑑定</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">血清類型ç‰</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> E </span><span style="font-family: 新細明體,serif;">病毒的感染能力</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">包括已經執行的減毒方法</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> F </span><span style="font-family: 新細明體,serif;">å·²çŸ¥çš„åŸºå› ç‰¹æ€§é‘‘å®š</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">標記ã€æ’å…¥ã€å‰ªé™¤ç‰</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> G </span><span style="font-family: 新細明體,serif;">質體</span> </p><p><span style="font-family: calibri;"> H </span><span style="font-family: 新細明體,serif;">èŒæ ªçªè®Šçš„機率</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">éºå‚³å®‰å®šæ€§</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">動物細胞</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">應說明å°æ–¼å˜æ–¼å‹•ç‰©èµ·æºç´°èƒžå—è³ªå…§çš„å¤–ä¾†æ±¡æŸ“å› å</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">所採å–çš„é 防ã€æŽ’除或ä¸æ´»åŒ–措施。</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">åˆä»£ç´°èƒžï¼šæ‡‰æä¾›è£½é€ åˆä»£ç´°èƒžçš„èµ·æºçµ„ç¹”åŠç”¨é€”說</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">明。æä¾›åˆä»£ç´°èƒžæ ªè³‡æ–™ï¼ŒåŒ…括</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">下列å„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é …ï¼š</span> </p><p><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">動物的物種åŠå¹´é½¡ï¼ŒåŠåˆä»£ç´°èƒžçš„組織來æº</span> </p><p><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">該åˆä»£ç´°èƒžå‡ºè™•çš„動物å¥åº·ç‹€æ³ï¼Œä¾‹å¦‚：無特定的</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">病原èŒ</span> </p><p><span style="font-family: calibri;"> C </span><span style="font-family: 新細明體,serif;">用以確ä¿å‹•ç‰©é©ç•¶æ€§çš„動物飼養方å¼</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">隔離éŽç¨‹ç‰</span> </p><p><span style="font-family: calibri;"> )</span></p><p><span style="font-family: calibri;"> D </span><span style="font-family: 新細明體,serif;">用以確ä¿å‹•ç‰©é©ç•¶æ€§çš„ç¸é†«åŠå¯¦é©—室監視</span> </p><p><span style="font-family: calibri;"> E </span><span style="font-family: 新細明體,serif;">åˆä»£ç´°èƒžå—質製備的說明</span> </p><p><span style="font-family: calibri;"> F </span><span style="font-family: 新細明體,serif;">用以è‰æ˜Žç„¡å¤–ä¾†å› åå˜åœ¨çš„測試åŠçµæžœ</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">ç´°èƒžæ ª</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ çš„å—質應包å«äººé¡žæˆ–動物來æºçš„é€£çºŒç´°èƒžæ ªæˆ–å…©</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å€é«”</span><span style="font-family: calibri;"> (Diploid) </span><span style="font-family: 新細明體,serif;">ç´°èƒžæ ªã€‚</span> </p><p><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">人類細胞å—質，應包括使用的æ料與方法ã€èµ·å§‹çš„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">組織或器官ã€ç¨®æ—與地ç†çš„èµ·æºã€å¹´é½¡ã€æ€§åˆ¥åŠä¸€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">般生ç†ç‹€æ³çš„說明，如已知æ贈者之疾病å²ï¼Œæ‡‰æ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">供測試çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">動物細胞å—質，應包括物種ã€é«”ç³»ã€èµ·å§‹çš„組織或</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">器官ã€åœ°ç†èµ·æºã€å¹´é½¡ã€æ€§åˆ¥åŠä¸€èˆ¬ç”Ÿç†ç‹€æ³ï¼Œä¸¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¯èƒ½å˜æ–¼ç´°èƒžå…§çš„å¤–ä¾†å› å。</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">åŸºå› æ§‹ç¯‰é«”èˆ‡é‡çµ„ç´°èƒžæ ª</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°å¾žé‡çµ„</span><span style="font-family: calibri;"> DNA </span><span style="font-family: 新細明體,serif;">製å“åŠä½¿ç”¨é‡çµ„</span><span style="font-family: calibri;"> DNA </span><span style="font-family: 新細明體,serif;">的細胞å—質，應</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ供宿主細胞，åŠé‡çµ„</span><span style="font-family: calibri;"> DNA </span><span style="font-family: 新細明體,serif;">來æºåŠåŠŸèƒ½çš„資料，包括</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">：</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">宿主細胞：應說明宿主細胞的來æºã€ç›¸é—œçš„表ç¾åž‹åŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŸºå› åž‹ã€ç´°èƒžå®‰å®šæ€§åŠç‰¹æ€§é‘‘定的çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">åŸºå› æ§‹ç¯‰é«”</span><span style="font-family: calibri;"> (Gene Construct) </span><span style="font-family: 新細明體,serif;">：應說明引入宿主細</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">èƒžä¹‹åŸºå› è£½å‚™æ–¹æ³•ï¼ŒåŠé™åˆ¶î ¸åˆ‡å‰²åœ–。並æä¾›å®Œæ•´æ ¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">î ºé…¸åºåˆ—ã€è¡¨ç¾æž¶æ§‹ä¹‹èª¿ç¯€å› åã€è½‰è¯çš„胺基酸åºåˆ—</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，åŠé‡è¦åºåˆ—特色。</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">載體：應æ供載體的資料，包括載體來æºåŠåŠŸèƒ½çš„說</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">明，例如：複製的起æºã€æŠ—ç”Ÿç´ è€å—æ€§åŸºå› ã€å•Ÿå‹•åŸº</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å› åŠå¢žå¼·åŸºå› ç‰ã€‚應æ供構建載體之é™åˆ¶î ¸åˆ‡å‰²åœ–部</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä½åŠç‰¹æ€§é‘‘定之é‡è¦åŸºå› 標記。</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">æœ€çµ‚åŸºå› æž¶æ§‹ï¼šæ‡‰èªªæ˜Žè£½é€ æœ€çµ‚é‡çµ„åŸºå› æž¶æ§‹çš„éŽç¨‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼ŒåŒ…æ‹¬åŸºå› ç‰‡æ®µã€è¼‰é«”ã€æˆ–å…¶ä»–åŸºå› çš„çµ„åˆéŽç¨‹åŠ 以</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">說明，並æä¾›æœ€çµ‚åŸºå› æž¶æ§‹ä¹‹é™åˆ¶î ¸åˆ‡å‰²åœ–。</span> </p><p><span style="font-family: calibri;"> (5) </span><span style="font-family: 新細明體,serif;">é‡çµ„ç´°èƒžæ ªï¼šæ‡‰æä¾›å°‡æœ€çµ‚åŸºå› æž¶æ§‹ç§»è½‰è‡³å®¿ä¸»çš„æ–¹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法ã€ç§»è½‰çš„機制ã€è¤‡è£½çš„數é‡åŠè½‰ç§»å¾Œå®¿ä¸»ç´°èƒžå…§</span><span style="font-family: calibri;"> (</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠ å…¥é«”å¤–éºå‚³å› å</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">的生ç†ç‹€æ³ç‰è³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">細胞庫系統：應說明細胞庫建立的éŽç¨‹ï¼ŒåŒ…括：製備細</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">胞庫的方法ã€ä½Žæº«ä¿å˜æ–¹å¼åŠç´°èƒžåº«ä¹‹ç®¡åˆ¶ç‰è³‡æ–™ã€‚應</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é¿å…微生物污染åŠé˜²æ¢èˆ‡å…¶ä»–細胞交互污染。並é 防細</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">胞庫儲å˜ç’°å¢ƒç”¢ç”ŸåŠ‡çƒˆè®ŠåŒ–åŠé©ç•¶è¦æˆ’措施，例如：將</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">細胞庫å˜æ–¼ä¸åŒè™•çš„多個冷è—庫內。</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">種細胞庫</span><span style="font-family: calibri;"> (MCB)</span><span style="font-family: 新細明體,serif;">：應æ供種細胞庫內細胞æ·å²åŠç‰¹æ€§</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">鑑定。</span> </p><p><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">å°åŸºå› é‡çµ„製å“的種細胞庫細胞å—質是指從原始單</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一細胞複製，å«æœ‰åˆé©åŸºå› 構築體之感染細胞。</span> </p><p><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">å°éžåŸºå› é‡çµ„製å“，細胞å—質是指來自é¸å®šç”¨æ–¼è£½</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">備種細胞庫的æ¯ç³»ç´°èƒžæ ªã€‚應æä¾›é¸ä½œç¨®ç´°èƒžåº«çš„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…©å€é«”ç´°èƒžæ ªè³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">工作細胞庫</span><span style="font-family: calibri;"> (WCB)</span><span style="font-family: 新細明體,serif;">：應詳述由種細胞庫è¡ç”Ÿè‡³å·¥ä½œç´°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">胞庫之éŽç¨‹ï¼ŒåŒ…括工作細胞庫之鑑別系統ã€å„²å˜æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠå…¶ç´°ç›®ã€‚å°æ–¼æ¯ä¸€æ–°å·¥ä½œç´°èƒžåº«ï¼Œé ˆé€²è¡Œèˆ‡ç¾æœ‰ç´°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">胞庫å„é …å®šæ€§åŠç‰¹æ€§åˆ†æžä¹‹æ¯”較。必è¦æ™‚應說明æ¤å·¥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">作細胞庫之繼代數，以確ä¿å…¶ä¿è·æ€§æŠ—åŽŸè‡´æ¯’æ€§å› å</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之å˜åœ¨ã€‚並應詳述確ä¿åŸ¹é¤Šç´”度與鑑別之方法與æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">最終產å“細胞</span><span style="font-family: calibri;"> (End of production cells; EPC) </span><span style="font-family: 新細明體,serif;">：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應說明所使用最終生產細胞之特性，以è‰æ˜Žè©²ç”Ÿç”¢ç³»</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">統之一致性。應包括最終生產細胞表ç¾åž‹èˆ‡åŸºå› 型標</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">記之分æžçµæžœï¼Œä»¥ç¢ºèªå…¶é‘‘別與純度，並è‰æ˜Žå…¶ä¸å—</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">外來物質污染。åŒæ™‚應æä¾›è©²åŸºå› æ§‹ç¯‰é«”ä¹‹é™åˆ¶é…µç´ </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">分æžçµæžœã€‚</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">細胞庫之特性與試驗：應說明有關庫å˜ç´°èƒžä¹‹ç‰¹æ€§èˆ‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗，包括細胞å—質之鑑別ã€ç´”度與é©åˆæ€§è©¦é©—之資</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ–™åŠå…¶çµæžœï¼Œä»¥ç¢ºä¿å…¶å¯ç”¨æ–¼è£½é€ 。若細胞來æºç‚ºè¤‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">細胞動物</span><span style="font-family: calibri;"> (metazoan cells) </span><span style="font-family: 新細明體,serif;">，應æä¾›å°æ–¼ç¨®ç´°èƒžåº«</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">èˆ‡å·¥ä½œç´°èƒžåº«ä¹‹è² è·èŒ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ç´°èŒåŠçœŸèŒ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">與黴漿èŒæ¸¬è©¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">çµæžœï¼Œä»¥åŠå¯èƒ½æ±¡æŸ“è©²ç´°èƒžæ ªä¹‹ç—…æ¯’æª¢æ¸¬çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">細胞培養與採收</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">細胞的培養：應å°åŸ¹é¤ŠéŽç¨‹ã€ç”Ÿé•·æ›²ç·šæˆ–生長特性作</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">說明。並æ供純度ã€æ•ˆåƒ¹ã€æŠ—原生產ç‰çš„管制åŠæ¸¬è©¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">時間點資料。也應說明å°æ±¡æŸ“管制所採å–的措施。</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">細胞的採收：應說明原料藥由細胞分離所使用的採收</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">方法</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">沉澱ã€é›¢å¿ƒã€éŽæ¿¾</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，並æ供採收的標準åŠç”¢</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é‡ç‰è³‡æ–™ã€‚å°ç¶æŒæŽ¡æ”¶éŽç¨‹ç„¡èŒç‹€æ…‹åŠé 防污染所採</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å–çš„æŽªæ–½åŠ ä»¥èªªæ˜Žï¼Œå°ç”Ÿç‰©è² è·é‡è©¦é©—監視。如果原</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">料藥在後續處ç†å‰éœ€ä¿å˜ï¼Œå‰‡æ‡‰èªªæ˜Žå„²å˜æƒ…æ³åŠæ™‚é–“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é™åˆ¶ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">純化與後續處ç†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應說明純化éŽç¨‹ï¼Œä¸¦æª¢é™„鑑定ã€ç´”度ã€æ¿ƒåº¦åŠèˆ‡ç”¢å“或éž</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產å“有關的ä¸ç´”物的分æžæ¸¬è©¦æ–¹æ³•ã€‚於培養時使用的抗生</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç´ åŠå…¶ä»–æˆåˆ†</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¾‹å¦‚ç”Ÿé•·å› åã€æŠ—é«”</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，應於使用å‰åŠ 以</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">排除並確ä¿é 防交互污染的éŽç¨‹ã€‚</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">執行é©ç•¶çš„ä¸æ´»åŒ–æ¥é©Ÿï¼šæ‡‰èªªæ˜Ž</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">ä¸æ´»åŒ–å‰çš„純度。</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">去活化的方法åŠè©¦åŠ‘。</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">é 防å‡é›†åŠç¢ºä¿ä¸æ´»åŒ–劑å‡è³ªåŒ–的方法。</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">è£½é€ éŽç¨‹ä¸å¯¦æ–½ä¸æ´»åŒ–或滅èŒçš„階段。</span> </p><p><span style="font-family: calibri;"> (5) </span><span style="font-family: 新細明體,serif;">監視的åƒæ•¸ï¼šå°åŽ»æ´»åŒ–或滅èŒæ–¹æ³•çš„é©ç•¶æ€§èªªæ˜Žã€‚</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">純化æ¥é©Ÿï¼š</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">應說明抗原æˆåˆ†ç´”化的目的åŠåŽŸç†</span> </p><p><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">使用的方法，包括如色層分æžç”¨ç®¡æŸ±ã€è¶…速離心機</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€è¶…速éŽæ¿¾å™¨åŠå–®æ ªæŠ—é«”ç‰è©¦åŠ‘或è¨å‚™ã€‚</span> </p><p><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">產é‡ã€‚</span> </p><p><span style="font-family: calibri;"> C </span><span style="font-family: 新細明體,serif;">純化éŽç¨‹çš„測試</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">例如：</span><span style="font-family: calibri;">ELISA </span><span style="font-family: 新細明體,serif;">之æ•æ„Ÿåº¦åŠç‰¹ç•°æ€§</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> D </span><span style="font-family: 新細明體,serif;">純化éŽç¨‹ä¸ç„¡èŒç‹€æ…‹æˆ–ç”Ÿç‰©è² è·é‡è©¦é©—的監視，åŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é 防污染所採å–çš„è¦æˆ’措施。</span> </p><p><span style="font-family: calibri;"> E </span><span style="font-family: 新細明體,serif;">純化用色層分æžç®¡æŸ±åŠå¸é™„劑之å†ä½¿ç”¨åŠ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生。</span> </p><p><span style="font-family: calibri;"> F </span><span style="font-family: 新細明體,serif;">殘餘的ä¸ç´”物åŠè©¦åŠ‘的監視。</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">æµç¨‹åœ–åŠæ‰¹æ¬¡è¨˜éŒ„應æ供純度ã€é‘‘定åŠç”Ÿç‰©æ´»æ€§çš„管</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">制åŠæ¸¬è©¦æ™‚間點的資料。å°ç´”化原料藥之最終èªå®šæ¨™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">準。如果經純化的原料藥在進一æ¥è™•ç†å‰éœ€ä¿å˜æ™‚，</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應å°å…¶å„²å˜æƒ…æ³åŠæ™‚é–“é™åˆ¶åŠ 以說明。</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">安定性試驗：應å°ç´”化後ä¸é–“物質在æ¯å€‹éŽç¨‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">例如：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¸æ”¶ã€æ·»åŠ 穩定劑ã€æ·»åŠ 防è…劑ã€ä½Žå£“冷å‡ä¹¾ç‡¥å„²å˜ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">乾燥</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">çš„å®‰å®šæ€§çš„åŠ ä»¥èªªæ˜Žï¼Œä¸¦åŸ·è¡Œç›£è¦–ç”Ÿç‰©è² è·é‡è©¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—åŠæ‰€æŽ¡å–é 防污染的è¦æˆ’措施。</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">去毒性：å°é¡žæ¯’ç´ æˆ–å«æœ‰é¡žæ¯’ç´ çš„ç–«è‹—ï¼Œæ‡‰èªªæ˜Žæ¯’ç´ æˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">分的去毒性éŽç¨‹</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">去毒性所使用的方法åŠè©¦åŠ‘。</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">å¯¦æ–½åŽ»æ¯’æ€§çš„è£½é€ éŽç¨‹ã€‚</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">å°åŽ»æ¯’性使用方法的é©ç•¶æ€§åŠ 以è‰æ˜Žã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åˆæˆä¹‹åŽŸæ–™è—¥ï¼šåˆæˆåŽŸæ–™è—¥åŒ…括線性或複åˆä¹‹åˆæˆèƒœî ½é¡ž</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠç¶“修飾åˆæˆæˆ–åŠåˆæˆä¹‹å…疫原</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如</span><span style="font-family: calibri;"> lipopeptides </span><span style="font-family: 新細明體,serif;">ã€æ”œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¸¶è›‹ç™½è³ªä¹‹èƒœî ½æˆ–æ”œå¸¶è›‹ç™½è³ªçµåˆç‰©ä¹‹å¤šé†£é«”</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">åˆæˆèƒœî ½é¡žï¼šæ‡‰æä¾›å¤šèƒœî ½åˆæˆåŠç´”化éŽç¨‹ç‰çš„資料。</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">經修飾åˆæˆæˆ–åŠåˆæˆä¹‹å…疫原</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">å°åŽŸæ–™è—¥æˆ–ä¸é–“物質經化å¸æˆ–é…µç´ ä¿®é£¾è£½æˆï¼Œå¦‚：將</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…疫原接åˆè‡³è¼‰é«”ã€å°‡æ¯’ç´ ä»¥é…µç´ æˆ–åŒ–å¸æ–¹æ³•æ¸›æ¯’åŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">純化。æ¤ç¨®ä¿®é£¾ä½œç”¨å¯èƒ½æœƒæ”¹è®ŠåŽŸæ–™è—¥çš„å…疫抗原性</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€æ¯’性ã€å®‰å®šæ€§ã€æˆ–原料藥之藥動å¸ç‰¹æ€§ã€‚</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">è£½é€ æ–¹æ³•ï¼šæ‡‰èªªæ˜Ž</span> </p><p><span style="font-family: calibri;"> A </span><span style="font-family: 新細明體,serif;">為確ä¿çµåˆæˆ–修飾方法的é©ç•¶æ€§ï¼Œæ‡‰èªªæ˜ŽåŽŸæ–™è—¥çš„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">說明åŠæ¨™æº–。</span> </p><p><span style="font-family: calibri;"> B </span><span style="font-family: 新細明體,serif;">æ‡‰èªªæ˜Žè£½é€ éŽç¨‹åŠæ–¹æ³•ã€è£½ç¨‹ç®¡åˆ¶ã€ç”¢å“鑑定åŠç”Ÿ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">物活性的測試ã€ä»¥åŠç´”化的éŽç¨‹ã€‚</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">產å“è¦æ ¼ï¼šæ‡‰æª¢é™„æ¯ä¸€ç¶“修飾原料藥之è¦æ ¼ï¼ŒåŒ…å«é‘‘</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">別ã€ç´”度ã€æ•ˆåƒ¹ã€ç‰©ç†åŒ–å¸æ¸¬å®šåŠå®‰å®šæ€§è©¦é©—。若該</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¡ç”Ÿç‰©ä¹‹æª¢é©—çµæžœå°‡ç´€éŒ„於藥å“最終放行æˆç¸¾æ›¸ï¼Œå‰‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ¯ä¸€è¦æ ¼å‡æ‡‰æ供包å«è®Šç•°æ€§ä¼°è¨ˆå€¼èˆ‡ä¸Šä¸‹é™ä¹‹ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å ±å‘Šã€‚æœªå應åˆå§‹åŽŸæ–™è—¥èˆ‡è£½ç¨‹ä¸è©¦åŠ‘之移除æ¥é©Ÿé ˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">經確效，å¦å‰‡æ‡‰æœ‰å…¶æ®˜é¤˜é‡è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">批次記錄：應æ供完整</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">åŠ è¨»ç°½åè“‹ç« </span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">的代表性批次</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">記錄。</span> </p><p><span style="font-family: 新細明體,serif;">第五æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥之製程管制資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製程管制</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應å°æµç¨‹åœ–ä¸çš„製程ä¸æŽ¡æ¨£åŠæ¸¬è©¦æ–¹æ³•ä½œèªªæ˜Žï¼Œæ‡‰å»ºç«‹æŽ¥å—</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">或拒絕該製程ä¸æ‰¹æ¬¡çš„標準。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">製程確效</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應æä¾›å¯èƒ½å½±éŸ¿åŽŸæ–™è—¥è¦æ ¼çš„é‡è¦è£½ç¨‹æˆ–å› åæ‰€ä½œçš„ç¢ºæ•ˆç ”</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç©¶å ±å‘Šã€‚ç¢ºæ•ˆç ”ç©¶å ±å‘ŠåŠçµ±è¨ˆæ•¸æ“šæ‡‰èƒ½è‰æ˜Žèˆ‡ç”¢å“è¦æ ¼åŠå“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">質相關製程的差異性。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生長：應ä¾æ“šç›¸é—œç´€éŒ„，æä¾›æ¯å€‹ç”Ÿé•·éŽç¨‹çš„生長曲線或</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生長特性的鑑定。包括能è‰æ˜ŽæŠ—åŽŸè£½é€ æ•ˆçŽ‡çš„æ•¸æ“šï¼ŒåŠåœ¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生長情æ³ä¸‹èƒ½é¡¯ç¤ºåŸºå› 標記的安定性數據。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">採收：應ä¾ç´€éŒ„æ供採收的產é‡ã€ç´”度åŠæ•ˆåƒ¹ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸æ´»åŒ–：應ä¾ç´€éŒ„æä¾›ä¸æ´»åŒ–或滅èŒæ›²ç·šçš„æ述，也應測</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é‡æ®˜é¤˜æ´»æ€§çš„方法，åŠéˆæ•åº¦ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">純化：應æ供產é‡ã€ç´”度åŠç”Ÿç‰©æ´»æ€§çš„資料。並å°ä¸ç´”物</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">試劑ã€å…§æ¯’ç´ ã€ç´°èƒžè›‹ç™½è³ªæˆ–æ ¸é…¸åŠå…¶ä»–殘餘的汙染物</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">管制。應該採用公èªçš„標準</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如：國際單ä½</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">來進行比</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">較。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">微生物å¸ï¼šæ‡‰å°è£½ç¨‹ä¸ï¼Œç”¨æ–¼åŸ¹é¤ŠåŸºæ»…èŒã€é˜²è…劑的效率</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€åŽ»æ±¡æŸ“ã€ç´°èƒžå»¢æ£„å‰çš„åŽ»æ´»åŒ–ç¢ºæ•ˆåŠ ä»¥èªªæ˜Žã€‚å¦‚æžœè©²åŽŸ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">料藥為無èŒè—¥å“時，應符åˆã€Œç„¡èŒè£½ç¨‹ç¢ºæ•ˆã€ä¹‹ç›¸é—œè³‡æ–™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”Ÿç‰©è² è·é‡ä¹‹ç®¡åˆ¶ï¼šå°éžç‚ºç„¡èŒç‹€æ³ä¸‹çš„製程，應å°ç”Ÿç‰©è² </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è·é‡è©¦é©—進行測試。</span> </p><p><span style="font-family: 新細明體,serif;">第å…æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥製程一致性資料：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ¯ç¨®ç–«è‹—æˆåˆ†è£½ç¨‹è‡³å°‘è¦ç”¨</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">最好是連續的</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">三批原料藥以驗è‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">其製程之一致性。應說明å°ç…§æ¨™æº–å“之建立與使用。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°ç…§æ¨™æº–å“：應敘述一級å°ç…§æ¨™æº–å“與工作å°ç…§æ¨™æº–å“之製</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‚™ã€ç‰¹æ€§èˆ‡å®‰å®šæ€§ã€‚æ‡‰è©³è¿°æ ¸å®šæ–°å°ç…§æ¨™æº–å“之éŽç¨‹èˆ‡æŽ¥å—</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">標準。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">放行試驗：應檢附å„批次之放行檢驗çµæžœåŠå…¶ä»–相關資料</span><span style="font-family: calibri;"> (</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">如檢驗æˆç¸¾æ›¸</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">第七æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥之è¦æ ¼ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¦æ ¼</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å„原料藥之è¦æ ¼èˆ‡æª¢é©—應包括鑑別ã€ç´”度ã€æ•ˆåƒ¹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">生物活性</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">ã€èˆ‡æ•ˆåƒ¹æœ‰é—œä¹‹ç‰©ç†åŒ–å¸æ¸¬å®šï¼Œå¿…è¦æ™‚應å«å®‰å®šæ€§è©¦é©—。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°æ–¼é«˜ç´”度物質，純度應åƒç…§ç†è«–組æˆ</span><span style="font-family: calibri;"> (theoretical com-</span></p><p><span style="font-family: calibri;"> position) </span><span style="font-family: 新細明體,serif;">表示。於æŸäº›æƒ…æ³ä¸‹ï¼Œæœ€çµ‚æ”¾è¡Œå ±å‘Šä¸æ‡‰åŒ…å«æŠ—</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">原æˆåˆ†</span><span style="font-family: calibri;"> (component antigens) </span><span style="font-family: 新細明體,serif;">其安定ä¸é–“產物之檢驗çµæžœ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，並應æä¾›æ¯é …è¦æ ¼ä¹‹ç¢ºæ•ˆè©•ä¼°</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包å«è®Šç•°æ€§åŠä¿¡è³´å€é–“</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸ç´”物之資料</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應包å«åŽŸæ–™è—¥ä¸ä¸ç´”物之鑑別與å«é‡åˆ†æžæ•¸æ“š</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如å‡è† 電泳</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法ã€ç®¡æŸ±æ²–æã€è¥¿æ–¹å¢¨é»žæ³•ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€‚æ‡‰åŠ ä»¥é‘‘å®šèˆ‡å®šé‡ä¹‹ä¸ç´”</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">物包括：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">與產å“相關之ä¸ç´”物</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如抗原於製程或儲å˜æ™‚產生之變異</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">或改變</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">與製程相關之ä¸ç´”物：</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">培養基æˆåˆ†</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">細胞å—è³ªè›‹ç™½è³ªæˆ–æ ¸é…¸</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">純化éŽç¨‹ä¸æœªåŽ»é™¤ä¹‹è©¦åŠ‘</span> </p><p><span style="font-family: 新細明體,serif;">第八æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">疫苗類原料藥之å†è£½</span><span style="font-family: calibri;"> (Reprocessing) </span><span style="font-family: 新細明體,serif;">：</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°æ–¼å„原料藥å¯èƒ½å†è£½ä¹‹ç¨‹åºæ‡‰è¼‰æ˜Žï¼š</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">於製程管制或è¦æ ¼ä¸è¨‚å®šå‡ºé ˆå†è£½ä¹‹æ¢ä»¶æˆ–標準</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">å†è£½æ¥é©Ÿ</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">å†è£½æ¥é©Ÿä¹‹æ¨™æº–æ“作程åº</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ‡‰å¢žåŠ æˆ–ç¶“ä¿®å®šä¹‹è£½ç¨‹ç®¡åˆ¶æˆ–è¦æ ¼</span> </p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">批次生產紀錄ä¸æ‡‰è¨»æ˜Žå†è£½ç”¢å“之批號與相關文件</span> </p><p><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">確ä¿å†è£½æ‰¹æ¬¡ç”¢å“之鑑別ã€ç´”度ã€æ•ˆåƒ¹èˆ‡å®‰å®šæ€§ä¹‹ç¢ºæ•ˆè©•ä¼°</span> </p><p><span style="font-family: 新細明體,serif;">第ä¹æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“之組æˆèˆ‡ç‰¹æ€§ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">「疫苗類藥å“ã€ä¿‚指經é…æ–¹ã€èª¿è£½ã€å……å¡«ã€åŒ…è£ä¾›å³æ™‚使用</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—最終劑型，å¯èƒ½å«æœ‰å…¶ä»–活性或éžæ´»æ€§æˆåˆ†åŒ…括ä½åŠ‘ã€ä¿</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è…劑ã€å®‰å®šåŠ‘åŠ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">賦形劑。疫苗之é…方包括稀釋ã€å¸é™„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€èˆ‡ä½åŠ‘æˆ–æ·»åŠ ç‰©æ··åˆåŠ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">或</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">減壓冷å‡ä¹¾ç‡¥ä¾†è£½æˆè—¥å“。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應包å«æœ€çµ‚製å“ä¸æ‰€æœ‰åŽŸæ–™è—¥åŠè³¦å½¢åŠ‘的資料。如æˆåˆ†ä¸æœ‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">使用專利的製備或混åˆç‰©æ™‚，應æ供完整資料。å°äººé¡žæˆ–å‹•</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">物起æºçš„æˆåˆ†ï¼Œæ‡‰æ供能è‰æ˜Žå…¶ç„¡å¤–ä¾†å› å的測試çµæžœæˆ–分</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æžè‰æ˜Žæ›¸ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">組æˆã€è¦æ ¼ã€ä¸€è‡´æ€§åŠç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">組æˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應æ供藥å“所有æˆåˆ†ï¼ŒåŒ…括原料藥åŠå…¶ä»–å…§å«ç‰©ï¼Œä»¥åŠå…¶</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å–®ä½åŠ‘é‡ã€‚å°æŸäº›éžæ´»æ€§ç‰©è³ªï¼Œå…¶æ•¸é‡å¯ç”¨æ¿ƒåº¦ç™¾åˆ†æ¯”或</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é«”ç©èŽ«è€³æ¿ƒåº¦è¡¨ç¤ºã€‚</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">原料藥：應æä¾›æ¯ç¨®åŽŸæ–™è—¥çš„表單。</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">賦形劑：應æ供最終製å“å…§éžæ´»æ€§æˆåˆ†çš„表單ã€åˆ†æžè‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">明書或測試方法ã€æ¸¬è©¦çµæžœç‰ã€‚賦形劑包括</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">下列å„é …ï¼š</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">稀釋液</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括其體ç©èŽ«è€³æ¿ƒåº¦ã€é…¸é¹¼å€¼ç‰</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">填充劑</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">å¸é™„劑</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">éžä½åŠ‘</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">安定劑</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">例如醣類ã€é˜²æ½®åŠ‘</span><span style="font-family: calibri;">)</span></p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">ä½åŠ‘：應包å«åŒ–å¸è™•æ–¹ï¼ŒåŠå„種ä½åŠ‘æ¯å–®ä½åŠ‘é‡çš„數é‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">防è…劑：應æ供其化å¸å稱åŠå•†å“å，於單劑原料藥ä¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ·»åŠ é˜²è…劑的目的åŠæ•ˆèƒ½ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è¦æ ¼åŠæ¸¬è©¦æ–¹æ³•ï¼šæ‡‰å°ç”¢å“之鑑定ã€ç´”度ã€æ•ˆåƒ¹åŠæ¯æ‰¹è£½</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å“ä¹‹ä¸€è‡´æ€§ä¹‹æ¸¬è©¦æ–¹æ³•åŠ ä»¥èªªæ˜Žã€‚ä¸¦æ供原料藥的è¦æ ¼ï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠè‡³å°‘連續三批製å“的檢驗æˆç¸¾æ›¸ï¼šåŠåˆ†æžçµæžœã€‚</span> </p><p><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">性狀：應æ述其物ç†ç‹€æ…‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">冷å‡ä¹¾ç‡¥å›ºé«”ã€ç²‰æœ«ã€æ¶²é«”</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">ã€é¡è‰²ã€åŠæ¾„清度。</span> </p><p><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">鑑別：應æ述鑑別試驗之方法åŠå…¶ç‰¹ç•°æ€§èˆ‡éˆæ•åº¦ä¹‹è©•</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">估。</span> </p><p><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">純度åŠä¸ç´”物：應包括æˆå“純度之分æžåŠä¸ç´”物之鑑別</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">與定é‡ã€‚若該ä¸ç´”物係於製程ä¸åŠ 入或形æˆï¼Œæ‡‰è¨‚定其</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¯æŽ¥å—之範åœèˆ‡è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">效價：應具備該藥å“效價分æžä¹‹è³‡æ–™ï¼ŒåŒ…括分æžæ–¹æ³•ä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éˆæ•åº¦ã€ç‰¹ç•°æ€§ã€è®Šç•°æ€§ã€åŠå¯æŽ¥å—之範åœã€‚</span> </p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">檢驗æˆç¸¾æ›¸ï¼š</span> </p><p><span style="font-family: calibri;"> (1) </span><span style="font-family: 新細明體,serif;">應註明批號ã€æª¢é©—日期ã€æª¢é©—人員åŠè² 責人簽å</span> </p><p><span style="font-family: calibri;"> (2) </span><span style="font-family: 新細明體,serif;">應包括所有原料藥åŠæˆå“之檢驗æˆç¸¾æ›¸</span> </p><p><span style="font-family: calibri;"> (3) </span><span style="font-family: 新細明體,serif;">應ä¾è¦æ ¼é€é …檢驗</span> </p><p><span style="font-family: calibri;"> (4) </span><span style="font-family: 新細明體,serif;">原料藥檢驗æˆç¸¾æ›¸æ‡‰ç‚ºæ‰€é™„æˆå“批次使用之原料藥檢</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—æˆç¸¾æ›¸</span> </p><p><span style="font-family: calibri;"> (5) </span><span style="font-family: 新細明體,serif;">檢驗çµæžœç‚ºæ•¸å€¼è€…應以數據表示，檢驗方法為比å°æ¨™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">準å“者å¯ä»¥ã€Œ</span><span style="font-family: calibri;">Pass</span><span style="font-family: 新細明體,serif;">ã€è¡¨ç¤º</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">一致性：應æ供抽樣計畫，並詳述用以確ä¿æˆå“之鑑別ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">純度ã€å¼·åº¦åŠï¼æˆ–效價之試驗方法，以åŠå„批次間一致性</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之資料與æˆå“è¦æ ¼ï¼Œä¸”應包括至少連續三批æˆå“之檢驗æˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">績書åŠæª¢é©—çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">確效：應æ供放行試驗之æ¯é …方法的特異性ã€éˆæ•åº¦èˆ‡è®Š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">異性之確效評估。包括å°ç…§æ¨™æº–å“åŠå…¶ç¢ºæ•ˆã€‚若使用公定</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">書之分æžæ–¹æ³•ï¼Œæ‡‰èªªæ˜Žå…¶ä¾†æºä¾æ“šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第一○æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“ä¹‹è£½é€ æ¥èˆ‡æµç¨‹ï¼š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應æ供包括委託代ç†å•†åœ¨å…§çš„所有從事藥å“è£½é€ åŠæ¸¬è©¦ä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ æ¥è€…çš„å稱åŠä½å€ï¼Œä¸¦å°å…¶è²¬ä»»åŠ 以說明。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應æ供藥å“çš„è£½é€ æµç¨‹ï¼ŒåŒ…括滅èŒæ“作ã€ç„¡èŒè™•ç†éŽç¨‹ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">低壓冷å‡ä¹¾ç‡¥åŠåŒ…è£ç‰éŽç¨‹ä½œè©³ç´°çš„說明。需æä¾›æµç¨‹åœ–</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾†é¡¯ç¤ºè£½é€ éŽç¨‹ã€ä½¿ç”¨çš„è¨å‚™èˆ‡ææ–™ã€å¯¦æ–½æ“作的房間或</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å€åŸŸï¼ŒåŠæ¯ä¸€å€‹è£½é€ éŽç¨‹ä¸æ‰€å¯¦æ–½çš„製程ä¸ç®¡åˆ¶åŠæ¸¬è©¦çš„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">表單。應題供藥å“çš„ç¸½è£½é€ è¨˜éŒ„</span><span style="font-family: calibri;"> (Master Production R-</span></p><p><span style="font-family: calibri;"> ecord, MPR) </span><span style="font-family: 新細明體,serif;">，包括完整的å¸æ”¶</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">é©ç•¶çš„話</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ã€èª¿é…ã€è£</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¡«ã€æ¨™ç¤ºåŠåŒ…è£çš„è£½é€ èªªæ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第一一æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">容器與å°è“‹ï¼šæ‡‰æœ‰è£½ç¨‹ä¸æ‰€ç”¨ä¹‹å®¹å™¨èˆ‡å°è“‹å°æ–¼åŽŸæ–™è—¥åŠç”¢å“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">之åˆé©æ€§è©•ä¼°æ¸¬è©¦ï¼Œå¦‚å¸é™„ã€å¯æ»²å‡ºç‰©ã€ç”Ÿç‰©æ¸¬è©¦ç‰ã€‚並應有</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">儲å˜æœŸé™ä¸å®¹å™¨åŠå°è“‹å®Œæ•´æ€§ä¹‹è‰æ˜ŽåŠä¾›æ‡‰å•†è³‡è¨Šã€‚若容器或</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°è“‹ç³»çµ±å·²ç²è¨±å¯ï¼Œæ‡‰å…·å‚™è¨±å¯è‰æ˜Žä¾›åƒã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第一二æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">微生物之管制</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應æ供「無èŒè£½ç¨‹ç¢ºæ•ˆã€ä¸æ‰€è¿°ä¹‹ç›¸é—œè³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第一三æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安定性</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應敘述產å“之安定性以訂定其儲è—æ¢ä»¶èˆ‡æœ‰æ•ˆæœŸé™ï¼Œå¿…è¦æ™‚應</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有åŠè£½å“或調é…原液在特定儲å˜æˆ–é‹é€æ¢ä»¶ä¸‹ä¹‹å®‰å®šæ€§åŠå…¶ç¢º</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ•ˆè³‡æ–™ã€‚å®‰å®šæ€§è©¦é©—å ±å‘Šæ‡‰ä¾è¡Œæ”¿é™¢è¡›ç”Ÿç½²å…¬å‘Šä¹‹ã€Œè—¥å“安定</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">性試驗準則ã€å…§å®¹ç¢ºå¯¦åŸ·è¡Œï¼Œä¸¦æª¢é™„實驗方法ã€çµ±è¨ˆåˆ†æžåŠå®š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é‡åˆ†æžæ–¹æ³•çš„確效ç‰è³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安定性試驗計劃書：應æä¾›</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">但ä¸é™æ–¼</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">下列å„é …å®‰å®šæ€§</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">測試：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">效價</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">物ç†åŒ–å¸è¦æ ¼</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">低壓冷å‡ä¹¾ç‡¥æ™‚的水分å«é‡</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">酸鹼值</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ç„¡èŒæˆ–è² è·èŒç®¡åˆ¶</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">經冷å‡æˆ–解å‡å¾Œä¹‹ç´°èƒžå˜æ´»çŽ‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安定性資料</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">應æ供藥å“於最終容器或å°é–‰ç³»çµ±ã€å„²å˜ç‹€æ³ä¸‹ï¼Œæœ‰æ•ˆæœŸ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é™çš„çµæžœã€‚å°ä½Žå£“冷å‡ä¹¾ç‡¥å„²å˜çš„製å“，應æ供架å˜æœŸé™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">的數據。冷è—製å“，應æ供製å“經éŽå†·è—─解å‡å¾ªé‚„次數</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">後的安定性數據。</span> </p><p><span style="font-family: 新細明體,serif;">第一四æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç†åŠæ¯’性試驗資料</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“çš„èŒç¨®</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括亞種</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">的變更ã€è£½ç¨‹æ”¹è®Šã€é…方改變</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠçµæ§‹ç‰äº›å¾®å·®ç•°ï¼Œå¯èƒ½å°ç”¢å“çš„å…疫產生能力åŠæ¯’ç†ç‰ä½œç”¨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產生é‡å¤§å½±éŸ¿ï¼Œå› æ¤éœ€è—‰é©ç•¶çš„動物模å¼ï¼Œè§€å¯Ÿç”¢å“在活體ä¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產生任何éžé 期的å…ç–«åŠæ¯’ç†ä½œç”¨ï¼Œä¸¦åœ¨æ¯’性試驗或臨床試驗</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">時觀察æ¤ä½œç”¨ã€‚è—¥å“之藥ç†åŠæ¯’性試驗應符åˆè¡Œæ”¿é™¢è¡›ç”Ÿç½²ã€Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„ã€</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»</span><span style="font-family: calibri;"> 2) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">第一五æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物動力å¸è³‡æ–™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“之申請應說明其å¸æ”¶ã€åˆ†å¸ƒã€ä»£è¬ã€æŽ’泄åŠç™‚效ç‰</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">作用。視藥å“特性來æ供藥動å¸ã€è—¥æ•ˆå¸ç‰äººé«”åŠå‹•ç‰©è³‡æ–™ä»¥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾›å¯©æ ¸ï¼Œå¯åƒè€ƒè¡›ç”Ÿç½²å‡ºç‰ˆä¹‹ã€Œè—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗基準åŠç›¸é—œè³‡æ–™ã€</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»</span><span style="font-family: calibri;"> 3) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">第一å…æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床使用文ç»</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“查驗登記時，除應檢附國外臨床使用文ç»ç‰è³‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">料外，å¦æ‡‰å†ä¾æ“šè¡›ç”Ÿç½²ã€Œè—¥å“優良臨床試驗è¦ç¯„ã€</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åƒ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">考文ç»</span><span style="font-family: calibri;"> 4) </span><span style="font-family: 新細明體,serif;">åŠç›¸é—œè¦å®šç”³è«‹åœ‹å…§ä¾›æŸ¥é©—登記用藥å“臨床試</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é©—</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å¾—æª¢é™„åœ‹å…§è‡¨åºŠè©¦é©—å ±å‘Šè³‡æ–™ï¼Œæˆ–åŒæ™‚檢é€åœ‹å…§è‡¨åºŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗計畫書，以供審查</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。惟如欲å…除國內臨床試驗，則</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¯ä¾æœ¬ç½²æ·æ¬¡å…除國內臨床試驗å“é …ä¹‹å…¬å‘Šï¼Œæ£å¼å‘本署</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請å…除國內臨床試驗。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“å…除國內臨床試驗之原則</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»</span><span style="font-family: calibri;"> 5) </span><span style="font-family: 新細明體,serif;">：原</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">產國已上市ã€ä¸”具有å大先進國採用è‰æ˜Žè€…，其有效性åŠ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">安全性有發表文ç»å¯è³‡è‰æ˜Žï¼Œä¸”符åˆå·¦åˆ—å„é …ä¹‹ä¸€è€…ï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å› å¯å—試人數太少，或為é 防緊急ã€åš´é‡ä¹‹æ„ŸæŸ“性疾患</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠï¼æˆ–å…¶ä½µç™¼ç—‡ï¼Œæˆ–å› ç‰¹æ®Šéœ€è¦ç‰ï¼Œç¶“衛生署審查èªå®š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，係為無其他藥å“å¯å–代之疫苗。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">所申請疫苗之ä¿è·æ•ˆæžœæˆ–抗體å應，有é©ç•¶ä¹‹äºžè£”人種</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">資料以顯示無人種差異</span><span style="font-family: calibri;"> (Ethnic Insensitive) </span><span style="font-family: 新細明體,serif;">，且其</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">所é 防之特定微生物</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">群</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，亦無å€åŸŸæ€§å¾®ç”Ÿç‰©èŒç¨®</span><span style="font-family: calibri;"> (</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">包括亞型</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">的差異，或有具體資料顯示其å…疫作用å°ä¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŒå¾®ç”Ÿç‰©æŠ—原，具有交互ä¿è·çš„æ•ˆæžœï¼Œä¸¦æœ‰è¶³å¤ è©•ä¼°åœ‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人安全性</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">例如å°ç››è¡ŒçŽ‡é«˜ä¹‹åœ‹äººè‚炎患者的疫苗å應</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">資料。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“å¯å…除國內臨床試驗之é©ç”¨ç”³è«‹æ¢ä»¶ï¼Œä»¥é </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">防接種用主動å…疫類疫苗為主。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ç–«è‹—é¡žè—¥å“應æ供上述之資料å‘衛生署申請å…除國內臨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">床試驗。衛生署得è¦æ±‚åŽŸç”³è«‹å» å•†æ供具體文ç»ã€è³‡æ–™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，包括國內使用之效益評估</span><span style="font-family: calibri;"> (Cost-Benefit Analysis)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç‰è³‡æ–™ï¼Œä»¥ä¾¿é€²è¡Œå¿…è¦ä¹‹å¯©æ ¸å·¥ä½œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第一七æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物藥å“之藥å“å„ªè‰¯è£½é€ è¦ç¯„åŠç¢ºæ•ˆè³‡æ–™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物藥å“ä¹‹è£½é€ åŠè¼¸å…¥ï¼Œæ‡‰ç¬¦åˆè—¥äº‹æ³•åŠç›¸é—œè¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">從事人用生物藥å“è£½é€ æ¥è€…，應è˜å…·æœ‰ç”Ÿç‰©è—¥å“è£½é€ å°ˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">門知è˜ï¼Œä¸¦æœ‰äº”å¹´ä»¥ä¸Šè£½é€ ç¶“é©—ä¹‹æŠ€è¡“äººå“¡ï¼Œé§å» è² è²¬</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è£½é€ ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è£½é€ ã€è¼¸å…¥ä¹‹è—¥å“應符åˆã€Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„ã€ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物藥å“原液</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">原料藥</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之輸入，以生物藥å“è£½é€ æ¥è€…</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">為é™ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物製劑或生物技術產å“å·¥å» æ‡‰æœ‰ç¨ç«‹</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">棟</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¹‹å» æˆ¿ï¼Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">其空氣處ç†ç³»çµ±äº¦æ‡‰å„自ç¨ç«‹ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物製劑或生物技術產å“原料藥，應視實際需è¦ï¼Œå…·å‚™</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å¿…éœ€ä¹‹è£½é€ ã€åŠ 工或分è£ã€åŒ…è£è¨å‚™ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">生物製劑或生物技術產å“ç‰æ‡‰è¦–檢驗需è¦ï¼Œè¨ç½®ç”ŸèŒæ•¸</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗ã€æ»…èŒæª¢æŸ¥ã€ç†±åŽŸè©¦é©—ã€å®‰å…¨è©¦é©—ã€ç”Ÿç‰©æª¢å®šç‰ä¹‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å ´æ‰€ã€è¨æ–½åŠè¨å‚™ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">為é…åˆæˆ‘國</span><span style="font-family: calibri;"> GMP </span><span style="font-family: 新細明體,serif;">之實施，確ä¿è¼¸å…¥è—¥å“å“è³ªï¼Œè—¥å» ç¢º</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">實符åˆ</span><span style="font-family: calibri;"> GMP </span><span style="font-family: 新細明體,serif;">è¦å®šï¼Œåœ‹å¤–è—¥å» æ–¼è—¥å“登記å‰ï¼Œæ‡‰å…ˆæª¢é™„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è©²å» å·¥å» è³‡æ–™</span><span style="font-family: calibri;"> (Plant Master File</span><span style="font-family: 新細明體,serif;">ï¼›</span><span style="font-family: calibri;">PMF) </span><span style="font-family: 新細明體,serif;">申請備查。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">生物藥å“之輸入，應ä¾ç›¸é—œä¹‹åŸºæº–å–得生物藥å“ä¹‹å·¥å» </span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">資料</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括原料藥åŠè£½åŠ‘</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å» æ‡‰ä¾ã€Œè—¥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–ã€</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»</span><span style="font-family: calibri;"> 6)</span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，以é©ç•¶ä¹‹æ–¹æ³•ï¼Œé‡å°ä¸‹åˆ—äº‹é …ä¹‹é©ç•¶æ€§ï¼Œé€²è¡Œç¢ºæ•ˆï¼šæ”¯</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ´ç³»çµ±</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包括供水與空氣處ç†ç³»çµ±</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">，è¨å‚™ä¹‹å®‰è£ã€æ“作</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠå…¶æ€§èƒ½ï¼Œè¨å‚™ä¹‹æ¸…潔，製程åŠå„種分æžæ–¹æ³•ç‰ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">屬於生物藥å“特有之確效作æ¥ï¼Œè—¥å» 應自行檢附資料é€å¯©</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。行政院衛生署亦將é©æ™‚公告相關之è¦æ±‚。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥ç‰©å·¥å» ã€ç”Ÿç‰©è£½åŠ‘è£½è—¥å» æ‡‰æ–¼æ°‘åœ‹ä¹å一年七月å‰è¨ç½®</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">動物實驗管ç†å°çµ„。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¾æ“šå‹•ç‰©ä¿è·æ³•è¦å®š</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»</span><span style="font-family: calibri;"> 7) </span><span style="font-family: 新細明體,serif;">ï¼Œè¾²å§”æœƒé ’ä½ˆå‹•ç‰©</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">實驗管ç†å°çµ„è¨ç½®è¾¦æ³•ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">國內生物科技ã€è£½è—¥ç‰æ‰€æœ‰åˆ©ç”¨å¯¦é©—動物的機構，都必</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é ˆæˆç«‹å‹•ç‰©å¯¦é©—管ç†å°çµ„。æˆå“¡è‡³å°‘包括一ä½ç¸é†«å¸«æˆ–</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">經由農委會委託培訓單ä½è¨“ç·´åˆæ ¼çš„實驗動物專æ¥äººå“¡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼Œè² è²¬å¯©æŸ¥è©²æ©Ÿæ§‹é€²è¡Œå¯¦é©—å‹•ç‰©çš„ç ”ç©¶è¨ˆç•«ï¼Œç›£ç£ã€ä¸¦</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ供有關實驗動物飼養è¨æ–½æ”¹å–„建è°ã€‚åŒæ™‚，æ¯å¹´å®šæœŸ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‘實驗動物倫ç†å§”員會æ出監ç£å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第一八æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">檢驗å°ç·˜</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¼¸å…¥æˆ–è£½é€ ä¹‹ç–«è‹—é¡žè—¥å“，應申請檢驗å°ç·˜å¾Œï¼Œå§‹å¾—銷售</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å‡¡è£½é€ ã€è¼¸å…¥ç–«è‹—ä¹‹å» å•†ï¼Œæ‡‰æª¢é™„ç”Ÿç‰©è—¥å“檢驗å°ç·˜ç”³è«‹</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">書ã€åŒ…è£æ¸…å–®ã€åŽŸç”¢åœ‹åœ‹å®¶æª¢å®šæ©Ÿæ§‹ä¹‹æª¢é©—åˆæ ¼è‰æ˜Žï¼Œä½†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŽŸå» è‹¥ç¶“åœ‹å®¶æª¢å®šæ©Ÿæ§‹èªå¯æŽˆæ¬Šè‡ªè¡Œæª¢é©—者，å¯ç”¨åŽŸå» 之</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">檢驗紀錄åŠæˆç¸¾æ›¸ä»£æ›¿</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">ä¸Šè¿°å…©é …è³‡æ–™ï¼Œåœ‹ç”¢è£½å“å¾—å…附</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">ï¼Œè¡Œæ”¿é™¢è¡›ç”Ÿç½²æ ¸ç™¼ä¹‹è—¥å“許å¯è‰åŠæ ¸å‡†å®¹å™¨æ¨™ç±¤ä»¿å–®</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å½±å°æœ¬ã€ç”Ÿç‰©è—¥å“製程ã€æª¢é©—方法ã€è¦æ ¼åŠæœ‰é—œæ–‡ç»ã€æœ¬</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">批生物藥å“製程åŠæˆå“之檢定紀錄</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«è£½ç¨‹åˆ†è£æ•¸é‡ç´€éŒ„</span> </p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">ã€æˆç¸¾æ›¸ï¼Œå‘衛生署藥物食å“檢驗局申請；國產製å“應</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç”±è©²å» è‡ªè¡Œæª¢å®šåˆæ ¼å®ŒæˆåŒ…è£å¾Œå§‹å¾—為之。經該局審查與</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è¦æ ¼ç›¸ç¬¦æ™‚，å³æ´¾å“¡æŸ¥æ ¸å…¶è¼¸å…¥é‹é€ã€è²¯å˜ä¹‹æº«åº¦ç´€éŒ„符</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åˆå¾Œï¼›æŠ½å–樣å“檢驗，並將所請å°ç·˜ä¹‹ç”Ÿç‰©è—¥å“悉數先行</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°å˜åŽŸè™•ï¼Žç”±å» 商自行ä¿ç®¡ï¼Œä¿Ÿæª¢é©—åˆæ ¼å¾Œï¼Œå³æ´¾å“¡æ‹†å°</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼ŒæŒ‰å…¶æ ¸å‡†ä¹‹åŒ…è£ï¼Œå€‹åˆ¥åŠ 貼藥物檢查è‰ä»¥å®Œæˆå°ç·˜æ‰‹çºŒ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ï¼Œä¸¦æ ¸ç™¼ã€Œç”Ÿç‰©è—¥å“å°ç·˜è‰æ˜Žæ›¸ã€ã€‚å‰è¿°ä¹‹æª¢é©—，得由本</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">署藥物食å“檢驗局ä¾å¯¦éš›éœ€è¦æ±ºå®šæª¢é©—é …ç›®</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»</span><span style="font-family: calibri;"> 8</span></p><p><span style="font-family: calibri;"> ) </span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">基於é…åˆé˜²ç–«åŠä½œæ¥éœ€è¦ä¸‹åˆ—生物藥å“，得由衛生署藥物</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">食å“檢驗局以書é¢å¯©æŸ¥æœ‰é—œè¦å®šè³‡æ–™ï¼Œä¸¦æ´¾å“¡æŸ¥æ ¸å…¶è¼¸å…¥</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é‹é€ã€è²¯å˜ä¹‹æº«åº¦ç´€éŒ„符åˆå¾ŒæŒ‰å…¶æ ¸å‡†ä¹‹åŒ…è£ï¼Œå€‹åˆ¥åŠ è²¼</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥物檢查è‰ä»¥å®Œæˆå°ç·˜æ‰‹çºŒï¼Œä¸¦æ ¸ç™¼ã€Œç”Ÿç‰©è—¥å“å°ç·˜è‰æ˜Ž</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">書ã€ã€‚å¿…è¦æ™‚，藥物食å“檢驗局ä»å¾—抽樣，俟檢驗åˆæ ¼å¾Œ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">，å†åŠ 予å°ç·˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åƒè€ƒæ–‡ç»ï¼š</span> </p><p><span style="font-family: calibri;">1 Guidance for Industry: Content and Format of Chemistry, Manuf-</span></p><p><span style="font-family: calibri;"> acturing and Controls Information and Establishment Descripti-</span></p><p><span style="font-family: calibri;"> on Information for a Vaccine or Related Product - FDA/CBER/1/5</span></p><p><span style="font-family: calibri;"> /1999</span></p><p><span style="font-family: calibri;">2 87.6.24.</span><span style="font-family: 新細明體,serif;">衛署藥å—第</span><span style="font-family: calibri;"> 87040788 </span><span style="font-family: 新細明體,serif;">號公告之「藥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€</span> </p><p><span style="font-family: calibri;">3 87.5. </span><span style="font-family: 新細明體,serif;">衛生署出版之「藥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—基準åŠç›¸é—œè³‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æ–™ã€</span> </p><p><span style="font-family: calibri;">4 85.11.20 </span><span style="font-family: 新細明體,serif;">衛署藥å—第</span><span style="font-family: calibri;"> 85067127 </span><span style="font-family: 新細明體,serif;">號公告之「藥å“優良臨床試驗è¦ç¯„ã€</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">åŠ</span><span style="font-family: calibri;"> 89.12.12.</span><span style="font-family: 新細明體,serif;">衛署藥å—第</span><span style="font-family: calibri;"> 0890035812 </span><span style="font-family: 新細明體,serif;">號之相關è¦å®š</span> </p><p><span style="font-family: calibri;">5 87.12.30. </span><span style="font-family: 新細明體,serif;">以衛署藥å—第</span><span style="font-family: calibri;"> 87074774 </span><span style="font-family: 新細明體,serif;">號，公告第三次公告得å…除國內臨</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">床試驗之新藥å“，包括疫苗類藥å“åŠæ²»ç™‚精神或å…疫系統慢性疾病藥å“</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç‰äºŒé¡žè—¥å“之相關è¦å®š</span> </p><p><span style="font-family: calibri;">6 88.04.13. </span><span style="font-family: 新細明體,serif;">衛署藥å—第</span><span style="font-family: calibri;"> 88018122 </span><span style="font-family: 新細明體,serif;">號公告「藥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ã€</span> </p><p><span style="font-family: calibri;">7 87.11.4. </span><span style="font-family: 新細明體,serif;">總統è¯ç¸½</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">義å—第</span><span style="font-family: calibri;"> 8700224370 </span><span style="font-family: 新細明體,serif;">號令公布之「動物ä¿è·</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法ã€åŠ</span><span style="font-family: calibri;"> 89.1.19. </span><span style="font-family: 新細明體,serif;">以</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…«ä¹</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">農牧å—第</span><span style="font-family: calibri;"> 890100554 </span><span style="font-family: 新細明體,serif;">號公告之「動物ä¿</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è·æ³•æ–½è¡Œç´°å‰‡ã€</span> </p><p><span style="font-family: calibri;">8 87.06.20. </span><span style="font-family: 新細明體,serif;">為簡化生物藥å“檢驗å°ç·˜ç”³è«‹æ‰‹çºŒï¼Œä»¥è¡›ç½²è—¥å—第</span><span style="font-family: calibri;"> 8701949</span></p><p><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">號公告「生物藥å“檢驗å°ç·˜ä½œæ¥è¦å®šã€</span> </p><p><span style="font-family: calibri;"> </span></p>2013-12-05
查驗登記類,è—¥å“查驗登記審查準則,åŸºå› å·¥ç¨‹è—¥å“之查驗登記法è¦å‘½ä»¤è—¥å“查驗登記審查準則ï¼åŸºå› 工程藥å“之查驗登記<pre style="text-align: center;"><b><span style="font-size: 14pt; font-family: 標楷體; color: #333333;">è—¥å“查驗登記審查準則ï¼åŸºå› 工程藥å“之查驗登記 </span></b></pre><pre style="text-align: center;"><span style="font-size: 10pt; font-family: times new roman,serif; color: #333333;">(</span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">民國</span><span style="font-size: 10pt; font-family: 細明體; color: #000000;"> 91 </span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">å¹´</span><span style="font-size: 10pt; font-family: 細明體; color: #000000;"> 1 </span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">月</span><span style="font-size: 10pt; font-family: 細明體; color: #000000;"> 3 </span><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">日公布</span><span style="font-size: 10pt; font-family: times new roman,serif; color: #333333;">)</span> </pre><pre> </pre><pre><span style="font-family: 標楷體;">ç‚ºäº†åŠ å¼·åŸºå› å·¥ç¨‹è—¥å“的管ç†ï¼Œé 防和é¿å…ç¶“ç”±åŸºå› å·¥ç¨‹åŽŸæ–™åŠç”Ÿç”¢éŽç¨‹ </span></pre><pre><span style="font-family: 標楷體;">引進的病原，確ä¿åŸºå› 工程藥å“çš„åŸºå› ç©©å®šè¡¨ç¾ã€ç”¢å“å“質ã€å®‰å…¨åŠç™‚效 </span></pre><pre><span style="font-family: 標楷體;">，爰ä¾æ“šè—¥äº‹æ³•ç¬¬å››å二æ¢åŠä¸ƒåå››æ¢ï¼Œåˆ¶å®šã€Œè—¥å“æŸ¥é©—ç™»è¨˜å¯©æŸ¥æº–å‰‡ï¼ </span></pre><pre><span style="font-family: 標楷體;">åŸºå› å·¥ç¨‹è—¥å“之查驗登記ã€ã€‚本準則é©ç”¨æ–¼åŸºå› 工程藥å“æŸ¥é©—ç™»è¨˜æ™‚ï¼Œå° </span></pre><pre><span style="font-family: 標楷體;">æ–¼åŸºå› å·¥ç¨‹è£½åŠ‘ã€åŽŸæ–™ã€è£½ç¨‹ç®¡ç†ä»¥åŠç”¢å“之å“質ã€å®‰å…¨ã€ç™‚效的è¦æ±‚。 </span></pre><pre> </pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸€æ¢ æœ¬æº–å‰‡æ‰€ç¨±ä¹‹ã€ŒåŸºå› å·¥ç¨‹è—¥å“ã€åŒ…æ‹¬ã€ŒåŸºå› é‡çµ„蛋白質藥å“ã€åŠ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ã€Œå–®æ ªæŠ—é«”è—¥å“ã€ç‰ï¼Œä»¥åŸºå› å·¥ç¨‹æ–¹æ³•è£½é€ ä¹‹ç”Ÿç‰©è—¥å“ã€‚ã€ŒåŸºå› </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">é‡çµ„蛋白質藥å“ã€ï¼Œä¿‚æŒ‡ä»¥åŸºå› å·¥ç¨‹æ–¹æ³•ï¼Œå°‡ç”¢å“ä¹‹åŽ»æ°§æ ¸é†£æ ¸ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">é…¸ (DNA) 片段，藉由質體 (plasmid) 或病毒載體ç‰ï¼Œé€å…¥é© </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç•¶çš„å¾®ç”Ÿç‰©æˆ–ç´°èƒžæ ªå…§ã€‚è—‰æ¤åŸºå› 表ç¾å‡ºè›‹ç™½è³ªï¼Œå†ç¶“ç”±èƒå–åŠ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">純化ç²å¾—所需之產å“ã€‚æœ¬æº–å‰‡æ‰€ç¨±ä¹‹ã€Œå–®æ ªæŠ—é«”è—¥å“ã€ï¼Œä¿‚指經 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç”±ç´”æ ªèžåˆç˜¤ç´°èƒž (hybridomas) 產生之完整å…ç–«çƒè›‹ç™½åŠå…¶ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è¡ç”Ÿç‰©ã€‚ </span></pre><pre><span style="font-family: 標楷體;">ç¬¬äºŒæ¢ åŸºå› å·¥ç¨‹è—¥å“應檢附之資料： </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 åŸºå› å·¥ç¨‹åŽŸæ–™è—¥ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 種批系統ã€ç´°èƒžåº«èˆ‡åŽŸæ–™ä¹‹ç®¡åˆ¶ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">三 åŸºå› å·¥ç¨‹åŽŸæ–™è—¥çš„è£½ç¨‹ç®¡åˆ¶è³‡æ–™ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å›› å°ç…§æ¨™æº–å“∕血清組 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">五 åŸºå› å·¥ç¨‹åŽŸæ–™è—¥çš„è¦æ ¼åŠåˆ†æžæ–¹æ³• </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å… åŸºå› å·¥ç¨‹è—¥å“çš„è£½é€ åŠè¦æ ¼ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">七 åŸºå› å·¥ç¨‹è—¥å“試驗ä¸çš„æˆå“ï¼åŠ‘åž‹ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å…« 安定性資料 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ä¹ è—¥ç†åŠæ¯’性試驗資料 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一○ 藥物動力å¸è³‡æ–™ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一一 è‡¨åºŠä½¿ç”¨æ–‡ç» </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一二 其他 </span></pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸‰æ¢ åŸºå› å·¥ç¨‹åŽŸæ–™è—¥ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŸºå› å·¥ç¨‹åŽŸæ–™è—¥çš„å®šç¾©ç‚ºå°šæœªé…æ–¹èª¿è£½çš„æ´»æ€§åŸºå› å·¥ç¨‹é‡çµ„原料 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è—¥æˆåˆ†ã€‚原料藥應檢附的資料如下： </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 原料藥的說明；應包括 (但ä¸é™æ–¼) ä¸‹åˆ—é …ç›®ï¼šåŒ–å¸æ§‹é€ ， </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åˆç´šåŠæ¬¡å–®å…ƒæ§‹é€ ，分åé‡ï¼Œåˆ†åå¼ï¼Œæ³•å®šå稱 (如：US</span></pre><pre><span style="font-family: 標楷體;"> Adopted Name USAN </span><span style="font-family: 標楷體;">ç‰) ，抗體類型ï¼æ¬¡é¡žåž‹ç‰ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 原料藥的特性åŠçµæ§‹èªªæ˜Žï¼šæ‡‰æ供原料æˆåˆ†åŠæ¨™æº–å“çš„ç‰©ç† </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">化å¸ç‰¹æ€§ä»¥åŠæ‰¹æ¬¡ç®¡åˆ¶è³‡æ–™ (詳見ä¸è¯è—¥å…¸é™„錄) 。 </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) 原料藥的鑑別ã€ç´”度ã€å®‰å®šæ€§å’Œè£½ç¨‹ä¸€è‡´æ€§çš„測試，以確 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ä¿ç”Ÿç”¢åŠç´”化éŽç¨‹ä¹‹ä¸€è‡´æ€§ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) 化å¸ç‰¹æ€§è©¦é©—ã€è£½ç¨‹ç®¡åˆ¶ä»¥åŠæœ€çµ‚產å“試驗，例如： </span></pre><pre><span style="font-family: 標楷體;"> 1 </span><span style="font-family: 標楷體;">胺基酸組æˆï¼š </span></pre><pre><span style="font-family: 標楷體;"> 2 </span><span style="font-family: 標楷體;">部份胺基酸åºåˆ—分æžï¼š </span></pre><pre><span style="font-family: 標楷體;"> 3 </span><span style="font-family: 標楷體;">胜 圖èœï¼š </span></pre><pre><span style="font-family: 標楷體;"> 4 </span><span style="font-family: 標楷體;">分åé‡ä¹‹æ¸¬å®šï¼š </span></pre><pre><span style="font-family: 標楷體;"> 5 </span><span style="font-family: 標楷體;">é¸æ®–åŸºå› ä¹‹æ»¯ç•™ (cloned-gene retention)： </span></pre><pre><span style="font-family: 標楷體;"> 6 </span><span style="font-family: 標楷體;">總蛋白質： </span></pre><pre><span style="font-family: 標楷體;"> 7 </span><span style="font-family: 標楷體;">醣類之測定： </span></pre><pre><span style="font-family: 標楷體;"> 8 </span><span style="font-family: 標楷體;">化å¸ç´”度： </span></pre><pre><span style="font-family: 標楷體;"> 9 </span><span style="font-family: 標楷體;">宿主細胞è¡ç”Ÿæ€§è›‹ç™½è³ªã€DNA 之分æžï¼š </span></pre><pre><span style="font-family: 標楷體;"> 10 </span><span style="font-family: 標楷體;">å…疫化å¸åˆ†æžï¼š </span></pre><pre><span style="font-family: 標楷體;"> 11 </span><span style="font-family: 標楷體;">ç”Ÿç‰©è² è·é‡ï¼Œå…§æ¯’ç´ ä¹‹å®šé‡åˆ†æžæ³•ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">三 å°æ–¼å‡ºç¾è½‰è¯å¾Œä¿®é£¾çš„蛋白質æˆåˆ† (如醣基化ã€ç¡«é…¸åŒ–ã€ç£· </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">酸化或甲醯化ç‰) ，則需è¦æ›´å¤šçš„物ç†åŒ–å¸ç‰¹æ€§è³‡æ–™ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å›› èˆ‡å…¶ä»–è—¥å“ (如其他蛋白ã€æ¯’ç´ ã€æ ¸é†«æ”¾å°„性藥å“ã€æ ¸é…¸æˆ– </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">化å¸å“ç‰) çµåˆçš„產物，需è¦æ›´å¤šçš„物ç†åŒ–å¸ç‰¹æ€§è³‡æ–™ã€‚應 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">包括產å“çµåˆæˆ–共軛éµçµçš„程度，未修飾產物的é‡ï¼Œæ¸¸é›¢ç‰© </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">的移除 (ä¾‹å¦‚æ¯’ç´ ã€æ ¸é†«æ”¾å°„性藥å“ã€é€£æŽ¥ç‰©ç‰) ，åŠä¿®é£¾ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">後產物的安定性。應說明測試方法åŠè©¦é©—çµæžœç‰è³‡æ–™ï¼Œå¦‚清 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">楚的色層分æžåœ–片ã€SDS-PAGE 或洋èœè† 電泳法圖片åŠå…‰èœ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">資料ç‰ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">五 生物活性： </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應æ出原料藥的效價 (potency) 和活性 (bioactivity)</span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">之敘述與çµæžœï¼Œä¸¦èˆ‡å°ç…§æ¨™æº–å“比å°ã€‚應說明分æžæ–¹æ³•åŠç¢º </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">效資料，包括使用的方法åŠæ¨™æº–å“ï¼Œè£½é€ æ‰¹æ¬¡é–“åŠåŒæ‰¹æ¬¡å…§ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">分æžçµæžœçš„變異性，以åŠåˆ†æžçµæžœå¯æŽ¥å—的範åœã€‚ </span></pre><pre><span style="font-family: 標楷體;">ç¬¬å››æ¢ ç¨®æ‰¹ç³»çµ±ã€ç´°èƒžåº«èˆ‡åŽŸæ–™ä¹‹ç®¡åˆ¶ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 原料åŠè©¦åŠ‘ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) æ‡‰è¡¨åˆ—æ‰€æœ‰ä½¿ç”¨æ–¼è£½é€ åŽŸæ–™èˆ‡åŠè£½å“æˆä»½ä¹‹å稱ã€æ¸¬è©¦æ–¹ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">法與è¦æ ¼ï¼Œæˆ–å…¶åƒè€ƒæ–‡ç»ã€‚å°æ–¼è³¼è²·ä¹‹åŽŸæ–™ï¼Œæ‡‰æœ‰ä¾›æ‡‰å•† </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">之分æžè‰æ˜Žèˆ‡è‡ªå®¶æª¢å®šçµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) æ‡‰è¡¨åˆ—æ‰€æœ‰ä½¿ç”¨æ–¼è£½é€ åŽŸæ–™èˆ‡åŠè£½å“之特殊試劑與æ料， </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">如培養基ã€ç·©è¡æ¶²ã€è¡€æ¸…ã€æŠ—ç”Ÿç´ ã€å–®æ ªæŠ—é«”ã€é˜²è…劑。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">在æŸäº›æƒ…形，如輔助性之生技產å“ä½¿ç”¨æ–¼åŽŸæ–™è—¥ä¹‹è£½é€ éŽ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">程 (ä¾‹å¦‚å–®æ ªæŠ—é«”ä½¿ç”¨æ–¼è¦ªå’Œæ€§è‰²å±¤åˆ†æž) ，應詳述其製 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å‚™éŽç¨‹åŠç‰¹æ€§ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">三) 動物性原料ã€è©¦åŠ‘åŠæˆåˆ†çš„ç®¡åˆ¶ï¼šè‹¥æ–¼è£½é€ éŽç¨‹ä¸æœ‰ä½¿ç”¨ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">由動物來æºå–得之原料時，需è‰æ˜Žå…¶ä¸å«å¤–來物質，如牛 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">海綿狀腦病變 Bovine Spongiform Encephalopathy (BSE</span></pre><pre><span style="font-family: 標楷體;"> ) </span><span style="font-family: 標楷體;">物質，與其他動物病毒。 </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">å››) 申請時應有ä¸å«æœ‰å¤–來物之確效資料或証明。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 æµç¨‹åœ–ï¼šæ‡‰æœ‰ä¸€ä»½å®Œæ•´è£½é€ éŽç¨‹ä¹‹æµç¨‹åœ–åŠå…¶èªªæ˜Žã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">三 製程：製程ä¸ï¼Œä¾å…¶æ料來æºä¹‹ä¸åŒï¼Œæ‡‰æœ‰å„相關之資料。 </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) å‹•ç‰©ä¾†æº </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å°æ–¼åœ¨è£½é€ éŽç¨‹ä¸æ‰€ä½¿ç”¨çš„å‹•ç‰©ï¼Œå¦‚ç”¨ä¾†è£½é€ è…¹æ°´çš„è€é¼ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ã€ç”¢ç”Ÿè¡€æ¸…抗體的兔åã€æˆ–æ˜¯åŸºå› è½‰æ®–å‹•ç‰©ï¼Œæ‡‰ä¾å¯¦éš›éœ€ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è¦è¼‰æ˜Žï¼š </span></pre><pre><span style="font-family: 標楷體;"> 1 </span><span style="font-family: 標楷體;">所使用之動物來æºå’Œç¨®é¡ž (è‹¥ç‚ºåŸºå› è½‰æ®–å‹•ç‰©ï¼Œå‰‡é ˆåŒ… </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å«å…¶è£½å‚™åŽŸç†åŠåŸºå› 穩定性)</span></pre><pre><span style="font-family: 標楷體;"> 2 </span><span style="font-family: 標楷體;">åŸºå› é‡çµ„é«”çš„è£½é€ æ–¹æ³•åŠè½‰æ®–åŸºå› å‹•ç‰©çš„åŸºå› ç©©å®šæ€§ </span></pre><pre><span style="font-family: 標楷體;"> 3 </span><span style="font-family: 標楷體;">外來物質的篩é¸èˆ‡æª¢ç–«éŽç¨‹ </span></pre><pre><span style="font-family: 標楷體;"> 4 </span><span style="font-family: 標楷體;">動物飼養之控管 </span></pre><pre><span style="font-family: 標楷體;"> 5 </span><span style="font-family: 標楷體;">ç¸é†«ç›£ç£ </span></pre><pre><span style="font-family: 標楷體;"> 6 </span><span style="font-family: 標楷體;">å°æ–¼ç‰›è£½å“é ˆè¨»æ˜Žå…¶ä¾†æº </span></pre><pre><span style="font-family: 標楷體;"> 7 </span><span style="font-family: 標楷體;">其他相關資料 (å¯åƒè€ƒä¸è¯è—¥å…¸åŠå…¶ä»–相關è¦ç¯„) 。 </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) 細胞來æºï¼š </span></pre><pre><span style="font-family: 標楷體;"> 1 </span><span style="font-family: 標楷體;">細胞å—質ã€å®¿ä¸»ç´°èƒžåŠè¼‰é«”表ç¾ç³»çµ±ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (1) </span><span style="font-family: 標楷體;">åŸºå› é‡çµ„蛋白質： </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應詳細敘述宿主細胞和載體表ç¾ç³»çµ±åŠç´°èƒžä¾†æºèˆ‡ç¨® </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">類。 </span></pre><pre><span style="font-family: 標楷體;"> (i) </span><span style="font-family: 標楷體;">宿主細胞 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應æä¾›ç”¨æ–¼ç”Ÿç”¢è£½é€ çš„å®¿ä¸»ç´°èƒžä¾†æºï¼Œç›¸é—œçš„è¡¨ç¾ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åž‹å’ŒåŸºå› åž‹ä¹‹èªªæ˜Žã€‚å®¿ä¸»ç´°èƒžç‰¹æ€§æ‡‰åŒ…æ‹¬è¡¨ç¾åž‹å’Œ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŸºå› åž‹æ¨™è¨˜çš„æ¸¬å®šï¼Œä»¥æ±ºå®šç´°èƒžå®‰å®šæ€§ã€ç´”åº¦å’Œé¸ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">擇性之監控。 </span></pre><pre><span style="font-family: 標楷體;"> (ii) </span><span style="font-family: 標楷體;">è¼‰å…¥åŸºå› ä¹‹ä¾†æºèˆ‡ç‰¹æ€§ï¼š </span></pre><pre><span style="font-family: 標楷體;"> A </span><span style="font-family: 標楷體;">應詳細說明æ¤å…¥å®¿ä¸»ç´°èƒžä¹‹è¼‰å…¥åŸºå› 的建構 (包 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ‹¬åŸºå› çš„ä¾†æº) 。 </span></pre><pre><span style="font-family: 標楷體;"> B </span><span style="font-family: 標楷體;">æ‡‰èªªæ˜Žè¼‰å…¥åŸºå› çš„è£½å‚™æ–¹æ³•ï¼Œä¸¦åŒ…æ‹¬å…¶é™åˆ¶ 切 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">割圖。 </span></pre><pre><span style="font-family: 標楷體;"> C </span><span style="font-family: 標楷體;">應æä¾›è¼‰å…¥åŸºå› çš„ç·¨ç¢¼å€åŸŸåŠè¡¨ç¾è¼‰é«”的外緣控 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">制å€åŸŸ (flanking control regions) ä¹‹æ ¸ é…¸ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åºåˆ—分æžã€‚轉è¯å¾Œä¹‹èƒºåŸºé…¸åºåˆ—，以åŠæ‰€æœ‰é‡è¦ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åºåˆ—特性鑑定之說明。 </span></pre><pre><span style="font-family: 標楷體;"> (iii) </span><span style="font-family: 標楷體;">載體 (Vector) 的建構： </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ‡‰èªªæ˜Žè¼‰é«”çš„åŸºå› æ§‹é€ ï¼Œæ‡‰åŒ…æ‹¬è¼‰é«”çµ„æˆéƒ¨ä»½ä¹‹ä¾† </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æºå’ŒåŠŸèƒ½ï¼Œå¦‚è¤‡è£½ä¹‹èµ·å§‹é»žï¼ŒæŠ—ç”Ÿç´ è€å—åŸºå› ï¼Œå•Ÿ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å‹•åŸºå› åºåˆ—ï¼Œå¢žå¼·åŸºå› åºåˆ—。並應æä¾›é™åˆ¶ 切割 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">圖。é™åˆ¶ åˆ‡å‰²åœ–è‡³å°‘æ‡‰æ¨™ç¤ºå»ºæ§‹åŸºå› è¼‰é«”çš„é™åˆ¶ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">切割點。並應該指出生產細胞特性鑑定化之é‡è¦ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŸºå› æ¨™è¨˜ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (iv) </span><span style="font-family: 標楷體;">åŸºå› æœ€çµ‚è¼‰å…¥é«”çš„å»ºæ§‹ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ‡‰åŒ…æ‹¬è¼‰å…¥åŸºå› ã€è¼‰é«”æˆ–å…¶ä»–åŸºå› ç‰ï¼Œé€æ¥è£½å‚™æˆ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŸºå› æœ€çµ‚è¼‰å…¥é«”çš„æ•˜è¿°åŠé™åˆ¶ 切割圖。圖上應至 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å°‘æŒ‡å‡ºåŸºå› æœ€çµ‚è¼‰å…¥é«”ä¹‹åˆ‡å‰²é»žã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (v) </span><span style="font-family: 標楷體;">é‡çµ„ç´°èƒžæ ªä¹‹é¸æ®–åŠå»ºç«‹ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應該æä¾›å°‡åŸºå› æœ€çµ‚è¼‰å…¥é«”å¼•é€²å®¿ä¸»çš„æ–¹æ³•ï¼Œå‚³é€ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">çš„æ©Ÿåˆ¶ï¼Œå¼•é€²åŸºå› çš„æ•¸ç›® (copy numbers) ，åŠåŸº </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å› æœ€çµ‚è¼‰å…¥é«”åœ¨å®¿ä¸»ç´°èƒžå…§çš„ä½ç½® (如嵌入染色體 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">或é¡å¤–染色體的ä½ç½®) ã€‚æ‡‰èªªæ˜ŽåŸºå› æœ€çµ‚è¼‰å…¥é«”ä¹‹ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">增殖與表ç¾çš„效率，é‡çµ„細胞的é¸æ“‡ï¼ŒåŠç¨®ç´°èƒžåº« </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">的建立。 </span></pre><pre><span style="font-family: 標楷體;"> (2) </span><span style="font-family: 標楷體;">å–®æ ªæŠ—é«”.</span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">èªªæ˜Žå–®æ ªæŠ—é«”çš„ç™¼å±•ï¼ŒåŒ…æ‹¬æ¯ç´°èƒžçš„特性，人類細胞 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ供者的æ·å²ï¼Œå…疫原，無é™å¢žç”ŸåŒ–çš„éŽç¨‹ï¼Œç¯©é¸ï¼Œ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŠç´°èƒžé¸æ®–çš„éŽç¨‹ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> 2 </span><span style="font-family: 標楷體;">種批系統 (seed lot system)： </span></pre><pre><span style="font-family: 標楷體;"> (1) </span><span style="font-family: 標楷體;">åŸºå› å·¥ç¨‹è—¥å“之原料管制應符åˆã€Œç¨®æ‰¹ç³»çµ±ã€ä¹‹è¦æ±‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">，建立細胞庫，目的在確ä¿ç”Ÿç”¢ä¸æœ‰è¶³å¤ 且åŒå“質的 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç”Ÿç”¢æ ªé‹ç”¨ï¼ŒåŠæ¯ä¸€æ‰¹ (Lot) 產å“之å“質相åŒã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (2) </span><span style="font-family: 標楷體;">å¤§éƒ¨ä»½çš„ç”Ÿç”¢æ ªéƒ½æ˜¯ç¶“ç”±äººå·¥ç¯©æª¢æˆ–åŸºå› é‡çµ„ç‰æŠ€è¡“ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">所得到的æˆæžœã€‚在é 備細胞庫å‰å¿…é ˆç¢ºå®šæ¤ç”Ÿç”¢æ ªæœ‰ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç©©å®šçš„åŸºå› ï¼Œä½¿è©²æ ªèƒ½å¤ ç©©å®šçš„è£½é€ æ‰€éœ€çš„ç”¢å“。也 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">就是說在大é‡ç”Ÿç”¢æ™‚或在多代的ç¹æ®–後，ä»ç„¶èƒ½ç©©å®š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è£½é€ æ‰€éœ€çš„ç”¢å“。 </span></pre><pre><span style="font-family: 標楷體;"> (3) </span><span style="font-family: 標楷體;">通常一個種細胞庫ä¿å˜æœ‰ 100-300 å€‹ç¨®æº (Seed</span></pre><pre><span style="font-family: 標楷體;"> Unit) </span><span style="font-family: 標楷體;">，由最原始的細胞所ç¹æ®–而æˆã€‚å†ç”±ç¨®ç´°èƒžåº« </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ä¸çš„一個單ä½ï¼Œç¶“ç¹æ®–製æˆç”± 100-200 細胞æºçµ„æˆ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">的工作細胞庫。æ¯ä¸€å€‹åˆ°å…©å€‹å·¥ä½œç´°èƒžåº«å°‡ä½œç‚ºå°‡ä¾† </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">大é‡ç”Ÿç”¢æ™‚的種æºã€‚申請者應ä¾ç´°èƒžåŸ¹é¤Šçš„表ç¾ç‹€æ³ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">來訂定生產時所能é”到的最高細胞複製繼代數。 </span></pre><pre><span style="font-family: 標楷體;"> (4) </span><span style="font-family: 標楷體;">è£½é€ æ™‚å¿…éœ€ä½¿ç”¨ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ä¹‹å®¿ä¸»-載體複åˆé«” (</span></pre><pre><span style="font-family: 標楷體;"> host-vector combination) </span><span style="font-family: 標楷體;">且經確效之種批系統(</span></pre><pre><span style="font-family: 標楷體;"> seed lot system) </span><span style="font-family: 標楷體;">ä½œç‚ºè£½é€ ä¹‹åŸºç¤Žã€‚è©²ç¨®æ‰¹ç³»çµ±åŒ… </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å«è¡ç”Ÿè‡ªå®¿ä¸»ï¼è¼‰é«”複åˆé«”之主種批 (master seed</span></pre><pre><span style="font-family: 標楷體;"> lot) </span><span style="font-family: 標楷體;">的種細胞庫 (master cell bankï¼›MCB) åŠå·¥ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">作細胞庫 (working cell bankï¼›WCB) 。其相關培養 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ã€èƒå–與純化之éŽç¨‹ä»¥åŠè£½é€ 批次之界定應建立並詳 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">述之。 </span></pre><pre><span style="font-family: 標楷體;"> (i) </span><span style="font-family: 標楷體;">種細胞庫 (Master Cell Bank; MCB)</span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">種細胞庫指å«æœ‰ç‰¹å®šåŸºå› 與表ç¾è¼‰é«”轉殖的第一代 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">細胞å‡è³ªæ‡¸æµ®æ¶²ï¼Œä»¥ç‰é«”ç©åˆ†è£è‡³å€‹åˆ¥å®¹å™¨ä¸ä¿å˜ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">如於液態氮ä¸) 。在æŸäº›æƒ…æ³ä¸‹ï¼Œå¾—分別建立表 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç¾è¼‰é«”與宿主細胞的å„自種細胞庫。 </span></pre><pre><span style="font-family: 標楷體;"> A </span><span style="font-family: 標楷體;">應詳述種細胞庫之製備åŠæ¸¬è©¦ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> B </span><span style="font-family: 標楷體;">應詳述種細胞庫建立日期，細胞庫å˜é‡ï¼Œç®¡åˆ¶æ–¹ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">法åŠå„²å˜æ¢ä»¶ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> C </span><span style="font-family: 標楷體;">應說明用於鑑定種細胞庫的é©ç•¶è¡¨ç¾åž‹æ¨™è¨˜ (例 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">如型態，åŒåŠŸ ) ç‰ç‰¹æ€§çµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> D </span><span style="font-family: 標楷體;">種細胞庫å°æ–¼å…§ç”Ÿæ€§åŠå¤–來物 (例如 Murine r-</span></pre><pre><span style="font-family: 標楷體;"> etroviruses </span><span style="font-family: 標楷體;">，Epstein-Barr virus，黴漿èŒï¼Œ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç´°èŒï¼Œéœ‰èŒï¼Œå…¶ä»–病毒和ï¼æˆ–類似病毒顆粒) çš„ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">測試。 </span></pre><pre><span style="font-family: 標楷體;"> (ii) </span><span style="font-family: 標楷體;">工作細胞庫 (Manufacture Working Cell Bank;</span></pre><pre><span style="font-family: 標楷體;"> MWCB </span><span style="font-family: 標楷體;">或 Working Cell Bank; WCB) 工作細胞庫 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">指來自種細胞庫且在有é™ç¹¼ä»£æ•¸ (finite passage</span></pre><pre><span style="font-family: 標楷體;"> level) </span><span style="font-family: 標楷體;">培養下之å‡è³ªæ‡¸æµ®æ¶²ï¼Œä»¥ç‰é‡é«”ç©åˆ†è£è‡³ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">個別容器ä¸ä¿å˜ (如於液態氮ä¸) 。 </span></pre><pre><span style="font-family: 標楷體;"> A </span><span style="font-family: 標楷體;">應詳述工作細胞庫的製備åŠæ¸¬è©¦ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> B </span><span style="font-family: 標楷體;">應詳述工作細胞庫的建立日期，細胞庫數é‡ï¼Œç”± </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">種細胞庫å€å¢žçš„細胞代數åŠå„²å˜æ¢ä»¶ã€‚若沒有種 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">細胞庫，應æ出工作細胞庫的特性çµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">＊上述二種細胞庫以相åŒæ–¹å¼ä¿å˜ï¼Œä¸€æ—¦å°‡å…¶è‡ªå„²å˜ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">處å–出，å³ä¸å†æ”¾å›žã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (iii) </span><span style="font-family: 標楷體;">最終生產細胞 (Maximum End-of-Production Cel-</span></pre><pre><span style="font-family: 標楷體;"> ls, MEPC </span><span style="font-family: 標楷體;">或 End of Production Cell, EPC) 最 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">終生產細胞係指於組織培養或醱酵採收或終æ¢ç´°èƒž </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">培養時的細胞。 </span></pre><pre><span style="font-family: 標楷體;"> A </span><span style="font-family: 標楷體;">需說明最終生產細胞的特性，åŠå…¶ç”Ÿé•·æ™‚能顯示 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">安定性的生產系統。 </span></pre><pre><span style="font-family: 標楷體;"> B </span><span style="font-family: 標楷體;">需包括最終生產細胞之表ç¾åž‹æˆ–åŸºå› åž‹æ¨™è¨˜ä»¥è¨¼ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">實其特性和純度之分æžçµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> C </span><span style="font-family: 標楷體;">應包å«ç”¨ä»¥æ”¯æŒæœ€çµ‚生產細胞沒有污染外來物的 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">測試çµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> 3 </span><span style="font-family: 標楷體;">細胞的培養åŠæŽ¡æ”¶ (harvest)</span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">需說明細胞接種，培養åŠæŽ¡æ”¶çš„éŽç¨‹ï¼ŒåŸ¹é¤ŠåŸºçš„組æˆï¼Œ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">準備的器æåŠæ»…èŒæ–¹å¼ï¼ŒåŸ¹é¤ŠåŸºçš„æ»…èŒåŠé˜²æ¢å¤–來物污 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">染發酵的éŽç¨‹ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (1) </span><span style="font-family: 標楷體;">å°æ–¼ç´°èƒžåŸ¹é¤Šæ‡‰èªªæ˜Žï¼šæŽ¥ç¨®åŠåŸ¹é¤Šç”Ÿç”¢çš„æ¢ä»¶åŠæ‰¹æ¬¡ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">的大å°ï¼Œè‹¥æœ‰ä¸åŒï¼Œå‰‡æ‡‰èªªæ˜Žã€‚æ“作éŽç¨‹åŠè£½ç¨‹ç®¡åˆ¶ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應包括：é©ç•¶çš„æ“作åŠç®¡åˆ¶åƒæ•¸ (如：醱酵時間，細 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">胞å€å¢žæ™‚間，細胞培養純度，細胞å˜æ´»çŽ‡ï¼Œé…¸é¹¼åº¦ï¼Œ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二氧化碳ç‰å€¼) 的建立。若蛋白質生產需è¦èª˜ç™¼ï¼Œä¹Ÿ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應æ供誘發æ¢ä»¶å’Œä½¿ç”¨çš„管制。 </span></pre><pre><span style="font-family: 標楷體;"> (2) </span><span style="font-family: 標楷體;">å°æ–¼å°‡ç”Ÿç”¢åŽŸæ–™è—¥ä¹‹ç´°èƒžé‡‹æ”¾è‡³ç’°å¢ƒæ™‚，所採å–çš„ç´° </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">胞去活化éŽç¨‹äº¦æ‡‰åŠ 以說明。 </span></pre><pre><span style="font-family: 標楷體;"> (3) </span><span style="font-family: 標楷體;">若細胞培養的上清液或細胞離心沈澱物在使用å‰ç¶“éŽ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">儲å˜ï¼Œé ˆæ出儲è—期的安定性資料。在單一å€åŸŸå…§è¶… </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">éŽä¸€ç¨®ç´°èƒžæ ªçš„æ“作或任何器æ有超éŽä¸€ç¨®ä»¥ä¸Šçš„ç´° </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">èƒžæ ªä½¿ç”¨æ™‚é ˆæŒ‡å‡ºï¼Œä¸¦èªªæ˜Žé˜²æ¢äº¤å‰æ±¡æŸ“çš„éŽç¨‹ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">三) 純化åŠå¾ŒçºŒçš„處ç†éŽç¨‹ </span></pre><pre><span style="font-family: 標楷體;"> 1 </span><span style="font-family: 標楷體;">需詳述純化åŠå¾ŒçºŒçš„處ç†éŽç¨‹ï¼ŒåŒ…括é¸ç”¨æ–¹æ³•çš„åˆç†æ€§ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">，åŠé˜²æ¢æ±¡æŸ“或阻絕交å‰æ±¡æŸ“的措施。應說明製程ä¸å° </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç”Ÿç‰©è² è·åŠå…§æ¯’ç´ é™åˆ¶çš„管制ã€æ–¹æ³•ç¢ºæ•ˆåŠæ‰¹æ¬¡åˆæ ¼æ¢ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">件。 </span></pre><pre><span style="font-family: 標楷體;"> 2 </span><span style="font-family: 標楷體;">å°æ–¼å…±åŒä½¿ç”¨å€åŸŸåŠè¨å‚™æ‡‰èªªæ˜Žç”¨ä¾†éš”離或防æ¢äº¤å‰æ±¡ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">染的管制。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å›› 批次記錄：應æ出一完整原料藥生產éŽç¨‹çš„代表性批次記錄 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">。 </span></pre><pre><span style="font-family: 標楷體;">ç¬¬äº”æ¢ åŸºå› å·¥ç¨‹åŽŸæ–™è—¥çš„è£½ç¨‹ç®¡åˆ¶è³‡æ–™ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 製程管制的資料：應æä¾›éŽç¨‹ä¸ç®¡åˆ¶æ–¹æ³•çš„敘述，例如與醱 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">酵培養，採收åŠåŠ 工的方法。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 製程確效的資料：應æä¾›ç¢ºæ•ˆè³‡æ–™ã€‚è‹¥å› é‡ç”¢è€Œæ”¹è®Šè£½ç¨‹ (</span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">如醱酵éŽç¨‹ä¹‹æ”¹è®Š) ï¼Œå‰‡é ˆæ出å†ç¢ºæ•ˆçš„資料åŠçµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) 細胞培養åŠæŽ¡æ”¶éŽç¨‹çš„ç¢ºæ•ˆç ”ç©¶ï¼šæ‡‰èªªæ˜Žè£½ç¨‹ç®¡åˆ¶ä¹‹ç¢ºæ•ˆ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">資料ã€é‡è¦åƒæ•¸åŠè‰æ˜Žæ–‡ä»¶ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) 純化éŽç¨‹çš„ç¢ºæ•ˆç ”ç©¶ï¼šèªªæ˜Žç§»é™¤å¤–ä¾†ç‰© (如：管柱污染物 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ï¼Œå…§æ¯’ç´ ã€æŠ—ç”Ÿç´ ã€å®¿ä¸»è›‹ç™½è³ªã€DNA ã€åŠç—…毒ç‰) åŠç´” </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">化éŽç¨‹çš„確效åŠè‰æ˜Žã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">三 æ»…èŒåŠç„¡èŒæ“作éŽç¨‹ï¼šæ‡‰ç„¡å¾®ç”Ÿç‰©ä¹‹æ±¡æŸ“ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) 確ä¿å…§å®¹ç‰©ä¸å—污染或交å‰æ±¡æŸ“的方法 </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) 製程ä¸å¾®ç”Ÿç‰©è² è·é‡èˆ‡å…§æ¯’ç´ çš„é™åº¦ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">三) 執行無èŒåˆ†è£ (Sterilization Fill)</span></pre><pre><span style="font-family: 標楷體;">第å…æ¢ å°ç…§æ¨™æº–å“∕血清組： </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 å°ç…§æ¨™æº–å“：如使用國際å°ç…§æ¨™æº–å“ (WHO ，NIBSC) 或藥 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å…¸å°ç…§æ¨™æº–å“ (如ä¸è¯è—¥å…¸ã€USP ç‰) ï¼Œé ˆæª¢é™„è©²æ¨™æº–å“之 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è¦æ ¼èˆ‡åˆ†æžæˆç¸¾æ›¸ã€‚若國際上尚無生物效價或化å¸å°ç…§æ¨™æº– </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å“，申請者å¯è‡ªè¡Œå»ºç«‹å» 內一級å°ç…§æ¨™æº–å“ã€‚ä½†é ˆæª¢é™„è©²å° </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">照標準å“之製備標準作æ¥éŽç¨‹ã€ç‰¹æ€§ã€è¦æ ¼ã€åˆ†æžæˆç¸¾æ›¸åŠ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">安定性數據。並附上測試çµæžœï¼Œä¾‹å¦‚標準å“的物ç†åŒ–å¸ã€ç”Ÿ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">物活性測定åŠåˆ†æžè¨¼æ˜Žæ›¸ã€‚若有使用åˆæ ¼çš„æ–°å°ç…§æ¨™æº–å“， </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">則應æ供該標準å“之安定性資訊。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 å» å…§å·¥ä½œæ¨™æº–å“ï¼šå» å…§å·¥ä½œæ¨™æº–å“é ˆæª¢é™„å…¶è£½å‚™ã€ç‰¹æ€§ã€è¦ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ ¼ã€è©¦é©—åŠçµæžœã€‚äº¦æ‡‰æª¢é™„è©²å» å…§å·¥ä½œæ¨™æº–å“以å‰è¿°å°ç…§æ¨™ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">準å“æ‰€æ ¡æ£ä¹‹æ•¸æ“šã€‚並應附上以主è¦æ¨™æº–å“為å°ç…§ä¹‹å» 內工 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">作標準å“æ ¡æ£è³‡æ–™ã€‚ </span></pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸ƒæ¢ åŸºå› å·¥ç¨‹åŽŸæ–™è—¥çš„è¦æ ¼åŠåˆ†æžæ–¹æ³•ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 原料藥è¦æ ¼åŠæ¸¬è©¦ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) 應敘述原料藥之放行測試ã€è²¯æž¶æœŸã€è¦æ ¼åŠåˆ†æžæ–¹æ³•ã€‚應 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æå‡ºè¶³ä»¥ç¢ºå®šå…¶åŽŸæ–™è—¥é‘‘åˆ¥ï¼Œç´”åº¦ï¼Œæ•ˆåƒ¹åŠ (或) 力價之 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è¦æ ¼èˆ‡æ¸¬è©¦æ³•ï¼Œä»¥åŠæ¯æ‰¹ç”¢å“間的一致性資料。å°æ–¼éžè—¥ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">典之方法，應æ供分æžä¹‹ç¢ºæ•ˆï¼Œä»¥é¡¯ç¤ºå…¶å¯é©ç”¨æ€§ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) 分æžè‰æ˜Žæ›¸åŠåˆ†æžçµæžœ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應附上至少連續三批å“管的原料藥分æžè‰æ˜Žæ›¸åŠçµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 ä¸ç´”ç‰©ä¹‹å½¢å¼ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應附上分æžè³‡æ–™ï¼ŒåŒ…æ‹¬è›‹ç™½è³ªåŽŸæ–™è—¥ä¹‹è®Šç•°é«”å½¢å¼ (例如： </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">切割ã€èšé›†ã€åŽ»èƒºã€æ°§åŒ–ç‰) ，åŠéžç”¢å“相關之ä¸ç´”物 (例 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å¦‚åŠ å·¥éŽç¨‹è©¦åŠ‘åŠç´°èƒžåŸ¹é¤Šçµ„æˆ) 。 </span></pre><pre><span style="font-family: 標楷體;">ç¬¬å…«æ¢ åŸºå› å·¥ç¨‹è—¥å“çš„è£½é€ åŠè¦æ ¼ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應æ出藥å“之處方æˆåˆ†åŠçµ„æˆã€å–®ä½åŠ‘é‡å’Œæ‰¹æ¬¡é‡ï¼Œä»¥åŠæœ€çµ‚產 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å“之è¦æ ¼ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 è—¥å“æˆä»½çš„è¦æ ¼åŠæ–¹æ³• </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) 包括所有活性æˆä»½å’Œè¼”助æˆä»½ä¹‹åŽŸæ–™è—¥ã€‚應æ供所有活性 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æˆåˆ†æ¸¬è©¦åŠè¦æ ¼çš„敘述，åŠè¼”助性產å“çš„è¦æ ¼ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) 賦形劑：所有賦形劑的資訊。 </span></pre><pre><span style="font-family: 標楷體;"> 1 </span><span style="font-family: 標楷體;">藥典的賦形劑：應列出賦形劑引用藥典的出處。 </span></pre><pre><span style="font-family: 標楷體;"> 2 </span><span style="font-family: 標楷體;">éžè—¥å…¸ä¸Šçš„賦形劑：應說明測試方法åŠè¦æ ¼ã€‚å°æ–°è³¦å½¢ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">劑，應說明其製備，特性和管制。å°æ–¼ä¸å…·æ´»æ€§çš„人體 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">或動物來æºä¹‹æˆä»½ï¼Œæ‡‰æ供測試çµæžœæˆ–確效資料，以顯 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">示沒有外來物之污染。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 è£½é€ è€…ï¼šæ‡‰æä¾›æ‰€æœ‰è£½é€ å•†çš„å稱與地å€ã€‚包括原料 (委託 </span></pre><pre><span style="font-family: 標楷體;"> ) </span><span style="font-family: 標楷體;">è£½é€ åŠæª¢é©—ç‰ï¼Œä¸¦æ‡‰æ•˜è¿°å…¶è²¬ä»»æ¸å±¬ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">三 è£½é€ åŠåŒ…è£æ–¹æ³• </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應æ供完整敘述原料藥é…方和æˆå“之é‡ç”¢è£½é€ éŽç¨‹æµç¨‹åœ–。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">說明滅èŒæ“作ã€ç„¡èŒè™•ç†ã€å†·å‡ä¹¾ç‡¥åŠåŒ…è£éŽç¨‹ã€‚æµç¨‹åœ–應 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">指出生產éŽç¨‹ã€è£½ç¨‹ç®¡åˆ¶å’Œæ¸¬è©¦çµæžœï¼Œç‰©æµåŠäººæµæ–¹å‘與無 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">èŒæ“作ç‰æ•˜è¿°ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å›› è—¥å“è¦æ ¼èˆ‡æ¸¬è©¦æ–¹æ³• </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">一) å–樣éŽç¨‹ï¼šåŒ…括監控æ¯æ‰¹æˆå“的採樣éŽç¨‹ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> (</span><span style="font-family: 標楷體;">二) è¦æ ¼åŠæ¸¬è©¦æ–¹æ³•ï¼šéœ€æ出特性鑑定ã€ç´”度ã€æ•ˆåƒ¹å’Œï¼æˆ–力 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">價測試方法的敘述，以åŠæ¯æ‰¹æˆå“間的一致性åŠæˆå“使用 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è¦æ ¼ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> 1 </span><span style="font-family: 標楷體;">æ供至少連續三批æˆå“的分æžè¨¼æ˜Žæ›¸åŠåˆ†æžçµæžœã€‚ </span></pre><pre><span style="font-family: 標楷體;"> 2 </span><span style="font-family: 標楷體;">應æä¾›éžè—¥å…¸æ¸¬è©¦æ³•ä¹‹ç¢ºæ•ˆè³‡æ–™ã€‚ </span></pre><pre><span style="font-family: 標楷體;">第ä¹æ¢ åŸºå› å·¥ç¨‹è—¥å“試驗ä¸çš„æˆå“ï¼åŠ‘åž‹ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應æ出藥å“é…æ–¹ï¼Œè£½é€ éŽç¨‹ï¼Œä¸åŒé»žçš„臨床試驗所使用的物質和 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">商æ¥åŒ–é‡ç”¢çš„原料藥和藥å“批次之間的差異性。如有差異性，應 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">完整的敘述這些差異性。如果試驗ä¸çš„藥物劑型是ä¸åŒæ–¼å³å°‡ä¸Š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">市的æˆå“，如é©ç•¶çš„話，應該æ供用以支æŒäºŒç¨®åŠ‘åž‹çš„ç”Ÿç‰©ç›¸ç‰ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">性和ï¼æˆ–藥物動力相ç‰æ€§çš„æ¯”è¼ƒè³‡æ–™ã€‚å¦‚æžœè£½é€ éŽç¨‹å’Œï¼æˆ–地點 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">是ä¸åŒï¼Œæ‡‰æ出以é©åˆ‡çš„測試，來評估比較試驗ä¸å’Œå•†æ¥åŒ–的產 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å“資料。 </span></pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸€â—‹æ¢ åŸºå› å·¥ç¨‹ç”¢å“的安定性試驗資料：應敘述該產å“之安定性以訂 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">定其儲è—æ¢ä»¶èˆ‡æœ‰æ•ˆæœŸé™ï¼Œå¿…è¦æ™‚應有原料藥ã€åŠè£½å“æˆ–èª¿é… </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŽŸæ¶²åœ¨è£½é€ ã€ç‰¹å®šå„²å˜æˆ–é‹é€æ¢ä»¶ä¸‹ä¹‹å®‰å®šæ€§åŠå…¶ç¢ºæ•ˆè³‡æ–™ã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å®‰å®šæ€§è©¦é©—å ±å‘Šæ‡‰ä¾è¡Œæ”¿é™¢è¡›ç”Ÿç½²å…¬å‘Šä¹‹ã€Œè—¥å“安定性試驗準 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">則ã€å…§å®¹ç¢ºå¯¦åŸ·è¡Œï¼Œä¸¦æª¢é™„實驗方法ã€çµ±è¨ˆåˆ†æžåŠå®šé‡åˆ†æžæ–¹ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">法的確效ç‰è³‡æ–™ã€‚應包括監控生物活性åŠåˆ†è§£ç”¢ç‰©å¦‚åˆ‡å‰²ï¼Œèš </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">集，去胺，氧化形å¼çš„測試çµæžœåŠä¸é–“產å“儲å˜çš„資料。 </span></pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸€ä¸€æ¢ è—¥ç†åŠæ¯’性試驗資料 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 åŸºå› å·¥ç¨‹ç”¢å“的氨基酸åºåˆ—ã€åŠçµæ§‹ç‰çš„些微差異，å¯èƒ½ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å°ç”¢å“çš„è—¥ç†åŠæ¯’ç†ç‰ä½œç”¨ç”¢ç”Ÿé‡å¤§å½±éŸ¿ï¼Œå› æ¤éœ€è—‰é©ç•¶ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">的動物模å¼ï¼Œè§€å¯Ÿç”¢å“在活體ä¸ç”¢ç”Ÿä»»ä½•éžé 期的藥ç†ä½œ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">用，並在毒性試驗或臨床試驗時觀察æ¤è—¥ç†ä½œç”¨ã€‚è—¥å“之 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è—¥ç†åŠæ¯’性試驗應符åˆè¡Œæ”¿é™¢è¡›ç”Ÿç½²åˆ¶å®šä¹‹ã€Œè—¥å“éžè‡¨åºŠ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">試驗安全性è¦ç¯„ã€çš„內容。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 由於生物技術åŠåˆ†å生物å¸çš„çªé£›çŒ›é€²ï¼Œåœ‹ç§‘會已修訂「 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŸºå› é‡çµ„實驗準則ã€ã€‚將實驗室防è·åˆ†ç‚º P1 ã€P2ã€P3〠</span></pre><pre><span style="font-family: 標楷體;"> P4 </span><span style="font-family: 標楷體;">四個ç‰ç´šï¼Œä¸¦è¦æ±‚æˆç«‹ç”Ÿç‰©å¯¦é©—安全委員會。P1 ç´š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">是å±éšªæ€§ä½Žçš„åŸºå› é‡çµ„實驗，與一般微生物實驗室相åŒç‰ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç´šï¼›P2 則是較å±éšªæ€§çš„åŸºå› é‡çµ„實驗，其病原微生物如 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">沙門æ°èŒç‰ã€‚至於 P3 級指把å±éšªæ€§é«˜ç—…毒當載體，如狂 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">çŠ¬ç—…æ¯’ç‰ 21 種；P4 級指å±éšªæ€§æœ€é«˜çš„病毒如伊波拉病 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ¯’ç‰ 14 種。為了è½å¯¦åŸºå› é‡çµ„å¯¦é©—æº–å‰‡ï¼Œç›¸é—œåœ˜é«”æ‡‰è¨ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">置生物實驗安全委員會，定期監ç£æŸ¥æ ¸ã€‚ </span></pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸€äºŒæ¢ è—¥ç‰©å‹•åŠ›å¸è³‡æ–™ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŸºå› é‡çµ„蛋白質產å“之蛋白質修飾作用，å°è—¥å“之å¸æ”¶ã€ä»£è¬ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŠç™‚效有é‡è¦ä¹‹å½±éŸ¿ã€‚å› æ¤åœ¨æŸ¥é©—登記申請時，ä»éœ€æ供以該 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">申請之產å“執行之藥動å¸ã€è—¥æ•ˆå¸ç‰äººé«”åŠå‹•ç‰©è³‡æ–™ä»¥ä¾›å¯©æ ¸ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">。 </span></pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸€ä¸‰æ¢ è‡¨åºŠä½¿ç”¨æ–‡ç»ï¼š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŸºå› é‡çµ„蛋白質產å“æŸ¥é©—ç™»è¨˜æ™‚ï¼Œé™¤æ‡‰æª¢é™„åœ‹å¤–è‡¨åºŠä½¿ç”¨æ–‡ç» </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">ç‰è³‡æ–™å¤–，å¦æ‡‰å†ä¾æ“šæœ¬ç½²ã€Œè—¥å“è‡¨åºŠè©¦é©—ç”³è«‹é ˆçŸ¥ã€åŠç›¸é—œ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">è¦å®šç”³è«‹åœ‹å…§ä¾›æŸ¥é©—登記用藥å“臨床試驗 (得檢附國內臨床試 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">é©—å ±å‘Šè³‡æ–™ï¼Œæˆ–åŒæ™‚檢é€åœ‹å…§è‡¨åºŠè©¦é©—計畫書，以供審查) 。 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">惟如欲å…除國內臨床試驗，則å¯ä¾æœ¬ç½²æ·æ¬¡å…除國內臨床試驗 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">å“é …ä¹‹å…¬å‘Šï¼Œæ£å¼å‘本署申請å…除國內臨床試驗。 </span></pre><pre><span style="font-family: 標楷體;">ç¬¬ä¸€å››æ¢ å…¶ä»– </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">一 æ供專利è‰æ˜Žæ–‡ä»¶ä¾›åƒï¼šç‚ºå°ˆé‡æ™ºæ…§è²¡ç”¢åŠå°ˆåˆ©æ¬Šäººä¹‹æ¬Š </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">益，申請時應å°æ™ºæ…§è²¡ç”¢åŠå°ˆåˆ©æ¬Šä¿è·è‡ªè¡Œäº†è§£èˆ‡éµå®ˆã€‚ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">二 申請者應æä¾›åŽŸé–‹ç™¼å» è‰æ˜Žæ–‡ä»¶ä¾›åƒ </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">三 容器ï¼å°è“‹ç³»çµ± </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">應說明容器åŠå°é–‰ç³»çµ±ï¼Œå’Œè—¥å“之相容性。å°æ–¼æ»…èŒç”¢å“，應 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">æ供在建è°ä¿å˜æœŸé–“容器åŠå°é–‰å®Œæ•´çš„è‰æ“šã€‚ </span></pre><pre><span style="font-family: 標楷體;">åƒè€ƒæ–‡ç»ï¼š </span></pre><pre><span style="font-family: 標楷體;">1 </span><span style="font-family: 標楷體;">ä¸è¯è—¥å…¸ç¬¬äº”版，附錄肆ã€è£½åŠ‘通則åŠä¸€èˆ¬è¦å®šå…三ã€åŸºå› 工程製劑以 </span></pre><pre><span style="font-family: 標楷體;"> </span><span style="font-family: 標楷體;">åŠ å…一ã€å–®æ ªæŠ—體製劑 </span></pre><pre><span style="font-family: 標楷體;">2 Guidance for Industry for the Submission of Chemistry, Manufa-</span></pre><pre><span style="font-family: 標楷體;"> cturing, and Controls Information for a Therapeutic Recombina-</span></pre><pre><span style="font-family: 標楷體;"> nt DNA-Derived Product or a Monoclonal Antibody Product for In</span></pre><pre><span style="font-family: 標楷體;"> Vivo Use - FDA 8/1996</span></pre>2013-12-05
化å¸è£½é€ 管制類,è—¥å“å„ªè‰¯è£½é€ ,è—¥å“å„ªè‰¯è£½é€ è¦ç¯„行政解釋藥å“å„ªè‰¯è£½é€ è¦ç¯„詳如附件2013-12-05
化å¸è£½é€ 管制類,è—¥å“å„ªè‰¯è£½é€ ,è—¥å“å„ªè‰¯è£½é€ è¦ç¯„ï¼šä¾›è£½é€ ç”¨è¡€æ¼¿åŽŸæ–™ä½œæ¥åŸºæº–行政解釋藥å“å„ªè‰¯è£½é€ è¦ç¯„-ä¾›è£½é€ ç”¨ä¹‹è¡€æ¼¿åŽŸæ–™ä½œæ¥åŸºæº–<p style="text-align: center;"><b><span style="font-family: 新細明體,serif; font-size: 16pt;">è—¥å“å„ªè‰¯è£½é€ è¦ç¯„ï¼šä¾›è£½é€ ç”¨ä¹‹è¡€æ¼¿åŽŸæ–™ä½œæ¥åŸºæº–</span></b><b> </b></p><p><span style="font-family: 新細明體,serif;">第一æ¢ã€è—¥å“å„ªè‰¯è£½é€ è¦ç¯„ï¼šä¾›è£½é€ ç”¨ä¹‹è¡€æ¼¿åŽŸæ–™ä½œæ¥åŸºæº–</span>(<span style="font-family: 新細明體,serif;">以下簡稱本基準</span>)<span style="font-family: 新細明體,serif;">，所訂定之內容係å°æ血機æºï¼Œè‡ªè¡€æ¶²æ”¶é›†ã€è™•ç†è‡³å„²å˜åŠé…é€è¡€æ¼¿ç‰éŽç¨‹æ‰€æ‡‰éµå¾ªä¹‹å„ªè‰¯è£½é€ è¦ç¯„，以確ä¿è©²ã€Œä¾›è£½é€ 用血漿ã€ä¹‹å®‰å…¨èˆ‡å“質。</span> </p><p><span style="font-family: 新細明體,serif;">第二æ¢ã€æœ¬åŸºæº–所用之專有å詞，其æ„義如下：</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€è¡€æ¶²ï¼šä¿‚指來自單一æ血者所收集之全血，</span>.<span style="font-family: 新細明體,serif;">經éµå ‚作æ¥å¾Œï¼Œå¯ä¾›è¼¸è¡€æˆ–進一æ¥è£½é€ 使用。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€å–®ä½ï¼šä¿‚指來自單一æ血者單次所收集到之全血或其æˆåˆ†è¡€ä¹‹å®¹é‡ï¼Œå…§å«æœ‰é©é‡ä¹‹æŠ—å‡è¡€åŠ‘，並標示其收集é‡ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">三ã€æˆåˆ†è¡€ï¼šä¿‚指以物ç†æˆ–機械方å¼ï¼Œè‡ªä¸€å€‹å–®ä½å…¨è¡€åˆ†é›¢å‡ºä¹‹éƒ¨åˆ†æˆåˆ†ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å››ã€è¡€æ¼¿ï¼šä¿‚指æ£å¸¸è¡€æ¶²ä¸ä¹‹æ¶²é«”æˆåˆ†ï¼Œæ‡‰å«æœ‰é©é‡ä¹‹è¡€æ¼¿è›‹ç™½è³ªæˆåˆ†ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">五ã€å›žæ”¶è¡€æ¼¿ï¼šä¿‚指經由一個單ä½å…¨è¡€åˆ†é›¢å‡ºä¹‹æˆåˆ†è¡€æ¼¿ï¼Œä¾›é€²ä¸€æ¥è£½é€ 血槳製劑之原料。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å…ã€è¡€æ¼¿åˆ†é›¢éš¸è¡“：係指æ血者之血液，經由儀器將血漿與其他血çƒä¹‹æˆåˆ†åˆ†é–‹ï¼Œä¸¦æŠŠè‡³å°‘å«ç´…è¡€çƒä¹‹æˆåˆ†è¼¸å›žåŽŸæ血者之éŽç¨‹ã€‚å¿…è¦æ™‚æ¤éŽç¨‹å¯é‡è¦†é€²è¡Œã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">七ã€åŽŸæ–™è¡€æ¼¿ï¼ˆåˆ†é›¢è¡“血漿）：係指經分離術å–得之血漿，供進一æ¥è£½é€ 血漿製劑之原料。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å…«ã€è¡€æ¼¿åŽŸæ–™åŒ…括回收血漿åŠåŽŸæ–™è¡€æ¼¿</span>(<span style="font-family: 新細明體,serif;">分離術血漿</span>)<span style="font-family: 新細明體,serif;">。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">ä¹ã€æè¡€æ©Ÿæ§‹ï¼šä¿‚æŒ‡ç¶“è¡›ç”Ÿç½²æ ¸å‡†ï¼›ä½œç‚ºå…¨è¡€æˆ–æˆåˆ†è¡€ä¹‹æ”¶é›†ã€ä½œæ¥ã€å„²å˜æˆ–é…é€åŠå…¶è»Ÿã€ç¡¬é«”作æ¥ä¹‹æ©Ÿæ§‹ï¼ŒåŒ…括國內外之æè¡€ä¸å¿ƒæˆ–血液收集機構。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">åã€ä½œæ¥ï¼šä¿‚指於血液收集之後，進行血液相容性試驗之å‰ï¼Œæ‰€é€²è¡Œä¹‹æ¥é©Ÿï¼ŒåŒ…括æ血者所ææ¯ä¸€å–®ä½è¡€æ¶²ä¹‹è˜åˆ¥ã€æˆåˆ†è¡€ä¹‹è£½å‚™ã€è¡€æ¸…å¸æª¢é©—ã€æ¨™ç¤ºèˆ‡ç›¸é—œè¨˜éŒ„之ä¿å˜ç‰ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å一ã€è¨å‚™ï¼šç”¨æ–¼è¡€æ¶²å’Œæˆåˆ†è¡€ä¹‹æ”¶é›†ã€ä½œæ¥ã€å„²å˜å’Œé…é€æ‰€éœ€ä¹‹å„€å™¨ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å二ã€æ血者：符åˆè¡›ç”Ÿç½²ã€Œæ血者å¥åº·æ¨™æº–ã€åŠç›¸é—œè¦å®šä¹‹æ血人。</span> </p><p><span style="font-family: 新細明體,serif;">第三æ¢ã€æè¡€æ©Ÿæ§‹æ‡‰ç½®è² è²¬äººä¸€ä½ï¼Œä¸¦é…ç½®è¶³å¤ ä¹‹äººå“¡ä»¥åŸ·è¡Œã€ç£å°Žè¡€æ¶²ä¹‹æ”¶é›†ã€è™•ç†ã€åŒ…è£ã€å„²å˜æˆ–é…é€ã€‚è©²è² è²¬äººåŠå“¡å·¥å‡æ‡‰å…·å‚™é©ç•¶ä¹‹å¸è˜ã€ç¶“驗，並視è·å‹™éœ€è¦æŽ¥å—åƒèˆ‡åŸ·è¡Œæœ¬åŸºæº–實務之訓練。</span> </p><p><span style="font-family: 新細明體,serif;">第四æ¢ã€è‹¥æœ‰å¯èƒ½å¼•èµ·è¡€è£½å“之å“質與安定顧慮之員工，應被排除於血液或æˆåˆ†è¡€ä¹‹æŽ¡é›†ã€è™•ç†ã€æ¸¬è©¦ã€å„²å˜åŠé…é€ç‰å·¥ä½œå ´æ‰€å¤–。</span> </p><p><span style="font-family: 新細明體,serif;">第五æ¢ã€æ血機構之å“è³ªç®¡åˆ¶éƒ¨é–€èˆ‡è£½é€ éƒ¨é–€æ‡‰åˆ†åˆ¥ç¨ç«‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…æ¢ã€æ血機構應書é¢è¨‚定員工之作æ¥è¡›ç”Ÿè¦ç¯„，並勵行之。è¦ç¯„之內容ä¸å¾—少於下列å„é …ï¼š</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€é…åˆå·¥ä½œæ€§è³ªä¹‹å®šæœŸå¥åº·æª¢æŸ¥ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€é˜²æ¢ç½¹æ‚£ç–¾ç—…或開放性創å£å“¡å·¥å°ç”¢å“之安全性或å“è³ªé€ æˆä¸è‰¯å½±éŸ¿ä¹‹æŽªæ–½ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">三ã€é€²å…¥å·¥ä½œå ´æ‰€æ™‚å¿…é ˆæ¸…æ´—æˆ–æ¶ˆæ¯’é›™æ‰‹ï¼Œä¸¦ä¸å¾—有飲食ã€æŠ½è¸ã€æˆ–其他足以妨害衛生之行為。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å››ã€é…åˆå·¥ä½œæ€§è³ªæ‡‰ç©¿æˆ´å·¥ä½œæœã€æ‰‹å¥—ç‰ä¹‹æ¨™æº–。</span> </p><p><span style="font-family: 新細明體,serif;">第七æ¢ã€æ血機構應符åˆè¡›ç”Ÿç½²ã€Œé†«ç™‚機構è¨ç½®æ¨™æº–ã€ä¹‹ã€Œæ血機構è¨ç½®æ¨™æº–表ã€åŠç›¸é—œè¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第八æ¢ã€æè¡€æ©Ÿæ§‹æ‡‰å…·æœ‰è¶³å¤ ç©ºé–“ä»¥ä¾›ä¸‹åˆ—éœ€è¦ä½¿ç”¨ï¼š</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€å…·ç§å¯†æ€§ä¹‹æª¢æŸ¥å ´æ‰€ï¼Œä»¥æ±ºå®šæ血者是å¦åˆé©ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€å¯é™ä½Žæ血者血液被污染之風險，並é¿å…其暴露於無關之æ“作和è¨å‚™ä¸ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">三ã€å…·æœ‰ä¾›å°šæœªå®Œæˆæª¢é©—之血液或æˆåˆ†è¡€æª¢ç–«éš”離儲å˜ä¹‹å ´æ‰€ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å››ã€å°åˆé©—çµæžœæœ‰å•é¡Œä¹‹è¡€æ¶²æˆ–æˆåˆ†è¡€å…·æœ‰å¯æª¢ç–«éš”離儲å˜ä»¥å‚™è¤‡é©—ä¹‹å ´æ‰€ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">五ã€å…·æœ‰æœ€çµ‚產å“é…é€å‰å„²å˜å ´æ‰€ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å…ã€å…·æœ‰ä¾›ä¸åˆç”¨ç”¢å“和試劑隔離儲å˜ã€æ”¾ç½®ç‰å ´æ‰€ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">七ã€å…·æœ‰èƒ½é¿å…污染血液和æˆåˆ†è¡€æ”¶é›†è™•ç†ã€å„²å˜å’Œé…é€ç‰ä½œæ¥ä¹‹å ´æ‰€ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å…«ã€å…·æœ‰æ供血漿原料作æ¥ä¹‹é©åˆå ´æ‰€ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">ä¹ã€å…·æœ‰ä¾›åŒ…è£ã€æ¨™ç¤ºå’Œå…¶ä»–作æ¥æ‰€éœ€ä¹‹å ´æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第ä¹æ¢ã€æ血機構應ç¶æŒæ•´æ½”ã€‚å…¶è¡€æ¶²æ”¶é›†å ´æ‰€æ‡‰ç¶æŒæ•´æ½”ã€é€šé¢¨ã€å…‰ç·šå……足，並應有病媒防除æ¨æ–½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第åæ¢ã€æ血機構應æä¾›è¶³å¤ æ¸…æ½”æ´—æ‰‹ä¹‹è¨æ–½å’Œè¡›æµ´è¨å‚™ï¼Œæ‡‰å…·é˜²æ¢ç”±ä¸‹æ°´é“倒æµæˆ–虹å¸ä½œç”¨ä¹‹è£ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å一æ¢ã€è¡€æ¶²æ”¶é›†ä¹‹å ´æ‰€å°æ–¼å»¢æ£„物之處ç†æ‡‰å…·æœ‰é©ç•¶ä¹‹ç®¡åˆ¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å二æ¢ã€æ血機構之儀器è¨å‚™ç”¨æ–¼è¡€æ¶²å’Œæˆåˆ†è¡€ä¹‹æ”¶é›†ã€å„²å˜å’Œé…é€æ‡‰ç¶æŒæ•´é½Šã€</span>.<span style="font-family: 新細明體,serif;">清潔，並置放於容易清洗和ç¶è·ä¹‹åœ°é»žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å三æ¢ã€æ血機構之儀器è¨å‚™æ‡‰ä¾æ¨™æº–æ“作程åºé€²è¡Œæ¸…潔或消毒滅èŒã€å®šæœŸæª¢æŸ¥æ ¡æ£ã€ç¶è·ä¿é¤Šèˆ‡ç¢ºæ•ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第åå››æ¢ã€æ血機構之滅èŒè¨å‚™æ‡‰ç¶“éŽè¨è¨ˆã€ç¶è·ä¸¦æŒ‰æ¨™æº–æ“作程åºä½¿ç”¨ä»¥ç¢ºä¿èƒ½æ¶ˆæ»…微生物。滅èŒéŽç¨‹æ‡‰é”到於飽和蒸汽下</span>121.5<span style="font-family: 新細明體,serif;">℃</span><span style="font-family: 新細明體,serif;">ç¶æŒäºŒå分é˜æˆ–乾熱</span>170<span style="font-family: 新細明體,serif;">℃</span><span style="font-family: 新細明體,serif;">二å°æ™‚所ç²å¾—之滅èŒæ•ˆæžœã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å五æ¢ã€æ血機構之所有用於血液和æˆåˆ†è¡€æ”¶é›†ã€è™•ç†ã€å„²å˜å’Œé…é€æ‰€ä½¿ç”¨ä¹‹è©¦åŠ‘åŠç›¸é—œå™¨æ，å‡æ‡‰å˜æ”¾åœ¨å®‰å…¨ã€è¡›ç”Ÿä¹‹åœ°æ–¹ä¸”應排列整齊。</span> </p><p><span style="font-family: 新細明體,serif;">第åå…æ¢ã€æ血機構之所有與輸血用血液和æˆåˆ†è¡€æŽ¥è§¸ä¹‹è¡¨é¢æ‡‰ç‚ºç„¡èŒã€ç„¡ç†±åŽŸä¸”沒有干擾產å“之安全ã€ç´”度ã€åŠ›åƒ¹èˆ‡æ•ˆèƒ½ä¹‹æƒ…事。å°éžè¼¸è¡€ç”¨ä¹‹è¡€æ¶²æˆ–æˆåˆ†è¡€ï¼Œæ‰€ä½¿ç”¨ä¹‹æœ€çµ‚容器和瓶（ç½ï¼‰è“‹æ‡‰æ¸…潔且無表é¢å›ºé«”顆粒以åŠå…¶ä»–污染物。</span> </p><p><span style="font-family: 新細明體,serif;">第å七æ¢ã€æ血機構之æ¯ä¸€è¡€æ¶²æ”¶é›†å®¹å™¨åŠå…¶å¯èƒ½ä¹‹é™„屬容器，在使用å‰ã€å¾Œå‡æ‡‰æª¢è¦–有å¦ç ´æ或污染。若充填後有密å°ç ´æ或異常變色，則連åŒå……填物å‡æ‡‰åšé©ç•¶è™•ç½®å¾Œä¸Ÿæ£„。</span> </p><p><span style="font-family: 新細明體,serif;">第åå…«æ¢ã€æ血機構之æ¯ä¸€æ‰¹æ¬¡æ‰€ä½¿ç”¨ä¹‹è©¦åŠ‘或試液，å‡æ‡‰æŠ½å–具代表性檢體，ä¾æ‰€è¨‚定之標準æ“作程åºï¼Œå®šæœŸæ¸¬è©¦å…¶æ˜¯å¦ç¬¦åˆè¦æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第åä¹æ¢ã€æ血機構使用之試劑åŠç›¸é—œè€—æ應ä¾å» 商之說明書仔細評估，並作æˆæ¨™æº–作æ¥ç¨‹åºæ›¸ï¼Œåˆ‡å¯¦åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第二åæ¢ã€æ血機構與血液接觸之物å“應無èŒä¸”儘å¯èƒ½ç‚ºæ‹‹æ£„å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第廿一æ¢ã€æ血機構之所有血液åŠæˆåˆ†è¡€è£½ç¨‹æ‡‰åˆ¶å®šæ¨™æº–作æ¥ç¨‹åºã€‚血漿之篩é¸ä½œæ¥æ‡‰ä¾è¡›ç”Ÿç½²ã€Œæ血者å¥åº·æ¨™æº–ã€åŠç›¸é—œè¦å®šåš´è¬¹åŸ·è¡Œã€‚血漿篩檢試劑應å–å¾—è¡›ç”Ÿç½²æ ¸ç™¼ä¹‹è¨±å¯è‰ï¼Œå°šç„¡è¨±å¯è‰è€…æ‡‰å…ˆè¡Œç”³è«‹è©•ä¼°ç ”ç©¶ã€‚ç‚ºæ—©æœŸé 防åŠé¿å…ä¸æ˜Žç¶“血傳染疾病之感染，衛生署得以命令管制æ血者之來æºåŠé™åˆ¶è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第廿二æ¢ã€</span>.<span style="font-family: 新細明體,serif;">å°æ–¼è¡€æ¶²ã€æˆåˆ†è¡€åŠåŽŸæ–™è¡€æ¼¿ä¹‹æ”¶é›†ã€è™•ç†ã€å„²å˜å’Œé…é€æ‡‰åˆ¶å®šæ›¸é¢æ¨™æº–作æ¥ç¨‹åºã€‚æ“作人員在作æ¥éŽç¨‹ä¸æ‡‰èƒ½å®¹æ˜“å–得該標準作æ¥ç¨‹åºã€‚該作æ¥ç¨‹åºæ‡‰è‡³å°‘包å«ä¸‹åˆ—è¦æ±‚：</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€æ±ºå®šé©åˆæ血者的標準，包括病æ·è³‡æ–™ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€å°æ–¼æ血者進行測試åŠè©•ä¼°çš„方法，包括判定æ血者是å¦åˆæ ¼çš„éŽç¨‹ï¼Œèˆ‡æª¢é©—çµæžœå¯æŽ¥å—的最大åŠæœ€å°å€¼ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">三ã€ç”¨æ–¼æŽ¡è¡€åŠè¡€æ¶²è™•ç†çš„容器åŠæº¶æ¶²å‡æ‡‰ç¬¦åˆæœ€é«˜ç„¡èŒä¹‹è¦æ±‚。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å››ã€è¡€æ¶²è’集的éŽç¨‹ï¼ŒåŒ…括血液è’集é‡ç‰è³‡æ–™ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">五ã€æˆåˆ†è¡€çš„製備方法。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å…ã€è£½å‚™éŽç¨‹ä¸ä»»ä½•çš„測試åŠæ‰€é€²è¡Œé‡è¤‡æ¸¬è©¦çš„紀錄。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">七ã€è¨˜éŒ„任何æ血者åŠå—血者的ä¸è‰¯å應作用。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å…«ã€å„²è—血漿åŠè©¦åŠ‘處所的溫度紀錄。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">ä¹ã€æ¨™ç¤ºå„é …æœ€çµ‚ç”¢å“的末效期。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">åã€è¡€æ¼¿åŽŸæ–™è‡ªæ血者到最終產å“之相關資料。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å一ã€è¡€æ¼¿åŽŸæ–™ä¹‹è’集ã€è£½å‚™ä»¥åŠæª¢æ¸¬æ‰€éœ€è€—æåŠè©¦åŠ‘çš„å“質管制措施。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å二ã€ä½¿ç”¨å„€å™¨ä¹‹ç¶æŒåŠæ ¡æ£çš„作æ¥æ™‚程åŠæ¨™æº–æ“作程åºã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å三ã€ç”¢å“æ£ç¢ºçš„標示程åºï¼Œä¸¦å‚™æœ‰é©ç•¶çš„安全防è·æ©Ÿåˆ¶ä»¥ç¢ºä¿èƒ½æ˜Žç¢ºè¾¨èªã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">åå››ã€åˆ¶å®šåŽŸæ–™è¡€æ¼¿åˆ†é›¢è¡“çš„æ“作æ¥é©Ÿã€‚．</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å五ã€åˆ¶å®šæˆåˆ†è¡€æ¼¿çš„æ“作æ¥é©Ÿï¼ŒåŒ…括血漿的分離，混åˆ</span>(Pooling)<span style="font-family: 新細明體,serif;">ã€æ¨™ç¤ºåŠé…é€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第廿三æ¢ã€æ血機構之血液收集程åºæ‡‰åš´äºˆç®¡åˆ¶ã€‚血袋系統使用å‰å¿…é ˆåšæå‚·åŠæ±¡æŸ“檢查，血袋缺陷å¯èƒ½å½±éŸ¿ç”¢å“å“è³ªå¿…é ˆåŠ ä»¥è¨»æ˜Žä¸¦å ±å“管部門處ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第廿四æ¢ã€</span>.<span style="font-family: 新細明體,serif;">æ血機構血液之收集ã€ä½œæ¥åŠé…é€ç‰æ‰€æœ‰éŽç¨‹å¿…é ˆéµç…§æ¨™æº–作æ¥ç¨‹åºæ“作。</span> </p><p><span style="font-family: 新細明體,serif;">第廿五æ¢ã€æ血機構之æˆåˆ†è¡€æ‡‰æ–¼å¯†é–‰ç³»çµ±å…§æ“作。若為開放系統應在é©ç•¶å ´æ‰€é€²è¡Œï¼Œä»¥é¿å…微生物污染。</span> </p><p><span style="font-family: 新細明體,serif;">第廿å…æ¢ã€æ血機構之引用新æ“作程åºåŠä»»ä½•æ”¹è®Šå‰å¿…é ˆäºˆä»¥ç¢ºæ•ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第廿七æ¢ã€æè¡€æ©Ÿæ§‹ä¹‹è£½é€ éŽç¨‹ä¸ï¼Œè¡€æ¶²åŠæˆåˆ†è¡€çš„æ‰€æœ‰å®šå®¹å™¨é ˆæœ‰æ˜Žç¢ºæ¨™ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第廿八æ¢ã€å¯èƒ½å°ç”¢å“之安全性與純度有ä¸è‰¯å½±é¥—之人員，應é¿å…進入收集ã€è™•ç†ã€å„²å˜æˆ–é…é€è¡€æ¶²æˆ–æˆåˆ†è¡€ä¹‹å€åŸŸã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第廿ä¹æ¢ã€æ血機構之所有紀錄，應ä¾ç…§ç›¸é—œæ³•è¦æ–¼æœ€çµ‚æˆå“放行或é…é€å‰äºˆä»¥å¯©æ ¸ã€‚å¯©æ ¸æˆ–éƒ¨ä»½å¯©æ ¸å¯åœ¨è¡€æ¶²æ”¶é›†ã€è™•ç†ã€åŠè²¯å˜æœŸé–“或之後執行。å°æ–¼çµè«–ã€è¿½è¹¤ã€ä»»ä½•æœªèªªæ˜Žçš„矛盾點或未符åˆè¦æ ¼ä¹‹ä¸åˆæ ¼ç”¢å“，å‡æ‡‰äºˆå¾¹åº•èª¿æŸ¥ä¸¦è¨˜éŒ„之。</span> </p><p><span style="font-family: 新細明體,serif;">第三åæ¢ã€æ血機構之包è£ææ–™åŠæ¨™ç¤ºæ料之驗收ã€æ¨™è˜ã€å„²å˜ã€ç®¡ç†ã€å–樣ã€æª¢é©—ç‰é …目，應制定書é¢ç®¡åˆ¶ä½œæ¥ç¨‹åºä¸¦éµè¡Œä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…一æ¢ã€æ血機構之產å“應標示å稱ã€æ血者è˜åˆ¥è™Ÿç¢¼ï¼ˆæˆ–產å“編號）ã€æ©Ÿæ§‹å稱ã€æœ‰æ•ˆæœŸé™åŠè²¯å˜æ¢ä»¶ã€‚åŽŸæ–™è¡€æ¼¿æ‡‰ç‰¹åˆ¥æ¨™ç¤ºç‚ºï¼šåƒ…ä¾›è£½é€ è¡€æ¶²è£½åŠ‘ä½¿ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…二æ¢ï¼Œæ血機構經包è£åŠæ¨™ç¤ºä¹‹ç”¢å“，於最後之æ“作éŽç¨‹ä¸æ‡‰äºˆæª¢æŸ¥ï¼Œä»¥ç¢ºä¿æ¯ä¸€å®¹å™¨æˆ–包è£ä¹‹æ¨™è˜å‡å±¬æ£ç¢ºç„¡èª¤ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…三æ¢ã€æè¡€æ©Ÿæ§‹æ‡‰åˆ¶è¨‚åŒ…æ‹¬ä¸‹åˆ—äº‹é …ä¹‹ç”¢å“倉儲書é¢ä½œæ¥ç¨‹åºï¼Œä¸¦éµè¡Œä¹‹ï¼š</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€ç”¢å“於准用å‰ä¹‹æª¢ç–«éš”離貯å˜æŽªæ–½ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€å¾—以ä¿è‰ç”¢å“之æˆåˆ†ã€å«é‡èˆ‡å“質ä¸å—影響之儲å˜æº«åº¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…å››æ¢ã€æè¡€æ©Ÿæ§‹æ‡‰åˆ¶è¨‚åŒ…æ‹¬ä¸‹åˆ—äº‹é …ä¹‹æ›¸é¢é…é€ä½œæ¥ç¨‹åºï¼Œä¸¦éµè¡Œä¹‹ï¼š</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€ä»¥å…ˆè£½å…ˆé…é€ç‚ºåŽŸå‰‡ï¼Œä½†å¾—å› æ‡‰éœ€è¦ä½œæš«æ™‚且é©ç•¶ä¹‹èª¿æ•´ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€é˜²æ¢ç”¢å“之æˆåˆ†ã€å«é‡ã€å“質å—到ä¸è‰¯ç’°å¢ƒå› ç´ å½±éŸ¿ä¹‹é…é€æ–¹å¼ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">三ã€å»ºç«‹èƒ½è¿…速回收已é…é€ç”¢å“之系統。</span> </p><p><span style="font-family: 新細明體,serif;">第å…五æ¢ã€ç”¢å“完æˆé…é€ä½œæ¥å¾Œï¼Œè‹¥ç™¼ç¾è©²æ‰¹ç”¢å“有任何å¯ç–‘或發生å•é¡Œç‹€æ³æ™‚，應由原æ血機構主動回收處ç†ï¼Œä¸¦å°‡å›žæ”¶è™•ç†æƒ…å½¢å‘è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå ±å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…å…æ¢ã€æ血機構å“質管制部門之è·è²¬åŠä½œæ¥ç¨‹åºï¼Œé ˆéµè¡Œä¸‹åˆ—è¦å®šï¼š</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€è² è²¬åˆ¶å®šå¯©æ ¸å®Œæ•´é©ç•¶çš„è¦æ ¼ã€ä½œæ¥æ¨™æº–åŠè©¦é©—程åºä»¥ç¢ºä¿è¡€æ¶²åŠæˆåˆ†è¡€çš„安全ã€ç´”度與效能。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€é©ç•¶é‘‘別åŠè™•ç†æ‰€æœ‰è©¦é©—樣å“以æ£ç¢ºè¾¨æ˜Žæª¢é«”之特定單ä½æˆ–å…¶æ血者的鑑定çµæžœã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…七æ¢ã€æœ¬åŸºæº–所定有關æ血者血液採集ã€è£½ç¨‹ã€ç®¡åˆ¶ã€åŠé…é€ä¹‹ç´€éŒ„，應供作定期評估產å“å“質標準之ä¾æ“šï¼Œä»¥æ±ºå®šç”¢å“之è¦æ ¼ã€è£½ç¨‹æˆ–管制作æ¥ç¨‹åºæ˜¯å¦éœ€è¦æ”¹é€²ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€æœ¬åŸºæº–所定所有紀錄應至少ä¿å˜è‡³è©²æ‰¹ç”¢å“ä¹‹è£½å‚™å ±å‘Šå®Œæˆèµ·è‡³å°‘å年或æˆåˆ†è¡€ç”¢å“有效期é™éŽå¾Œå…個月（以æ¤äºŒè€…ä¸ä¹‹æœ‰æ•ˆæœŸé™è¼ƒé²è€…為準）。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€æœ¬åŸºæº–所定所有紀錄或其副本在ä¿å˜æœŸé–“，應å˜æ–¼é©ç•¶å ´æ‰€ï¼Œä¸¦éš¨æ™‚供有關主管單ä½ç¨½æŸ¥ï¼›ç¨½æŸ¥äººå“¡å¾—å½±å°æˆ–以其他方法複製該紀錄或其副本。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">三ã€æœ¬åŸºæº–所定所有紀錄å‡æ‡‰ä¿å˜ï¼Œä¾›ä½œå®šæœŸè©•ä¼°ç”¢å“å“質標準之ä¾æ“šï¼Œä»¥æ±ºå®šç”¢å“之è¦æ ¼ï¼Œè£½ç¨‹æˆ–管制作æ¥ç¨‹åºæ˜¯å¦éœ€è¦æ”¹é€²ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第å…å…«æ¢ã€æ血機構之血液採集紀錄應予ä¿å˜ï¼Œä¸¦åŒ…括下列å„é …ï¼š</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">一ã€æ血者之篩é¸åŠè¡€æ¨£é‘‘定çµæžœï¼ŒåŒ…括其用藥æ·å²ã€å¥åº·æª¢æŸ¥ã€ç¥‰æœƒè¡Œç‚ºå–å‘åŠåˆ†é›¢è¡“æè¡€åŒæ„書。若採血éŽç¨‹ä¸æ–·æ‡‰è¨˜éŒ„åŽŸå› ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">二ã€è¨˜éŒ„ä¸åˆæ ¼æè¡€ä¹‹åŽŸå› ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">三ã€æ血者發生採血ä¸è‰¯å應時之怨訴處ç†å’Œå ±å‘Šï¼Œæ‡‰åŒ…æ‹¬æ‰€æœ‰çš„èª¿æŸ¥ç ”ç©¶å’Œå¾ŒçºŒç™¼å±•æƒ…å½¢ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å››ã€æŽ¡è¡€å‰è‹¥å…ˆç¶“å…疫注射，應有書é¢åŒæ„ã€æŠ—原種類ã€å…¶æ³¨å°„é‡èˆ‡æ³¨å°„途徑之紀錄。</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">五ã€è¨˜éŒ„æ血者和其先å‰æ¯æ¬¡æ贈之血液單ä½è™Ÿç¢¼ã€‚</span> </p><p><span> </span><span style="font-family: 新細明體,serif;">å…ã€è¡€æ¶²ä¹‹æŽ¡é›†æ™‚é–“ã€åœ°é»žå’ŒæŽ¡è¡€è€…之姓å。</span> </p><p><span style="font-family: 新細明體,serif;">第å…ä¹æ¢ã€æ血機構å°æ¯ä¸€æå†è€…應有è˜åˆ¥è™Ÿç¢¼ï¼Œä»¥å€‹åˆ¥è¨˜éŒ„其血液之採集ã€å¥åº·æª¢æŸ¥å ±å‘Šï¼Œä»¥åŠè©²æ血者血液所製備之血液產å“或任何æˆåˆ†è¡€ä¹‹ç”¢å“å稱åŠæ‰¹è™Ÿã€ä¸¦æ•˜è¿°é€™äº›ç”¢å“來æºåŠæœ€çµ‚產å“é…é€æƒ…形。</span> </p><p><span style="font-family: 新細明體,serif;">第四åæ¢ã€æ血機構æ供之產å“應有完整的é…é€ç´€éŒ„，始能追溯相關的批號ã€æ”¶å—者之å稱和地å€ã€é…é€æ•¸é‡ã€é…é€æ—¥æœŸã€æœ‰æ•ˆæœŸé™æˆ–血液之採集日期。</span> </p><p><span style="font-family: 新細明體,serif;">第四å一æ¢ã€æ血機構å°æ–¼é€€å›žä¹‹ç”¢å“於鑑è˜å‰æ‡‰åˆ†åˆ¥æª¢ç–«éš”離儲å˜ã€‚è‹¥å°æ–¼é€€å›žç”¢å“之儲å˜ã€é‹é€æ¢ä»¶ï¼Œæˆ–å“質ã€å®¹å™¨ã€æ¨™ç¤ºç‰ä¹‹å®‰å…¨æ€§ã€å“質ç‰æœ‰ç–‘慮，則應å†è¡Œæª¢é©—或調查以確定其符åˆæ—¢å®šä¹‹è¦æ ¼ï¼Œå¦å‰‡è©²ç”¢å“應予鎖毀並記錄之。</span> </p><p><span style="font-family: 新細明體,serif;">第四å二æ¢ã€æ血機構å°æ血者在血液採集éŽç¨‹ä¸æˆ–其後所產生之任何ä¸é©åæ‡‰çš„æ€¨è¨´å ±å‘Šæ‡‰ä»¥æ›¸é¢è¦å®šå…¶è™•ç†ä½œæ¥ç¨‹åºï¼Œä¸¦éµè¡Œä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第四å三æ¢ã€æ血者在æè¡€éŽç¨‹é‡æœ‰å±æ€¥ç”Ÿå‘½ç‹€æ³ï¼Œæ血機構之醫師應å³ä¾å…¶è¨å‚™äºˆä»¥æ•‘治或採å–一切必è¦æŽªæ–½ï¼Œä¸¦å°‡ç·Šæ€¥è™•ç½®éŽç¨‹ä½œæˆå ±å‘Šæª¢è¨Žè©•ä¼°ï¼Œä»¥ä¾›è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŸ¥æ ¸ã€‚</span> </p>2013-12-05
化å¸è£½é€ 管制類,è—¥å“å„ªè‰¯è£½é€ ,è—¥å“å„ªè‰¯è£½é€ è¦ç¯„：原料藥作æ¥åŸºæº–行政解釋藥å“å„ªè‰¯è£½é€ è¦ç¯„-原料藥作æ¥åŸºæº–<p><span style="font-family: 新細明體,serif;">è—¥å“å„ªè‰¯è£½é€ è¦ç¯„原料藥作æ¥åŸºæº–</span> </p><p><span style="font-family: 新細明體,serif;">è¡Œ</span> <span style="font-family: 新細明體,serif;">政</span> <span style="font-family: 新細明體,serif;">院</span> <span style="font-family: 新細明體,serif;">è¡›</span> <span style="font-family: 新細明體,serif;">生</span> <span style="font-family: 新細明體,serif;">ç½²</span> </p><p><span style="font-family: 新細明體,serif;">ä¸è¯æ°‘國ä¹å一年四月</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">è—¥å“å„ªè‰¯è£½é€ è¦ç¯„原料藥作æ¥åŸºæº–</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">目錄</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">é 次</span> </p><p><span style="font-family: 新細明體,serif;">壹ã€ç¸½å‰‡</span><span 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style="font-family: calibri;">...............................................................................11 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€è¨æ–½</span><span style="font-family: calibri;">...........................................................................................12 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€æ±¡æŸ“管制</span><span style="font-family: calibri;"> .................................................................................13 </span></p><p><span style="font-family: 新細明體,serif;">肆ã€è¨å‚™</span><span style="font-family: calibri;"> ...........................................................................................13 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€è¨è¨ˆåŠå»ºé€ </span><span style="font-family: calibri;">...............................................................................13 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€æ¸…æ½”åŠç¶è·</span><span style="font-family: calibri;"> .............................................................................13 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€æ ¡æ£</span><span style="font-family: calibri;">...........................................................................................14 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€é›»è…¦ç³»çµ±</span><span style="font-family: calibri;">...................................................................................14 </span></p><p><span style="font-family: 新細明體,serif;">ä¼ã€çµ„織與人事</span><span style="font-family: calibri;">...................................................................................15 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€è³‡æ ¼</span><span style="font-family: calibri;">...........................................................................................15 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€è¡›ç”Ÿ</span><span style="font-family: calibri;">...........................................................................................16 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€é¡§å•</span><span style="font-family: calibri;">...........................................................................................16 </span></p><p><span style="font-family: 新細明體,serif;">陸ã€åŽŸæ–™ç®¡åˆ¶</span><span style="font-family: calibri;">.......................................................................................16 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€åŽŸæ–™ç®¡ç†</span><span style="font-family: calibri;">...................................................................................16 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€å–樣和檢驗</span><span style="font-family: calibri;"> ...........................................................................17 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€å„²å˜</span><span style="font-family: calibri;">...........................................................................................17 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€å›žæ”¶æº¶åŠ‘ã€æ¯æ¶²åŠå›žæ”¶ç”¢ç‰©ä¹‹ç®¡åˆ¶</span><span style="font-family: calibri;"> .....................................18 </span></p><p><span style="font-family: 新細明體,serif;">　五ã€æ‹’用</span><span style="font-family: calibri;"> .......................................................................................18 </span></p><p><span style="font-family: 新細明體,serif;">　å…ã€æ°´</span><span style="font-family: calibri;"> .............................................................................................18 </span></p><p><span style="font-family: 新細明體,serif;">柒ã€è£½é€ 與製程管制</span><span style="font-family: calibri;">...........................................................................18 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€è£½é€ 管制</span><span style="font-family: calibri;"> .................................................................................18 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€è£½ç¨‹ç®¡åˆ¶</span><span style="font-family: calibri;"> ................................................................................ 19 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€æ‰¹æ¬¡æ··åˆ</span><span style="font-family: calibri;">...................................................................................20 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€æ±¡æŸ“管制</span><span style="font-family: calibri;"> .................................................................................20 </span></p><p><span style="font-family: 新細明體,serif;">　五ã€é‡è£½æˆ–å†è£½</span><span style="font-family: calibri;">...............................................................................21 </span></p><p><span style="font-family: 新細明體,serif;">æŒã€åŒ…è£åŠæ¨™ç¤ºç®¡åˆ¶</span><span style="font-family: calibri;">...........................................................................21 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€ä¸€èˆ¬ç®¡åˆ¶</span><span style="font-family: calibri;">...................................................................................21 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€åŒ…è£å’Œæ¨™ç¤ºä½œæ¥</span><span style="font-family: calibri;"> .....................................................................22 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€æ¨™ç¤ºç®¡åˆ¶</span><span style="font-family: calibri;">...................................................................................23 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€å®¹å™¨å’Œå°è“‹ç®¡åˆ¶</span><span style="font-family: calibri;"> .....................................................................23 </span></p><p><span style="font-family: 新細明體,serif;">玖ã€å„²å˜åŠé‹éŠ·</span><span style="font-family: calibri;">...................................................................................23 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€å„²å˜</span><span style="font-family: calibri;">...........................................................................................23 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€é‹éŠ·</span><span style="font-family: calibri;">...........................................................................................23 </span></p><p><span style="font-family: 新細明體,serif;">拾ã€å“質管制</span><span style="font-family: calibri;">.......................................................................................23 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€å“質管ç†</span><span style="font-family: calibri;">...................................................................................23 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€å“質管制</span><span style="font-family: calibri;">...................................................................................24 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€å¯¦é©—室管制</span><span style="font-family: calibri;">...............................................................................25 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€è®Šæ›´ç®¡åˆ¶</span><span style="font-family: calibri;">...................................................................................28 </span></p><p><span style="font-family: 新細明體,serif;">拾壹ã€ç´€éŒ„èˆ‡å ±å‘Š</span><span style="font-family: calibri;">...............................................................................29 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€æ–‡ä»¶ç³»çµ±</span><span style="font-family: calibri;">...................................................................................29 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€è¨å‚™æ¸…潔和使用紀錄</span><span style="font-family: calibri;">...............................................................29 </span></p><p><span style="font-family: 新細明體,serif;">三ã€åŽŸæ–™ã€åŽŸæ–™è—¥åŒ…è£ææ–™åŠæ¨™ç¤ºç´€éŒ„</span><span style="font-family: calibri;">.......................................30 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€è£½é€ 管制標準書</span><span style="font-family: calibri;">.......................................................................30 </span></p><p><span style="font-family: 新細明體,serif;">　五ã€æ‰¹æ¬¡è£½é€ åŠç®¡åˆ¶ç´€éŒ„</span><span style="font-family: calibri;">...............................................................31 </span></p><p><span style="font-family: 新細明體,serif;">　å…ã€è£½é€ ç´€éŒ„å¯©æ ¸</span><span style="font-family: calibri;">...........................................................................31 </span></p><p><span style="font-family: 新細明體,serif;">　七ã€å¯¦é©—室紀錄</span><span style="font-family: calibri;">...............................................................................32 </span></p><p><span style="font-family: 新細明體,serif;">　八ã€é‹éŠ·ç´€éŒ„</span><span style="font-family: calibri;">...................................................................................32 </span></p><p><span style="font-family: 新細明體,serif;">　ä¹ã€æ€¨è¨´ç´€éŒ„</span><span style="font-family: calibri;">...................................................................................33 </span></p><p><span style="font-family: 新細明體,serif;">拾貳ã€æ€¨è¨´èˆ‡é€€å›žåŽŸæ–™è—¥</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">或ä¸é–“產å“</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">之處ç†</span><span style="font-family: calibri;">................................33 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€æ€¨è¨´</span><span style="font-family: calibri;">...........................................................................................33 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€é€€å›ž</span><span style="font-family: calibri;">...........................................................................................34 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€å›žæ”¶</span><span style="font-family: calibri;">...........................................................................................34 </span></p><p><span style="font-family: 新細明體,serif;">拾åƒã€ç¢ºæ•ˆ</span><span style="font-family: calibri;">...........................................................................................34 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€ç¢ºæ•ˆæ”¿ç–</span><span style="font-family: calibri;">...................................................................................34 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€é©—è‰</span><span style="font-family: calibri;">...........................................................................................35 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€è£½ç¨‹ç¢ºæ•ˆ</span><span style="font-family: calibri;">...................................................................................35 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€ç¢ºæ•ˆå¯©æŸ¥</span><span style="font-family: calibri;">...................................................................................38 </span></p><p><span style="font-family: 新細明體,serif;">　五ã€æ¸…潔方法確效</span><span style="font-family: calibri;">...........................................................................38 </span></p><p><span style="font-family: 新細明體,serif;">　å…ã€åˆ†æžæ–¹æ³•ç¢ºæ•ˆ</span><span style="font-family: calibri;">...........................................................................39 </span></p><p><span style="font-family: 新細明體,serif;">拾肆ã€è‡¨åºŠè©¦é©—用原料藥</span><span style="font-family: calibri;">...................................................................40 </span></p><p><span style="font-family: 新細明體,serif;">　一ã€ä¸€èˆ¬åŽŸå‰‡</span><span style="font-family: calibri;">...................................................................................40 </span></p><p><span style="font-family: 新細明體,serif;">　二ã€å“質ä¿è‰æŽªæ–½</span><span style="font-family: calibri;">...........................................................................40 </span></p><p><span style="font-family: 新細明體,serif;">　三ã€å“質管制部門</span><span style="font-family: calibri;">...........................................................................40 </span></p><p><span style="font-family: 新細明體,serif;">　四ã€è¨å‚™å’Œè¨æ–½</span><span style="font-family: calibri;">................................................................................40 </span></p><p><span style="font-family: 新細明體,serif;">　五ã€åŽŸæ–™ç®¡åˆ¶</span><span style="font-family: calibri;">...................................................................................40 </span></p><p><span style="font-family: 新細明體,serif;">　å…ã€è£½é€ 和製程管制</span><span style="font-family: calibri;"> .....................................................................41 </span></p><p><span style="font-family: 新細明體,serif;">　七ã€è£½ç¨‹ç¢ºæ•ˆ</span><span style="font-family: calibri;">...............................................................41 </span></p><p><span style="font-family: 新細明體,serif;">　八ã€è®Šæ›´ç®¡åˆ¶åŠç´€ç¶ </span><span style="font-family: calibri;">......................................................41 </span></p><p><span style="font-family: 新細明體,serif;">　ä¹ã€å¯¦é©—室管制</span><span style="font-family: calibri;">............................................................41 </span></p><p><span style="font-family: 新細明體,serif;">　åã€æ–‡ä»¶ç³»çµ±</span><span style="font-family: calibri;">...............................................................41 </span></p><p><span style="font-family: 新細明體,serif;">拾ä¼ã€å§”è¨—è£½é€ æˆ–æª¢é©—</span><span style="font-family: calibri;">......................................................42 </span></p><p><span style="font-family: 新細明體,serif;">拾陸ã€ä»£ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†</span><span style="font-family: calibri;"> ...........43 </span></p><p><span style="font-family: 新細明體,serif;">一ã€é©ç”¨ç¯„åœ</span><span style="font-family: calibri;">.................................................................43 </span></p><p><span style="font-family: 新細明體,serif;">二ã€éŠ·å”®ä¹‹åŽŸæ–™è—¥æˆ–ä¸é–“產å“之å¯è¿½æº¯æ€§</span><span style="font-family: calibri;">.............................43 </span></p><p><span style="font-family: 新細明體,serif;">三ã€å“質管ç†</span><span style="font-family: calibri;">.................................................................43 </span></p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸæ–™è—¥æˆ–ä¸é–“產å“之å†åˆ†åŒ…è£ã€å†æ¨™ç¤ºåŠæŒæœ‰</span><span style="font-family: calibri;">.................43 </span></p><p><span style="font-family: 新細明體,serif;">五ã€å®‰å®šæ€§</span><span style="font-family: calibri;">....................................................................43 </span></p><p><span style="font-family: 新細明體,serif;">å…ã€è³‡è¨Šäº¤æ›</span><span style="font-family: calibri;">.................................................................44 </span></p><p><span style="font-family: 新細明體,serif;">七ã€æ€¨è¨´åŠå›žæ”¶ä¹‹è™•ç†</span><span style="font-family: calibri;">.....................................................44 </span></p><p><span style="font-family: 新細明體,serif;">å…«ã€é€€å›žè™•ç†</span><span style="font-family: calibri;">................................................................44 </span></p><p><span style="font-family: 新細明體,serif;">拾柒ã€ç”Ÿç‰©æŠ€è¡“è£½é€ ä¹‹åŽŸæ–™è—¥</span><span style="font-family: calibri;">.............................................45 </span></p><p><span style="font-family: 新細明體,serif;">一ã€é€šå‰‡</span><span style="font-family: calibri;">......................................................................45 </span></p><p><span style="font-family: 新細明體,serif;">二ã€ç´°èƒžåº«çš„ç¶è·å’Œç´€éŒ„之ä¿å˜</span><span style="font-family: calibri;">........................................46 </span></p><p><span style="font-family: 新細明體,serif;">三ã€ç´°èƒžåŸ¹é¤Š</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">發酵</span><span style="font-family: calibri;">.........................................................47 </span></p><p><span style="font-family: 新細明體,serif;">å››ã€æ”¶é›†ã€åˆ†é›¢åŠç´”化</span><span style="font-family: calibri;">....................................................47 </span></p><p><span style="font-family: 新細明體,serif;">五ã€ç—…毒去除和去活性化æ¥é©Ÿ</span><span style="font-family: calibri;">...........................................47 </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">è—¥ç‰©è£½é€ é¡žåˆ¥åŠæœ¬åŸºæº–é©ç”¨ç¯„åœ</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">è£½é€ ä¹‹è—¥ç‰©é¡žåˆ¥</span><span style="font-family: calibri;">) </span></p><p><span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥è£½é€ é¡žåˆ¥</span> </p><p><span style="font-family: 新細明體,serif;">ç°åº•å…§ä¹‹è£½é€ æ¥é©Ÿé©ç”¨æœ¬åŸºæº–</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">化å¸è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥èµ·å§‹åŽŸæ–™è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">åŠ å…¥èµ·å§‹åŽŸæ–™æ–¼è£½ç¨‹ä¸é–‹å§‹è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">ä¸é–“產å“è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">分離和純化</span> </p><p><span style="font-family: 新細明體,serif;">物ç†æ€§æ“作和包è£</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">動物來æºä¹‹åŽŸæ–™è—¥</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">動物來æºä¹‹è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">器官ã€é«”液åŠçµ„織之收集</span> </p><p><span style="font-family: 新細明體,serif;">切割ã€æ··åˆåŠèµ·å§‹æ¥é©Ÿ</span> </p><p><span style="font-family: 新細明體,serif;">åŠ å…¥èµ·å§‹åŽŸæ–™æ–¼è£½ç¨‹ä¸é–‹å§‹è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">分離和純化</span> </p><p><span style="font-family: 新細明體,serif;">物ç†æ€§æ“作和包è£</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">æ¤ç‰©èƒå–來æºä¹‹åŽŸæ–™è—¥</span><span style="font-family: calibri;">) </span></p><p><span style="font-family: 新細明體,serif;">æ¤ç‰©èƒå–</span> </p><p><span style="font-family: 新細明體,serif;">æ¤ç‰©ä¹‹æ”¶é›†</span> </p><p><span style="font-family: 新細明體,serif;">切割åŠé–‹å§‹èƒå–</span> </p><p><span style="font-family: 新細明體,serif;">åŠ å…¥èµ·å§‹åŽŸæ–™æ–¼è£½ç¨‹ä¸é–‹å§‹è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">分離和純化</span> </p><p><span style="font-family: 新細明體,serif;">物ç†æ€§æ“作和包è£</span> </p><p><span style="font-family: 新細明體,serif;">生物技術發酵</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">ç´°èƒžåŸ¹é¤Šè£½ç¨‹è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">種æºç´°èƒžåº«åŠå·¥ä½œç´°èƒžåº«çš„建立</span> </p><p><span style="font-family: 新細明體,serif;">工作細胞庫的ç¶æŒ</span> </p><p><span style="font-family: 新細明體,serif;">細胞培養發酵éŽç¨‹</span> </p><p><span style="font-family: 新細明體,serif;">分離åŠç´”化</span> </p><p><span style="font-family: 新細明體,serif;">物ç†æ€§æ“作和包è£</span> </p><p><span style="font-family: 新細明體,serif;">å‚³çµ±ç™¼é…µè£½ç¨‹è£½é€ </span> </p><p><span style="font-family: 新細明體,serif;">細胞庫的建立</span> </p><p><span style="font-family: 新細明體,serif;">細胞庫的ç¶æŒ</span> </p><p><span style="font-family: 新細明體,serif;">進入發酵éŽç¨‹</span> </p><p><span style="font-family: 新細明體,serif;">分離åŠç´”化</span> </p><p><span style="font-family: 新細明體,serif;">物ç†æ€§æ“作和包è£</span> </p><p><span style="font-family: calibri;"> (Increasing GMP requirements) </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> GMP</span><span style="font-family: 新細明體,serif;">è¦æ±‚é€æ¼¸å¢žåŠ </span> </p><p><span style="font-family: 新細明體,serif;">壹ã€ç¸½å‰‡</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€</span> <span style="font-family: 新細明體,serif;">說明</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€ç›®çš„</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">è—¥å“å„ªè‰¯è£½é€ ä½œæ¥è¦ç¯„原料藥作æ¥åŸºæº–</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本基準</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¾è—¥å“å„ªè‰¯è£½é€ è¦ç¯„è¦å®šè¨‚定之。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">æœ¬åŸºæº–ç‚ºåŽŸæ–™è—¥ä¹‹è£½é€ ã€åŠ å·¥ã€åŒ…è£ã€åŠå„²å˜ä¹‹ä½œæ¥åŸºæº–。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">本基準為原料藥自起始原料開始，包括影響å“質åŠç´”度的製程確效ã€æ›¸é¢ä½œæ¥ç¨‹åºã€è£½ç¨‹ç®¡åˆ¶ã€å–樣ã€ç›£æŽ§åŠæ–‡ä»¶ç´€éŒ„ç‰ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">本基準所使用之</span><span style="font-family: calibri;"> "</span><span style="font-family: 新細明體,serif;">應</span><span style="font-family: calibri;"> " </span><span style="font-family: 新細明體,serif;">å—ï¼Œè¡¨ç¤ºè©²é …è¦æ±‚è¦äºˆä»¥åŸ·è¡Œï¼Œé™¤éžèƒ½æå‡ºè©²é …ä¹‹åŸ·è¡Œæ˜¯ä¸å¯è¡Œçš„，或是顯示出有相ç‰ç¨‹åº¦æˆ–有更好的執行方法，以ä¿è‰å“質。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€ç¯„åœ</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">本基準é©ç”¨ç¯„åœï¼š</span> </p><p><span style="font-family: calibri;"> (1). </span><span style="font-family: 新細明體,serif;">è£½é€ äººç”¨å’Œè‡¨åºŠè©¦é©—ç”¨è—¥å“之原料藥。</span> </p><p><span style="font-family: calibri;"> (2). </span><span style="font-family: 新細明體,serif;">è£½é€ ç„¡èŒçš„原料藥。原料藥滅èŒæˆ–ç„¡èŒçš„製程應ä¾æ»…èŒè£½åŠ‘</span><span style="font-family: calibri;">GMP</span><span style="font-family: 新細明體,serif;">之è¦æ±‚執行。</span> </p><p><span style="font-family: calibri;"> (3). </span><span style="font-family: 新細明體,serif;">由化å¸åˆæˆï¼Œèƒå–，細胞培養</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">發酵，利用天然物或çµåˆä¸Šè¿°çš„è£½ç¨‹æ‰€è£½é€ çš„åŽŸæ–™è—¥ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">本基準ä¸é©ç”¨ç¯„åœï¼š</span> </p><p><span style="font-family: calibri;"> (1). </span><span style="font-family: 新細明體,serif;">疫苗，細胞</span><span style="font-family: calibri;"> ( whole cell)</span><span style="font-family: 新細明體,serif;">，全血和血漿</span><span style="font-family: calibri;"> (whole blood and plasma)</span><span style="font-family: 新細明體,serif;">，全血和血漿è¡ç”Ÿç‰©ï¼ŒåŠç›´æŽ¥ä½¿ç”¨åŸºå› 治療的原料藥。</span> </p><p><span style="font-family: calibri;"> (2). </span><span style="font-family: 新細明體,serif;">氣體藥物ã€è£½åŠ‘型原料藥åŠè£½é€ 管制特定之放射性原料藥。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å°ˆç”¨å詞定義</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">下列之å稱åŠå®šç¾©æ˜¯æ供幫助使用本基準之閱讀。</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">è—¥å“：除本基準有特別è¦å®šå¤–，係指藥事法第å…æ¢æ‰€ç¨±ä¹‹ã€Œè—¥å“ã€ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">原料藥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è—¥å“有效主æˆåˆ†</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">：係指一種經物ç†ã€åŒ–å¸è™•ç†æˆ–生物技術éŽç¨‹è£½é€ 所得具藥ç†ä½œç”¨ä¹‹æ´»æ€§ç‰©</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">æˆåˆ†</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，常用於藥å“ã€ç”Ÿç‰©æŠ€è¡“產å“ä¹‹è£½é€ ã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">åŠè£½å“或ä¸é–“產å“：指任何產å“è£½é€ éŽç¨‹ä¸æ‰€å¾—之產物ï¹æ¤ç”¢ç‰©ç¶“éš¨å¾Œä¹‹è£½é€ éŽç¨‹ã€å³å¯æˆç‚ºç”¢å“者。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">產å“：指經éŽæ‰€æœ‰è£½é€ éŽç¨‹å¾Œï¼Œæ‰€å¾—到的最終原料藥。</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">標示：指所有標籤ã€ä»¿å–®åŠé™„隨物å“刊載之文å—或圖形。</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">批：指ä¾æ“šç›¸åŒè£½é€ éŽç¨‹ä¸å–®ä¸€ä¹‹è£½é€ 指示，所製得特定é‡ä¹‹è—¥å“或其他物質，具有å‡ä¸€ä¹‹ç‰¹æ€§åŠå“è³ªï¼›å¦‚åœ¨é€£çºŒæ€§è£½é€ éŽç¨‹ä¸ï¼Œä¿‚指在一段時間內所產生之特定數é‡ï¼Œæˆ–在一定é™åº¦å…§ï¼Œèƒ½ç¶æŒå‡ä¸€ä¹‹ç‰¹æ€§å“質者。</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">批號：指足以追溯æ¯æ‰¹ç”¢å“或其他物質之完整資料而附編之任何明確之文å—ã€æ•¸å—ã€ç¬¦è™Ÿã€æˆ–其組åˆã€‚</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">å«é‡ï¼šæŒ‡</span> </p><p><span style="font-family: calibri;">(1) </span><span style="font-family: 新細明體,serif;">產å“之æˆåˆ†å«é‡</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如é‡é‡</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">é‡é‡ã€é‡é‡</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">容é‡ã€å–®ä½åŠ‘é‡</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">容ç©åŸºæº–ç‰</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">(2) </span><span style="font-family: 新細明體,serif;">產å“之力價或效價，亦å³ç¶“éŽé©é‡ä¹‹å¯¦é©—æ¸¬è©¦æˆ–è¶³å¤ ä¹‹è‡¨åºŠæ•¸æ“šæ‰€ç¢ºç«‹ä¹‹æ²»ç™‚æ•ˆæžœã€‚</span> </p><p><span style="font-family: calibri;">9. </span><span style="font-family: 新細明體,serif;">æ ¡æ£ï¼šåœ¨ç‰¹å®šçš„é™åˆ¶åŠé©ç•¶çš„é‡æ¸¬ç¯„åœå…§ï¼Œå±•ç¤ºä¸€ç‰¹å®šçš„儀器或è£ç½®ï¼Œèˆ‡å¯è¿½æº¯æ€§ä¹‹æ¨™æº–å“在é©ç•¶æ™‚間間隔內，所產出çµæžœä¹‹æ¯”較。</span> </p><p><span style="font-family: calibri;">10. </span><span style="font-family: 新細明體,serif;">å¯æŽ¥å—標準：è¦æ ¼å’ŒæŽ¥å—</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">拒用標準。如接å—之å“質標準或ä¸æŽ¥å—之å“質標準，並å«å¯ä½œç‚ºæ±ºå®šæŽ¥å—或拒用之一個批次的原料ã€ä¸é–“產å“ã€åŒ…è£ææ–™ã€æˆ–產å“之å–樣計畫，æ¤å稱亦å¯æ‡‰ç”¨æ–¼ç¢ºæ•ˆã€‚</span> </p><p><span style="font-family: calibri;">11. </span><span style="font-family: 新細明體,serif;">污染：原料或ä¸é–“產å“或原料藥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å¦‚åœ¨è£½é€ ã€å–樣ã€åˆ†åŒ…è£æˆ–å†åŒ…è£ã€å„²å˜æˆ–é‹é€éŽç¨‹ä¸</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">éå—化åˆç‰©ã€å¾®ç”Ÿç‰©æˆ–外來物ç‰ä¸ç´”物之混入。</span> </p><p><span style="font-family: calibri;">12. </span><span style="font-family: 新細明體,serif;">交å‰æ±¡æŸ“：一物質或產å“被å¦ä¸€ç‰©è³ªæˆ–產å“污染。</span> </p><p><span style="font-family: calibri;">13. </span><span style="font-family: 新細明體,serif;">å“質ä¿è‰ï¼šç‚ºç¢ºä¿åŽŸæ–™è—¥é”到既定å“質è¦æ±‚，所進行之所有組織性活動。</span> </p><p><span style="font-family: calibri;">14. </span><span style="font-family: 新細明體,serif;">å“è³ªç®¡åˆ¶éƒ¨é–€ï¼šè² å“質管制責任之人員或組織。</span> </p><p><span style="font-family: calibri;">15. </span><span style="font-family: 新細明體,serif;">隔離：原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“ã€åŽŸæ–™è—¥ä»¥ç‰©ç†æˆ–其他有效的方法分隔，以ç‰å¾…下一æ¥ä¹‹è™•ç†ã€‚</span> </p><p><span style="font-family: calibri;">16. </span><span style="font-family: 新細明體,serif;">外來物質：由生產éŽç¨‹ä»¥å¤–的來æºæ‰€å¼•é€²çš„ä¸ç´”物。</span> </p><p><span style="font-family: calibri;">17. </span><span style="font-family: 新細明體,serif;">ä¸ç´”物：任何å˜åœ¨æ–¼ç”¢å“ä¸ï¼Œä¸å±¬æ–¼åŽŸæ–™è—¥åŒ–åˆç‰©ä¹‹ç‰©è³ªã€‚</span> </p><p><span style="font-family: calibri;">18. </span><span style="font-family: 新細明體,serif;">未鑑別ä¸ç´”物：僅經定性鑑定之ä¸ç´”物（如層æžæ»¯ç•™æ™‚間）。</span> </p><p><span style="font-family: calibri;">19. </span><span style="font-family: 新細明體,serif;">已鑑別ä¸ç´”物：完æˆçµæ§‹ç‰¹æ€§é‘‘定之ä¸ç´”物。</span> </p><p><span style="font-family: calibri;">20. </span><span style="font-family: 新細明體,serif;">ä¸ç´”物æ述：原料藥所å˜åœ¨ä¹‹å·²é‘‘別åŠæœªé‘‘別之ä¸ç´”物的æ述。</span> </p><p><span style="font-family: calibri;">21. </span><span style="font-family: 新細明體,serif;">潛在ä¸ç´”物：基於ç†è«–之考é‡ï¼Œåœ¨è£½ç¨‹ä¸ä¹Ÿè¨±æœƒç”¢ç”Ÿä¹‹ä¸ç´”物。æ¤ä¸ç´”物在原料藥ä¸ä¹Ÿè¨±å‡ºç¾æˆ–ä¸å‡ºç¾ã€‚</span> </p><p><span style="font-family: calibri;">22. </span><span style="font-family: 新細明體,serif;">毒性ä¸ç´”物：ä¸ç´”物具有顯著ä¸è‰¯ç”Ÿç‰©æ´»æ€§è€…。</span> </p><p><span style="font-family: calibri;">23. </span><span style="font-family: 新細明體,serif;">ç†è«–產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">：原料藥或ä¸é–“產å“ä¾å„種æˆåˆ†ä½¿ç”¨çš„數é‡ï¼Œåœ¨æ²’有æ¼å¤±åŠéŒ¯èª¤ä¹‹å¯¦éš›ç”Ÿç”¢ä¸‹ï¼Œæ‰€æ‡‰ç”Ÿç”¢çš„數é‡æˆ–百分率。</span> </p><p><span style="font-family: calibri;">24. </span><span style="font-family: 新細明體,serif;">é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">：原料藥或ä¸é–“產å“基於製程發展和確效的數據，é 期在任何é©ç•¶éšŽæ®µç”¢å‡ºä¹‹æ•¸é‡æˆ–ç†è«–產é‡ç™¾åˆ†æ¯”。</span> </p><p><span style="font-family: calibri;">25. </span><span style="font-family: 新細明體,serif;">實際產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">：在é©ç•¶éšŽæ®µä¹‹è£½é€ ã€åŠ 工或包è£ä¹‹å¯¦éš›ç”Ÿç”¢çš„數é‡æˆ–百分率。</span> </p><p><span style="font-family: calibri;">26. </span><span style="font-family: 新細明體,serif;">製程管制：在生產ä¸æª¢é©—和執行的工作，用以監測或需è¦æ™‚調整製程者。</span> </p><p><span style="font-family: calibri;">27. </span><span style="font-family: 新細明體,serif;">é—œéµè£½é€ åƒæ•¸ï¼šç”Ÿç”¢çš„åƒæ•¸å¿…é ˆè¢«æŽ§åˆ¶åœ¨æ—¢å®šæ“作的範åœå…§ï¼Œä»¥ç¢ºä¿åŽŸæ–™è—¥æˆ–ä¸é–“產å“能符åˆå“質åŠç´”度的è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;">28. </span><span style="font-family: 新細明體,serif;">é—œéµè£½é€ æ¥é©Ÿï¼šä¿‚指生產æ¥é©Ÿå¿…é ˆè¢«æŽ§åˆ¶åœ¨æ—¢å®šæ“作的範åœå…§ï¼Œä»¥ç¢ºä¿åŽŸæ–™è—¥æˆ–ä¸é–“產å“能符åˆå“質åŠç´”度的è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;">29. </span><span style="font-family: 新細明體,serif;">放大試製：原料藥的生產是由商æ¥åŒ–生產è¦æ¨¡æ¸›ä½Žè‡³å…·ä»£è¡¨æ€§å’Œæ¨¡æ“¬ä¹‹ç”Ÿç”¢è¦æ¨¡ã€‚</span> </p><p><span style="font-family: calibri;">30. </span><span style="font-family: 新細明體,serif;">物料：泛指容器ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºæ料之通用å稱。</span> </p><p><span style="font-family: calibri;">31. </span><span style="font-family: 新細明體,serif;">原料：任何用於生產原料藥之æˆåˆ†ï¼ŒåŒ…括起始原料ã€è£½ç¨‹åŠ©åŠ‘ã€æº¶åŠ‘和試劑。</span> </p><p><span style="font-family: calibri;">32. </span><span style="font-family: 新細明體,serif;">起始原料：用於åˆæˆåŽŸæ–™è—¥ä¹‹ç‰©è³ªï¼Œå…¶å…ƒç´ 為併入原料藥和</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或ä¸é–“產å“之çµæ§‹ä¸è€…。</span> </p><p><span style="font-family: calibri;">33. </span><span style="font-family: 新細明體,serif;">溶劑：在åˆæˆåŽŸæ–™è—¥æˆ–ä¸é–“產å“時，所有用於製備溶液或懸浮體之無機或有機的液體。</span> </p><p><span style="font-family: calibri;">34. </span><span style="font-family: 新細明體,serif;">è©¦åŠ‘ï¼šç”¨æ–¼è£½é€ åŽŸæ–™è—¥æˆ–ä¸é–“產å“而ä¸å±¬æ–¼èµ·å§‹åŽŸæ–™æˆ–溶劑之物質。</span> </p><p><span style="font-family: calibri;">35. </span><span style="font-family: 新細明體,serif;">一級å°ç…§æ¨™æº–å“：特殊部份或批次之原料藥或ä¸é–“產å“，經éŽåš´æ ¼åˆ†æžæª¢é©—顯ç¾é«˜ç´”度者。æ¤æ¨™æº–å“購自經確èªçš„來æºæˆ–å–®ç¨çš„åˆæˆè£½å‚™æˆ–由生產物質進一æ¥ç´”化者。</span> </p><p><span style="font-family: calibri;">36. </span><span style="font-family: 新細明體,serif;">å°ç…§æ¨™æº–å“：已建立å“質和純度之原料藥或ä¸é–“產å“或其他物質，顯示與一級å°ç…§æ¨™æº–å“之比較çµæžœï¼Œä»¥ä½œç‚ºä¾‹è¡Œå¯¦é©—室分æžä¹‹åƒè€ƒã€‚</span> </p><p><span style="font-family: calibri;">37. </span><span style="font-family: 新細明體,serif;">æ¯æ¶²ï¼šçµæ™¶å¾Œï¼Œæ®˜ç•™çš„飽和液體。æ¯æ¶²å¯èƒ½å«æœ‰æœªå應之起始原料ã€ä¸é–“產å“，原料藥或ä¸ç´”物。</span> </p><p><span style="font-family: calibri;">38. </span><span style="font-family: 新細明體,serif;">回收：為è¦ä½¿ç‰©è³ªé©åˆé€²ä¸€æ¥ä¹‹ä½¿ç”¨ï¼Œæ‰€ä½œä¹‹ä»»ä½•ç¨‹åºè™•ç†ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">39. </span><span style="font-family: 新細明體,serif;">純化程åºï¼šç‚ºæ昇原料藥或ä¸é–“產å“純度的製程，例如：çµæ™¶ã€è’¸é¤¾ã€æˆ–層æžç‰ã€‚</span> </p><p><span style="font-family: calibri;">40. </span><span style="font-family: 新細明體,serif;">確效：係指有文件è‰æ˜Žçš„行動，能è‰å¯¦ä»»ä½•ç¨‹åºã€è£½ç¨‹ã€æ©Ÿæ¢°è¨å‚™ã€åŽŸæ–™ã€è¡Œå‹•æˆ–系統，切實能導致é 期之效果。</span> </p><p><span style="font-family: calibri;">41. </span><span style="font-family: 新細明體,serif;">確效計畫書：說明將如何執行確效之書é¢è¨ˆç•«æ›¸ï¼Œå…§å®¹åŒ…括予以測試之指標ã€ç”¢å“特質ã€ç”Ÿç”¢è¨å‚™ã€ä»¥åŠæ¸¬è©¦åˆæ ¼ä¹‹åˆ¤å®šæ¨™æº–。</span> </p><p><span style="font-family: calibri;">42. </span><span style="font-family: 新細明體,serif;">製程確效：確èªåŽŸæ–™è—¥ç”¢å“ä¹‹è£½é€ ç¨‹åºåŠå…¶ç®¡åˆ¶æ¢ä»¶ï¼Œå…·æœ‰è‰¯å¥½çš„有效性與å†ç¾æ€§ã€‚</span> </p><p><span style="font-family: calibri;">43. </span><span style="font-family: 新細明體,serif;">先期性確效：為一種原料藥產å“上市å‰æ‰€é€²è¡Œä¹‹ç¢ºæ•ˆæŽªæ–½ï¼Œé©ç”¨ä¸‹åˆ—兩種狀æ³ï¼š</span> </p><p><span style="font-family: calibri;">(1). </span><span style="font-family: 新細明體,serif;">新原料藥產å“：新申請查驗登記之原料藥。</span> </p><p><span style="font-family: calibri;">(2). </span><span style="font-family: 新細明體,serif;">既有原料藥產å“更改</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">或更新</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">製程ã€è£½é€ å ´æ‰€ã€è£½é€ è¨å‚™ç‰è£½é€ æ¢</span> <span style="font-family: 新細明體,serif;">件而å¯èƒ½æœƒé‡å¤§å½±éŸ¿åŽŸæ–™è—¥ç”¢å“之å“質特性者。</span> </p><p><span style="font-family: calibri;">44. </span><span style="font-family: 新細明體,serif;">併行性確效：å°ä¸€ç‰¹å®šåŽŸæ–™è—¥ç”¢å“而言，ä¾ç…§å¯¦éš›ç”Ÿç”¢ä¹‹è¦æ¨¡åŠæ¢ä»¶ï¼Œå°±æ‰€å¯†é›†è£½é€ 之連續數批該原料藥所作之確效。</span> </p><p><span style="font-family: calibri;">45. </span><span style="font-family: 新細明體,serif;">回溯性確效：å°ä¸€ç‰¹å®šåŽŸæ–™è—¥ç”¢å“而言，利用以往生產ã€æ¸¬è©¦èˆ‡ç®¡åˆ¶ä¹‹ç´¯ç©æ•¸æ“šï¼Œå°å·²ä¸Šå¸‚產å“所åšä¹‹ç¢ºæ•ˆï¼Œé€šå¸¸ä»¥é€£çºŒæ•¸æ‰¹ç”¢å“之相關數據行之。</span> </p><p><span style="font-family: calibri;">46. </span><span style="font-family: 新細明體,serif;">é©—è‰ï¼šç‚ºå°æ–¼è¨æ–½åŠè¨å‚™æœ¬èº«ä¹‹æ€§èƒ½ç¢ºèªæœ‰é—œäº‹å®œã€‚é©—è‰æ˜¯è£½ç¨‹ç¢ºæ•ˆçš„一部份（但ä¸ä¾·é™ï¼‰ï¼›å³è¨è¨ˆé©—è‰ã€å®‰è£é©—è‰ï¼Œæ“作驗è‰ï¼Œå’Œæ€§èƒ½é©—è‰ã€‚</span> </p><p><span style="font-family: calibri;">47. </span><span style="font-family: 新細明體,serif;">化å¸å應：乃指一起始物或ä¸é–“產å“，經由化å¸è½‰æ›è€Œç”Ÿæˆä¸€ç¨®æ–°çš„化åˆç‰©</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如：éµä¹‹å½¢æˆã€æ°§åŒ–ã€é‚„原ç‰</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">çš„éŽç¨‹ã€‚</span> </p><p><span style="font-family: calibri;">48. </span><span style="font-family: 新細明體,serif;">é‡è¤‡åŒ–å¸åæ‡‰ï¼šåŠ å…¥æ–°é®®çš„è©¦åŠ‘æˆ–æº¶åŠ‘åˆ°æœªå應物ä¸ï¼Œè€Œä¸”由開始å†é€²è¡Œä¸€æ¬¡åŒ–å¸å應。這些ä¸åŒ…括化å¸å應繼續的進行或在相åŒå®¹å™¨å…§åŠ 入更多的溶劑作延長å應，以確ä¿å應完æˆæˆ–å¢žåŠ åŽŸæ–™è—¥ç”¢çŽ‡å’Œ</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或純度者（如繼續氫化æ¥é©Ÿï¼‰ã€‚</span> </p><p><span style="font-family: calibri;">49. </span><span style="font-family: 新細明體,serif;">物ç†æ“作：係指ä¸ç¶“由化å¸å應而能改變物質純度或物性的製程，包括如çµæ™¶ã€å†çµæ™¶ã€å‡è† éŽæ¿¾ã€å±¤æžã€ç ”磨ã€ä¹¾ç‡¥ã€æˆ–æ··åˆç‰ã€‚</span> </p><p><span style="font-family: calibri;">50. </span><span style="font-family: 新細明體,serif;">é‡è£½ï¼šå°‡ä¸åˆæ¨™æº–或è¦æ ¼ä¹‹ä¸é–“產å“或原料藥，以原製程é‡è¤‡ä¸€å€‹æˆ–更多的æ¥é©Ÿè£½é€ 。而這些æ¥é©Ÿç‚ºå·²ç¶“建立之製程的一部份。</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">例如使用相åŒæº¶åŠ‘進行å†çµæ™¶</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">51. </span><span style="font-family: 新細明體,serif;">å†è£½ï¼šå°æ–¼ä¸ç¬¦åˆæ¨™æº–或è¦æ ¼ä¹‹ä¸é–“產å“或原料藥，å†ç”¨èˆ‡å·²å»ºç«‹ä¹‹è£½ç¨‹ä¸åŒä¹‹æ¥é©Ÿè£½é€ 。例如：使用ä¸åŒæº¶åŠ‘進行å†çµæ™¶ã€‚</span> </p><p><span style="font-family: calibri;">52. </span><span style="font-family: 新細明體,serif;">有效期間：在原料藥容器</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">標籤上標明之日期，è¨è¨ˆåœ¨æ¤æ™‚é–“ä¸ï¼ŒåŽŸæ–™è—¥å¦‚æžœä¾ç‰¹å®šçš„æ¢ä»¶å„²å˜ï¼Œå‰‡å¯ä¿æŒç¬¦åˆæ‰€å»ºç«‹çš„è¦æ ¼å…§ï¼›è€Œåœ¨æœ‰æ•ˆæœŸé–“外則ä¸æ‡‰è¢«ä½¿ç”¨ã€‚</span> </p><p><span style="font-family: calibri;">53. </span><span style="font-family: 新細明體,serif;">å†é©—日期：為確ä¿åŽŸæ–™è—¥ä»é©åˆä½¿ç”¨ï¼Œé ˆå†æª¢é©—之日期。</span> </p><p><span style="font-family: calibri;">54. </span><span style="font-family: 新細明體,serif;">å†é©—期間：原料藥如果儲å˜åœ¨ç‰¹å®šæ¢ä»¶ä¸‹ï¼Œå¯è¢«èªç‚ºç¬¦åˆè¦æ ¼è€Œå¯ç”¨æ–¼è£½é€ è—¥å“之期間。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">è²³ã€ç’°å¢ƒè¡›ç”Ÿ</span> </p><p><span style="font-family: 新細明體,serif;">一ã€</span> <span style="font-family: 新細明體,serif;">應有書é¢ä½œæ¥ç¨‹åºæŒ‡æ´¾è² 責衛生相關作æ¥çš„äººå“¡ï¼Œä¸¦ä¸”è©³è¿°æœ‰é—œå» æˆ¿åŠè¨æ–½ä¹‹æ¸…潔的時程ã€æ–¹æ³•ã€è¨å‚™ã€åŠä½¿ç”¨æ–¼æ¸…潔的物質。該書é¢ç¨‹åºæ‡‰äºˆä»¥éµå¾ªã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ ã€åŠ å·¥ã€åŒ…è£æˆ–儲å˜ä¸é–“產å“åŠåŽŸæ–™è—¥çš„å» æˆ¿ï¼Œæ‡‰ä¿æŒæ¸…æ½”åŠè¡›ç”Ÿã€‚å» æˆ¿æ‡‰é¿å…è€é¼ ã€é³¥é¡žã€æ˜†èŸ²ã€åŠå…¶ä»–害蟲的出沒。污水ã€åžƒåœ¾åŠå…¶ä»–廢棄物應å³æ™‚以安全衛生的方å¼è™•ç½®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€</span> <span style="font-family: 新細明體,serif;">應有書é¢ä½œæ¥ç¨‹åºè¦ç¯„é©ç•¶çš„ä½¿ç”¨æ»…é¼ è—¥ã€æ®ºèŸ²åŠ‘ã€æ®ºèŒåŠ‘ã€æ¶ˆæ¯’劑ã€æ¸…æ½”åŠè¡›ç”Ÿç”¨è—¥åŠ‘。應防æ¢ä¸Šè¿°è—¥åŠ‘污染è¨å‚™ã€åŽŸæ–™ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“或原料藥，並應切實執行。經ä¸å¤®ä¸»ç®¡æ©Ÿé—œè¨»å†Šè¨±å¯ä¹‹æ»…é¼ è—¥ã€æ®ºèŸ²åŠ‘ã€åŠæ®ºèŒåŠ‘始得使用。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€</span> <span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥å» å°æœ‰å®³å»¢æ£„物ã€æœ‰æ¯’容器ã€æœ‰å®³æ°£é«”ã€ç²‰å¡µã€å»¢æ°´åŠç”Ÿç‰©æ€§æˆåˆ†ç‰ï¼Œæ‡‰ä¾ç›¸é—œä¸»ç®¡å–®ä½è¦å®šè™•ç†ï¼›å…¶åŽŸå‰‡å¦‚下：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">有害廢棄物åŠæœ‰æ¯’容器ç‰ï¼Œæ‡‰è¨å°ˆç”¨å„²å˜å ´æ‰€åŠ 以收集，並ä¾å…¶æ€§è³ªåŠ 以分解後，予以é©ç•¶ç„šåŒ–或掩埋處ç†ã€‚有毒容器如予利用，應經é©ç•¶æ¸…æ´—ï¼Œä¸¦æ‡‰åš´åŠ ç®¡åˆ¶ï¼Œä¸å¾—作為食å“容器。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">有害氣體或粉塵，應è¨ç½®å¯†é–‰è¨å‚™èˆ‡å±€éƒ¨æŽ’æ°£è£ç½®åŠè² 壓æ“作予以收集，並應ä¾å…¶æ€§è³ªäºˆä»¥æ´—滌ã€å¸æ”¶ã€æ°§åŒ–ã€é‚„原ã€ç‡ƒç‡’或其他有效處ç†ï¼Œå…¶å»¢æ°£ä¸å«æœ‰ç²‰å¡µè€…，並應先予離心ã€éŽæ¿¾ã€æ´—滌ç‰é™¤å¡µè™•ç†æŽ’氣並應符åˆç©ºæ°£æ±¡æŸ“物排放標準之è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">廢水之處ç†ï¼Œæ‡‰å…·å‚™è¶³å¤ 容ç©ä¹‹ä¸æ»²æ€§è²¯æ± ï¼Œä¸¦åŠ è¨é…¸åŒ–ã€é¹¼åŒ–ã€ä¸å’Œã€æ´»æ€§ç¢³å¸é™„或其他有效處ç†ï¼Œéš¨æ™‚ç¶æŒæ£å¸¸æ“ä½œï¼Œä»¥ç ´å£žæˆ–åŽ»é™¤å»¢æ°´ä¸æ®˜ç•™æœ‰æ¯’æˆåˆ†ï¼Œæ”¾æµæ°´ä¸¦æ‡‰ç¬¦åˆæ”¾æµæ°´æ¨™æº–之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åƒã€å» 房與è¨æ–½</span> </p><p><span style="font-family: 新細明體,serif;">一ã€</span> <span style="font-family: 新細明體,serif;">è¨è¨ˆåŠå»ºé€ </span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ ã€åŠ å·¥ã€åˆ†åŒ…è£ã€æˆ–儲å˜ä¸é–“產å“æˆ–åŽŸæ–™è—¥çš„å» æˆ¿ï¼Œå‡æ‡‰æœ‰é©ç•¶çš„è¨è¨ˆã€å¤§å°ã€å»ºé€ åŠä½ç½®ï¼Œæ‡‰æ˜“æ–¼æ“作ã€æ¸…æ½”åŠç¶è·ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ä»»ä½•å» æˆ¿æ‡‰æœ‰é©ç•¶çš„空間，以利è¨å‚™åŠæ‰€æœ‰åŽŸæ–™ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“或原料藥有秩åºçš„置放，以防æ¢æ··é›œåŠæ±¡æŸ“。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“åŠåŽŸæ–™è—¥åœ¨å» 房內的æ¬é‹é€šè·¯ï¼Œæ‡‰å–„åŠ è¨è¨ˆï¼Œä»¥é¿å…混雜和污染。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">下列作æ¥å ´æ‰€ï¼Œæ‡‰æœ‰ç‰¹å®šçš„å€åŸŸå’Œç®¡åˆ¶ç³»çµ±ï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">刪除</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">å’Œä¸é–“產å“的驗收ã€é‘‘定ã€å„²å˜ã€æ‹’用和准用之放行審查；</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">儲å˜æ”¾è¡Œä¹‹åŽŸæ–™ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“åŠåŽŸæ–™è—¥ï¼›</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">ä¸é–“產å“åŠåŽŸæ–™è—¥å–樣作æ¥ï¼›</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">拒用之原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“åŠåŽŸæ–™è—¥è™•ç½®å‰ä¹‹å˜æ”¾ï¼›</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">è£½é€ åŠåŠ 工作æ¥ï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">包è£åŠæ¨™ç¤ºä½œæ¥ï¼›</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“放行é‹éŠ·å‰ä¹‹éš”離儲å˜ï¼›</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">實驗室的作æ¥ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å·¥ä½œå ´æ‰€å¤–æ‡‰è¨ä¼‘æ¯å®¤ã€æµ´å®¤ç‰ä¾›å“¡å·¥ä½¿ç”¨ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°æ–¼æœ‰å¾®ç”Ÿç‰©é™é‡è¦æ ¼ä¹‹åŽŸæ–™è—¥ï¼Œå…¶ä½¿ç”¨è¨æ–½æ‡‰å…·é™åˆ¶æœ‰å®³å¾®ç”Ÿç‰©æ±¡æŸ“之è¨è¨ˆã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å¯¦é©—å®¤é€šå¸¸èˆ‡è£½é€ å€åˆ†é–‹ï¼Œæœ‰äº›å¯¦é©—室，特別是用於製程管制者，如果生產製程ä¸å½±éŸ¿å¯¦é©—室測試者，å¯è€ƒæ…®è¨åœ¨è£½é€ 作æ¥å ´æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¨æ–½</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有的è¨æ–½æ‡‰ç¬¦åˆä½¿ç”¨è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">é‡è¦è¨æ–½ï¼ˆå¦‚製程空調åŠæ°´ç³»çµ±ï¼‰æ‡‰å®šæ™‚監測，以確定符åˆè¦æ ¼ã€‚當超éŽç•Œå®šä¹‹æ¥µé™æ™‚，應採å–é©ç•¶çš„行動。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應ä¾é©ç•¶éœ€è¦è¨ç½®é€šé¢¨ç³»çµ±ï¼Œä¸¦åŒ…括控制空氣壓力ã€å¾®ç”Ÿç‰©ã€ç²‰å¡µã€æ¿•åº¦åŠæº«åº¦ä¹‹è¨å‚™ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥暴露之生產環境å€åŸŸï¼Œæ‡‰æœ‰é©ç•¶çš„空氣éŽæ¿¾ã€ç²‰å¡µæ”¶é›†å’ŒæŽ’氣系統，以控制空氣微粒åŠäº¤å‰æ±¡æŸ“。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">生產å€çš„空氣如有循環，應有é©ç•¶çš„監測以控制污染或交å‰æ±¡æŸ“。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">作æ¥ç®¡ç·šæ‡‰æœ‰é˜²é½ã€é˜²æ¢è¡¨é¢æ²ˆç©åŠé˜²æ¢æ´©æ¼çš„措施，以é¿å…原料藥被污染。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">排水è¨å‚™ä¹‹æŽ’水管應具有é©ç•¶å¤§å°ï¼ŒæŽ’æ°´å£æ‡‰æœ‰é˜²æ¢æ±¡æ°´å›žæµä¹‹è£ç½®ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">任何用於原料藥或ä¸é–“產å“ä¹‹è£½é€ ã€åŠ 工或貯å˜ç‰©ä¹‹å»ºç¯‰ç‰©ï¼Œæ‡‰æœ‰é©ç•¶çš„ç¶è·åŠç¶ä¿®ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ±¡æŸ“管制</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">生產æ¯ä¸€ç¨®æ•æ„Ÿæ€§åŽŸæ–™è—¥ï¼Œå¦‚é’é»´ç´ é¡žå’Œé å¢åèŒç´ é¡žï¼Œæ‡‰æœ‰å®Œå…¨éš”é–‹ä¹‹å» æˆ¿ï¼Œå…¶ç©ºæ°£è™•ç†ç³»çµ±ã€æ°´åŠè¨å‚™æ‡‰èˆ‡å…¶ä»–原料藥之系統應予ç¨ç«‹ï¼ŒåŒæ™‚建立é©ç•¶é‡æ¸¬ç´€éŒ„並防æ¢äººå“¡åœ¨ä¸åŒå€åŸŸæ´»å‹•ç”¢ç”Ÿä¹‹äº¤å‰æ±¡æŸ“。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">高藥ç†æ´»æ€§æˆ–毒性之原料藥，例如æŸäº›é¡žå›ºé†‡åŠå…·ç´°èƒžæ¯’性之抗癌藥物，亦應考慮使用單ç¨ä¹‹è¨æ–½ï¼Œä»¥é¿å…污染。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">肆ã€è¨å‚™</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¨è¨ˆåŠå»ºé€ </span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç”¨æ–¼è£½é€ ã€åŠ å·¥ã€åˆ†åŒ…è£åŠå„²å˜ä¸é–“產å“和原料藥之è¨å‚™ï¼Œæ‡‰æœ‰é©ç•¶çš„è¨è¨ˆã€å¤§å°ï¼Œä»¥æ–¹ä¾¿ä½¿ç”¨æ“作ã€æ¸…æ½”åŠç¶è·ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨å‚™å»ºé€ 時，和原料ã€ä¸é–“產å“或原料藥直接接觸的表é¢ï¼Œæ‡‰ä¸å…·æœ‰å應性ã€åŠ æˆæ€§ã€æˆ–å¸æ”¶æ€§ï¼Œä¸æœƒæ”¹è®Šä¸é–“產å“åŠåŽŸæ–™è—¥ä¹‹æ—¢å®šè¦æ ¼çš„å“質。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">任何作æ¥æ‰€éœ€ç‰©å“，如：潤滑劑ã€ç†±åª’或冷å‡åŠ‘ç‰ï¼Œå‡ä¸å¾—與原料ã€åŒ…è£ææ–™ã€ä¸é–“產å“或原料藥直接接觸，以å…影響ä¸é–“產å“åŠåŽŸæ–™è—¥ä¹‹å“質與安全。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨å‚™è¨è¨ˆã€å»ºé€ ã€åŠå®‰è£æ‡‰é¡§åŠæ¸…洗時方便性；若有需è¦äº¦æ‡‰è€ƒæ…®æ»…èŒçš„方便性。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨å‚™å®œæŽ¡å¯†é–‰ç³»çµ±ï¼ŒæŽ¡é–‹æ”¾æ™‚應é¿å…éå—污染。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨å‚™é©—è‰</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">è¨å‚™æ‡‰ä¾æ“šæ ¸å¯çš„è¨è¨ˆè¦æ ¼ã€æ³•è¦è¦å®šå’Œè¨å‚™è£½é€ å» å•†ä¹‹å»ºè°å®‰è£ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">應ä¾æ“šè£½ç¨‹å»ºç«‹è¨å‚™æ“作的é™åˆ¶åŠå®¹å¿åº¦ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">主è¦è¨å‚™å’Œå®‰è£ä¹‹ç¾è¡Œå»ºé€ 圖，應予ä¿å˜ï¼›</span> </p><p><span style="font-family: 新細明體,serif;">二ã€</span> <span style="font-family: 新細明體,serif;">清潔åŠç¶è·</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥çš„è£½é€ ã€åŠ å·¥ã€åˆ†åŒ…è£ã€æˆ–儲å˜æ‰€ä½¿ç”¨çš„è¨å‚™ï¼ŒåŒ…括器具，應建立清洗åŠç¶è·çš„書é¢ç¨‹åºä¸¦éµå¾ªä¹‹ã€‚這些程åºè‡³å°‘應包括以下之å„é …ï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">應指派è¨å‚™æ¸…æ½”åŠç¶è·è²¬ä»»äººå“¡ï¼›</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">建立清潔åŠç¶è·çš„時間表，並應包括需è¦æ¶ˆæ¯’之è¨å‚™çš„消毒時間表；</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">清潔åŠç¶è·æ–¹æ³•å’Œä½¿ç”¨æ¸…潔劑之說明，必è¦æ™‚è¦æœ‰æ‹†å¸åŠè£ç½®å„è¨å‚™é›¶ä»¶ä¹‹æ–¹æ³•ï¼Œä»¥ç¢ºä¿é©ç•¶ä¹‹æ¸…æ½”åŠç¶è·ï¼›</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">去除或擦去先å‰æ‰¹æ¬¡ä¹‹è˜åˆ¥æ¨™èªŒï¼›</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">防æ¢å·²æ¸…潔之è¨å‚™åœ¨ä½¿ç”¨å‰è¢«æ±¡æŸ“ï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">è¨å‚™ä½¿ç”¨å‰æ‡‰åšæ¸…潔檢查；</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">è¨å®šè£½é€ 完æˆå’Œè¨å‚™æ¸…潔間隔的最長時間。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">當è¨å‚™ç”¨æ–¼ç”Ÿç”¢åŒä¸€ä¸é–“產å“或原料藥時，在é©ç•¶æ™‚間間隔應予以清潔，以防æ¢ç‰¹å®šç‰©è³ªæˆ–微生物滋長。在接近原料藥最後的純化æ¥é©Ÿï¼Œå¿…é ˆç¢ºä¿é¿å…批次間的相互污染，ä¸æœƒå½±éŸ¿æœ€å¾Œæ—¢å®šä¹‹ä¸ç´”物æ述是很é‡è¦çš„。然而，通常上述的情形ä¸é©ç”¨æ–¼ç”Ÿç‰©æ€§åŽŸæ–™è—¥ï¼Œå› ç‚ºè¨±å¤šè£½é€ æ¥é©Ÿä¿‚在無èŒçš„情æ³ä¸‹é€²è¡Œï¼Œæ‰€ä»¥æ¯å€‹æ‰¹æ¬¡é–“，è¨å‚™å¿…é ˆåŠ ä»¥æ¸…æ´—å’Œæ»…èŒã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç”¨ä»¥è£½é€ ä¸åŒç”¢å“之è¨å‚™ï¼Œæ‡‰æ–¼ç”Ÿç”¢ä¸åŒç”¢å“時徹底清潔，以é 防污染和交å‰æ±¡æŸ“。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è‹¥å¿…é ˆæŽ¡ç”¨å›°é›£æ¸…æ´—çš„ç‰¹æ®Šè¨å‚™çš„ä¸é–“產å“或原料藥，需è¦å°ˆç”¨è¨å‚™ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">清潔方法ã€æ¸…潔劑ã€åŠæ¸…潔度的é¸æ“‡æ‡‰æ˜Žç¢ºä¸”é©ç•¶ã€‚清潔劑</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如：溶劑</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">çš„é¸æ“‡æ‡‰ä¾æ“šä¸‹åˆ—原則：</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">清潔劑å°åŽŸæ–™ã€å…ˆé©…物ã€å‰¯ç”¢ç‰©åŠä¸é–“產å“或原料藥ç‰æ®˜ç•™ç‰©çš„清除能力。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">清潔劑是å¦æœƒæ®˜ç•™ã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">與è¨å‚™æ質的相容性。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€æ ¡æ£</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">用以管制ã€ç›£æ¸¬åŠæª¢é©—以ä¿è‰æœ€å¾ŒåŽŸæ–™è—¥å“質之é‡è¦è¨å‚™ï¼Œæ‡‰ä¾æ›¸é¢ä½œæ¥ç¨‹åºåšå®šæœŸæ ¡æ£ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨å‚™æ ¡æ£æ‡‰ä½¿ç”¨å¯è¿½æº¯ä¹‹æœ‰ä¿è‰çš„標準å“。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ ¡æ£ç´€éŒ„應予ä¿å˜ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨å‚™æ ¡æ£ç¾æ³çš„標示應明顯易見。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">未符åˆæ ¡æ£ä½¿ç”¨æ¨™æº–之è¨å‚™ä¸æ‡‰ä½¿ç”¨ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ ¡æ£çµæžœèˆ‡æ ¸å¯æ¨™æº–有å差時，應予以調查，以了解其是å¦æœƒå°æœ€å¾Œä¹‹åŽŸæ–™è—¥å“è³ªé€ æˆå½±éŸ¿ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€é›»è…¦ç³»çµ±</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">自動å¼ã€æ©Ÿæ¢°å¼ã€æˆ–é›»åå¼è£½é€ è¨å‚™ã€æˆ–其他形å¼çš„è¨å‚™ï¼ŒåŒ…括用於ä¸é–“產å“æˆ–åŽŸæ–™è—¥è£½é€ çš„é›»è…¦ï¼Œæ‡‰åšå®šæœŸä¹‹æ ¡æ£ã€æŸ¥é©—ã€æˆ–檢查，以確ä¿æ£å¸¸çš„åŠŸèƒ½ã€‚æ ¡æ£åŠæª¢æŸ¥çš„çµæžœå‡æ‡‰ä¿å˜æ›¸é¢ç´€éŒ„。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">電腦系統應有之書é¢ä½œæ¥ç¨‹åºè‡³å°‘應å«</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">系統æ“作；</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">系統驗è‰å’Œç¢ºæ•ˆï¼›</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">ä¸æ£å¸¸é‹ä½œä¸‹æ‡‰çŸ¯æ£çš„æ¥é©Ÿï¼›</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">檢測和紀錄錯誤，和執行矯æ£ï¼›</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">å†é–‹å§‹åŸ·è¡ŒåŠå›žå¾©æ•¸æ“šï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">授權åŠåŸ·è¡Œï¼›</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">紀錄之改變；</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">é›»åç°½å</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">使用電åç°½å者</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">系統應予以é©ç•¶çš„安è£é©—è‰èˆ‡æ“作驗è‰ï¼Œä»¥é¡¯ç¤ºé›»è…¦ä¹‹è»Ÿç¡¬é«”é©ç”¨æ–¼æŒ‡å®šä¹‹åŠŸèƒ½ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">確效之深度åŠç¯„åœæ˜¯åŸºæ–¼é›»è…¦ç³»çµ±æ‡‰ç”¨ä¹‹ç”¨é€”多寡ã€è¤‡é›œæ€§åŠé‡è¦æ€§ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">已驗è‰ä¹‹å…¬ç”¨è»Ÿé«”ç„¡é ˆå†åŸ·è¡Œç›¸åŒå±¤æ¬¡ä¹‹æ¸¬è©¦ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ‰€æœ‰é›»è…¦ç³»çµ±æ‡‰æœ‰è¶³å¤ çš„ç®¡åˆ¶ï¼Œä»¥é˜²æ¢éžæ¬Šè²¬äººå“¡é€²å…¥æˆ–改變軟體數據或電腦硬體。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">é‡è¦æ•¸æ“šä»¥äººå·¥è¼¸å…¥è€…，應å¦å¤–æŸ¥æ ¸è¼¸å…¥ä¹‹æ£ç¢ºæ€§ã€‚æ¤æŸ¥æ ¸å¯ç”±å¦ä¸€æ“作員或系統本身執行。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有å°é›»è…¦ç³»çµ±æ‰€ä½œçš„改變，應由æ£å¼çš„授權人員執行ã€æ–‡ä»¶åŒ–åŠæ¸¬è©¦ã€‚所有改變；包括硬體ã€è»Ÿé«”和其他é‡è¦çµ„æˆä¹‹ä¿®æ£å’ŒåŠ 強，應予ä¿ç•™ç´€éŒ„，以顯示修改後之系統ä»ç¶æŒåœ¨ç¢ºæ•ˆçš„情æ³ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">ä¹</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有改變應經éŽå“質管制單ä½ä¹‹æ ¸å¯ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç³»çµ±ç•¶æ©Ÿæˆ–å¤±æ•ˆæœƒé€ æˆé‡è¦ç´€éŒ„數據永久失去者，應æ供備用系統。</span> </p><p><span style="font-family: 新細明體,serif;">ä¼ã€</span> <span style="font-family: 新細明體,serif;">組織與人事</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€è³‡æ ¼</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應é…ç½®æœ‰è¶³å¤ çš„åˆæ ¼äººå“¡ä»¥åŸ·è¡ŒåŠç£å°Žæ¯ä¸€åŽŸæ–™è—¥çš„è£½é€ ã€åŠ å·¥ã€åŒ…è£ã€å„²å˜ã€æˆ–å“質檢驗之作æ¥ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥å» å„éƒ¨é–€è² è²¬äººã€ç£å°Žäººå“¡åŠå“¡å·¥å‡æ‡‰å…·å‚™é©ç•¶ä¹‹å¸è˜ã€ç¶“驗，並接å—åƒèˆ‡åŸ·è¡ŒæŒ‡å®šå·¥ä½œä¹‹å¯¦å‹™æ•™è‚²è¨“練。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">訓練課程應涵蓋員工所執行的特定作æ¥ï¼Œä»¥åŠèˆ‡å“¡å·¥è·è²¬ç›¸é—œçš„ç¾è¡Œè—¥å“å„ªè‰¯è£½é€ è¦ç¯„。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¡›ç”Ÿ</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">作æ¥äººå“¡æ‡‰æœ‰è‰¯å¥½çš„衛生åŠå¥åº·çš„æ“作習慣。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">作æ¥äººå“¡æ‡‰ç©¿æˆ´æ¸…潔之ä¿è·æ€§é…備，如：é ã€è‡‰ã€æ‰‹åŠè‡‚ç‰è¦†è“‹ï¼Œä»¥é˜²æ¢åŽŸæ–™è—¥åŠä¸é–“產å“éå—污染。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">作æ¥äººå“¡æ‡‰é¿å…直接接觸原料藥或ä¸é–“產å“。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å¸è¸ã€é£²é£Ÿã€å–飲料和食物儲å˜ï¼Œæ‡‰é™åˆ¶åœ¨ç‰¹å®šä¹‹éžç”Ÿç”¢æˆ–管制å€ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">任何人員感染傳染性的疾病或具開放性創å£ï¼Œä¸æ‡‰åƒèˆ‡å¯èƒ½å°åŽŸæ–™è—¥å“質產生ä¸åˆ©å½±éŸ¿çš„作æ¥ã€‚若有員工發生æ¤ç¨®å¥åº·ä¸ä½³ç‹€æ³ï¼Œæ‡‰å‘ä¸Šç´šäººå“¡å ±å‘Šã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åªæœ‰ç²å¾—ç£å°Žäººå“¡åŒæ„者，æ‰å¯ä»¥é€²å…¥è¢«è¨å®šç‚ºé™åˆ¶å€çš„å» æˆ¿åŠè¨æ–½å ´æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é¡§å•</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æŒ‡å°Žè£½é€ ã€åŠ å·¥ã€åŒ…è£ã€æˆ–儲å˜åŽŸæ–™è—¥æˆ–ä¸é–“產å“的顧å•ï¼Œå°æ‰€è˜ä»»æŒ‡å°Žçš„é …ç›®ï¼Œæ‡‰æ›¾æŽ¥å—éŽå……分的教育ã€è¨“練或具備é©ç•¶çš„經驗。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">顧å•çš„姓åã€åœ°å€ã€è³‡æ ¼èªå®šåŠæ‰€æ供的æœå‹™é …ç›®ï¼Œéœ€åŠ ä»¥ç´€éŒ„ä¸¦ä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">陸ã€åŽŸæ–™ç®¡åˆ¶</span> </p><p><span style="font-family: 新細明體,serif;">一ã€åŽŸæ–™ç®¡ç†</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">一般管制</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">應有書é¢ç¨‹åºè©³è¨‚原料的購買ã€æŽ¥æ”¶ã€é‘‘定ã€éš”離ã€å„²å˜ã€è™•ç†ã€å–樣ã€æ¸¬è©¦ã€åŠæ ¸å‡†æˆ–拒收ç‰ä½œæ¥ç¨‹åºï¼Œä¸¦æ‡‰åˆ‡å¯¦åŸ·è¡Œã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">若有é©ç•¶çš„è‰æ“šé¡¯ç¤ºä¾›æ‡‰å•†èƒ½ç©©å®šçš„æ供符åˆè¦æ ¼çš„原料，則由供應商æä¾›å“質分æžè‰æ˜Žï¼Œé™¤é‘‘別試驗外，自行檢驗的é‡å¯ä»¥é…Œäºˆæ¸›å…。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">è£½é€ å•†æ‡‰æœ‰ç”¨ä»¥è©•ä¼°é‡è¦åŽŸæ–™ä¾›æ‡‰å•†ä¹‹ç³»çµ±ã€‚若變更供應商應ä¾æœ¬åŸºæº–「變更管制ã€ç« 節相關è¦å®šåŸ·è¡Œã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">接收åŠéš”離</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">在收到原料但尚未驗收å‰ï¼Œæ‡‰å…ˆç›®è¦–檢查æ¯æ¡¶æˆ–æ¯æ‰¹åŽŸæ–™æ˜¯å¦å·²æœ‰æ£ç¢ºçš„標示，桶身是å¦ç ´æ或å°æ¢æ˜¯å¦æœ‰ç ´è£‚ã€é©ç•¶çš„填塞物åŠæ±¡æŸ“ç‰ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">個別桶或相åŒæ‰¹æ¬¡ä¹‹å¤šæ¡¶åŽŸæ–™ï¼Œæ‡‰çµ¦äºˆå€‹åˆ¥çš„代碼ã€æ‰¹è™Ÿæˆ–驗收的號碼。這些代碼å¯ç”¨ä¾†è¨˜éŒ„æ¯æ‰¹åŽŸæ–™æ”¾ç½®çš„地點。應有系統辨è˜æ¯æ‰¹åŽŸæ–™ä¹‹ç‹€æ³ã€‚儲å˜åŽŸæ–™çš„大型容器åŠå…¶é™„屬物和洩料管線應有é©ç•¶çš„標示。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">若原料之é‹é€ä¸æ˜¯æŽ¡ç”¨å°ˆç”¨å®¹å™¨ï¼Œæ‡‰ç¢ºä¿å®¹å™¨æœªé交å‰æ±¡æŸ“。æ„å³æ‡‰æä¾›è‡³å°‘ä¸‹åˆ—ä¸€é …è³‡æ–™ä¾†ä¿è‰ä¹‹ï¼š</span> </p><p><span style="font-family: calibri;">(1). </span><span style="font-family: 新細明體,serif;">清潔è‰æ˜Žæ–‡ä»¶</span> </p><p><span style="font-family: calibri;">(2). </span><span style="font-family: 新細明體,serif;">å¾®é‡ä¸ç´”物檢驗</span> </p><p><span style="font-family: calibri;">(3). </span><span style="font-family: 新細明體,serif;">供應商稽查紀錄</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å–樣和檢驗</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å–樣數目åŠé …ç›®ï¼Œæ‡‰æ ¹æ“šé©ç•¶çš„標準。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å–樣應在特定å€åŸŸå…§æ“作，且應è¨è¨ˆåŸ·è¡Œçš„æ¥é©Ÿï¼Œä»¥é˜²æ¢å–樣的樣å“或其他的原料éå—污染。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">被å–樣的容器應å°å¿ƒçš„打開，並隨後å°ä¸Šï¼Œä¸¦æ‡‰æ¨™ç¤ºç‚ºå·²è¢«å–樣。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ¯ä¸€ç¨®åŽŸæ–™è‡³å°‘應執行鑑別之確èªæ¸¬è©¦ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">若無法å–å¾—å¯ä¿¡è³´çš„分æžè‰æ˜Žæ›¸ï¼Œæ‡‰åŸ·è¡Œå®Œæ•´çš„分æžæ¸¬è©¦ã€‚æ‡‰å®šæœŸæŸ¥æ ¸åˆ†æžè‰æ˜Žæ›¸çš„å¯ä¿¡è³´åº¦ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°æ–¼å…·å±éšªæ€§æˆ–劇毒性的原料，若已å‘供應商å–得分æžè‰æ˜Žæ›¸ï¼Œä»¥è‰æ˜Žè©²åŽŸæ–™ç¬¦åˆè¦æ ¼ï¼Œå‰‡ä¸é ˆå†æª¢é©—。經由目視檢查原料桶ã€æ¨™ç¤ºåŠæ‰¹è™Ÿç´€éŒ„，亦有助於辨èªå±éšªæ€§æˆ–劇毒性的原料。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">儲å˜æ–¼å¤§å®¹å™¨ä¸ä¹‹åŽŸæ–™æ‡‰å®šæœŸå†è©•ä¼°ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ¯ä¸€æ‰¹æ¬¡ä¹‹å†å›žæ”¶æº¶åŠ‘使用å‰æ‡‰å†æª¢é©—，以確èªç¬¦åˆåŽŸè£½ç¨‹æˆ–後續應用之è¦æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å„²å˜</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料的處置åŠå„²å˜ï¼Œæ‡‰é¿å…變質åŠç™¼ç”Ÿäº¤å‰æ±¡æŸ“。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">袋è£æˆ–ç®±è£çš„原料應離地儲å˜ï¼Œä¸”有é©ç•¶çš„置放空間，以利清潔åŠæª¢é©—。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">儲å˜æ–¼å®¤å¤–之原料應使用é©ç•¶çš„容器，供è˜åˆ¥ä¹‹æ¨™ç¤ºæ‡‰ä¿æŒæ¸…晰易讀。使用å‰å®¹å™¨æ‡‰é©åº¦æ¸…潔以防æ¢æ±¡æŸ“。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">在測試或檢驗和å“質管制部門放行使用å‰ï¼ŒåŽŸæ–™æ‡‰éš”離處ç†ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">准用之原料應儲å˜æ–¼æŽ§åˆ¶æ¢ä»¶ä¸‹ï¼Œä¸¦èª¿åº¦ä½¿å…ˆé€²å…ˆç”¨ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">拒用之原料應放置於隔離空間且應標示åŠç®¡åˆ¶ï¼Œä»¥é˜²æ¢å…¶åœ¨è£½é€ æˆ–åŠ å·¥æ“作ä¸è¢«èª¤ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å›žæ”¶æº¶åŠ‘ã€æ¯æ¶²åŠå›žæ”¶ç”¢ç‰©ä¹‹ç®¡åˆ¶</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">回收溶劑ã€æ¯æ¶²ã€äºŒæ¬¡å›žæ”¶ç”¢ç‰©æˆ–其他原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºæ料之回收，應訂定書é¢ä½œæ¥ç¨‹åºï¼Œå…¶å…§å®¹æ‡‰åŒ…å«é©ç•¶çš„檢驗和管制，以確ä¿å›žæ”¶åŽŸæ–™ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºæ料符åˆæ–¼è£½é€ åŠ å·¥æ¨™æº–ï¼Œä¸”ä¸å½±éŸ¿åŽŸæ–™è—¥å’Œä¸é–“產å“çš„å“質。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">使用回收溶劑ã€æ¯æ¶²å’Œå…¶ä»–å›žæ”¶ç‰©è³ªæ‡‰åœ¨æ‰¹æ¬¡è£½é€ ç´€éŒ„ä¸æœ‰é©ç•¶ä¹‹ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ‹’用</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“ã€åŽŸæ–™è—¥ä¸èƒ½ç¬¦åˆæ—¢å®šè¦æ ¼æ‡‰äºˆæ‹’用，被拒用者應予註明åŠéš”離。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">拒用之處置應予記錄。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">當一個批次之原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“ã€åŽŸæ–™è—¥è¢«æ‹’用，應評估其他的批次是å¦ä¹Ÿæœƒå—相åŒçš„影響。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€æ°´</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥è£½é€ ä½¿ç”¨ä¹‹æ°´åŠè’¸æ±½ï¼Œæ‡‰è‰æ˜Žå¯ç¬¦åˆä½¿ç”¨æ¨™æº–åŠä¸å½±éŸ¿åŽŸæ–™è—¥çš„å“質。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è‹¥ç‚ºç›´æŽ¥åŠ å…¥åŽŸæ–™è—¥è£½ç¨‹ä¹‹è’¸æ±½ï¼Œæ‡‰æœ‰é©ç•¶ä¸”ç¶“æ ¸å¯çš„è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應用於製程åˆæœŸæ¥é©Ÿä¹‹æ°´è³ªï¼Œè‡³å°‘應符åˆåœ‹å®¶è‡ªä¾†æ°´æ¨™æº–。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">在é‡è¦ä¹‹æ¥é©Ÿ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">例如最後分離和çµæ™¶</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，或在早期之æ¥é©Ÿä¹‹ç”¨æ°´ä¸å˜æœ‰å½±éŸ¿åŽŸæ–™è—¥å“質之ä¸ç´”物，且最後æ¥é©Ÿç„¡æ³•åŽ»é™¤çš„ç‹€æ³ä¸‹ï¼Œé ˆæœ‰è¼ƒç‚ºåš´æ ¼ä¹‹åŒ–å¸å’Œå¾®ç”Ÿç‰©ä¹‹æ°´è³ªè¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">處ç†æ°´è³ªé”到è¨å®šè¦æ ¼ä¹‹ç¨‹åºéœ€äºˆä»¥ç¢ºæ•ˆåŠç›£æ¸¬ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç”¨æ–¼è£½é€ éžç¶“è…¸é“è—¥å“之éžç„¡èŒåŽŸæ–™è—¥ï¼Œå…¶ç”¨æ–¼æœ€å¾Œåˆ†é›¢ç´”åŒ–ä¹‹æ°´è³ªï¼Œæ‡‰äºˆç›£æ¸¬å’ŒæŽ§åˆ¶å¾®ç”Ÿç‰©è² è·é‡åŠå…§æ¯’ç´ ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">柒ã€è£½é€ åŠè£½ç¨‹ç®¡åˆ¶</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è£½é€ 管制</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ åŠè£½ç¨‹ç®¡åˆ¶æ‡‰è¨‚定書é¢ä¹‹è£½é€ 管制標準書，並應切實執行。訂定標準書之目的在於確ä¿åŽŸæ–™è—¥åŠä¸é–“產å“之å“質åŠç´”度。æ¤æ¨™æº–æ›¸æ‡‰èªªæ˜Žåœ¨è£½é€ çš„æ¯ä¸€å€‹éŽç¨‹ä¸ä¹‹åŽŸæ–™ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“和原料藥的製程管制ã€æ¸¬è©¦æˆ–檢驗。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼Œæ‡‰ç¶“å“質管制部門審查åŠæ ¸å¯ã€‚生產åŠè£½é€ 應éµå¾ªæ›¸é¢æ¨™æº–書而且製程的控制應在生產æ“作時立å³äºˆä»¥è¨˜éŒ„，與書é¢ç¨‹åºä¹‹å差應記錄並說明。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ åŽŸæ–™è—¥æˆ–ä¸é–“產å“æ‰€ä½¿ç”¨çš„åŽŸæ–™ï¼Œæ‡‰åŠ ä»¥ç¨±é‡æˆ–é‡æ¸¬ï¼Œä¸¦æ‡‰ç¶æŒå…¶çµ„æˆã€å“質åŠç´”度。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料由原容器分è£è‡³å…¶ä»–å®¹å™¨ä»¥ç‚ºå¾€å¾Œè£½é€ ä¹‹ä½¿ç”¨ï¼Œæ‡‰é¸æ“‡é©ç•¶çš„分è£å®¹å™¨ï¼Œä¸”應標示下列資料：</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">原料å稱åŠä»£ç¢¼ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">收貨或管制號碼。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">新容器ä¸åŽŸæ–™çš„é‡é‡æˆ–é‡æ¸¬å€¼ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料秤é‡ã€é‡æ¸¬ã€æˆ–分段之æ“作應予以確èªã€‚使用å‰ï¼Œç”Ÿç”¢äººå“¡æ‡‰ç¢ºèªæ¤åŽŸæ–™ç¬¦åˆè©²åŽŸæ–™è—¥æˆ–ä¸é–“產å“è£½é€ æ‰€éœ€ä¹‹è¦æ ¼ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ä¸é–“產å“或原料藥的é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">åŠç†è«–產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼Œæ‡‰æ ¹æ“šæ¯å€‹é©ç•¶çš„è£½é€ éšŽæ®µå®Œæˆæ™‚之測試çµæžœä¾†æŽ¨æ–·ã€‚é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">之é©ç•¶ç¯„åœæ‡‰ä¾æ“šå…ˆå‰å¯¦é©—室試製ã€æ”¾å¤§è©¦è£½åŠæ”¾å¤§è£½é€ 之數據建立。é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">有åå·®æ™‚ï¼Œæ‡‰èª¿æŸ¥å…¶åŽŸå› åŠä»¥æ›¸é¢è¨˜éŒ„，了解å—影響批次的處ç†æ–¹å¼ä¸¦ä½œçŸ¯æ£æŽªæ–½ï¼Œä»¥é™ä½Žå†ç™¼ç”Ÿçš„å¯èƒ½ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ åŽŸæ–™è—¥æˆ–ä¸é–“產å“主è¦çš„è¨å‚™åŠæ°¸ä¹…è£½é€ ä¹‹ç®¡ç·šè£ç½®ï¼Œæ‡‰é©ç•¶æ¨™ç¤ºå…¶å…§å®¹ç‰©ã€‚å¿…è¦æ™‚ï¼Œäº¦æ‡‰æ¨™ç¤ºå…¶ç”¨æ–¼è£½é€ æ¥é©Ÿä¹‹ç›®çš„。æ¯æ‰¹æ¬¡ä¹‹åŽŸæ–™è—¥ä¹‹æ‰¹æ¬¡ç´€éŒ„ï¼Œæ‡‰åŒ…æ‹¬è£½é€ ç”¨ä¹‹ä¸»è¦è¨å‚™ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應建立ä¸é–“產å“儲å˜æ™‚é–“é™åˆ¶åŠæ¢ä»¶ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">ä¹</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">用於é‡è£½åŠå†è£½ä¹‹ä¸é–“產å“åŠåŽŸæ–™è—¥ï¼Œåœ¨æ“作å‰æ‡‰äºˆä»¥éš”離。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è£½ç¨‹ç®¡åˆ¶</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">製程ä¸çš„產物ã€ä¸é–“產å“和原料藥之å–樣方法，應有書é¢ç¨‹åºï¼Œä¸¦æ‡‰åˆ‡å¯¦åŸ·è¡Œã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å–樣的計畫和程åºæ‡‰æ ¹æ“šæœ‰æ•ˆçš„數據åŠæŽ¡ç”¨ç§‘å¸ã€åš´è¬¹çš„å–樣作æ¥æ–¹æ³•ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">製程ä¸çš„管制åŠè¦æ ¼æ‡‰ç”±å¯¦é©—室試製ã€æ”¾å¤§æ‰¹æ¬¡è©¦è£½ä¹‹æ•¸æ“šçµæžœå°Žå‡ºï¼Œä¸¦ä¾æ“šæœ€å¾Œå¤§é‡è£½é€ 批次所ç²å¾—的數據å†åšèª¿æ•´ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°æœƒå½±éŸ¿åŽŸæ–™è—¥æˆ–ä¸é–“產å“å“質之製程，其進行ä¸ä¹‹æª¢æ¸¬åŠç®¡åˆ¶æ‡‰å»ºç«‹æ›¸é¢ä½œæ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">愈後段的åˆæˆã€åˆ†é›¢å’Œç´”化æ¥é©Ÿï¼Œæ„ˆéœ€è¦åš´æ ¼çš„製程管制。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">製程ä¸æª¢é©—å¯ç”±å…·æœ‰ä¸€å®šè³‡æ ¼ä¹‹è£½é€ 人員執行，在先å‰å“è³ªç®¡åˆ¶éƒ¨é–€å·²ç¶“æ ¸å¯æŽˆæ¬Šä¹‹ç¯„åœå…§ï¼Œè©²äººå“¡å¯é©åº¦èª¿æ•´è£½é€ éŽç¨‹ã€‚所有的調整åŠå…¶çµæžœéƒ½è¦åœ¨æ‰¹æ¬¡ç´€éŒ„ä¸å®Œæ•´ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ‰¹æ¬¡æ··åˆ</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">製程ä¸çš„æ··åˆï¼ˆä¾‹å¦‚收集數次離心物質於åŒä¸€ä¹¾ç‡¥å™¨æˆ–æ··åˆæ©Ÿï¼Œæ··åˆå¹¾æ‰¹æ¬¡çš„ä¸é–“產å“ç”¨æ–¼ä¸‹ä¸€å€‹è£½é€ æ¥é©Ÿï¼Œå°¾æ•¸çš„æ··åˆï¼‰ï¼Œæ‡‰äºˆä»¥é©ç•¶çš„管制åŠè¨‚定書é¢ä½œæ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">製程ä¸é ˆæ··åˆä¹‹ç‰©è³ªæ‡‰è¨‚定é©ç•¶çš„è¦æ ¼ï¼Œä»¥ç¢ºä¿æ··åˆçš„å“質。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">數批次之原料藥混åˆæˆå¤§æ‰¹æ¬¡æ™‚，混åˆå‰ä¹‹æ‰¹æ¬¡æ‡‰ç¬¦åˆæ—¢å®šè¦æ ¼ï¼Œä¸¦æ‡‰ç‚ºç›¸åŒçš„è£½ç¨‹æ‰€è£½é€ è€…ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">最終混åˆçš„最大批é‡ï¼Œæ‡‰å—é™æ–¼æœ€å¤§æ··åˆæ©Ÿçš„最大工作容é‡ã€‚任何兼併混åˆçš„æ¥é©Ÿï¼Œä¾‹å¦‚：乾燥，應在å¯ç¢ºä¿å…¶æ··åˆå‡å‹»çš„è¨å‚™ä¸åŸ·è¡Œã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ¯ä¸€æ··åˆæ‰¹æ¬¡æ‰€ä½¿ç”¨æ—³æ‰¹è™Ÿæˆ–管制碼，應能追溯至製æˆæ¤æ··åˆç‰©çš„個別批次。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥的物ç†å±¬æ€§å¾ˆé‡è¦ï¼ˆå¦‚使用於固體å£æœæˆ–æ‡¸æµ®è£½åŠ‘ï¼‰ï¼Œå› æ¤æ··åˆè£½ç¨‹éœ€ç¢ºæ•ˆï¼Œä»¥ç¢ºä¿æ··åˆæ‰¹æ¬¡ä¹‹å‡ä¸€æ€§ï¼Œç¢ºæ•ˆä½œæ¥éœ€åŒ…å«å¯èƒ½å½±éŸ¿æ··åˆå¾ŒåŽŸæ–™è—¥çš„主è¦å±¬æ€§ï¼ˆå¦‚粒徑分佈ã€çœŸå‡å¯†åº¦ï¼‰ä¹‹æ¸¬è©¦ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ··åˆæ‰¹æ¬¡çš„有效期間或å†é©—日期之訂定，應ä¾æ“šæ··åˆç‰©ä¸æœ€æ—©æ‰¹æ¬¡çš„è£½é€ æ—¥æœŸã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ±¡æŸ“管制</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“ä¹‹è£½é€ ï¼Œæ‡‰åœ¨é˜²æ¢å…¶ä»–化åˆç‰©æˆ–外來物污染之方法下æ“作。例如使用經éŽè¨è¨ˆçš„è¨å‚™ã€è¨å‚™æ‡‰æ”¾ç½®åœ¨é©ç•¶ç’°å¢ƒæŽ§åˆ¶çš„å ´æ‰€ï¼Œä¸”æ‡‰æœ‰é©ç•¶çš„清潔和ç¶è·ï¼›è‹¥æœ‰å¿…è¦ï¼Œä½¿ç”¨å°ˆç”¨çš„è¨å‚™ï¼›åŠé©ç•¶ç´”化的溶劑和原料。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">在乾燥ã€ç ”磨ã€éŽç¯©ã€æ··åˆã€å’ŒåŒ…è£ä½œæ¥æ™‚，應特別的注æ„，以防æ¢ç”¢å“éå—污染。應注æ„çš„äº‹é …åŒ…æ‹¬ä¸‹åˆ—å„é …ï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">å¿…è¦æ™‚，使用密閉的系統進行分離和乾燥；</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">ä¾éœ€è¦ä½¿ç”¨è‡ªå‹•çš„粉體傳é€ç³»çµ±é€²æ–™åŠå¸æ–™ï¼›</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">使用é©ç•¶çš„空調和防塵系統。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°å…·ç‰¹å®šå…§æ¯’ç´ é™é‡ä¹‹ä¸é–“產å“或原料藥，應建立書é¢ä½œæ¥ç¨‹åºä¸¦éµå¾ªä¹‹ï¼Œä»¥æŽ§åˆ¶å…§æ¯’ç´ ä¹‹ç”¢ç”Ÿæˆ–æ±¡æŸ“ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">廢棄物之儲å˜åŠè™•ç†ï¼Œæ‡‰ä»¥è¡›ç”Ÿçš„方法定期處置。廢棄物之容器應清楚標示，以玆è˜åˆ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€é‡è£½æˆ–å†è£½</span> </p><p><span style="font-family: 新細明體,serif;">　</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€é‡è£½</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">å°‡ä¸ç¬¦åˆæ¨™æº–或è¦æ ¼ä¹‹åŽŸæ–™è—¥æˆ–ä¸é–“產å“，以原來已經建立且為製程一部分的æ¥é©Ÿï¼Œåˆ©ç”¨é‡è¤‡å†çµæ™¶æˆ–以其他é©ç•¶ä¹‹åŒ–å¸æˆ–物ç†æ“作é‡è¤‡è£½é€ </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如溶解ã€éŽæ¿¾ã€å±¤æžã€ç ”磨</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，一般視為å¯ä»¥è¢«æŽ¥å—。如果æ¤é‡è£½çš„æ¥é©Ÿæ˜¯å¤§å¤šæ•¸æ‰¹æ¬¡è£½é€ 的一部份，則æ¤é‡è£½è¦åŒ…å«åœ¨è£½é€ 管制標準書ä¸ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">由製程ä¸ç®¡åˆ¶æª¢é©—çš„çµæžœé¡¯ç¤ºè£½é€ 未完æˆï¼Œé€²è€Œç¹¼çºŒæ“ä½œçš„è£½é€ æ¥é©Ÿï¼Œè¦–為æ£å¸¸è£½ç¨‹çš„一部份，ä¸è€ƒæ…®ç‚ºé‡è£½ã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">除原來已經建立的製程外，將未å應的原料ã€ä¸é–“產å“放回製程ä¸ï¼Œä¸¦é€²è¡Œé‡è¤‡çš„化å¸å應視為é‡è£½ã€‚在採å–é‡è£½ä¹‹å‰ï¼Œæ‡‰äºˆä»¥è©•ä¼°ï¼Œä»¥ç¢ºä¿ä¸æœƒå› 為潛在å¯èƒ½ç”¢ç”Ÿçš„副產物åŠéŽåº¦åŒ–å¸å應的物質，å°åŽŸæ–™è—¥åŠä¸é–“產å“çš„å“質有ä¸è‰¯çš„影響。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€å†è£½</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">å°æ–¼ä¸ç¬¦åˆå·²å»ºç«‹çš„標準或è¦æ ¼çš„批次決定å†è£½ä¹‹å‰ï¼Œæ‡‰èª¿æŸ¥å…¶ä¸ç¬¦åˆçš„åŽŸå› ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">為確ä¿ç”¢å“çš„å“質，å†è£½æ‡‰äºˆä»¥é©ç•¶çš„評估：檢驗ã€å®‰å®šæ€§è©¦é©—ã€å’Œé¡¯ç¤ºèˆ‡ä½¿ç”¨åŽŸè£½ç¨‹è£½é€ çš„å“質相當之文件。</span> </p><p><span style="font-family: 新細明體,serif;">併行性確效一般é©ç”¨æ–¼é”æˆå†è£½æ–¹æ³•çš„確效。å¯åˆ©ç”¨ç¢ºæ•ˆè¨ˆç•«æ›¸è¨‚定å†è£½çš„æ¥é©Ÿï¼Œé€²è¡Œçš„æ–¹å¼ï¼ŒåŠé 期的çµæžœã€‚</span> </p><p><span style="font-family: 新細明體,serif;">如果åªæœ‰ä¸€å€‹æ‰¹æ¬¡éœ€è¦å†è£½ï¼Œè€Œå…¶å“質å¯è¢«æŽ¥å—，則å¯äºˆä»¥è¨˜éŒ„和放行。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">應有比較原製程與å†è£½ä¹‹æ¯ä¸€æ‰¹ç”¢å“çš„ä¸ç´”物æ述之æ¥é©Ÿã€‚當原分æžæ–¹æ³•ä¸é©ç”¨æ–¼å†è£½ä¹‹æ‰¹æ¬¡æ™‚，應採用其它替代之分æžæ–¹æ³•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æŒã€åŒ…è£åŠæ¨™ç¤ºç®¡åˆ¶</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä¸€èˆ¬ç®¡åˆ¶</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°æ–¼åŽŸæ–™è—¥æ‰€ä½¿ç”¨çš„標示åŠåŒ…è£æ料，å‡æ‡‰å…·å‚™æ›¸é¢ä½œæ¥ç¨‹åºï¼Œèªªæ˜Žå®ƒå€‘的接收ã€é‘‘別ã€å„²å˜ã€è™•ç†ã€å–樣ã€æª¢é©—åŠæ¸¬è©¦ï¼Œä¸¦æ‡‰äºˆä»¥éµå¾ªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有的標示和包è£æ料，應符åˆå·²å»ºç«‹çš„è¦æ ¼ã€‚ä¸ç¬¦åˆè¦æ ¼è€…，應予以拒用。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">放行使用å‰ä¹‹æ¨™ç¤ºå’ŒåŒ…è£æ料，應有具代表性的å–樣ã€æª¢é©—或測試。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ¯ä¸€æ‰¹æ”¶è²¨ä¹‹æ¨™ç¤ºå’ŒåŒ…è£æ料，應有接收ã€æª¢é©—ã€æ¸¬è©¦ã€å‡†ç”¨æˆ–拒用之紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€åŒ…è£å’Œæ¨™ç¤ºä½œæ¥</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">確ä¿æ£ç¢ºæ¨™ç¤ºåŠåŒ…è£æ料的使用，應建立書é¢ä½œæ¥ç¨‹åºï¼Œä¸”應切實éµå¾ªä¸¦è¨˜éŒ„之。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ä¸åŒå½¢å¼æˆ–ç‰ç´šçš„原料藥之標示應予以分開儲å˜ä¸¦æ¸…楚è˜åˆ¥ï¼Œä»¥é˜²æ¢æ··é›œã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ä¸é–“產å“或原料藥容器的標籤，應有å稱和è˜åˆ¥ç¢¼ï¼Œæ‰¹æ¬¡è™Ÿç¢¼å’Œå„²å˜æ¢ä»¶ï¼Œå¦‚æžœæ¤æ¢ä»¶å°ä¸é–“產å“或原料藥å“質ä¿è‰å¾ˆé‡è¦çš„話。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">如果ä¸é–“產å“或原料藥是é‹é€å‡ºå» ，標籤應å«æœ‰åŽŸè£½é€ è€…ä¹‹å» åã€åœ°å€ï¼Œå…§å®¹ç‰©å«é‡ï¼Œå’Œç‰¹åˆ¥çš„é‹é€æ¢ä»¶åŠä»»ä½•æ³•å¾‹ä¸Šç‰¹åˆ¥çš„è¦æ±‚。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥若å†åŒ…è£ã€å†æ¨™ç¤ºæˆ–åŠ å·¥è€…èˆ‡åŽŸè£½é€ è€…ä¸åŒæ™‚，亦應標示出來。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ¨™ç¤ºç®¡åˆ¶</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">標籤的發放ã€ä½¿ç”¨å’Œé€€å›žæ‡‰è¨‚定書é¢ä½œæ¥ç¨‹åºï¼Œå…¶ç™¼æ”¾ã€ä½¿ç”¨å’Œé€€å›žä¹‹æ•¸é‡æ‡‰å½¼æ¤ç¬¦åˆã€‚若有差異時應予以調查åŠè¨˜éŒ„之。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°æœ‰æ‰¹è™Ÿä¹‹æ¨™ç±¤ï¼Œå¦‚有剩餘，應予銷毀。其他未å°è£½è€…應予以é©ç•¶çš„鑑別ã€å„²å˜ï¼Œä»¥å…混雜。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">舊å¼å’ŒéŽæ™‚的標籤應予銷毀。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">標籤å°è£½è£ç½®åœ¨åŒ…è£ä½œæ¥ä½¿ç”¨æ™‚應予監測，以確ä¿æ‰€æœ‰å°è£½çš„標籤符åˆæœ¬æ‰¹æ¬¡æ‰€è¦æ±‚之è¦æ ¼ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">經éŽåŒ…è£åŠæ¨™ç¤ºä½œæ¥ä¹‹åŽŸæ–™è—¥æ‡‰äºˆæª¢æŸ¥ï¼Œä»¥ç¢ºä¿æ¯ä¸€å®¹å™¨åŠåŒ…è£çš„標示å‡å±¬æ£ç¢ºç„¡èª¤ã€‚檢查的çµæžœæ‡‰è¨˜éŒ„æ–¼æ‰¹æ¬¡è£½é€ ç´€éŒ„æˆ–ç®¡åˆ¶ç´€éŒ„ä¸ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">標籤發放å‰æ‡‰æª¢æŸ¥æ˜¯å¦æ£ç¢ºåŠé©ç”¨ï¼Œä¸¦å°‡çµæžœç™»éŒ„æ–¼æ‰¹æ¬¡è£½é€ ç´€éŒ„æˆ–ç®¡åˆ¶ç´€éŒ„ä¸ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">為防æ¢æ··é›œåŠæ±¡æŸ“，標示作æ¥èˆ‡å…¶ä»–原料藥的æ“作應有é©ç•¶çš„隔離。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">包è£åŠæ¨™ç¤ºçš„措施在臨使用之å‰æ‡‰åŠ 以檢查，以確ä¿ä¸å±¬æ–¼æœ¬æ¬¡æ“作者皆已移除，並將çµæžœç™»éŒ„æ–¼æ‰¹æ¬¡è£½é€ ç´€éŒ„æˆ–ç®¡åˆ¶ç´€éŒ„ä¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å®¹å™¨å’Œå°è“‹ç®¡åˆ¶</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">容器和å°è“‹ç³»çµ±æ‡‰æä¾›é©ç•¶çš„ä¿è·ï¼Œä»¥é˜²æ¢åŽŸæ–™è—¥åœ¨å„²å˜æˆ–使用時å—å¤–åœ¨å› ç´ çš„å½±éŸ¿è€Œè®Šè³ªæˆ–éå—污染。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">容器åŠå°è“‹æ‡‰äºˆä»¥æ¸…潔，且ä¸æœƒèˆ‡å„²å˜ä¹‹ç”¢å“產生å應ã€åŠ æˆæ€§æˆ–å¸é™„，而改變原料藥è¦æ ¼èˆ‡å“質。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">如回收容器å†ä½¿ç”¨ï¼Œå…¶æ¸…潔應ä¾æ›¸é¢ä½œæ¥ç¨‹åºåŸ·è¡Œï¼Œè€Œä¸”應將先å‰çš„標示去除或抹滅。</span> </p><p><span style="font-family: 新細明體,serif;">玖ã€å„²å˜å’Œé‹éŠ·</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å„²å˜</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“的儲å˜ï¼Œæ‡‰å»ºç«‹æ›¸é¢ä½œæ¥ç¨‹åºï¼Œä¸¦äºˆéµå¾ªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應有é©ç•¶ç’°å¢ƒè¨æ–½ï¼Œä»¥å„²å˜æ‰€æœ‰çš„原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“或原料藥。å°æ–¼ç¶æŒç”¢å“性能之é‡è¦å„²å˜æ¢ä»¶ï¼Œæ‡‰æœ‰ç¶æŒæ¤æ¢ä»¶ä¹‹ç´€éŒ„。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">如果沒有å¦ä¸€ç³»çµ±å¯é˜²æ¢éžæ¬Šè²¬äººå“¡ä½¿ç”¨è¢«éš”離ã€æ‹’用ã€é€å›žã€æˆ–回收之原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“或原料藥，則在決定其處ç†æ–¹å¼ä¹‹å‰ï¼Œæ‡‰äºˆä»¥åˆ†é–‹å„²å˜æ–¼ç‰¹å®šçš„暫時儲å˜å€ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€é‹éŠ·</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“çš„é‹éŠ·ï¼Œæ‡‰å»ºç«‹æ›¸é¢ä½œæ¥ç¨‹åºï¼Œä¸¦äºˆä»¥éµå¾ªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">在å“質管制部門之評估工作未完æˆå‰ï¼ŒåŽŸæ–™è—¥æˆ–ä¸é–“產å“ä¸æ‡‰æ”¾è¡Œé‹éŠ·çµ¦ç¬¬ä¸‰è€…。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“應以ä¸å½±éŸ¿å…¶å“質的方法é‹é€ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“產å“æ‰€é ˆä¹‹ç‰¹æ®Šé‹é€å’Œå„²å˜æ¢ä»¶æ‡‰æ–¼æ¨™ç¤ºä¸Šèªªæ˜Žï¼Œä¸¦æ‡‰äºˆä»¥éµå¾ªã€‚å…¶æ¢ä»¶æ‡‰ç¬¦åˆè—¥å…¸ä¹‹æ¨™æº–定義，或應精確的標明儲å˜çš„溫度。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應建立能迅速收回已é‹éŠ·ç”¢å“之系統</span> </p><p><span style="font-family: 新細明體,serif;">拾ã€å“質管制</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€å“質管ç†</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å“質原則</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">è—¥å» æ‡‰å§”æ´¾æœ‰é—œè³‡æ·±äººå“¡ï¼Œæˆç«‹å“質ä¿è‰ç³»çµ±ç©æ¥µåƒèˆ‡ç®¡ç†ï¼Œå…¶çµ„ç¹”ç« ç¨‹æ‡‰ä»¥æ›¸é¢è¨‚之。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">管ç†ç³»çµ±æ‡‰åŒ…å«çµ„織架構ã€æŽªæ–½ã€ç¨‹åºã€è³‡æºå’ŒåŸ·è¡Œï¼Œä»¥ç¢ºä¿åŽŸæ–™è—¥ä¹‹å“質和純度。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">所有å“質相關的活動於執行時應予以記錄。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">任何與已建立æ¥é©Ÿä¹‹å差，應予以記錄和說明。é‡è¦çš„å差應予以調查ã€ä¸¦å°‡èª¿æŸ¥éŽç¨‹å’Œçµæžœè¨˜éŒ„之。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">內部å“è³ªç¨½æ ¸</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">為確ä¿åŽŸæ–™è—¥ä¹‹å“è³ªå’Œç´”åº¦ï¼Œä¾‹è¡Œä¹‹å…§éƒ¨ç¨½æ ¸æ‡‰ä¾æ ¸å¯ä¹‹æ™‚程執行。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">ç¨½æ ¸ç™¼ç¾ä¹‹äº‹é …和矯æ£çš„è¡Œå‹•æ‡‰äºˆä»¥è¨˜éŒ„ï¼Œä¸¦å‘ŠçŸ¥å» å…§è² è²¬äººã€‚ç¶“åŒæ„的矯æ£è¡Œå‹•ï¼Œæ‡‰åœ¨ä¸€å®šçš„期é™å…§ä»¥æœ‰æ•ˆçš„方法完æˆã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å“質審查</span> </p><p><span style="font-family: 新細明體,serif;">應執行例行的原料藥å“質審查以確èªè£½ç¨‹çš„一致性。æ¤å¯©æŸ¥é€šå¸¸æ¯å¹´æ‡‰åŸ·è¡Œä¸¦æ‡‰è¨‚定書é¢ä½œæ¥ç¨‹åºã€‚至少應å«ä¸‹åˆ—é …ç›®ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查關éµæ¥é©Ÿå’Œæ‰€æœ‰ç”¢å“測試的çµæžœï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查ä¸ç¬¦åˆè¦æ ¼ä¹‹æ‰€æœ‰æ‰¹æ¬¡ï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查所有å差和ä¸ç¬¦åˆäº‹é …åŠå…¶ç›¸é—œèª¿æŸ¥ï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查任何應用於製程åŠåˆ†æžæ–¹æ³•ä¹‹æ”¹è®Šï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">5</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">å¯©æŸ¥æ‰€æœ‰é€²è¡Œä¹‹å®‰å®šæ€§ç ”ç©¶çš„çµæžœï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查所有å“質相關的退回ã€æ€¨è¨´åŠå›žæ”¶ï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">7</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查矯æ£è¡Œå‹•ä¹‹é©ç•¶æ€§ï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">8</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查å†ç¢ºæ•ˆä¹‹å¿…è¦æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å“質管制</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å“質管制部門</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">è—¥å» å“è³ªç®¡åˆ¶éƒ¨é–€å’Œè£½é€ éƒ¨é–€æ‡‰åˆ†åˆ¥ç¨ç«‹ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">å“è³ªç®¡åˆ¶éƒ¨é–€æ‡‰æŸ¥æ ¸èˆ‡æ ¸å‡†æ‰€æœ‰èˆ‡å“質相關之文件之發行。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">å“質管制部門å¯æŽˆæ¬Šè£½é€ 部門，執行製程ä¸çš„檢驗和ä¸é–“產å“之放行。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">å“質管制部門之è·è²¬åŠä½œæ¥ç¨‹åºå‡æ‡‰ä»¥æ›¸é¢å®šä¹‹ï¼Œä¸¦æ‡‰åˆ‡å¯¦åŸ·è¡Œã€‚而且應ä¸åªé™æ–¼å«ä¸‹åˆ—之è·è²¬ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">æ ¸å‡†æˆ–æ‹’ç”¨æ‰€æœ‰åŽŸæ–™ã€åŒ…è£ææ–™ã€æ¨™ç±¤å’ŒåŽŸæ–™è—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">å¯©æ ¸åŠæ ¸å‡†è£½é€ 紀錄，以確ä¿æ²’有錯誤和å差。如有錯誤或å差發生時，予以徹底的調查åŠè§£æ±ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">æ ¸å‡†æˆ–æ‹’ç”¨å§”è¨—å…¶ä»–å…¬å¸è£½é€ ã€åŠ å·¥ã€åŒ…è£æˆ–æ“作ä¸é–“產å“或原料藥。</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">審查åŠæ ¸å¯ç¢ºæ•ˆè¨ˆç•«æ›¸ã€ç”¢å“ã€è£½é€ ã€è¨å‚™æˆ–其他的改變åŠæ±ºå®šä½•æ™‚需è¦å†ç¢ºæ•ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">5</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">所有æ¥é©Ÿã€è¦æ ¼ä¹‹æ ¸å¯æˆ–拒用，以åŠå°å½±éŸ¿åŽŸæ–™è—¥æˆ–ä¸é–“產å“å“質和純度之調查。</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">應有é©ç•¶çš„實驗室è¨æ–½ï¼Œä¾›æª¢é©—å’Œå¯©æ ¸</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">或拒用</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">原料ã€åŒ…è£æ料和原料藥。</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">7</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">定期評估æ¥é©Ÿã€æ”¿ç–ã€è£½é€ 和管制之執行çµæžœã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¦æ ¼</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">應æ供所有原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“或</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">和原料藥之è¦æ ¼ï¼Œä¸”應由å“è³ªç®¡åˆ¶éƒ¨é–€æ ¸å¯ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">應有判定所有原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“或</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">和原料藥是å¦ç¬¦åˆæ—¢å®šè¦æ ¼ä¹‹æ–¹æ³•ã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">已建立化å¸åˆæˆæ¥é©Ÿä¹‹æ¯ä¸€ç¨®åŽŸæ–™è—¥å‡æ‡‰æœ‰ä¸ç´”物æ述，以說明å˜åœ¨æ–¼ä»£è¡¨æ€§è£½ç¨‹ä¸å·²é‘‘別或未鑑別之ä¸ç´”物。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å¯¦é©—室管制</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">一般管制</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">ç”±è—¥å» æœ‰é—œéƒ¨é–€è¨‚å®šä¹‹è¦æ ¼ã€æ¨™æº–å“ã€å–樣計畫ã€æª¢é©—程åºã€æˆ–其他所è¦å®šä¹‹å¯¦é©—室管制措施，åŠå…¶æœ‰é—œä¹‹ä»»ä½•æ”¹è®Šï¼Œå‡æ‡‰ç¶“å“質管制部門審定後方得執行。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">實驗室管制的å„é …ä½œæ¥æ‡‰åˆ‡å¯¦éµå¾ªä¸¦è¨˜éŒ„執行éŽç¨‹ï¼Œå¦‚與上述è¦å®šæœ‰æ‰€åå·®ï¼Œæ‡‰åŠ ä»¥è¨˜éŒ„ä¸¦ä½œåˆç†åˆ¤é‡‹ã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">應訂定儀器ã€è£ç½®ã€å„€éŒ¶åŠè¨˜éŒ„器ç‰ä¹‹æ ¡æ£æ›¸é¢ä½œæ¥ç¨‹åºï¼Œåœ¨é©ç•¶çš„æœŸé–“å…§äºˆä»¥æ ¡æ£ã€‚內容應明確è¦å®šæ ¡æ£æ–¹æ³•ã€æ—¥ç¨‹è¡¨ã€æº–確度åŠç²¾å¯†åº¦çš„範åœï¼Œä»¥åŠæœªèƒ½ç¬¦åˆæº–確度</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">精密度範åœæ™‚的補救措施。ä¸æ‡‰ä½¿ç”¨ä¸ç¬¦åˆè¦æ ¼çš„儀器ã€è£ç½®ã€å„€éŒ¶åŠè¨˜éŒ„器。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">å°ç…§æ¨™æº–å“（例如經å†ç´”化後å“質符åˆæ¨™æº–之產å“）應予以é©ç•¶ä¹‹è£½å‚™ã€é‘‘別ã€å„²å˜ã€æ¸¬è©¦ï¼Œä»¥ç¢ºä¿å…¶é©ç”¨æ€§ã€‚å°ç…§æ¨™æº–å“應與一級å°ç…§æ¨™æº–å“比較後方é©ç”¨ã€‚</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">分æžè©¦åŠ‘之製備åŠæ¨™ç¤ºæ‡‰ä¾æ“šå·²å»ºç«‹ä¹‹æ›¸é¢ä½œæ¥ç¨‹åºåŸ·è¡Œã€‚分æžè©¦åŠ‘åŠæ¨™æº–å“溶液應標示有效期間或å†é©—日期。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">分æžè‰æ˜Žæ›¸</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">åŽŸæ–™è—¥å» æ‡‰å¯æ出æ¯ä¸€æ‰¹æ¬¡ä¹‹ä¸é–“產å“或原料藥å¯é 的分æžè‰æ˜Žæ›¸ï¼Œä»¥ä¾›ç´¢å–。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">ä¸é–“產å“或原料藥之分æžè‰æ˜Žæ›¸ï¼Œæ‡‰å«å稱ã€ç‰ç´š</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å¿…è¦çš„話</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，åŠæ‰¹æ¬¡è™Ÿç¢¼å’Œæ”¾è¡Œæ—¥æœŸã€‚ä¸é–“產å“或原料藥無論使用有效日期或å†é©—日期，都應將有效日期或å†é©—日期顯示於標籤和分æžè‰æ˜Žæ›¸ä¸Šã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">分æžè‰æ˜Žæ›¸æ‡‰åˆ—出æ¯å€‹ä¾æ“šè—¥å…¸æˆ–客戶è¦æ±‚ä¹‹æª¢é©—é …ç›®ï¼Œå«å¯æŽ¥å—標準，檢驗所得之數å—çµæžœ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如果檢驗之çµæžœç‚ºæ•¸å—者</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">分æžè‰æ˜Žæ›¸æ‡‰ç”±å“ä¿å–®ä½æ¬Šè²¬äººå“¡ç°½ååŠè¨»æ˜Žæ—¥æœŸã€åœ°å€ï¼Œå¦‚為分包è£æˆ–å†è£½è€…，則分æžè‰æ˜Žæ›¸æ‡‰å«åˆ†åŒ…è£æˆ–å†è£½è€…之地å€ã€é›»è©±è™Ÿç¢¼åŠåŽŸè£½é€ å» ä¹‹åƒè€ƒè³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">如果分æžè‰æ˜Žæ›¸æ˜¯ç”±åˆ†åŒ…è£å•†ï¼Œå†è£½é€ 商ã€ç¶“紀人或貿易商所發出，則分æžè‰æ˜Žæ›¸æ‡‰é¡¯ç¤ºåšåˆ†æžçš„實驗室之å稱，地å€å’Œé›»è©±è™Ÿç¢¼ã€‚ä¹Ÿæ‡‰é™„ä¸ŠåŽŸè£½é€ å» ä¹‹å稱，地å€å’ŒåŽŸå» 該批次分æžè‰æ˜Žæ›¸ä¹‹è¤‡æœ¬ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">é‹éŠ·å‰çš„檢驗與放行</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">æ¯ä¸€æ‰¹æ¬¡çš„原料藥或ä¸é–“產å“，在放行å‰æ‡‰åŸ·è¡Œé©ç•¶çš„實驗室檢驗，以判定是å¦ç¬¦åˆæœ€çµ‚è¦æ ¼ã€‚</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">ä¸ç¬¦åˆæ—¢å®šæ¨™æº–或è¦æ ¼çš„原料藥或ä¸é–“產å“應予以拒用。拒用的產å“之é‡è£½æˆ–å†è£½æ‡‰éµå¾ªé©ç•¶çš„書é¢ä½œæ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">任何檢驗çµæžœè¶…出è¦æ ¼è€…，應ä¾æ›¸é¢ä½œæ¥ç¨‹åºäºˆä»¥èª¿æŸ¥å’Œè¨˜éŒ„。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">å†å–樣和å†æª¢é©—，應ä¾æ›¸é¢ä½œæ¥ç¨‹åºåŸ·è¡Œã€‚</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">è¦æ±‚ä¸èƒ½å«æœ‰å®³å¾®ç”Ÿç‰©ä¹‹åŽŸæ–™è—¥ï¼Œæ‡‰åŸ·è¡Œé©ç•¶çš„微生物之檢驗。</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">æ¯ä¸€åŽŸæ–™è—¥ä¸ç´”物æ述之ä¸ç´”物é‡åŒ–或鑑別å‡æ‡‰å»ºæª”並ä¿å˜ã€‚ä¸ç´”物包括有機物ã€ç„¡æ©Ÿç‰©å’Œæ®˜ç•™æœ‰æ©Ÿæº¶åŠ‘。一般大於或ç‰æ–¼</span><span style="font-family: calibri;"> 0.1%</span><span style="font-family: 新細明體,serif;">以上之ä¸ç´”物應予鑑別。ä¸ç´”物æ述的檢驗程åºæ‡‰ä»¥æ›¸é¢è¨‚之，並據以執行。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥之安定性試驗</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">應有試驗計畫，以評估原料藥的安定性，並應ä¾å®‰å®šæ€§è©¦é©—çš„çµæžœï¼Œä¾†æ±ºå®šé©ç•¶çš„儲å˜æ¢ä»¶åŠå†é©—日期。試驗計畫應予書é¢è¨‚定並據以執行，包括：</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">æ¯å¹´ç”¨æ–¼åŸ·è¡Œå®‰å®šæ€§è©¦é©—之批次數目ã€å–樣數é‡åŠæ¸¬è©¦æœŸé–“ï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">用於安定性試驗的儲備樣å“之儲å˜æ¢ä»¶ï¼›</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">安定性試驗的方法應具安定性指標，並應予確效。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">安定性試驗之樣å“，應儲å˜åœ¨æ¨¡æ“¬å¸‚售的容器ä¸ã€‚例如：原料藥以èšä¹™çƒ¯è¢‹æ”¾ç½®åœ¨ç´™æ¡¶ä¸å‡ºå”®ï¼Œå‰‡æ‡‰ä½¿ç”¨èˆ‡å¸‚å”®åŒæ質的袋ååŠè¼ƒå°åž‹åŒæ質的桶å，來包è£å®‰å®šæ€§è©¦é©—之樣å“。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">安定性試驗一般包括三個連續é‡ç”¢æ‰¹æ¬¡çš„產å“ã€‚è‹¥ä»¥å¾€çš„ç ”ç©¶æ•¸æ“šæˆ–æ–‡ç»è³‡æ–™é¡¯ç¤ºï¼Œè©²åŽŸæ–™è—¥èƒ½è‡³å°‘ç¶æŒå…©å¹´çš„安定，則åˆæœŸçš„試驗å¯ä½¿ç”¨å°‘於三批次的樣å“。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">æ¯å¹´æ¯ä¸€åŽŸæ–™è—¥æ‡‰æœ‰ä¸€å€‹æ‰¹æ¬¡ç´å…¥å®‰å®šæ€§è©¦é©—計畫ä¸é€²è¡Œå®‰å®šæ€§è©¦é©—</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">該年無生產æ¤ç”¢å“除外</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，且一年至少測試一次，以決定é©ç•¶æœ‰æ•ˆæœŸé–“åŠå†é©—日期。這些測試之紀錄應予ä¿å˜ã€‚</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">å¯æŽ¡ç”¨æ”¾å¤§è©¦è£½çš„批次執行試驗，以暫訂有效期é™ï¼Œä½†éœ€ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">放大試製批次所用的製法åŠç¨‹åºæ˜¯æ¨¡æ“¬é‡ç”¢è£½é€ è¦æ¨¡ä½¿ç”¨çš„最終製程；</span> </p><p><span style="font-family: 新細明體,serif;">（</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體,serif;">）</span> <span style="font-family: 新細明體,serif;">其原料藥的å“質符åˆé‡ç”¢ç”Ÿç”¢ç”¢å“之標準。</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">å¦‚æžœè£½é€ å ´æ‰€ã€åŽŸæ–™ã€åŒ…è£ææ–™æˆ–è£½é€ ç¨‹åºæ”¹è®Šï¼Œå‰‡æ‡‰è©•ä¼°æ¤æ”¹è®Šæ˜¯å¦å½±éŸ¿åŽŸæ–™è—¥çš„安定性。</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">一般建è°é•·æœŸè©¦é©—第一年æ¯ä¸‰å€‹æœˆæ¸¬å®šä¸€æ¬¡ï¼Œç¬¬äºŒå¹´æ¯å…個月一次，之後æ¯å¹´ä¸€æ¬¡ï¼Œè¦–情æ³è€Œå®šã€‚</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">生物性原料藥或其他架儲期é™ä¸€å¹´æˆ–æ›´çŸæ™‚間之原料藥，å‰ä¸‰å€‹æœˆæ‡‰æ¯æœˆæ¸¬è©¦ï¼Œå‰©é¤˜çš„時間則æ¯ä¸‰å€‹æœˆæ¸¬è©¦ä¸€æ¬¡ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">有效期間åŠå†é©—日期</span> </p><p><span style="font-family: 新細明體,serif;">原料藥容器標籤或檢驗çµæžœè‰æ˜Žæ‡‰åˆ—出有效期間或å†é©—æ—¥æœŸï¼Œå…¶è¨‚å®šæ˜¯åŸºæ–¼å®‰å®šæ€§ç ”ç©¶æ‰€å°Žå‡ºä¹‹æ•¸æ“šè©•ä¼°çš„çµæžœã€‚一般採用å†é©—日期而éžæœ‰æ•ˆæœŸé–“。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">儲備樣å“</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">代表æ¯æ‰¹æ¬¡ä¹‹åŽŸæ–™è—¥çš„儲備樣å“，應ä¿å˜è‡³è©²æ‰¹æ¬¡æœ‰æ•ˆæœŸé–“後一年。至於標示å†é©—日期者為該批次é‹éŠ·å¾Œä¸‰å¹´ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">儲備樣å“é‡æ‡‰ç‚ºè¶³ä¾›æ‰€æœ‰è¦å®šæª¢é©—所需è¦ä¹‹å…©å€ä»¥ä¸Šï¼Œä»¥åˆ¤å®šåŽŸæ–™è—¥æ˜¯å¦ç¬¦åˆè¦æ ¼ã€‚儲備樣å“的儲å˜æ¢ä»¶æ‡‰èˆ‡ç”¢å“標示上所註明的相åŒï¼Œä¸”應使用與上市產å“相åŒæˆ–更好ä¿å˜çš„包è£ã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">除éžç›®è¦–檢查會影響儲備樣å“的完整，å¦å‰‡å…·ä»£è¡¨æ€§ä¹‹å„²å‚™æ¨£å“，æ¯å¹´è‡³å°‘應目視檢查一次是å¦æœ‰è®Šè³ªè·¡è±¡ã€‚檢查çµæžœæ‡‰äºˆä»¥è¨˜éŒ„åŠä¿å˜ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">試驗用動物</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">用於測試原料ã€è£½ç¨‹ä¸ä¸é–“產å“åŠåŽŸæ–™è—¥è¦æ ¼ä¹‹å‹•ç‰©ï¼Œæ‡‰äºˆä»¥é¤Šè·åŠç®¡åˆ¶ï¼Œä»¥ç¢ºä¿å…¶é©ç”¨æ€§ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">動物應予以辨è˜åŠè¨˜éŒ„其試驗的經æ·éŽç¨‹ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€è®Šæ›´ç®¡åˆ¶</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">變更管制之系統</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">為了製程最é©åŒ–åŠç¢ºä¿é€£çºŒç‹€æ…‹çš„製程管制之æŒçºŒé‹ä½œï¼Œæ‡‰å»ºç«‹ä¸€å€‹æ£å¼çš„變更管制系統，用來評估åŠæ ¸å‡†æ出之è¦æ ¼ã€æ¸¬è©¦æ¥é©Ÿã€åŽŸæ–™ã€è¨æ–½ã€æ”¯æ´ç³»çµ±ã€è¨å‚™ã€è£½é€ æ¥é©Ÿã€åŒ…è£æ料或電腦硬軟體之改變。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">ä»»ä½•è®Šæ›´æ‡‰ç”±è—¥å» çš„é©ç•¶éƒ¨é–€åŠ 以è‰æ“¬ã€å¯©æŸ¥åŠæ ¸å‡†ï¼Œè€Œå¾Œå†ç”±å“è³ªç®¡åˆ¶éƒ¨é–€åŠ ä»¥å¯©æŸ¥åŠæ ¸å®šã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">ç•¶åŸ·è¡Œå·²è¢«æ ¸å®šä¹‹è®Šæ›´æ™‚ï¼Œé ˆç¢ºå®šæ‰€æœ‰ç›¸é—œæ–‡ä»¶éƒ½å·²ä¿®æ£ã€‚</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">ç•¶è®Šæ›´è¢«åŸ·è¡Œå¾Œï¼Œæ‡‰è©•ä¼°åœ¨æ”¹è®Šå¾Œçš„ç¬¬ä¸€å€‹è£½é€ æ‰¹æ¬¡ç”¢å“或檢驗之çµæžœã€‚</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">å°é—œéµæ¥é©Ÿæ”¹è®Šè€Œé€ æˆå·²å»ºç«‹ä¹‹å†é©—或有效期間有潛在影響者，應å°ä¿®æ”¹çš„è£½ç¨‹ï¼Œå¢žåŠ æ¨£å“ä»¥åŸ·è¡ŒåŠ é€Ÿæˆ–é•·æœŸä¹‹å®‰å®šæ€§è©¦é©—ã€‚</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">è£½é€ å’Œè£½ç¨‹ç®¡åˆ¶æ¥é©Ÿçš„改變å¯èƒ½æœƒå½±éŸ¿åŽŸæ–™è—¥ä¹‹å“è³ªæ™‚ï¼Œæ‡‰å‘ŠçŸ¥ä½¿ç”¨ä¹‹è£½åŠ‘å» ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">變更管制之分級</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">變更管制之計畫應æ供分級制來評估原料ã€è£½é€ å ´æ‰€ã€è£½é€ è¦æ¨¡ã€è£½é€ è¨å‚™åŠç”Ÿç”¢è£½ç¨‹çš„變更。æ¤åˆ†ç´šçš„程åºæ‡‰ç”¨æ–¼æ±ºå®šä½•ç¨®ç¨‹åº¦çš„檢驗ã€ç¢ºæ•ˆåŠæ›¸é¢ç´€éŒ„，以作為å°ä¸€å€‹å·²ç¢ºæ•ˆè£½ç¨‹æ˜¯å¦éœ€è¦è®Šæ›´çš„判釋。ä¾æ“šè®Šæ›´çš„性質åŠç¨‹åº¦ï¼Œä»¥åŠé€™äº›è®Šæ›´å¯èƒ½å°è£½ç¨‹é€ æˆçš„影響å¯åˆ†ç‚ºæ¬¡è¦æ”¹è®ŠåŠä¸»è¦æ”¹è®ŠäºŒç¨®ã€‚總之，å°å·²ç¢ºæ•ˆè£½ç¨‹æ‰€ä½œçš„變更應以科å¸åŒ–的判斷來決定需è¦é‚£äº›é™„åŠ çš„è©¦é©—åŠç¢ºæ•ˆç ”究。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">次è¦æ”¹è®Šæ‡‰å®šç¾©ç‚ºå°åŽŸæ–™è—¥çš„é‡è¦å±¬æ€§ä¸è‡´é€ æˆå¯åµæ¸¬çš„影響者。這類變更ä¸æœƒä½¿è£½ç¨‹é¡¯ç¾ä»»ä½•å¯åˆ†è¾¨çš„改變，故所需執行之檢驗åŠç¢ºæ•ˆæœ€å°‘。例如è¨å‚™ä¹‹</span><span style="font-family: calibri;">"</span><span style="font-family: 新細明體,serif;">åŒé¡žå–代</span><span style="font-family: calibri;">"</span><span style="font-family: 新細明體,serif;">；如è¨å‚™ä¿®å¾©è‡³åŽŸç¢ºæ•ˆæ™‚的狀態，或使用相åŒçš„或類似的è¨å‚™ã€‚若能妥善地安è£åŠé©—è‰ï¼Œæ‡‰ä¸è‡´å½±éŸ¿è£½ç¨‹ã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">主è¦æ”¹è®Šæ‡‰å®šç¾©ç‚ºå¯èƒ½å°åŽŸæ–™è—¥çš„é‡è¦å“質屬性產生顯著的影響者。例如：改變最終çµæ™¶ç”¨çš„溶劑，å¯èƒ½å°åŽŸæ–™è—¥çš„ä¸ç´”物æè¿°ã€ç‰©ç†å±¬æ€§ã€åŠå…¶ä»–é‡è¦å“è³ªä¹‹å±¬æ€§ç”¢ç”Ÿé¡¯è‘—çš„å½±éŸ¿ã€‚é€™äº›è®Šæ›´æ‡‰åŠ ä»¥æ¸¬è©¦åŠå¿…è¦æ™‚應予以å†ç¢ºæ•ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">拾壹ã€ç´€éŒ„èˆ‡å ±å‘Š</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€æ–‡ä»¶ç³»çµ±</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有用於生產原料藥或ä¸é–“產å“所使用的文件，應ä¾æ›¸é¢ä½œæ¥ç¨‹åºäºˆä»¥è£½ä½œã€å¯©æŸ¥ã€æ ¸å‡†å’Œç™¼è¡Œã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有文件的發行ã€ä¿®æ£ã€å–代和廢æ¢ï¼Œå‡æ‡‰æœ‰æ‰€ç®¡åˆ¶ï¼Œä»¥ä¿å˜ä¿®æ£ä¹‹ç¶“æ·ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應建立ä¿å˜é©ç•¶æ–‡ä»¶ç³»çµ±ä¹‹æ›¸é¢ä½œæ¥ç¨‹åºï¼›å¦‚ç ”ç™¼éŽç¨‹çš„紀錄ã€æ‰¹é‡æ”¾å¤§ç´€éŒ„ã€æŠ€è¡“移轉紀錄ã€è£½ç¨‹ç¢ºæ•ˆç´€éŒ„ã€è¨“練紀錄ã€ç”Ÿç”¢ç´€éŒ„ã€ç®¡åˆ¶ç´€éŒ„ã€é‹éŠ·ç´€éŒ„和怨訴紀錄ç‰ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有生產ã€æŽ§åˆ¶å’ŒéŠ·å”®ä¹‹ç´€éŒ„，尤其和原料藥批次相關者，其紀錄至少應ä¿å˜è‡³è©²æ‰¹æ¬¡æœ‰æ•ˆæœŸé–“後一年。å°æ–¼è¨‚有å†é©—日期的原料藥，其紀錄應ä¿ç•™è‡³è©²æ‰¹ç”¢å“完全é‹éŠ·å¾Œä¸‰å¹´ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有原料åŠåŽŸæ–™è—¥å®¹å™¨çš„紀錄至少應ä¿å˜è‡³è©²æ‰¹æ¬¡æœ‰æ•ˆæœŸé–“後一年。å°æ–¼è¨‚有å†é©—日期的原料藥，其紀錄應ä¿ç•™è‡³è©²æ‰¹ç”¢å“完全é‹éŠ·å¾Œä¸‰å¹´ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有的紀錄æ£æœ¬æˆ–å‰¯æœ¬ï¼Œç”±ç´€éŒ„æ‰€è¨˜è¿°ä¹‹é …ç›®é–‹å§‹ï¼Œä¸€ç›´åˆ°ä¿å˜çš„期間內，應隨時å¯ä¾›è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œäººå“¡çš„稽查åŠå½±å°ã€‚若經由電腦或其他方å¼å¯ç«‹å³æª¢ç´¢çš„紀錄，亦å¯æŽ¥å—。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">紀錄å¯ä»¥æ£æœ¬ã€é›»å記錄或其真實影本，如：影å°ã€å¾®ç¸®è»Ÿç‰‡æˆ–原始文件的其他真實影本ç‰åŠ 以ä¿å˜ã€‚如使用縮影技術，如微縮軟片，應具備隨時å¯ä»¥ä½¿ç”¨çš„閱讀機åŠè¤‡å°è£ç½®ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">書é¢ç´€éŒ„æ‡‰åŠ ä»¥ä¿å˜ï¼Œé€™äº›æ•¸æ“šå¯ç”¨æ–¼è©•ä¼°å„原料藥的å“質。æ¯å¹´è‡³å°‘è¦è©•ä¼°ä¸€æ¬¡ï¼Œä»¥æ±ºå®šæ˜¯å¦éœ€è¦æ”¹è®Šè¦æ ¼ã€è£½é€ ã€æˆ–管制程åºã€‚評估程åºæ‡‰ä»¥æ›¸é¢è¨‚之，並據以éµå¾ªã€‚æ‡‰åŒ…æ‹¬ä¸‹åˆ—é …ç›®ï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">審查ã€æ ¸å‡†æˆ–拒用之具代表性批次åŠå…¶ç›¸é—œç´€éŒ„ï¼›</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">審查原料藥之製程改變ã€å®‰å®šæ€§æ•¸æ“š</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">計畫書，怨訴ã€å›žæ”¶ã€é€€å›žã€æŒ½å›žï¼Œä»¥åŠå差之調查之執行。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è¨å‚™æ¸…潔和使用紀錄</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">主è¦è¨å‚™çš„清洗åŠç¶è·</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">例行性ç¶è·é™¤å¤–：如潤滑åŠèª¿æ•´</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，應有書é¢ç´€éŒ„，其上載明日期ã€æ™‚é–“ã€åŽŸæ–™è—¥æˆ–ä¸é–“產å“æ¯æ‰¹è£½é€ 批次號碼和執行清潔人員。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">如果è¨å‚™å±¬å–®ä¸€ç”¢å“ä½¿ç”¨ï¼Œè€Œä¸”é€™é …ç”¢å“的批次åŠè£½é€ ä¿‚ä¾æ•¸å—é †åºé€²è¡Œï¼Œå…¶æ¸…æ´—ã€ç¶è·åŠä½¿ç”¨çš„紀錄å¯ç‚ºæ‰¹æ¬¡ç´€éŒ„的一部份，或å¯ä»¥åˆ†é–‹ä¿å˜ï¼ˆå¦‚è¨å‚™æ—¥èªŒç°¿ï¼‰ã€‚使用åŠæª¢æŸ¥æ¸…æ´—åŠç¶è·çš„人員，應在紀錄上註明日期，並簽åï¼Œä»¥é¡¯ç¤ºè©²é …å·¥ä½œæ¥å·²å®Œæˆã€‚ç´€éŒ„é …ç›®æ‡‰ä¾äº‹æƒ…ç™¼ç”Ÿçš„å…ˆå¾Œé †åºæŽ’列。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€åŽŸæ–™ã€ç”¢å“包è£ææ–™åŠæ¨™ç¤ºç´€éŒ„</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">紀錄內容應包括下列å„é …ï¼š</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ¯æ¬¡æ”¶è²¨æ™‚之æ¯æ‰¹åŽŸæ–™ã€åŽŸæ–™è—¥ã€ä¸é–“產å“ã€åŒ…è£ææ–™åŠæ¨™ç¤ºä¹‹é‘‘別å稱åŠæ•¸é‡ã€ä¾›æ‡‰å•†å稱ã€åœ¨ä¾›æ‡‰å•†è™•ä¹‹æ‰¹è™Ÿ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">è‹¥å¯å¾—知</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，接收編碼åŠæŽ¥æ”¶æ—¥æœŸç‰ã€‚若主è¦è£½é€ 者並éžä¾›æ‡‰å•†ï¼Œå‰‡è£½é€ å» ä¹‹å…¬å¸å稱åŠåœ°å€ï¼Œäº¦æ‡‰ä¸€ä½µç™»è¨˜ï¼Œä»¥ç¢ºä¿åŽŸæ–™è—¥æˆ–ä¸é–“產å“çš„å“質；</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">執行任何測試或檢驗之çµæžœåŠå…¶çµè«–ï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å„原料與ä¸é–“產å“個別的å˜è²¨ç´€éŒ„應相符；</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">標示åŠåŽŸæ–™è—¥åŒ…è£ææ–™è¦æ ¼çš„測試åŠå¯©æŸ¥æ‡‰ä»¥æ›¸é¢ç´€éŒ„ï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">拒用之原料ã€åŽŸæ–™è—¥åŒ…è£ææ–™åŠæ¨™ç¤ºç‰çš„處置。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å››ã€è£½é€ 管制標準書</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">為確ä¿æ‰¹æ¬¡èˆ‡æ‰¹æ¬¡é–“çš„å‡ä¸€æ€§ï¼ŒåŽŸæ–™è—¥æˆ–ä¸é–“產å“çš„è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼ŒåŒ…æ‹¬æ‰¹æ¬¡å¤§å°ç‰ï¼Œæ‡‰ç”±å°ˆäººåˆ¶è¨‚，註明日期並簽å，å†ç¶“由他人ç¨ç«‹å¯©æ ¸ï¼Œè¨»æ˜Žæ—¥æœŸä¸¦ç°½åã€‚è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸æ‡‰ç”±å“質管制單ä½å¯©æŸ¥åŠæ ¸å®šï¼Œå…¶åˆ¶è¨‚應有書é¢ä½œæ¥ç¨‹åºèªªæ˜Žï¼Œä¸”åŠ ä»¥éµå¾ªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸æ‡‰åŒ…æ‹¬ï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“çš„å稱和è˜åˆ¥åƒè€ƒç¢¼</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">有åƒè€ƒç¢¼è€…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">原料或ä¸é–“產å“完整清單，其å稱或代碼應能顯示å“質特性；</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">æ£ç¢ºçš„敘述æ¯ä¸€åŽŸæ–™æˆ–ä¸é–“產å“çš„é‡é‡æˆ–é‡æ¸¬å€¼ï¼Œä½¿ç”¨ç›¸åŒçš„稱é‡åˆ¶åº¦</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">米制ã€å¸¸è¡¡åˆ¶ã€æˆ–藥衡制</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">；若有é©ç•¶çš„辨è˜ï¼Œå…許åˆç†çš„變異；</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">è£½é€ å ´æ‰€åŠä¸»è¦è£½é€ è¨å‚™ï¼›</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">è£½é€ æ¥é©Ÿé †åºï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">製程åƒæ•¸ä½¿ç”¨ä¹‹ç¯„åœï¼›</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">å–樣æ¥é©Ÿå’Œè£½ç¨‹ç®¡åˆ¶åŠå…¶å¯æŽ¥å—範åœï¼›</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">完æˆå€‹åˆ¥è£½é€ æ¥é©Ÿå’Œ</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">或全部製程之時間é™åˆ¶ï¼›</span> </p><p><span style="font-family: calibri;">9. </span><span style="font-family: 新細明體,serif;">æ–¼é©ç•¶çš„製程階段，敘述é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">或é‡æ¸¬å€¼ä¹‹ç¯„åœï¼›</span> </p><p><span style="font-family: calibri;">10. </span><span style="font-family: 新細明體,serif;">é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">的說明，包括最大åŠæœ€å°çš„é‡é‡æˆ–é 期產é‡ç™¾åˆ†çŽ‡ä¹‹ç¯„åœï¼Œè¶…出該範åœå³éœ€é€²è¡Œèª¿æŸ¥ï¼›</span> </p><p><span style="font-family: calibri;">11. </span><span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“之儲å˜è¦æ±‚，包括包è£ææ–™ã€æ¨™ç¤ºå’Œç‰¹æ®Šå„²å˜çš„æ¢ä»¶ï¼›</span> </p><p><span style="font-family: calibri;">12. </span><span style="font-family: 新細明體,serif;">å®Œæ•´çš„è£½é€ ç¨‹åºä»»ä½•ç‰¹åˆ¥æ³¨æ„äº‹é …æˆ–åƒè€ƒè³‡æ–™ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">五ã€æ‰¹æ¬¡è£½é€ åŠç®¡åˆ¶ç´€éŒ„</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應建立æ¯ä¸€æ‰¹æ¬¡åŽŸæ–™è—¥çš„æ‰¹æ¬¡è£½é€ åŠç®¡åˆ¶ç´€éŒ„，åŠå…¶å®Œæ•´ç›¸é—œçš„資料。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應å«æº–ç¢ºçš„è£½é€ ç¨‹åºæˆ–åƒè€ƒé©ç•¶çš„è£½é€ ç®¡åˆ¶æ¨™æº–æ›¸ï¼ŒæŸ¥æ ¸å…¶æº–ç¢ºåº¦ã€æ—¥æœŸå’Œç°½å。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應å«æ‰¹æ¬¡è£½é€ çš„æ¯ä¸€å€‹é‡è¦æ¥é©Ÿï¼ŒåŒ…括：</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">日期ã€æ™‚é–“ï¼›</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">æ¯ä¸€å€‹ä¸»è¦çš„使用è¨å‚™å稱之è˜åˆ¥ï¼›</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">æ¯ä¸€æ‰¹æ¬¡ä¹‹ç‰¹å®šè˜åˆ¥ï¼ŒåŒ…括é‡é‡ã€æª¢é©—çµæžœåŠè£½é€ ä¸ä½¿ç”¨ä¹‹åŽŸæ–™ã€ä¸é–“產å“和任何é‡è£½</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">å†è£½ç”¢å“之批號；</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">é—œéµè£½ç¨‹åƒæ•¸ä¹‹å¯¦éš›è¨˜éŒ„çµæžœï¼›</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">製程åŠå¯¦é©—室管制çµæžœï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">在é©ç•¶è£½é€ 階段的實際與ç†è«–產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">之比較說明；</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“的包è£åŠæ¨™ç¤ºä¹‹æè¿°ï¼›</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">å–樣之作æ¥ï¼›</span> </p><p><span style="font-family: calibri;">9. </span><span style="font-family: 新細明體,serif;">æ“作æ¯ä¸€å€‹é—œéµæ¥é©Ÿæ™‚的執行者åŠç›´æŽ¥ç›£ç£è€…æˆ–æ ¸å°è€…之簽åï¼›</span> </p><p><span style="font-family: calibri;">10. </span><span style="font-family: 新細明體,serif;">任何å差調查之執行åŠçµæžœï¼›</span> </p><p><span style="font-family: calibri;">11. </span><span style="font-family: 新細明體,serif;">放行檢驗的çµæžœã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…ã€è£½é€ ç´€éŒ„å¯©æ ¸</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應建立放行å‰ä¹‹å¯©æŸ¥å’Œæ ¸å‡†æ‰¹æ¬¡è£½é€ ã€ç®¡åˆ¶å’Œå¯¦é©—室紀錄</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包å«åŒ…è£åŠæ¨™ç¤º</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">åŠæ±ºå®šåŽŸæ–™è—¥æ˜¯å¦ç¬¦åˆæ—¢å®šè¦æ ¼çš„書é¢ä½œæ¥ç¨‹åºï¼Œä¸¦äºˆä»¥éµå¾ªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">é—œéµè£½é€ æ¥é©Ÿçš„æ‰¹æ¬¡è£½é€ åŠç®¡åˆ¶ç´€éŒ„，應由å“質管制部門審查åŠæ ¸å‡†ï¼Œä»¥ç¢ºå®šæ‰¹æ¬¡æ”¾è¡Œæˆ–é‹éŠ·å‰ï¼Œç¬¦åˆå·²å»ºç«‹åŠæ ¸å‡†çš„書é¢ç¨‹åºåŠè¦æ ¼ã€‚éžé—œéµè£½é€ æ¥é©Ÿçš„æ‰¹æ¬¡è£½é€ åŠç®¡åˆ¶ç´€éŒ„，å¯ç”±åˆæ ¼ä¹‹è£½é€ 人員或其他單ä½äººå“¡ä¾æ ¸å¯ä¹‹æ¥é©Ÿå¯©æ ¸ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°æ–¼ä¸‹åˆ—無法解釋的差異所進行之調查，應建立書é¢ä½œæ¥ç¨‹åºï¼Œä¸¦äºˆä»¥éµå¾ªï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">çµæžœä¸ç¬¦åˆè£½é€ 管製標準書之é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">範åœè€…ï¼›</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">ä¸ç¬¦åˆæ—¢å®šè¦æ ¼ä¹‹æ‰¹æ¬¡ï¼›</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">任何ä¸ç¬¦åˆæ—¢å®šè¦æ ¼ä¹‹æª¢é©—çµæžœã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">除調查原料藥失效或差異批次外，ä¸è«–與æ¤æ‰¹æ¬¡æœ‰é—œä¹‹å…¶ä»–批次是å¦å·²é‹éŠ·ï¼Œä»æ‡‰åŠ 以調查。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應製備書é¢èª¿æŸ¥ç´€éŒ„，其內容應包å«ï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">èª¿æŸ¥çš„åŽŸå› ï¼›</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">執行調查摘è¦æ‡‰åŒ…括所有實驗室的檢驗åŠå…¶çµæžœï¼›</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">調查çµæžœæ‡‰åŒ…括調查ä¸æ‰€æœ‰å¯¦é©—室檢驗的çµæžœï¼›</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">與失敗或差異相關的批次，所作的矯æ£è¡Œå‹•åŠå…¶çµè«–ï¼›</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">è² è²¬æ ¸å®šèª¿æŸ¥ç´€éŒ„äººå“¡çš„ç°½ååŠæ—¥æœŸã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">七ã€å¯¦é©—室紀錄</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">實驗室紀錄應包括為了需è¦ç¢ºä¿ç¬¦åˆå·²å»ºç«‹ä¹‹æ—¢å®šè¦æ ¼ã€æ¨™æº–ã€æª¢é©—å’Œå«é‡ä¹‹æ¸¬è©¦ï¼Œæ‰€ç²å¾—之所有數據：</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">待測樣å“çš„æ述，包括：樣å“來æºã€æ•¸é‡ã€æ‰¹è™Ÿæˆ–其他特定編號ã€å–樣日期åŠæ¸¬è©¦æ—¥æœŸã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">æ¯ç¨®æ¨£å“檢驗方法的說明。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">ä¾æ“šæ–¹æ³•ä¹‹è¦æ±‚，æ¯ä¸€æ¨£å“å–用的é‡é‡æˆ–é‡æ¸¬çµæžœï¼ŒåŠè£½å‚™å¯¦é©—室åƒè€ƒæ¨™æº–å“ã€è©¦åŠ‘和溶液åŠå…¶æ¸¬è©¦æ•¸æ“šæˆ–引用åƒè€ƒç‰ä¹‹è¨˜éŒ„。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">æ¯æ¬¡æª¢é©—ç²å¾—之所有數據的完整記錄，包括由實驗室儀器所測得的圖表åŠåœ–èœï¼ŒåŠå…¶æ£ç¢ºåœ°åˆ¤å®šï¼Œä»¥é¡¯ç¤ºä¸é–“產å“ã€åŽŸæ–™è—¥ã€æˆ–製程åŠæ‰¹æ¬¡ä¹‹æª¢é©—çµæžœã€‚</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">與檢驗相關的所有計算之紀錄，包括：é‡æ¸¬å–®ä½ã€è½‰æ›ä¿‚數åŠç•¶é‡ä¿‚數。</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">檢驗çµæžœçš„陳述，並包å«å¦‚何測試原料ã€ä¸é–“產å“或原料藥ç‰ä¹‹å“質ã€ç´”度åŠèˆ‡æ—¢å®šæ¨™æº–比較的çµæžœã€‚</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">æ¯æ¬¡æª¢é©—時執行人員的簽åã€æˆ–縮寫å，以åŠæ¸¬è©¦æ—¥æœŸã€‚</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">應由第二ä½äººå“¡çš„ç°½åã€æˆ–縮寫å，以顯示其已å°åŽŸå§‹ç´€éŒ„çš„æ£ç¢ºæ€§ã€å®Œæ•´æ€§åŠç¬¦åˆæ—¢å®šçš„標準進行å†å¯©æŸ¥ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應ä¿å˜ä¸‹åˆ—完整之紀錄</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">任何已建立分æžæ–¹æ³•ä¹‹ä¿®æ£ï¼ŒåŒ…括修æ£ä¹‹ç†ç”±ï¼Œç¢ºèªä¿®å®šä¹‹çµæžœçš„準確度和å¯ä¿¡åº¦è‡³å°‘與已建立方法相當之數據；</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">實驗室åƒè€ƒæ¨™æº–å“ã€è©¦åŠ‘標準溶液之製備和檢驗</span><span style="font-family: calibri;">; </span></p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">å®šæœŸæ ¡æ£å¯¦é©—室儀器ã€è£ç½®ã€å„€éŒ¶å’Œè¨˜éŒ„è£ç½®ï¼›</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">原料藥之所有安定性試驗的執行；</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">ä¸ç¬¦åˆè¦æ ¼ä¹‹èª¿æŸ¥ã€‚</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å…«ã€é‹éŠ·ç´€éŒ„</span> </p><p><span style="font-family: 新細明體,serif;">é‹éŠ·ç´€éŒ„應å«åŽŸæ–™è—¥æˆ–ä¸é–“產å“å稱，收件人的å稱ã€æ—¥æœŸã€å¯„出數é‡ã€æ‰¹è™Ÿæˆ–控制號碼。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¹ã€æ€¨è¨´ç´€éŒ„</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應有特定的檔案以ä¿å˜åŽŸæ–™è—¥æ¯ä¸€å€‹æ€¨è¨´çš„書é¢ç´€éŒ„。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">怨訴書é¢ç´€éŒ„檔案應ä¿å˜åœ¨åŽŸæ–™è—¥ä¹‹è£½é€ ã€åŠ å·¥ã€åŒ…è£ä¹‹æª”案ä¸ã€‚若這些書é¢ç´€éŒ„檔能隨時å–得供查閱，則æ¤æª”案亦å¯ä¿å˜äºˆä»–處。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥的怨訴書é¢ç´€éŒ„應至少ä¿ç•™åˆ°åŽŸæ–™è—¥æœ‰æ•ˆæœŸé–“後一年或收到怨訴後一年，å–時間較長者。若為有å†é©—日期的原料藥，æ¤æ›¸é¢è³‡æ–™æ‡‰ä¿ç•™åˆ°è©²æ‰¹æ¬¡é‹éŠ·å¾Œä¸‰å¹´ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">怨訴書é¢ç´€éŒ„應包括：</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">怨訴者姓å和地å€ï¼›</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">æ出怨訴者之姓å和電話號碼；</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">怨訴的性質</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«åŽŸæ–™è—¥ä¹‹å稱ã€æ‰¹è™Ÿ</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">接到怨訴的日期；</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">åˆæœŸçš„處ç†</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å«æ—¥æœŸåŠè™•ç†è¡Œå‹•ä¹‹äººå“¡</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">任何後續的處ç†ï¼›</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">æ供原怨訴者之回覆的內容</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å«æ—¥æœŸåŠè¢«å›žè¦†è€…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">å°ä¸é–“產å“或原料藥處ç†çš„最後è£æ±ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">拾貳ã€æ€¨è¨´èˆ‡é€€å›žåŽŸæ–™è—¥</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">或ä¸é–“產å“</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">之處ç†</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€æ€¨è¨´</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å°æ‰€æœ‰æ›¸é¢åŠå£é æ出之怨訴，應以書é¢è¦å®šå…¶è™•ç†ä½œæ¥ç¨‹åºï¼Œä¸¦éµå¾ªä¹‹ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç„¡è«–å£é 或書é¢çš„怨訴å‡æ‡‰äºˆè¨˜éŒ„，而且ä¾æ›¸é¢ä½œæ¥ç¨‹åºé€²è¡Œèª¿æŸ¥ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">怨訴之紀錄應予ä¿å˜ï¼Œä»¥ä½œç‚ºè©•ä¼°æœªä¾†çš„趨勢，與產å“ç›¸é—œä¹‹æ€¨è¨´é »çŽ‡åŠå…¶åš´é‡æ€§ã€‚若有必è¦ï¼Œæ‡‰ç«‹å³äºˆä»¥çŸ¯æ£ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">回應訴怨而åšä¹‹èª¿æŸ¥ï¼Œæ‡‰ä»¥æ›¸é¢è¨˜éŒ„之，內容應包括調查çµæžœåŠæ‡‰æŽ¡å–的矯æ£æŽªæ–½ã€‚èª¿æŸ¥å ±å‘Šç´€éŒ„æˆ–å…¶å‰¯æœ¬ï¼Œæ‡‰èˆ‡èª¿æŸ¥å‰ä¾æ—¢å®šç¨‹åºåŸ·è¡Œä¹‹ç´€éŒ„檔案一併ä¿å˜ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">若未進行調查，亦應以書é¢è¨˜éŒ„之，內容應包括為何ä¸éœ€èª¿æŸ¥çš„ç†ç”±ï¼Œä»¥åŠä½œæ¤æ±ºå®šä¹‹è² 責人員姓å。</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">二ã€é€€å›ž</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">退回原料藥或ä¸é–“產å“之接收ã€æ“作ã€æª¢é©—和處置應建立書é¢ä½œæ¥ç¨‹åºï¼Œä¸¦äºˆä»¥éµå¾ªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">退回的原料藥或ä¸é–“產å“經鑑別後應分開儲å˜ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">若被退回的原料藥或ä¸é–“產å“是回到庫å˜å“å˜æ”¾è™•ï¼Œå‰‡é€€å›žä¹‹åŽŸå› ä¸å¯æ˜¯å› å“質的å•é¡Œï¼Œè€Œä¸”所退回的原料藥產å“之完整性應予以確èªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">若無法確ä¿è¢«é€€å›žçš„原料藥或ä¸é–“產å“çš„å“質或純度，則該產å“應予以銷毀；若經é‡è£½æˆ–å†è£½å¾Œå°šèƒ½ç¬¦åˆæ—¢å®šè¦æ ¼è€…，則å¯é€²è¡Œé‡è£½æˆ–å†è£½ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“退回之紀錄應予以ä¿å˜ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">三ã€å›žæ”¶</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應有書é¢ä½œæ¥ç¨‹åºè¦å®šåœ¨ä½•ç¨®æƒ…æ³ä¸‹éœ€è€ƒé‡ç”¢å“的回收。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">回收之書é¢ä½œæ¥ç¨‹åºæ‡‰åŒ…å«æœ‰å¦‚何評估ã€é€šå‘ŠåŠå›žæ”¶ç‰©æ‡‰å¦‚何處置。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">若發生嚴é‡ä¸è‰¯å應事件或潛在生命å¨è„…的情æ³æ™‚ï¼Œæ‡‰é€šå ±åœ°æ–¹åŠä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">拾åƒã€ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">一ã€ç¢ºæ•ˆæ”¿ç–</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è—¥å» ç¢ºæ•ˆä¹‹æ”¿ç–ã€ç›®æ¨™åŠé”æˆçš„方法，應包括製程ã€æ¸…潔方法ã€åˆ†æžæ–¹æ³•ã€è£½ç¨‹ç®¡åˆ¶æª¢é©—方法ã€é›»è…¦ç³»çµ±åŠè¨è¨ˆã€å¯©æŸ¥ã€æ ¸å‡†äººå“¡ä¹‹è·è²¬ï¼ŒåŠæ¯ä¸€ç¢ºæ•ˆéšŽæ®µä¹‹æ–‡ä»¶ï¼Œæ‡‰å»ºç«‹æ›¸é¢ä½œæ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ‰€æœ‰åŽŸæ–™è—¥è£½é€ æ¥é©Ÿå‡æ‡‰å»ºç«‹æ›¸é¢ä¹‹ç¢ºæ•ˆä½œæ¥è¨ˆç•«ï¼Œä¸¦äºˆä»¥éµå¾ªã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç¢ºæ•ˆç ”ç©¶ç‚ºç¢ºä¿ç‰¹å®šè£½é€ 程åºçš„å¯ä¿¡åº¦å’Œä¸€è‡´æ€§ï¼Œä»¥åŠä½¿æœ€çµ‚原料藥具å‡ä¸€æ€§ï¼Œä¸¦ç¬¦åˆæ—¢å®šè¦æ ¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€é©—è‰</span> </p><p><span style="font-family: 新細明體,serif;">執行製程確效å‰ï¼Œå…¶ä½¿ç”¨çš„è¨æ–½åŠè¨å‚™æ‡‰å®Œæˆé©ç•¶çš„é©—è‰ã€‚é©—è‰ä¸€èˆ¬å«ä¸‹åˆ—é …ç›®ï¼š</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨è¨ˆé©—è‰</span> <span style="font-family: 新細明體,serif;">為一種確èªä½œæ¥ï¼Œæ—¨åœ¨ç¢ºèªè¨æ–½æˆ–è¨å‚™æˆ–系統能é©åˆä½¿ç”¨çš„目的。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">安è£é©—è‰</span> <span style="font-family: 新細明體,serif;">為一種確èªä½œæ¥ï¼Œæ—¨åœ¨ç¢ºèªè¨æ–½æˆ–è¨å‚™æ–¼æ—¢è¨‚æ¢ä»¶ä¸‹å®‰è£ï¼Œä¸¦èƒ½æ–¼é™åˆ¶æ¢ä»¶èˆ‡è€å—範åœå…§å‘ˆæ†å®šæ€§èƒ½ä¹‹æŽªæ–½ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ“作驗è‰</span> <span style="font-family: 新細明體,serif;">為一種確èªä½œæ¥ï¼Œæ—¨åœ¨ç¢ºèªè¨æ–½æˆ–è¨å‚™æ–¼å…¶æ“作極é™ç¯„åœèˆ‡æ£å¸¸ç¯„åœå…§èƒ½æ£å¸¸é‹è½‰ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">性能驗è‰</span> <span style="font-family: 新細明體,serif;">為一種確èªä½œæ¥ï¼Œç‚ºæ“作驗è‰ä¹‹ä¸€ç¨®ï¼Œæ—¨åœ¨ç¢ºèªè¨æ–½æˆ–è¨å‚™èƒ½æŒçºŒç©©å®šçš„表ç¾å…¶æ‡‰æœ‰ä¹‹æ€§èƒ½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è£½ç¨‹ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">製程確效之執行應包括å°æœ€çµ‚原料藥å“質åŠç´”度有é‡å¤§å½±éŸ¿çš„æ¥é©Ÿï¼š</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">è—‰é‡è¦çš„產å“屬性來鑑別原料藥。應考慮的屬性包括：化å¸ç´”度ã€å®šæ€§å’Œå®šé‡çš„ä¸ç´”物æ述；物ç†ç‰¹æ€§å¦‚粒徑大å°ã€å‡</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">真密度ã€å¤šé …晶態形狀ã€æ°´ä»½åŠæº¶åŠ‘å«é‡ã€å‡ä¸€åº¦åŠå¾®ç”Ÿç‰©</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">產å“易é微生物污染者</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">鑑別å¯èƒ½å½±éŸ¿åŽŸæ–™è—¥é‡è¦å“質屬性的製程åƒæ•¸ã€‚é‡è¦çš„製程åƒæ•¸æ‡‰ç”±ç§‘å¸åŒ–的判斷來決定，通常ä¾æ“šç”¢å“çš„ç ”ç©¶ã€æ”¾å¤§è©¦é©—æ‰¹æ¬¡æˆ–è£½é€ ç¶“é©—æ‰€ç²å¾—之資訊來訂定。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">è¨‚å®šåœ¨ä¾‹è¡Œè£½é€ èˆ‡è£½ç¨‹ç®¡åˆ¶ä¸‹çš„æ¯ä¸€å€‹é‡è¦è£½ç¨‹åƒæ•¸ä¹‹ç¯„åœã€‚訂定é‡è¦è£½ç¨‹åƒæ•¸ä¹‹ç¯„åœæ‰€ä¾æ“šçš„æ•¸æ“šï¼Œé€šå¸¸å¾—è‡ªå¯¦é©—å®¤ç ”ç©¶æˆ–æ”¾å¤§è©¦è£½çš„æ‰¹æ¬¡ï¼Œé™¤éžæ¤ç‰¹æ®Šçš„åƒæ•¸åªèƒ½ç”±é‡ç”¢è¦æ¨¡æ™‚æ‰èƒ½æ¸¬å¾—。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">舉例å¯èƒ½å®šç¾©ç‚ºé‡è¦è£½ç¨‹çš„æ¥é©Ÿå¦‚下：</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">相變化，如溶解或çµæ™¶ï¼›</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">相分離，如éŽæ¿¾æˆ–離心；</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">引起化å¸è®ŠåŒ–çš„æ¥é©Ÿï¼›</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">改變溫度或</span><span style="font-family: calibri;">pH</span><span style="font-family: 新細明體,serif;">çš„æ¥é©Ÿï¼›</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">多種原料之混åˆæ¥é©Ÿï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">æ“作æ¥é©Ÿæœƒå¼•èµ·è¡¨é¢ç©ã€ç²’徑大å°ã€å‡</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">真密度ã€æˆ–å‡ä¸€åº¦æ”¹è®Šè€…。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åœ¨è£½ç¨‹ç¢ºæ•ˆç ”ç©¶ä¸ä¸»è¦è£½ç¨‹åƒæ•¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如å應時間ã€å應溫度ã€å應物之比例ã€æ¿ƒåº¦ã€å£“力ã€</span><span style="font-family: calibri;">pH</span><span style="font-family: 新細明體,serif;">值ã€åŠä¸ç´”物å«é‡</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">應予控制åŠç›£æ¸¬ã€‚與å“質ä¸ç›¸é—œçš„製程åƒæ•¸ï¼Œä¾‹å¦‚使能é‡ä¹‹æ¶ˆè€—é”最å°åŒ–åŠè¨å‚™ä½¿ç”¨çš„變異數控制，ä¸éœ€è¦åŒ…å«æ–¼ç¢ºæ•ˆè£½ç¨‹ä¸ã€‚</span> <span style="font-family: 新細明體,serif;">製程確效應確èªæ¯ä¸€ç¨®åŽŸæ–™è—¥ä¹‹ä¸ç´”物æ述是在è¦æ ¼é™åˆ¶å…§ã€‚而且是與製程發展時所測得或用於毒ç†ç ”究之批次相似</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€è£½ç¨‹ç¢ºæ•ˆè¨ˆç•«æ›¸</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">應建立書é¢çš„確效計畫書明述如何執行製程確效。æ¤è¨ˆç•«æ›¸æ‡‰ç”±å“質管制部門和其他權責單ä½ä¹‹å¯©æŸ¥å’Œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">確效計畫書應包å«ä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: calibri;">(1) </span><span style="font-family: 新細明體,serif;">確效之目的和範åœï¼›</span> </p><p><span style="font-family: calibri;">(2) </span><span style="font-family: 新細明體,serif;">ç¢ºæ•ˆè² è²¬éƒ¨é–€ä¹‹çµ„ç¹”ã€äººäº‹åŠæ¬Šè²¬ä»»å‹™ï¼›</span> </p><p><span style="font-family: calibri;">(3) </span><span style="font-family: 新細明體,serif;">經é©ç•¶åˆ¤å®šå¾Œï¼Œé¸æ“‡åŸ·è¡Œä¹‹ç¢ºæ•ˆç¨®é¡žï¼›</span> </p><p><span style="font-family: calibri;">(4) </span><span style="font-family: 新細明體,serif;">製程確效作æ¥å¯¦æ–½çš„次數；</span> </p><p><span style="font-family: calibri;">(5) </span><span style="font-family: 新細明體,serif;">用於製程之原料åŠå…¶å“質</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如回收或新的溶劑</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">(6) </span><span style="font-family: 新細明體,serif;">製程說明</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如化å¸å“ã€æ“作單元ã€è£½ç¨‹æµç¨‹åœ–的討論</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">(7) </span><span style="font-family: 新細明體,serif;">所有製程使用之主è¦è¨å‚™ï¼Œå…¶ç¨®é¡ž</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">è¨è¨ˆã€å®‰è£å’Œæ“作驗è‰ï¼›</span> </p><p><span style="font-family: calibri;">(8) </span><span style="font-family: 新細明體,serif;">原料藥é‡è¦å“質屬性；</span> </p><p><span style="font-family: calibri;">(9) </span><span style="font-family: 新細明體,serif;">é‡è¦è£½ç¨‹åƒæ•¸å’Œæ“作範åœï¼›</span> </p><p><span style="font-family: calibri;">(10) </span><span style="font-family: 新細明體,serif;">å–樣計畫</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如收集樣å“之å–樣點ã€é »çŽ‡ã€é‡ã€å’Œæ”¶é›†æ¨£å“çš„æ¥é©Ÿ</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">(11) </span><span style="font-family: 新細明體,serif;">è¦æ ¼åŠæª¢é©—數據；</span> </p><p><span style="font-family: calibri;">(12) </span><span style="font-family: 新細明體,serif;">é”æˆç¢ºæ•ˆå¯æŽ¥å—的標準；</span> </p><p><span style="font-family: calibri;">(13) </span><span style="font-family: 新細明體,serif;">當製程確效失敗時應éµå¾ªä¹‹æ¥é©Ÿã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">任何確效計畫的改變應予é©ç•¶çš„判定並以書é¢å®šä¹‹ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€å…ˆæœŸæ€§ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">先期性確效應用於原料藥é‹éŠ·å‰ï¼Œç‚ºæ–°çš„或本質上經éŽä¿®æ£æ‰€ä½¿ç”¨çš„è£½é€ è£½ç¨‹ã€‚æ¤ç¨®å…ˆæœŸæ€§ç¢ºæ•ˆçš„é”æˆæ‡‰åŒ…å«ä¾ç…§å·²å»ºç«‹çš„確效計畫，å°å¤šæ¬¡æ‰¹æ¬¡çš„è£½é€ ã€å–樣åŠæª¢é©—，以得到並評估已書é¢è¨‚定作æ¥ç¨‹åºä¹‹è£½ç¨‹åŠåˆ†æžç®¡åˆ¶çš„資訊。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">è£½ç¨‹åŸ·è¡Œå…ˆæœŸæ€§ç¢ºæ•ˆæ™‚ï¼Œæ‡‰ç”±å¯¦é©—å®¤ç ”ç©¶åŠæ”¾å¤§è©¦è£½æ‰¹æ¬¡æ‰€å¾—之數據確èªé‡è¦çš„å“質屬性和è¦æ ¼ã€é‡è¦æ¥é©Ÿã€æŽ§åˆ¶ç¯„åœåŠè£½ç¨‹ä¸æ¸¬è©¦ã€‚經放大試製批次所ç²å¾—之數據應能æä¾›å†ç¢ºèªæˆ–改進先å‰ä¹‹å·¥ä½œï¼›ç”Ÿç”¢æ”¾å¤§æ‰¹æ¬¡æ‰€ç²å¾—之數據則應顯示出製程之一致性。</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">製程確效執行的次數應ä¾æ“šè£½ç¨‹çš„複雜性或製程改變之大å°ä¾†è€ƒé‡ã€‚雖然一般的原則應採用連續三次åˆæ ¼çš„批次，但為ä¿è‰è£½ç¨‹çš„一致性，也å¯ä»¥å¦å¤–å¢žåŠ æ‰¹æ¬¡åŠ ä»¥è‰æ˜Ž</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如複雜的原料藥製程或完æˆæ™‚間較長的原料藥製程</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€‚è‹¥ç¢ºæ•ˆå¤±æ•—çš„åŽŸå› èˆ‡è£½ç¨‹çš„æœ¬èº«ç„¡é—œ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">如åœé›»æˆ–è¨å‚™æ壞</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">，則æ¤æ‰¹æ¬¡æ‡‰ç”±ç¢ºæ•ˆç ”究ä¸åŽ»é™¤ï¼Œè€Œå†åŠ 入其他批次之確效數據。</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">è£½ç¨‹ç¢ºæ•ˆæ‡‰ä½¿ç”¨èƒ½å¤ å®šé‡ç”¢å“屬性å“質的分æžæ–¹æ³•ã€‚分æžæ•¸æ“šçµæžœæ‡‰äºˆè©•ä¼°ã€‚ç¢ºæ•ˆå ±å‘Šæ‡‰ç¶“æ ¸å‡†è¨ˆç•«æ›¸ä¹‹ç›¸åŒå–®ä½äºˆä»¥æ ¸å‡†ã€‚</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€ä½µè¡Œæ€§ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">併行性確效å¯è€ƒé‡ç‚ºå…ˆæœŸæ€§ç¢ºæ•ˆçš„一部分。批次有é™ä¸èƒ½åœ¨ä¸€å®šçš„時間內完æˆåŽŸæ–™è—¥è£½ç¨‹çš„確效，以致無法æä¾›å†æ¬¡è£½é€ 所需之åƒè€ƒæ•¸æ“šï¼Œå…¶åŽŸå› 包括：</span> </p><p><span style="font-family: calibri;">(1). </span><span style="font-family: 新細明體,serif;">僅生產有é™æ‰¹æ¬¡çš„原料藥供臨床試驗用藥或罕見疾病用藥使用；</span> </p><p><span style="font-family: calibri;">(2). </span><span style="font-family: 新細明體,serif;">ä¸å¸¸ç”Ÿç”¢ä¹‹åŽŸæ–™è—¥æ‰¹æ¬¡ï¼ˆå¸‚å ´éœ€æ±‚æœ‰é™ï¼Œå¤šä¸”è¤‡é›œçš„è£½é€ æ¥é©Ÿä¸”完æˆæ™‚間長之製程）；</span> </p><p><span style="font-family: calibri;">(3). </span><span style="font-family: 新細明體,serif;">經由修æ£ä¹‹è£½ç¨‹æ‰€è£½é€ 之原料藥批次（如確效製程之é‡è¦æ“作åƒæ•¸ä¸åœ¨å·²è‰æ˜Žä¹‹å¯æŽ¥å—範åœï¼Œä¸”經密集分æžæ¸¬è©¦è€…）。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">在上述情æ³ä¸‹ï¼Œè—¥å» æ‡‰åŸ·è¡Œä¸‹åˆ—æ‰€æœ‰äº‹é …ï¼š</span> </p><p><span style="font-family: calibri;">(1). </span><span style="font-family: 新細明體,serif;">以書é¢èªªæ˜Žåœ¨åŽŸæ–™è—¥é‹è²¨éŠ·å”®å‰æœªå®Œæˆç¢ºæ•ˆçš„åŽŸå› ï¼›</span> </p><p><span style="font-family: calibri;">(2). </span><span style="font-family: 新細明體,serif;">除了原料藥放行é‹éŠ·å‰ä¹‹é‡è¤‡è£½é€ 作æ¥ï¼Œæ‡‰åŸ·è¡Œæ‰€æœ‰æ‹¾åƒã€ä¸‰ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ç¯€æ‰€è¨Žè«–ä¹‹å…ˆæœŸæ€§ç¢ºæ•ˆçš„é …ç›®ï¼›</span> </p><p><span style="font-family: calibri;">(3). </span><span style="font-family: 新細明體,serif;">æ¯ä¸€æ‰¹åŽŸæ–™è—¥è£½ç¨‹ä¸ç›£æ¸¬åŠæª¢é©—åŠå…¶çµæžœï¼Œæ‡‰å¯é¡¯ç¤ºåŽŸæ–™è—¥ç”Ÿç”¢çš„çµæžœç¬¦åˆæ—¢å®šå“質特性和è¦æ ¼ï¼ˆæ¤æ•¸æ“šä¹Ÿæ‡‰ç´å…¥ç¢ºæ•ˆè¨ˆç•«åŠ 以評估，以判定製程之一致性）；</span> </p><p><span style="font-family: calibri;">(4). </span><span style="font-family: 新細明體,serif;">å“è³ªç®¡åˆ¶éƒ¨é–€æ‡‰è©•ä¼°æ‰¹æ¬¡è£½é€ è¨˜éŒ„ã€è£½ç¨‹ä¸ç®¡åˆ¶ã€å’Œç”±æ¯ä¸€å€‹æ‰¹æ¬¡è£½ç¨‹æ“作之分æžæ•¸æ“šï¼Œä»¥æ±ºå®šæ¯ä¸€å€‹æ‰¹æ¬¡æ˜¯å¦æ”¾è¡Œã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">下列å„é …éžåŸ·è¡Œç¢ºæ•ˆä¹‹æ£ç¢ºè¡Œç‚ºï¼š</span> </p><p><span style="font-family: calibri;">(1). </span><span style="font-family: 新細明體,serif;">ä¸ç•¶çš„延é²å®Œæˆæ™‚間或é¿é–‹æœ‰æ„義的確效；</span> </p><p><span style="font-family: calibri;">(2). </span><span style="font-family: 新細明體,serif;">在完æˆç¢ºæ•ˆå‰çš„一段時間，生產é‹éŠ·åŽŸæ–™è—¥ã€‚</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">原料藥在銷售å‰ï¼Œè£½é€ 的批次數é‡å’Œé »çŽ‡æ‡‰è¶³ä»¥å®Œæˆç¢ºæ•ˆï¼Œä¸æ‡‰ä»¥ä¸Šè¿°æƒ…æ³ä¹‹ä½µè¡Œæ€§ç¢ºæ•ˆå–代。如果數據分æžçš„çµæžœé¡¯ç¤ºå·²ç”Ÿç”¢éŠ·å”®è£½ç¨‹ä¹‹ç¢ºæ•ˆå°šæœªå®Œæˆï¼Œåœ¨åŸ·è¡ŒçŸ¯æ£ä¸”完æˆç¢ºæ•ˆä¹‹å‰ï¼Œä¸å‡†éŠ·å”®ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€å›žæº¯æ€§ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">回溯性確效å¯æ‡‰ç”¨æ–¼å·²å»ºç«‹ä¹‹è£½ç¨‹ï¼Œä¸”沒有會影響原料藥é‡è¦å“質屬性的é‡è¦æ”¹è®Šï¼ˆå¦‚原料ã€è¨å‚™ã€ç³»çµ±ã€è¨æ–½æˆ–åœ¨è£½é€ çš„è£½ç¨‹ï¼‰ã€‚é€™ç¨®ç¢ºæ•ˆæ–¹å¼åªæœ‰åœ¨éŽåŽ»çš„åŽŸæ–™è—¥æ‰¹æ¬¡å·²æœ‰è¶³å¤ çš„è³‡æ–™ä»¥é¡¯ç¤ºæ¤è£½ç¨‹å¯æŒçºŒè£½é€ å¯æŽ¥å—的產å“：</span> </p><p><span style="font-family: calibri;">(1) </span><span style="font-family: 新細明體,serif;">é‡è¦çš„產å“屬性åŠè£½ç¨‹æ¥é©Ÿåƒæ•¸å·²è¢«é‘‘別，並有書é¢æ–‡ä»¶ã€‚</span> </p><p><span style="font-family: calibri;">(2) </span><span style="font-family: 新細明體,serif;">以書é¢è¨‚定製程ä¸é©ç•¶çš„è¦æ ¼åŠç®¡åˆ¶ã€‚</span> </p><p><span style="font-family: calibri;">(3) </span><span style="font-family: 新細明體,serif;">除了æ“作人員的éŽå¤±æˆ–éžè¨å‚™é©ç”¨æ€§å¼•èµ·ä¹‹å¤±éˆå¤–，沒有異常的製程和產å“上的失敗率。</span> </p><p><span style="font-family: calibri;">(4) </span><span style="font-family: 新細明體,serif;">已建立原料藥的ä¸ç´”物æ述。</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">確效計畫書應包å«æ‰¹æ¬¡é¸æ“‡çš„標準åŠç”¨ä»¥è©•ä¼°åˆ¤å®šè£½ç¨‹ä¸€è‡´æ€§ä¹‹åˆ†æžæ•¸æ“šã€‚</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">由製程決定用於審查的批次數目。通常應檢測å到三å之連續批次的數據，以評估製程的一致性。任何ä¸ç¬¦è¦æ ¼ä¹‹æ‰¹æ¬¡äº¦æ‡‰åŒ…å«åœ¨å¯©æŸ¥ç¯„åœå…§ã€‚在審查期間的所有被é¸ç”¨ä¹‹æ‰¹æ¬¡æ‡‰ç”±åŒä¸€è£½ç¨‹æ‰€è£½å¾—，並éµå¾ªç›¸åŒä¹‹ç¾è¡ŒåŽŸæ–™è—¥çš„管制措施åŠæ¸¬è©¦æ–¹æ³•ã€‚å¦å¤–å¢žåŠ å°å„²å˜æ¨£å“之檢測，å¯ç”¨ä»¥ä¿è‰ç²å¾—製程回溯性確效必è¦ä¹‹æ•¸æ“šã€‚</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">應由é©ç•¶çš„人員評估所ç²å¾—之數據，並應製備å«çµæžœæ‘˜è¦å’Œé©ç•¶çµè«–ä¹‹æœ€çµ‚ç¢ºæ•ˆå ±å‘Šã€‚æ¤å ±å‘Šæ‡‰ç”±åŽŸæ ¸å‡†ç¢ºæ•ˆè¨ˆç•«æ›¸ä¹‹å–®ä½å¯©æŸ¥å’Œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">回溯性確效亦å¯ä½œç‚ºå…ˆæœŸæ€§ç¢ºæ•ˆä¹‹è£œå……和建立特定製程之信心之é¡å¤–數據。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç¢ºæ•ˆå¯©æŸ¥</span> </p><p><span style="font-family: 新細明體,serif;">系統和製程確效應在一定的期間內予以評估，以確èªæ“作方法ä»ç‚ºæœ‰æ•ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€æ¸…潔方法確效</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨å‚™çš„清潔方法應予以確效。通常清潔確效應在å¯èƒ½ç›´æŽ¥ç”¢ç”Ÿæ±¡æŸ“或交å‰æ±¡æŸ“，而影響產å“å“質之情æ³æˆ–è£½é€ çš„æ¥é©ŸåŸ·è¡Œã€‚在早期åˆæˆçš„æ¥é©Ÿï¼Œç”±æ–¼æ®˜ç•™ç‰©æœƒåœ¨ä¸‹å€‹ç´”化æ¥é©Ÿç§»é™¤ï¼Œä¹Ÿè¨±å¯ä»¥ä¸éœ€è¦ç¶“éŽç¢ºæ•ˆçš„清潔方法。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">確效計畫書應明確的說明：待清潔之è¨å‚™ã€æ–¹æ³•ã€ææ–™åŠç¨‹åº¦ã€éœ€è¦åµæ¸¬åŠç®¡åˆ¶çš„åƒæ•¸å’Œåˆ†æžæ–¹æ³•ã€‚æ¤è¨ˆç•«æ›¸æ‡‰æŒ‡å‡ºå–樣的方法（直接表é¢å–樣ã€æ´—滌å–樣），åŠå¦‚何收集ã€æ¨™ç¤ºã€åŠå‚³é€è‡³åˆ†æžå¯¦é©—室。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">清潔方法的確效應顯示è¨å‚™çœŸå¯¦çš„使用情æ³ã€‚如果ä¸åŒåŽŸæ–™è—¥æˆ–ä¸é–“產å“使用相åŒçš„è¨å‚™ï¼Œè€Œä¸”æ¤è¨å‚™çš„清潔是用相åŒçš„æ¥é©Ÿï¼Œå‰‡å¯ä»¥é¸æ“‡æœ€å·®ç‹€æ³çš„原料藥或ä¸é–“產å“進行確效。最差狀æ³ç”¢å“çš„é¸æ“‡æ‡‰ç¶œåˆè€ƒé‡ä¸‹åˆ—å› ç´ ï¼ŒåŒ…æ‹¬ï¼šæ•ˆåƒ¹ã€æ¯’性ã€æº¶è§£åº¦ã€å®‰å®šæ€§ã€æˆ–清潔困難度ç‰ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å–樣的方法應能é‡æ¸¬å‡ºæ¸…洗後å˜åœ¨æ–¼è¨å‚™è¡¨é¢çš„殘餘物之數é‡ã€‚å–樣方法通常包括直接表é¢å–樣ã€æ´—滌å–樣或其他的方法（如直接èƒå–），以檢驗ä¸å¯æº¶åŠå¯æº¶çš„殘留物。已確效的分æžæ–¹æ³•æ‡‰å…·æœ‰è¶³å¤ 的專一性åŠéˆæ•åº¦ï¼Œä»¥åµæ¸¬è¨å‚™æ¸…潔後之殘留物或污染物。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應ä¾æ“šæœ€æœ‰å®³æ®˜ç•™ç‰©çš„性質訂定實際å¯è¡Œä¸”能è‰å¯¦çš„é™é‡ç¯„åœã€‚最低濃度é™é‡è¨å®šçš„方法應ä¾æ“šæ–¼åŽŸæ–™è—¥æˆ–最有害殘留物之最å°è—¥ç†ã€ç”Ÿç†ä½œç”¨æ´»æ€§ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥è¦æ¸›å°‘å¾®ç”Ÿç‰©è² è·é‡å’Œå…§æ¯’ç´ æ±¡æŸ“çš„è£½ç¨‹ï¼Œåœ¨é€²è¡Œè¨å‚™æ¸…æ´—å’Œè¡›ç”Ÿçš„ç ”ç©¶æ™‚ï¼Œæ‡‰ç‰¹åˆ¥è€ƒé‡ã€‚（例如：éžç„¡èŒåŽŸæ–™è—¥ç”¨æ–¼è£½é€ éžç¶“è…¸é“之製劑）。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">確效後之清潔æ¥é©Ÿæ‡‰æœ‰æª¢æŸ¥çš„方法，以ä¿è‰æ¤æ¸…æ½”æ¥é©Ÿç”¨æ–¼ä¾‹è¡Œä¹‹æ¸…潔是有效的。å¯èƒ½çš„話，è¨å‚™äº¦æ‡‰ç›®è¦–檢查其清潔度。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€</span> <span style="font-family: 新細明體,serif;">分æžæ–¹æ³•ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應清楚了解分æžæ¥é©Ÿä¹‹ç›®çš„。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">除éžæŽ¡ç”¨æœ€æ–°è—¥å…¸æˆ–主管機關文ç»æœ‰è¨˜è¼‰ä¹‹åˆ†æžæ–¹æ³•ï¼Œå¦å‰‡åˆ†æžæ–¹æ³•é ˆåŠ 以確效。所有分æžæ–¹æ³•é©ç”¨æ€§ä¹‹ç¢ºèªæ‡‰æ–¼çœŸå¯¦æƒ…æ³ä¸‹åŸ·è¡Œï¼Œä¸¦äºˆä»¥ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">　</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應考慮下列典型的確效特性：</span> </p><p><span style="font-family: calibri;">1. </span><span style="font-family: 新細明體,serif;">準確度；</span> </p><p><span style="font-family: calibri;">2. </span><span style="font-family: 新細明體,serif;">精密度；</span> </p><p><span style="font-family: calibri;">3. </span><span style="font-family: 新細明體,serif;">專一性；</span> </p><p><span style="font-family: calibri;">4. </span><span style="font-family: 新細明體,serif;">最低檢測濃度；</span> </p><p><span style="font-family: calibri;">5. </span><span style="font-family: 新細明體,serif;">最低定é‡æ¿ƒåº¦ï¼›</span> </p><p><span style="font-family: calibri;">6. </span><span style="font-family: 新細明體,serif;">線性；</span> </p><p><span style="font-family: calibri;">7. </span><span style="font-family: 新細明體,serif;">範åœï¼›</span> </p><p><span style="font-family: calibri;">8. </span><span style="font-family: 新細明體,serif;">è€è®Šæ€§ï¼›</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€åˆ†æžç¢ºæ•ˆåŸ·è¡Œçš„程度應由分æžçš„目的åŠåŽŸæ–™è—¥è£½ç¨‹çš„階段決定。</span> </p><p><span style="font-family: 新細明體,serif;">拾肆ã€è‡¨åºŠè©¦é©—用原料藥</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ä¸€èˆ¬åŽŸå‰‡</span> </p><p><span style="font-family: 新細明體,serif;">å°æ–°è—¥å¯©æŸ¥ç™¼å±•éšŽæ®µè—¥å“çš„è£½é€ ï¼Œä¸æ˜¯æ‰€æœ‰å‰é¢ç« 節的內容都é©ç”¨ã€‚æœ¬ç« ç¯€æä¾›æ¤ç¨®ç‰¹æ®Šæƒ…æ³ä¸‹ç‰¹å®šçš„基準。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å“質ä¿è‰æŽªæ–½</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">確ä¿é©ç•¶çš„å“質管制措施åŠè—¥å“å„ªè‰¯è£½é€ è¦ç¯„原料藥作æ¥åŸºæº–的觀念已應用於æ¯ä¸€æ‰¹æ¬¡è‡¨åºŠè©¦é©—ç”¨åŽŸæ–™è—¥ä¹‹æ ¸å‡†æ©Ÿåˆ¶ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç”Ÿç”¢è‡¨åºŠè©¦é©—ç”¨åŽŸæ–™è—¥ä¹‹è£½é€ æ‡‰èˆ‡è£½åŠ‘ä¹‹è‡¨åºŠç™¼å±•éšŽæ®µæ‰€ç”¨åŽŸæ–™è—¥ä¸€è‡´ã€‚è£½ç¨‹å’Œåˆ†æžæ–¹æ³•éš¨è‘—å°è£½ç¨‹äº†è§£çš„å¢žåŠ å’Œè£½åŠ‘ç”±å‰è‡¨åºŠéšŽæ®µè‡³è‡¨åºŠéšŽæ®µçš„改變，å¯æœ‰å½ˆæ€§ä¿®æ£ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç”Ÿç”¢æ¬²ä½¿ç”¨æ–¼äººé¡žæˆ–å‹•ç‰©è‡¨åºŠè©¦é©—ç”¨è£½åŠ‘ä¹‹åŽŸæ–™è—¥æ™‚ï¼Œè£½é€ è€…æ‡‰ç¢ºä¿è‡¨åºŠè©¦é©—用原料藥是在åˆæ ¼ä¹‹è¨æ–½ä¸‹è£½é€ ，使用é©ç•¶çš„è£½é€ å’Œç®¡åˆ¶æ¥é©Ÿï¼Œä»¥ç¢ºä¿åŽŸæ–™è—¥ä¹‹å“質ã€å®‰å…¨å’Œå‡ä¸€æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å“質管制部門</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">用於臨床用原料藥，亦應建立與商æ¥åŒ–產å“相當的ç¨ç«‹å“è³ªç®¡åˆ¶éƒ¨é–€ï¼Œä»¥æ ¸å‡†å’Œæ‹’ç”¨æ¯æ‰¹æ¬¡ä¹‹åŽŸæ–™è—¥ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æŸäº›å“質管制部門執行的一般檢驗，å¯ä»¥åœ¨å…¶ä»–的地方æ“作。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å“質管制的檢驗應包å«åŽŸæ–™ã€åŒ…è£ç‰©ã€ä¸é–“產å“和原料藥的檢驗系統。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">ç”¨æ–¼ç ”ç©¶è©¦é©—ä¹‹åŽŸæ–™è—¥çš„æ¨™ç¤ºï¼Œæ‡‰äºˆé©ç•¶ç®¡åˆ¶å’Œé‘‘別。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è¨å‚™å’Œè¨æ–½</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åœ¨æ‰€æœ‰è‡¨åºŠç™¼å±•è©¦é©—éšŽæ®µä¹‹åŽŸæ–™è—¥è£½é€ ï¼Œæ‡‰è¨‚å®šæ›¸é¢ä½œæ¥ç¨‹åºï¼Œä»¥ä¿è‰ä½¿ç”¨ä¹‹è¨å‚™å·²æ ¡æ£ã€æ¸…æ½”åŠé©ç”¨ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è¨æ–½ä½¿ç”¨ä¹‹ç¨‹åºæ‡‰ç¢ºä¿åŽŸæ–™ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“和原料藥的æ“作，å¯é¿å…污染åŠäº¤å‰æ±¡æŸ“。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åŽŸæ–™ç®¡åˆ¶</span> </p><p><span style="font-family: 新細明體,serif;">生產供臨床試驗階段用原料藥之原料，應予以檢驗評估，或應由供應者æ供分æžè‰æ˜ŽåŠé‘‘別檢驗çµæžœã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è£½é€ 和製程管制</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å¯¦é©—ç´€éŒ„ç°¿æˆ–æ‰¹æ¬¡è£½é€ ç´€éŒ„ï¼Œå¯ç”¨ä¾†åšç‚ºè£½é€ 臨床試驗用原料藥所需之書é¢è³‡æ–™ï¼›å…§å®¹æ‡‰åŒ…å«æ‰€æœ‰è£½é€ 有關的原料ã€å®¹å™¨ã€å°è“‹ã€åŒ…è£ææ–™ã€æ¨™ç¤ºææ–™ã€ä¸é–“產å“ã€åŽŸæ–™è—¥ã€è¨å‚™ã€è£½é€ 和科å¸åŒ–的觀察。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">é 期產é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">率</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">å¯è¼ƒå•†æ¥åŒ–ä¹‹è£½é€ æœ‰æ›´å¤§çš„è®Šç•°å’Œå®šç¾©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è£½ç¨‹ç¢ºæ•ˆ</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åœ¨æ—©æœŸçš„è‡¨åºŠéšŽæ®µï¼Œå¸¸å¸¸åƒ…è£½é€ å–®ä¸€æ‰¹æ¬¡çš„åŽŸæ–™è—¥ã€‚é‡è¦çš„è£½é€ æ”¹è®Šå¯èƒ½ä½¿å¾—è£½é€ æ‰¹æ¬¡ä¹‹å†ç¾æ€§å›°é›£æˆ–ä¸æº–ç¢ºï¼Œå› æ¤å¯åªåŸ·è¡Œæœ‰é™çš„製程確效。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">當單一或有é™ä¹‹åŽŸæ–™è—¥æ‰¹æ¬¡è¢«è£½é€ 作為臨床試驗用製劑之情æ³ä¸‹ï¼Œä½µè¡Œæ€§ç¢ºæ•ˆä¹Ÿè¨±é©ç”¨ã€‚所ç²å¾—之確效數據應包括大部分製程和最後æ¥é©Ÿä¹‹æª¢é©—數據，以顯示æ¤è£½ç¨‹ç”¢é‡å’ŒåŽŸæ–™è—¥ç¬¦åˆæ—¢å®šä¹‹è¦æ ¼å’Œå“質。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">先期性的確效應使用於最åˆç”Ÿç”¢ç‚ºè‡¨åºŠè©¦é©—用之多個批次的原料藥，且無論這些原料藥的生產是å¦ç‚ºæ”¾å¤§è©¦è£½æˆ–å°é‡è£½é€ 。當放大試製或å°é‡è£½ç¨‹è¢«æ”¾å¤§ç‚ºå•†æ¥åŒ–ç”Ÿç”¢ï¼Œå…¶è£½ç¨‹æ‡‰é€²è¡Œå®Œæ•´ä¹‹ç¢ºæ•ˆç ”ç©¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è®Šæ›´ç®¡åˆ¶åŠç´€éŒ„</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">在臨床發展階段，當製程技術得到新資訊或放大生產時，é 期會變更製程。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有製程的修æ£æ‡‰äºˆä»¥é©ç•¶çš„書é¢ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å¯¦é©—室管制</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">用於評估臨床試驗用原料藥之分æžï¼Œæ‡‰åŸºæ–¼ç§‘å¸åŽŸç†ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應建立儲備原料藥樣å“之系統，並予以éµå¾ªã€‚æ¤ç³»çµ±æ‡‰ç¢ºä¿åœ¨ç”¢å“æ ¸å‡†ã€æœŸæ»¿æˆ–ä¸æ–·æ–°è—¥ç”³è«‹ç ”究ã€æ–°è—¥ç”³è«‹å¾Œï¼Œä»æœ‰è¶³å¤ 的儲備樣å“åŠé©ç•¶çš„ä¿å˜æœŸé–“。</span> </p><p><span style="font-family: 新細明體,serif;">åã€æ–‡ä»¶ç³»çµ±</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應建立確ä¿è‡¨åºŠè©¦é©—åœ¨ç™¼å±•å’ŒåŽŸæ–™è—¥è£½é€ æ‰€å¾—ä¹‹è³‡æ–™å‡ä»¥æ›¸é¢ç´€éŒ„的系統。æ¤é¡žè³‡æ–™æ‡‰ä½µå…¥è£½ç¨‹ç™¼å±•å ±å‘Šä¸ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">用於支æŒè‡¨åºŠè©¦é©—用原料藥批次放行的分æžæ–¹æ³•ä¹‹ç™¼å±•å’ŒåŸ·è¡Œï¼Œæ‡‰äºˆé©ç•¶çš„書é¢ç´€éŒ„。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">應有ä¿å˜è£½é€ 和控制紀錄之系統。æ¤ç³»çµ±æ‡‰ç¢ºä¿ç´€éŒ„在產å“æ ¸å‡†ã€æœŸæ»¿æˆ–ä¸æ–·æ–°è—¥ç”³è«‹ç ”究ã€æ–°è—¥ç”³è«‹å¾Œï¼Œä»æœ‰è¶³å¤ åŠé©ç•¶çš„ä¿å˜æœŸé–“。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">拾ä¼ã€å§”è¨—è£½é€ æˆ–æª¢é©—</span> </p><p><span style="font-family: 新細明體,serif;">一ã€</span> <span style="font-family: 新細明體,serif;">å§”è¨—è€…æ‡‰è©•ä¼°è£½é€ æˆ–æª¢é©—ä¹‹å—委託者，以確定å—委託者之æ“作éµå¾ªè—¥å“å„ªè‰¯è£½é€ è¦ç¯„原料藥作æ¥åŸºæº–。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€</span> <span style="font-family: 新細明體,serif;">委託者與å—委託者間應有書é¢ä¹‹åˆç´„書，並詳細訂定雙方的義務。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€</span> <span style="font-family: 新細明體,serif;">åˆç´„書ä¸æ‡‰è¨‚定賦予委託者評鑑å—委託者å“質之權利。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€</span> <span style="font-family: 新細明體,serif;">æœªå¾—åˆ°å§”è¨—è€…ä¹‹è©•ä¼°å’Œæ ¸å‡†å‰ï¼Œå—委託者ä¸æ‡‰è½‰å§”託任何工作給其èªå¯ä¹‹ç¬¬ä¸‰è€…。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€</span> <span style="font-family: 新細明體,serif;">å—委託者應ä¿å˜å’Œéš¨æ™‚å¯æä¾›è£½é€ æˆ–æª¢é©—çš„è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€</span> <span style="font-family: 新細明體,serif;">製程ã€è¨å‚™ã€æª¢é©—方法ã€è¦æ ¼æˆ–其他åˆç´„上的è¦æ±‚ä¸æ‡‰éš¨æ„變更，除éžæ¤è®Šæ›´å·²å‘ŠçŸ¥ä¸¦ç¶“å§”è¨—è€…æ ¸å‡†è€…ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€</span> <span style="font-family: 新細明體,serif;">å§”è¨—è€…æ‡‰è² ç”¢å“責任。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">拾陸ã€ä»£ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é©ç”¨ç¯„åœ</span> </p><p><span style="font-family: 新細明體,serif;">æœ¬ç« ç¯€é©ç”¨æ–¼ä¸æ˜¯åŽŸæ–™è—¥åŽŸè£½é€ å» ä¹‹ä»»ä½•ç¬¬ä¸‰è€…ï¼›å¦‚è²¿æ˜“ã€è²·è³£ã€å†æ¨™ç¤ºã€è™•ç†ã€åˆ†éŠ·æˆ–儲å˜åŽŸæ–™è—¥æˆ–ä¸é–“產å“者。</span> </p><p><span style="font-family: 新細明體,serif;">所有代ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†é ˆç¬¦åˆæœ¬åŸºæº–之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€éŠ·å”®ä¹‹åŽŸæ–™è—¥æˆ–ä¸é–“產å“之å¯è¿½æº¯æ€§</span> </p><p><span style="font-family: 新細明體,serif;">代ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†é ˆå®Œæ•´ä¿æœ‰å…¶éŠ·å”®ä¹‹åŽŸæ–™è—¥æˆ–ä¸é–“產å“çš„å¯è¿½æº¯æ€§è³‡æ–™ã€‚書é¢ç´€éŒ„應予以ä¿å˜</span><span style="font-family: calibri;"> [</span><span style="font-family: 新細明體,serif;">本基準拾壹ã€ä¸€ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">之內容</span><span style="font-family: calibri;">]</span><span style="font-family: 新細明體,serif;">。並å¯æ供，å«ï¼š</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åŽŸè£½é€ å» ä¹‹è˜åˆ¥ï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">åŽŸè£½é€ å» ä¹‹åœ°å€ï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">訂購單；</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æ貨單</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">é‹é€ç´€éŒ„</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">收據紀錄；</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">原料藥或ä¸é–“產å“å稱；</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">七</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">è£½é€ å•†è£½é€ æ‰¹è™Ÿï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å…«</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">é‹é€åŠåˆ†éŠ·ç´€éŒ„ï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">ä¹</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">所有å¯é 的分æžè‰æ˜Žæ›¸</span><span style="font-family: calibri;"> (COA)</span><span style="font-family: 新細明體,serif;">，å«åŽŸè£½é€ å» ä¹‹åˆ†æžè‰æ˜Žæ›¸ï¼›</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">å†é©—日期或有效期間。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å“質管ç†</span> </p><p><span style="font-family: 新細明體,serif;">代ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†æ‡‰å»ºç«‹æ›¸é¢ä½œæ¥ç¨‹åºï¼Œä¸¦ä¾æœ¬åŸºæº–所訂之內容，實施å“質管ç†ä¹‹ç³»çµ±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€åŽŸæ–™è—¥æˆ–ä¸é–“產å“之å†åˆ†åŒ…è£ã€å†æ¨™ç¤ºåŠæŒæœ‰ä¹‹è¦å®š</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€åŽŸæ–™è—¥æˆ–ä¸é–“產å“之å†åˆ†åŒ…è£è€…ã€å†æ¨™ç¤ºè€…åŠå…¶æŒæœ‰è€…，應éµå¾ªæœ¬åŸºæº–之è¦å®šï¼Œä»¥é¿å…混雜或æ害原料藥或ä¸é–“產å“之純度。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€å†åˆ†åŒ…è£æ‡‰åœ¨é©ç•¶çš„環境æ¢ä»¶ä¸‹æ“作，以é¿å…污染或交å‰æ±¡æŸ“。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å®‰å®šæ€§</span> </p><p><span style="font-family: 新細明體,serif;">如果原料藥或ä¸é–“產å“å†åˆ†åŒ…è£çš„å®¹å™¨èˆ‡åŽŸè£½é€ å» ä¹‹ç¨®é¡žä¸åŒï¼Œå‰‡æ‡‰åšå®‰å®šæ€§ç ”究，以調整有效期間或å†é©—日期。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è³‡è¨Šäº¤æ›</span><span style="font-family: calibri;">(Transfer of Information) </span></p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€ä»£ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†æ‡‰å°‡ç”±åŽŸæ–™è—¥æˆ–ä¸é–“產å“è£½é€ å» ä¹‹æ‰€æœ‰å“質或法è¦çš„資訊交付給購買之客戶，å之亦åŒã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€ä»£ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†ï¼Œæ‡‰æä¾›åŽŸè£½é€ å» ä¹‹åŽŸæ–™è—¥æˆ–ä¸é–“產å“çš„å稱和批次號碼，給購買之客戶。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€ç•¶è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ出è¦æ±‚時，代ç†å•†æ‡‰æä¾›åŽŸè£½é€ å» åŽŸæ–™è—¥æˆ–ä¸é–“產å“之鑑別的資料。å¯ç”±åŽŸè£½é€ å» ç›´æŽ¥å›žè¦†è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæˆ–ä¾æ“šä»£ç†å•†èˆ‡åŽŸè£½é€ å» æ³•å¾‹ä¸ŠæŽˆæ¬Šçš„é—œä¿‚ï¼Œç¶“éŽæŽˆæ¬Šçš„代ç†å•†å›žè¦†ã€‚</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">æŽˆæ¬Šè¡¨ç¤ºæ˜¯åŽŸè£½é€ å» ä¹‹æŽˆæ¬Š</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€åˆ†æžè‰æ˜Žæ›¸</span><span style="font-family: calibri;"> (COA) </span><span style="font-family: 新細明體,serif;">應符åˆæ–¼æœ¬åŸºæº–拾ã€ä¸‰ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ç« ç¯€ä¹‹å…§å®¹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€æ€¨è¨´åŠå›žæ”¶ä¹‹è™•ç†</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€ä»£ç†å•†ã€ç¶“紀人ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†æ‡‰ä¾æœ¬åŸºæº–æ‹¾è²³ç« ä¿æœ‰æ€¨è¨´åŠå›žæ”¶ä¹‹ç´€éŒ„。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€å¦‚果怨訴情æ³æ˜¯å±¬æ–¼ç†ç”±æ£ç•¶è€…，則代ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†ï¼Œæ‡‰èˆ‡åŽŸæ–™è—¥æˆ–ä¸é–“產å“åŽŸè£½é€ å» ä»”ç´°æª¢è¨Žæ¤æ€¨è¨´ï¼Œä»¥æ±ºå®šæ˜¯å¦éœ€è¦åšæ›´é€²ä¸€æ¥çš„行動，並告知其他已接收到æ¤åŽŸæ–™è—¥æˆ–ä¸é–“產å“之購買客戶或衛生主管機關，且應調查怨訴åŠå›žæ”¶çš„åŽŸå› ï¼Œä¸¦ç”±é©ç•¶çš„當事者予以記錄åŠä¿å˜ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€å¦‚果原料藥或ä¸é–“產å“之怨訴æ¸å› æ–¼åŽŸè£½é€ å» ï¼Œå‰‡ä»£ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†ä¿å˜çš„紀錄ä¸ï¼Œæ‡‰å«æœ‰ç”±åŽŸæ–™è—¥æˆ–ä¸é–“產å“所接å—到的所有回覆的資料</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">包å«æ供的日期åŠè³‡è¨Š</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€é€€å›žè™•ç†</span> </p><p><span style="font-family: 新細明體,serif;">退回的產å“應ä¾æ‹¾è²³ã€äºŒç« 節的è¦å®šè™•ç†ã€‚代ç†å•†ã€è²¿æ˜“商ã€ç¶“銷商ã€åˆ†åŒ…è£å•†ã€å†æ¨™ç¤ºå•†æ‡‰ä¿ç•™é€€å“產å“的文件紀錄。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體,serif;">拾柒ã€ç”Ÿç‰©æŠ€è¡“製程原料藥</span> </p><p><span style="font-family: 新細明體,serif;">本è¦ç¯„是é‡å°ç¶“由細胞培養</span><span style="font-family: calibri;">/</span><span style="font-family: 新細明體,serif;">ç™¼é…µè£½ç¨‹æ‰€è£½é€ åŽŸæ–™è—¥ä¹‹ç‰¹åˆ¥åŸºæº–ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">一ã€é€šå‰‡</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體,serif;">ã€</span> <span style="font-family: 新細明體,serif;">æœ¬ç« ä¸»è¦èªªæ˜Žåœ¨å‰è¿°ç« 節ä¸æœªèƒ½é©ç•¶åŠ 以涵蓋的部份，é‡å°ä½¿ç”¨å¤©ç„¶æˆ–ç¶“ç”±åŸºå› æ”¹é€ çš„ç”Ÿç‰©æœ‰æ©Ÿé«”</span><span style="font-family: calibri;">(organisms)</span><span style="font-family: 新細明體,serif;">ï¼Œé€²è¡Œç´°èƒžåŸ¹é¤Šæˆ–ç™¼é…µä¾†è£½é€ åŽŸæ–™è—¥æˆ–ä¸é–“產å“ç‰¹å®šçš„ç®¡åˆ¶ã€‚æœ¬ç« èˆ‡å…¶ä»–éƒ¨åˆ†ç« ç¯€ä¸¦éžç¨ç«‹è€Œä¸ç›¸é—œçš„ã€‚ä¸€èˆ¬è€Œè¨€ï¼Œåœ¨å…¶ä»–ç« ç¯€æ‰€æ述之原則是é©ç”¨çš„ã€‚ä»¥å‚³çµ±è£½ç¨‹è£½é€ å°åˆ†åé‡ç‰©è³ªä¹‹ç™¼é…µåŽŸç†å’Œåˆ©ç”¨åŸºå› æ”¹é€ æˆ–éžåŸºå› æ”¹é€ ç”Ÿç‰©æœ‰æ©Ÿé«”</span><span style="font-family: calibri;">(organisms)</span><span style="font-family: 新細明體,serif;">ä¾†è£½é€ è›‹ç™½è³ªåŠï¼ˆæˆ–）多胜</span> </p>2013-12-05
化å¸è£½é€ 管制類,è—¥å“å„ªè‰¯è£½é€ ,è—¥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–行政解釋藥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–<p style="text-align: center;"><b><span style="font-size: 13pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL013827"><span style="font-family: 新細明體,serif; color: windowtext; text-decoration: none; text-underline: none;">è—¥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº–</span></a> </span></b></p><p style="text-align: center;"><span style="font-size: 10pt;">(</span><span style="font-family: 新細明體,serif; font-size: 10pt;">民國</span><span style="font-size: 10pt;"> 88 <span style="font-family: 新細明體,serif;">å¹´</span> 04 <span style="font-family: 新細明體,serif;">月</span> 13 </span><span style="font-family: 新細明體,serif; font-size: 10pt;">日修æ£</span><span style="font-size: 10pt;">)</span> </p><table style="margin: auto auto auto 1.5pt; width: 100.92%;" border="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 一 ç·¨ 總則</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=1"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 1 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本藥å“å„ªè‰¯è£½é€ ç¢ºæ•ˆä½œæ¥åŸºæº– (以下簡稱本基準) ，為æå‡è—¥å“å“質ã€ç¢º </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä¿è—¥å“之有效性與安全性，進而é”到國際水準，特制訂本基準。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=2"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 2 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» æ‡‰ä¾æœ¬åŸºæº–，以é©ç•¶ä¹‹æ–¹æ³•ï¼Œé‡å°ä¸‹åˆ—äº‹é …ä¹‹é©ç•¶æ€§ï¼Œé€²è¡Œç¢ºæ•ˆï¼šæ”¯ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ´ç³»çµ± (包括供水與空氣處ç†ç³»çµ±) ，è¨å‚™ä¹‹å®‰è£ã€æ“作åŠå…¶æ€§èƒ½ï¼Œè¨å‚™ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之清潔，製程åŠå„種分æžæ–¹æ³•ç‰ã€‚未列入之其他å„種é‹ä½œäº¦æ‡‰è¦–å¿…è¦æ€§è‡ª </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行，或由主管單ä½æŒ‡å®šå¯¦æ–½ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=3"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 3 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">進行å„ç¨®ç¢ºæ•ˆæ™‚ï¼Œè—¥å» å¾—ä¸ä¾æ“šæœ¬åŸºæº–æ‰€åˆ—èˆ‰ä¹‹æ–¹æ³•ï¼Œè€Œè‡ªè¡ŒæŽ¡ç”¨å…¶ä»–å¯ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行之科å¸æ–¹æ³•ï¼ŒæƒŸæ‡‰èƒ½æ“¬é”本目標。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=4"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 4 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本基準之專用åè©žå…¶æ„義如下： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 確效：係指有文件è‰æ˜Žçš„行動，能è‰å¯¦ç¨‹åºã€è£½ç¨‹ã€æ©Ÿæ¢°è¨å‚™ã€åŽŸæ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">料或系統確實能æŒçºŒç©©å®šçš„導致é 期之效果。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 é©—è‰ï¼šç‚ºå°æ–¼è¨æ–½åŠè¨å‚™æœ¬èº«ä¹‹æ€§èƒ½ç¢ºèªæœ‰é—œäº‹å®œã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 安è£é©—è‰ï¼šç‚ºä¸€ç¨®ç¢ºèªä½œæ¥ï¼Œæ—¨åœ¨ç¢ºèªè¨æ–½æˆ–è¨å‚™æ–¼æ—¢è¨‚æ¢ä»¶ä¸‹å®‰è£ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">，並能於é™åˆ¶æ¢ä»¶èˆ‡è€å—範åœå…§å‘ˆç¾æ†å®šæ€§èƒ½ä¹‹æŽªæ–½ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› æ“作驗è‰ï¼šç‚ºä¸€ç¨®ç¢ºèªä½œæ¥ï¼Œæ—¨åœ¨ç¢ºé©—è¨æ–½æˆ–è¨å‚™æ–¼å…¶æ“作極é™ç¯„åœ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">與æ£å¸¸ç¯„åœå…§èƒ½é©ç•¶é‹è½‰ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 性能驗è‰ï¼šç‚ºä¸€ç¨®ç¢ºèªä½œæ¥ï¼Œç‚ºæ“作驗è‰ä¹‹ä¸€ç¨®ï¼Œæ—¨åœ¨ç¢ºèªè¨å‚™æˆ–è¨ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">施能æŒçºŒç©©å®šçš„表ç¾å…¶æ‡‰æœ‰ä¹‹æ€§èƒ½ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å… è£½ç¨‹ç¢ºæ•ˆï¼šç¢ºèªç”¢å“ä¹‹è£½é€ ç¨‹åºåŠå…¶ç®¡åˆ¶æ¢ä»¶ï¼Œå…·æœ‰è‰¯å¥½çš„有效性與 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">å†ç¾æ€§ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七 產å“確效：å°ç”±ç‰¹å®šè£½ç¨‹ç”Ÿç”¢æ‰€å¾—之產å“作é©ç•¶ä¹‹æ¸¬è©¦ï¼Œä»¥ç¢ºèªç”¢å“ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">於放行時，能符åˆæ‰€æ‡‰æœ‰çš„特性與安全性。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å…« 先期性確效：為一種產å“於上市å‰æ‰€é€²è¡Œä¹‹ç¢ºæ•ˆæŽªæ–½ï¼Œé©ç”¨æ–¼ä¸‹åˆ—å…© </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">類產å“： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> (</span><span style="font-family: 細明體; font-size: 11pt;">一) 新產å“：新申請查驗登記之產å“。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> (</span><span style="font-family: 細明體; font-size: 11pt;">二) 既有產å“於更改é…æ–¹ (包括æˆåˆ†åŠçµ„æˆ) ã€è£½é€ å ´æ‰€ã€è£½é€ è¨å‚™ã€ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">製程ç‰è£½é€ æ¢ä»¶è€Œå¯èƒ½æœƒé‡å¤§å½±éŸ¿ç”¢å“之å“質特性者。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä¹ å›žæº¯æ€§ç¢ºæ•ˆï¼šå°ä¸€ç‰¹å®šä¹‹ç”¢å“而言，利用以往生產ã€æ¸¬è©¦èˆ‡ç®¡åˆ¶ä¹‹ç´¯ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">ç©æ•¸æ“šï¼Œå°å·²ä¸Šå¸‚產å“，所作之製程確效，通常以連續åæ‰¹ä»¥ä¸Šç”¢å“ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">之相關數據行之。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一○ 併行性確效：å°ä¸€ç‰¹å®šä¹‹ç”¢å“而言，ä¾ç…§å¯¦éš›ç”Ÿç”¢ä¹‹è¦æ¨¡åŠæ¢ä»¶ï¼Œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">å°±æ‰€è£½é€ ä¹‹é€£çºŒä¸‰æ‰¹è©²ç”¢å“所作之製程確效。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一一 å†ç¢ºæ•ˆï¼šå†ç¢ºæ•ˆç‚ºå°ä¸€é€šéŽç¢ºæ•ˆä¹‹ç‰¹å®šç”¢å“，é‡è¡Œç¢ºæ•ˆä¹‹æŽªæ–½ï¼Œå¯ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">分下列兩種： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> (</span><span style="font-family: 細明體; font-size: 11pt;">一) 於原料ã€è¨æ–½æˆ–è¨å‚™ã€è£½é€ å ´æ‰€ã€æˆ–è£½é€ æ–¹æ³•æœ‰ç•°å‹•æ™‚ï¼Œæ‡‰é€²è¡Œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">之確效。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> (</span><span style="font-family: 細明體; font-size: 11pt;">二) 當併行性確效與回溯性確效之數據ä¸å……分，而ä¸èƒ½ä¾›è¶¨å‹¢åˆ†æžæ™‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">，應進行定期å†ç¢ºæ•ˆã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一二 確效計畫書：說明將如何進行確效之書é¢è¨ˆç•«æ›¸ï¼Œå…§å®¹åŒ…括予以測 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">試之指標，產å“特質，生產è¨å‚™ï¼Œä»¥åŠæ¸¬è©¦åˆæ ¼ä¹‹åˆ¤å®šæ¨™æº–。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一三 最差狀æ³ï¼šç‚ºæœ€èƒ½å°Žè‡´è£½ç¨‹æˆ–產å“的失敗之æ¢ä»¶ï¼ŒåŒ…å«è£½ç¨‹èˆ‡ç’°å¢ƒ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">之最高與最低極é™æ¢ä»¶ï¼Œä»¥åŠè™•æ–¼æ¨™æº–æ“作程åºå…§æœ€èƒ½å¼•èµ·è£½ç¨‹æˆ– </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">產å“的失敗之æ¢ä»¶ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=5"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 5 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» æ‡‰è¨ç½®å°ˆè²¬éƒ¨é–€æˆ–ç”±å“質管ç†å–®ä½ï¼Œè² 責主æŒç¢ºæ•ˆä½œæ¥ï¼Œä¸¦æŒ‡æ´¾å°ˆäºº </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">è² è²¬ç±ŒåŠƒï¼Œå”調並監ç£æœ‰é—œäº‹å‹™ã€‚å„部門進行確效作æ¥æ™‚，應有å“è³ªç®¡ç† </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">人員é…åˆåƒèˆ‡ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=6"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 6 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» è¨‚æœ‰ç¢ºæ•ˆä½œæ¥ä¹‹æ•´é«”è¨ˆç•«ï¼Œå…§å®¹åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 目錄。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 確效作æ¥æ¦‚è¿°åŠç›®æ¨™ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 確效專責部門之組織ã€äººäº‹åŠæ¬Šè²¬ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› 所用è¾å½™ä¹‹å®šç¾©ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 å„種è¨æ–½åŠè¨å‚™ä¹‹æ€§ç‹€æè¿°åŠè³‡æ–™ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å… å»ºç¯‰ç‰©æ›¸é¢è³‡æ–™ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七 å„種確效作æ¥ä¹‹è¨ˆç•«æ›¸ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å…« å„種確效標準作æ¥ç¨‹åºã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä¹ é 防性ç¶è·ä½œæ¥åŠçŸ¯æ£ä½œæ¥è¨ˆç•«ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一○ 人員培訓計畫。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一一 書é¢è³‡æ–™ä¹‹ä¿å˜è¦å®šã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一二 計畫書範例。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一三 確效標準作æ¥ç¨‹åºç¯„例。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一四 確效計畫之批准實施。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=7"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 7 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">é‡å°å„é …ç¢ºæ•ˆåŠé©—è‰ä½œæ¥ï¼Œåˆ†åˆ¥åˆ¶è¨‚確效計畫書，內容包括下列å„é …ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 確效或驗è‰ä¹‹é …目。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 確效或驗è‰ä¹‹ç›®çš„整體目標。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 é å®šå¯¦æ–½é »çŽ‡ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› è©²é …ç¢ºæ•ˆæˆ–é©—è‰ä¹‹è¨ˆç•«æ›¸åˆ¶è¨‚åŠå„次改訂日期，以åŠæ”¹è¨‚äº‹é …ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 確效或驗è‰æ–¹æ³•ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å… åˆæ ¼æ¨™æº–範åœã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七 數據或資料處ç†æ–¹æ³•ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å…« 確效或驗è‰æ›¸é¢è³‡æ–™ä¹‹æ”¹è¨‚程åºåŠä¿ç®¡ç›¸é—œäº‹é …。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä¹ åŸ·è¡Œç¢ºæ•ˆæˆ–é©—è‰ä¹‹è²¬ä»»å–®ä½åŠè² 責人員。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=8"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 8 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å„種確效或驗è‰è¨ˆç•«æ›¸æ‡‰ç”±æ¬Šè²¬å–®ä½åŠäººå“¡æ ¸å®šã€‚é‡å°å„種確效或驗è‰ä½œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ¥æ‡‰æœ‰å› 應之標準作æ¥ç¨‹åºã€‚å„種標準作æ¥ç¨‹åºæ‡‰è¼‰æœ‰åˆ¶è¨‚人ã€æ ¸å®šäººã€ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">制訂日期åŠæ ¸å®šæ—¥æœŸã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=9"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 9 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作æ¥ä¹‹çµæžœæ‡‰åŒ…括與確效計畫書å„é …å°æ‡‰ä¹‹å„種資料åŠæ•¸æ“šï¼Œå„別確 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">效作æ¥ç‰¹åˆ¥ä¹‹æŒ‡æ¨™è³‡æ–™åŠæ•¸æ“šï¼Œæ–¼å„è©²ç« ä¸å¦å†æŒ‡å®šä¹‹ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">確效作æ¥ä¹‹ç ”究çµæžœæ‡‰å½™é›†æˆæª”。經éŽæ‰¹å‡†çš„ç¢ºæ•ˆå ±å‘Šä¸ï¼Œæ‡‰æ›¸æ˜Žæ‰€ç¢ºæ•ˆ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä¹‹äº‹é …æ˜¯å¦ç¬¦åˆç¢ºæ•ˆæ¨™æº–，並以科å¸æ•¸æ“šè‰æ˜Žæœ‰é—œç¬¦åˆæ—¢è¨‚標準之推判。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 二 ç·¨ è¨æ–½ã€è¨å‚™</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;"> </span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 一 ç« è¨æ–½èˆ‡è¨å‚™ä¹‹ç¢ºæ•ˆ</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;"> </span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 一 節 安è£é©—è‰</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=10"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 10 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» æ–¼è¨ç½®ä¸€è¨æ–½æˆ–安è£è¨å‚™æ™‚，應進行安全驗è‰ï¼Œä»¥ç¢ºå®šè©²è¨æ–½æˆ–è¨å‚™ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">符åˆåŽŸè¨è¨ˆè¦æ ¼èˆ‡æ¢ä»¶ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=11"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 11 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">æœ¬é …é©—è‰ä½œæ¥è¨ˆç•«æ›¸ï¼Œå¾—以圖示ã€è¡¨åˆ—ç‰æ–¹å¼è¼”ä½æ–‡å—說明。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=12"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 12 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">æœ¬é …é©—è‰ä½œæ¥è¨ˆç•«æ›¸åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 é©—è‰é »çŽ‡åŠå稱。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 本驗è‰ä½œæ¥æ¦‚è¿°åŠç›¸é—œèƒŒæ™¯èªªæ˜Žã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 å„種有關之è˜åˆ¥è³‡æ–™ï¼ŒåŒ…括該è¨æ–½æˆ–è¨å‚™ä¹‹ç·¨è™Ÿï¼ŒåŠæ¨™æº–作æ¥ç¨‹åºä¹‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">編號ç‰ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› è©²é …è¨æ–½æˆ–è¨å‚™å®‰ç½®ä¹‹ç›®çš„。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 è©²é …è¨æ–½æˆ–è¨å‚™ä¹‹æ資ã€è¨è¨ˆåŠçµæ§‹ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å… é‹è½‰æˆ–ç¶è·è©²é …è¨æ–½æˆ–è¨å‚™æ‰€é ˆä¹‹æ”¯æ´äº‹é …åŠæ“¬æä¾›é…åˆä¹‹å…§å®¹ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七 åˆæ ¼æ¨™æº–。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å…« 計畫書之制訂人ã€æ ¸å®šäººåŠåˆ¶è¨‚ã€æ ¸å®šæ—¥æœŸã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=13"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 13 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">完æˆå®‰è£é©—è‰å¾Œï¼Œæ‡‰å½™æ•´æ‰€æœ‰æ•¸æ“šè³‡æ–™ï¼Œåˆ¤æ–·æ˜¯å¦åˆæ ¼ï¼Œä¸¦ç”±æ¬Šè²¬å–®ä½åŠ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æœ‰é—œäººå“¡æ ¸å¯å¾Œå†é€²è¡Œæ“作驗è‰ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;"> </span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 二 節 æ“作驗è‰èˆ‡æ€§èƒ½é©—è‰</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=14"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 14 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è¨æ–½æˆ–è¨å‚™æ–¼å®‰è£é©—è‰åˆæ ¼å¾Œï¼Œæ‡‰åŸ·è¡Œè©²è¨æ–½æˆ–è¨å‚™ä¹‹æ“作驗è‰ï¼Œä»¥ç¢ºå®š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">該è¨æ–½æˆ–è¨å‚™æ–¼å…¶æ“作æ£å¸¸ç¯„åœå…§èƒ½é©ç•¶é‹è½‰ï¼Œå¿…è¦æ™‚得以極é™ç¯„åœé©ç•¶ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">é‹è½‰ä¹‹ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=15"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 15 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">æœ¬é …é©—è‰ä½œæ¥ä¹‹æ–¹æ³•æ‡‰ä¾å„è¨æ–½æˆ–è¨å‚™ä¹‹æœ¬è³ªåˆ†åˆ¥è¨‚定。驗è‰ä¹‹è©¦é©—內容 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">應能表ç¾è©²è¨æ–½æˆ–è¨å‚™æ˜¯å¦é©ç•¶é©è½‰ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=16"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 16 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">é©—è‰è¨ˆç•«æ›¸åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 é©—è‰é »çŽ‡åŠå稱。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 é©—è‰ä½œæ¥æ¦‚è¿°åŠç›¸é—œèƒŒæ™¯èªªæ˜Žã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 å„種有關之è˜åˆ¥è³‡æ–™ï¼ŒåŒ…括該è¨æ–½æˆ–è¨å‚™ä¹‹è²¡ç”¢ç·¨è™Ÿï¼ŒåŠæ¨™æº–作æ¥ç¨‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">åºä¹‹ç·¨è™Ÿç‰ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› ç›®è¦–æª¢æŸ¥é …ç›®ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 å„種開關åŠæŒ‡ç¤ºç‡ˆä¹‹åŠŸèƒ½æª¢æŸ¥ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å… èˆ‡ç”¢å“å“質相關之å„種感應器ã€æŽ¢é‡ã€å£“力é‡ã€è¨˜éŒ„器ã€ç©ºæ°£æµé€Ÿè¨ˆ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">ã€æµé€šæ–¹å‘ã€å£“力åŠæº«åº¦ç‰ä¹‹åŠŸèƒ½æª¢æŸ¥åŠæ ¡æ£ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七 濾器之功能與有效性試驗。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å…« 清潔方法。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä¹ é©—è‰ç”¨å„€å™¨ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一○ é©—è‰ä¹‹åˆæ ¼æ¨™æº–。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一一 採用之統計å¸è©¦é©—è¨è¨ˆèˆ‡æ•¸æ“šè™•ç†æ–¹æ³•ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一二 ä¾è©¦é©—çµæžœä¹‹å»ºè°äº‹é …。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一三 例行å†é©—è‰ä¹‹æ™‚間表åŠé ˆä½œéžä¾‹è¡Œå†é©—è‰ä¹‹æŒ‡æ¨™ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一四 計畫書之制訂人ã€æ ¸å®šäººåŠåˆ¶è¨‚ã€æ ¸å®šæ—¥æœŸã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=17"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 17 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å¿…è¦æ™‚åœ¨ç©ºè½‰æˆ–è² è¼‰ä¸‹é€²è¡Œè¨æ–½æˆ–è¨å‚™ä¹‹æ€§èƒ½é©—è‰ï¼Œä»¥ç¢ºèªè©²è¨æ–½æˆ–è¨å‚™ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之基本性能。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=18"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 18 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">æœ¬é …é©—è‰ä½œæ¥ä¹‹é©—è‰å ±å‘Šæ›¸ä¸ï¼Œå¾—以試驗çµæžœè¼”ä½æ–‡å—說明。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;"> </span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 二 ç« è¨å‚™æ¸…潔方法之確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=19"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 19 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">æœ¬ç« æ‰€ç¨±æ¸…æ½”æ–¹æ³•ä¿‚æŒ‡å°‡è¨å‚™ä¸Šä¹‹æ®˜ç•™ç‰©åŽ»é™¤ä¹‹æ–¹æ³•èˆ‡éŽç¨‹ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=20"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 20 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">製藥有關å„種è¨å‚™æ‡‰æ–¼æ¯æ¬¡ä½¿ç”¨éŽå¾Œä»¥é©ç•¶æ–¹æ³•æ¸…潔之。é‡å°å„種清潔方 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">法應分別訂有標準作æ¥ç¨‹åºç¢ºå¯¦éµå®ˆä¹‹ï¼Œæ–¼æ¯æ¬¡æ“作時以書é¢ç´€éŒ„記載清 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ½”éŽç¨‹ä¹‹åŸ·è¡Œæƒ…形。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=21"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 21 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">在產製å„批åŒç¨®ç”¢å“ã€æ”¹ç”¢è£½ä¸åŒç”¢å“或改變清潔方法時，å‡æ‡‰å°‡æ¸…潔時 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之å„ç¨®å·®ç•°äº‹é …åˆ—è¼‰æ–¼è¨˜éŒ„ä¸ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=22"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 22 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å„種清潔方法應以確效作æ¥é©—è‰å…¶é©ç•¶æ€§ã€‚執行確效作æ¥å‰æ‡‰å…ˆæ“¬å…·ç¢ºæ•ˆ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">計畫書，內容應包括å–樣法ã€æª¢æ¸¬æ–¹æ³•ã€æ¨™çš„物åŠå…¶æ¿ƒåº¦ä¸Šé™ç‰ï¼Œç¶“è—¥å» </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">內權責單ä½åŠä¸»ç®¡äººå“¡ä¹‹æ ¸å®šå¾Œå¯¦æ–½ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=23"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 23 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效時應ä¾æ ¸å®šä¹‹ç¢ºæ•ˆæ¨™æº–作æ¥è¨ˆç•«æ“¬å®šç¢ºæ•ˆæ¨™æº–作æ¥ç¨‹åºï¼Œå†æ“šè€Œé€²è¡Œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之；該標準作æ¥ç¨‹åºä¸Šæ‡‰è¼‰æœ‰è² 責執行之單ä½åŠäººå“¡ã€ç¢ºæ•ˆä½œæ¥ä¹‹æ ¸å®šã€ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">清潔程度之判定標準åŠå†ç¢ºæ•ˆæ—¥æœŸã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=24"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 24 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">清潔方法之確效應能確實è‰æ˜Žæ¸…æ½”éŽç¨‹ä¹‹æœ‰æ•ˆæ€§ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=25"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 25 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作æ¥æ‡‰å¾—藉由直接表é¢å–樣或洗滌å–樣ç‰é©ç•¶ä¹‹æŽ¡æ¨£æ³•è¡Œä¹‹ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=26"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 26 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作æ¥æ™‚，檢體之分æžæ–¹æ³•æ‡‰å…·å‚™å°ˆä¸€æ€§åŠé©ç•¶ä¹‹éˆæ•åº¦ã€‚分æžä¹‹ç›®æ¨™ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">應以檢測殘留物或污染物為準。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=27"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 27 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">清潔方法經確效後，得用間接測試方法如導電度法作線上長期監控。任何 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">é–“æŽ¥æª¢æ¸¬æ–¹æ³•å¿…é ˆè¼”ä»¥è¨å‚™ç‹€æ³ä¹‹ç›¸é—œè³‡æ–™ã€‚æ¯æ¬¡ç¢ºæ•ˆæ™‚應將間接檢測之 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">書é¢è¨˜éŒ„列為åƒè€ƒè³‡æ–™ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=28"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 28 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作æ¥ä¹‹çµæžœå¿…é ˆå½™é›†æˆæª”。經éŽæ‰¹å‡†çš„ç¢ºæ•ˆå ±å‘Šä¸æ‡‰æ›¸æ˜Žæ‰€ç¢ºæ•ˆä¹‹æ¸… </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">潔方法是å¦ç¬¦åˆç¢ºæ•ˆæ¨™æº–，並以科å¸æ•¸æ“šè‰æ˜Žæœ‰é—œç¬¦åˆæ—¢è¨‚標準之推判。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=29"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 29 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">é‘‘æ–¼è¨å‚™èˆ‡ç”¢å“的變異範åœå·¨å¤§ï¼Œæœ¬åŸºæº–ä¸è¨å®šçµ±ä¸€ä¹‹è¦æ ¼æˆ–方法供決定 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">清潔方法是å¦æœ‰æ•ˆã€‚å„è—¥å» æ‡‰ä¾æœ¬èº«æ‰€æœ‰ä¹‹è¨å‚™åŠè£½åŠ‘之特性ã€è—¥å“原料 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">åŠè³¦å½¢åŠ‘之本質ã€æ¸…潔劑之物ç†åŒ–å¸æ€§è³ªåŠæ¯’性ã€èˆ‡åŒ–å¸åˆ†æžæ³•ä¹‹éˆæ•åº¦ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ç‰ï¼Œåˆ†åˆ¥åŸºæ–¼ç§‘å¸èƒŒæ™¯è€Œé©ç•¶åˆ¶è¨‚之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;"> </span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 三 ç« ç´”åŒ–æ°´ç³»çµ±ä¹‹ç¢ºæ•ˆ</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=30"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 30 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">æœ¬ç« æ‰€ç¨±ç´”åŒ–æ°´è™•ç†ç³»çµ±ï¼Œä¿‚æŒ‡è—¥å» å…§ç‚ºè£½é€ å„種高純度純化水 (å«ç´”æ·¨ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ°´åŠæ³¨å°„用水) 供製藥作æ¥ä½¿ç”¨ä¹‹è¨å‚™ã€‚一般用水åŠå¯¦é©—å®¤ç”¨æ°´ä¹‹è£½é€ ä¸ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">在本基準è¦å®šç¯„åœä¹‹å…§ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=31"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 31 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">純化水處ç†ç³»çµ±æ‡‰èƒ½æŒçºŒç©©å®šçš„供應既訂ç‰ç´šä¹‹ç´”化水。純化水處ç†ç³»çµ± </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之æ“作，應訂有標準作æ¥ç¨‹åºä»¥ä¾›éµå¾ªã€‚æ¯æ¬¡æ“作應有書é¢ç´€éŒ„記載系統 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之é‹è½‰æƒ…æ³ï¼Œå„異常狀æ³ï¼Œæ‡‰é€ä¸€è¨˜éŒ„ï¼Œä¸¦å ±è«‹æ¬Šè²¬å–®ä½äººå“¡è™•ç†ï¼Œè™•ç† </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">情形亦應詳細記錄之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=32"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 32 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» æ‡‰å®šæœŸæª¢æ¸¬ç´”åŒ–æ°´è™•ç†ç³»çµ±ï¼Œé©—è‰æ‰€è£½å¾—之純化水是å¦åˆæ–¼æ—¢è¨‚è¦æ ¼ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">，以供特定目的之用。為檢測純化水處ç†ç³»çµ±ï¼Œæ‡‰ä¾è—¥å“å„ªè‰¯è£½é€ è¦ç¯„訂 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">有檢測之標準作æ¥ç¨‹åºï¼Œæ“šè€ŒåŸ·è¡Œã€‚æ¯æ¬¡æª¢æ¸¬å¾Œæ‡‰å°‡çµæžœäºˆä»¥æ›¸é¢è¨˜éŒ„。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=33"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 33 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">純化水處ç†ç³»çµ±æ‡‰ä»¥ç¢ºæ•ˆä½œæ¥é©—è‰å…¶é©ç•¶æ€§ã€‚執行確效作æ¥å‰æ‡‰å…ˆæ“¬å…·ç¢º </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">效計畫書，內容應包括å–樣法ã€æª¢æ¸¬æ–¹æ³•ã€åˆæ ¼æ¨™æº–範åœç‰ï¼Œç¶“è—¥å» å…§æ¬Š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">責單ä½äººå“¡ä¹‹æ ¸å®šå¾Œå¯¦æ–½ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=34"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 34 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效時應ä¾æ ¸å®šä¹‹ç¢ºæ•ˆæ¨™æº–作æ¥è¨ˆç•«ï¼Œæ“¬å®šç¢ºæ•ˆæ¨™æº–作æ¥ç¨‹åºï¼Œå†æ“šè€Œé€² </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行之；該標準作æ¥ç¨‹åºä¸Šï¼Œæ‡‰è¼‰æœ‰è² 責執行之單ä½åŠäººå“¡ã€ç¢ºæ•ˆä½œæ¥ä¹‹æ ¸ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">定ã€æ˜¯å¦åˆæ ¼ä¹‹åˆ¤å®šæ¨™æº–åŠå†ç¢ºæ•ˆæ—¥æœŸã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=35"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 35 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">純化水處ç†ç³»çµ±ä¹‹ç¢ºæ•ˆç¯„åœï¼ŒåŒ…括系統在防制微生物污染以åŠå¯æº¶æ€§åŠä¸ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">溶性雜質摻雜ç‰ä¹‹èƒ½åŠ›ä¹‹è©•ä¼°ã€‚系統是å¦é€šéŽç¢ºæ•ˆï¼Œé™¤èˆ‡æ‰€ä¾›ä¹‹æ°´è³ªèƒ½åˆ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">乎å„該é©ç”¨ä¹‹æ°´è³ªè¦æ ¼å¤–，尚應包括系統是å¦èƒ½é•·æœŸæŒçºŒç©©å®šä¾›çµ¦åˆæ ¼ä¹‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">純化水。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=36"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 36 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效純化水處ç†ç³»çµ±æ™‚，得用é©ç•¶ä¹‹æŒ‘戰測試，但測試進行ä¸ï¼Œä¸å¾—é€ æˆ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">系統之微生物污染。故應定期å–樣測試微生物å«é‡ï¼Œä¸¦åœ¨ç³»çµ±ä¹‹é©ç•¶ç‰¹å®š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä½ç½®å®‰è£ç›£æ¸¬å„€å™¨ï¼Œä»¥ç¢ºä¿ç³»çµ±ä¹‹æ£å¸¸é‹è½‰ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=37"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 37 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效純化水處ç†ç³»çµ±æ‰€é ˆä¹‹æ›¸é¢è³‡æ–™ï¼ŒåŒ…括系統概è¦å’Œç³»çµ±æµç¨‹åœ–。æµç¨‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">圖之涵蓋範åœï¼Œæ‡‰åŒ…括由採水點至使用點間之所有相關è¨å‚™ï¼Œä¸¦åŒ…括å–樣 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">é»žã€‚è—¥å» æ‡‰éš¨æ™‚ä¿æŒä¸Šåˆ—資料與實物之一致性，æ¯å¹´åº¦ä¸¦è‡³å°‘è¤‡æ ¸ä¸€æ¬¡ï¼Œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">以確ä¿å…¶æ£ç¢ºæ€§èˆ‡æ‰€æœ‰è®Šæ›´è¨è¨ˆçš„åˆç†æ€§ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">本æ¢æ‰€è¿°å„種資料，å‡æ‡‰éš¨åŒç¢ºæ•ˆä½œæ¥æ‰€å¾—數據åŠæ–‡å—記述，彙總於確效 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å ±å‘Šä¸ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=38"><span style="color: windowtext; text-decoration: none; text-underline: none;">第</span><span style="color: windowtext; text-decoration: none; text-underline: none;"> 38 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">進行純化水確效作æ¥å‰ï¼Œæ‡‰å…ˆä¾æµç¨‹åœ–檢查所有系統和管路之æ£ç¢ºæ€§ï¼Œç„¶ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">後å†é–‹å§‹ç¢ºæ•ˆï¼Œä¸¦ä¾æ“šæ—¢è¨‚之æ“作æ¢ä»¶ã€æ¸…潔消毒作æ¥ç¨‹åºèˆ‡é »çŽ‡é€²è¡Œä¹‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=39"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 39 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作æ¥åˆ†ä¸‰å€‹éšŽæ®µï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 第一階段：æ¯æ—¥åœ¨æ¯å€‹ç´”化作æ¥è¨è¨ˆå–®å…ƒå’Œæ¯å€‹ä½¿ç”¨é»žæŽ¡æ¨£æª¢é©—ï¼ŒæŒ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">續二至四個星期。在使用點採樣之作æ¥ï¼Œå¿…é ˆæ¨¡æ“¬æ£å¸¸å–水作æ¥ï¼Œä¾‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">如使用水管å–æ°´ã€å–æ°´å‰çš„沖洗水管作æ¥ã€‚二至四個星期çµæŸå‰ï¼Œå¿… </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">é ˆå°‡ç´”åŒ–æ°´è™•ç†ç³»çµ±çš„確效標準作æ¥ç¨‹åºç·¨å®šå®Œç•¢ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 第二階段：驗è‰ä¾›æ°´ç³»çµ±æ–¼æ£å¸¸æ“作æ¢ä»¶ä¸‹ï¼Œå¯ä»¥ç©©å®šæŒçºŒä¾›æ‡‰é©ç•¶ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">å“質的水。確效的å–樣方å¼èˆ‡ç¬¬ä¸€éšŽæ®µç›¸åŒï¼ŒåŒ…括所列之å–樣點和期 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">間。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 第三階段：驗è‰è©²ä¾›æ°´ç³»çµ±æ–¼æ£å¸¸æ“作æ¢ä»¶ä¸‹ï¼Œä½¿ç”¨é•·æ™‚間後，ä»èƒ½ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">穩定æŒçºŒä¾›æ‡‰é©ç•¶å“質的純化水。確效作æ¥å¿…é ˆåŒ…æ‹¬åŽŸæ°´æ°´è³ªçš„è®Šç•° </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">。å–樣方å¼èˆ‡ç¬¬ä¸€éšŽæ®µç›¸åŒï¼›æ³¨å°„用水系統的å–æ¨£å¿…é ˆæ¯å¤©è‡³å°‘å–一 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">點，æ¯é€±æ‰€æœ‰ä½¿ç”¨é»žå‡èƒ½è¢«æ¸¬è©¦ã€‚當整年資料齊備後，確效å³å‘Šå®Œæˆ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=40"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 40 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">以上階段性確效作æ¥ä¸¦éžç‚ºå”¯ä¸€ä¹‹ç¢ºæ•ˆæ–¹æ³•ï¼Œä½†å…¶ä¸å·²åŒ…括了å°ç´”化水處 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ç†ç³»çµ±ç¢ºæ•ˆæ™‚æ‡‰å…·å‚™ä¹‹é …ç›®ã€‚è—¥å» å¾—ä»¥å…¶ä»–é©ç•¶æ–¹æ³•é€²è¡Œç¢ºæ•ˆï¼Œä½†æ˜¯é™¤äº† </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ‰€æŽ¡ç”¨ä¹‹æ–¹æ³•é ˆå…·å‚™ç§‘å¸åŸºç¤Žå¤–，應符åˆä¸‹åˆ—å„點： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 備有充足之資料，以支æŒç¢ºæ•ˆæ¨™æº–作æ¥ç¨‹åºä¹‹é©ç•¶æ€§ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 備有é©ç•¶ä¹‹æ•¸æ“šè³‡æ–™ï¼Œä»¥è‰æ˜Žè©²ç¢ºæ•ˆæ¨™æº–作æ¥ç¨‹åºå…·æœ‰æ•ˆæ€§ï¼Œä¸¦èƒ½æŒ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">續製出符åˆæ—¢è¨‚標準的純化水。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 備有é©ç•¶ä¹‹è³‡æ–™ä»¥è‰æ˜Žé€±æœŸæ€§çš„原水水質差異，ä¸æœƒå½±éŸ¿ä¾›æ°´ç³»çµ±ä¹‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">作æ¥åŠæ‰€è£½å‡ºä¹‹æ°´è³ªã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=41"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 41 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作æ¥æ™‚所涉åŠä¹‹å¾®ç”Ÿç‰©è©¦é©—ã€å„種水質檢驗之æ“作åŠå„相關è¦æ ¼ï¼Œæ‚‰ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ä¾å„è©²äº‹é …ä¹‹æª¢é©—æ³•ã€è¦æ ¼åŠæœ‰é—œä¹‹ç¢ºæ•ˆè¦å®šè™•ç†ä¹‹ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=42"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 42 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">完æˆç¢ºæ•ˆå¾Œï¼Œæ‡‰å°‡æ‰€å¾—資料彙總並作總çµå ±å‘Šï¼Œè©²å ±å‘Šå¿…é ˆæœ‰ç´”åŒ–æ°´è™•ç† </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">系統æ“作單ä½å’Œå“質管ç†å–®ä½ä¸»ç®¡ä¹‹ç°½æ ¸ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;"> </span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 å›› ç« ç©ºæ°£èª¿ç¯€ç³»çµ±ä¹‹ç¢ºæ•ˆ</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=43"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 43 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">æœ¬ç« æ‰€æŒ‡ä¹‹ç©ºæ°£èª¿ç¯€ç³»çµ±ä¿‚æŒ‡ç”¨æ–¼èª¿ç¯€ä½œæ¥å ´æ‰€ä¹‹æº«åº¦åŠæ¿•åº¦ï¼Œä¸¦åŽ»é™¤æˆ– </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">阻隔微粒物質與微生物ç‰æ±¡æŸ“æºä¹‹è¨æ–½ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=44"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 44 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效空氣調節系統之目的在於確定該系統能æŒçºŒç©©å®šçš„控制作æ¥å ´æ‰€ä¹‹ç©º </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ°£å“質，俾使製æˆä¹‹è—¥å“能ç¶æŒæ–¼æ—¢è¨‚之å“質且ä¸å—污染。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=45"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 45 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» æ‡‰æ–¼ç©ºæ°£èª¿ç¯€ç³»çµ±è¨‚æœ‰å®šæœŸç¶è·åŠç¢ºæ•ˆæŽªæ–½ï¼Œä¸¦æŒ‰è¨ˆç•«å¯¦æ–½ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=46"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 46 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">空氣調節系統確效計畫書ä¸æ‡‰é…備有空氣調節系統之管線é…置圖，圖ä¸æ˜Ž </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">示管線之ä½ç½®åŠç©ºæ°£æµå‘ã€å„濾器之ä½ç½®ã€ç©ºèª¿é–‹é—œä½ç½®ã€å„å ´æ‰€ä¹‹é€²é¢¨ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å£åŠå‡ºé¢¨å£ä½ç½®ç‰ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=47"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 47 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">空氣調節系統之確效包括下列å„é …ä¹‹é©—è‰ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 溫度。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 濕度。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 風é‡ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› æ›æ°£æ•¸ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 風速。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å… å£“å·®ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七 éŽæ¿¾æ•ˆçŽ‡ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=48"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 48 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">溫度控制之驗è‰æ‡‰ä»¥ç¶“éŽæ ¡æ£ä¹‹æº«åº¦è¨ˆè¨˜éŒ„ä¹‹ï¼Œäº¦å¾—ä»¥æ ¡æ£éŽä¹‹è‡ªå‹•è¨˜éŒ„ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">器連續記錄。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=49"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 49 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">濕度控制之驗è‰å¾—ä»¥æ ¡æ£éŽä¹‹è‡ªå‹•è¨˜éŒ„器記錄之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=50"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 50 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">風é‡æŽ§åˆ¶ä¹‹é©—è‰å¾—在進風å£èˆ‡å‡ºé¢¨å£è™•ä»¥æ ¡æ£éŽä¹‹é¢¨é‡è¨ˆæˆ–風速計測é‡ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=51"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 51 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">層æµè¨å‚™ä¹‹é¢¨é€Ÿé©—è‰ï¼Œå¾—ä»¥æ ¡æ£éŽä¹‹é¢¨é‡è¨ˆæˆ–風速計測é‡ä¹‹ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=52"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 52 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">壓差之驗è‰å¾—以é©ç•¶æ–¹æ³•è¡Œä¹‹ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=53"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 53 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å¿…è¦æ™‚ (如無èŒè£½åŠ‘) 宜將作æ¥å ´æ‰€å…§ä¹‹ç©ºæ°£æµå‹•åž‹æ…‹ä¹‹æ¸¬è©¦ç´å…¥ç¢ºæ•ˆä½œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ¥ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=54"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 54 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">éŽæ¿¾æ•ˆçŽ‡ä¹‹é©—è‰å°è±¡ç‚ºé«˜æ•ˆçŽ‡ç©ºæ°£éŽæ¿¾å™¨ï¼Œå¾—以é©ç•¶æ–¹æ³•è¡Œä¹‹ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=55"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 55 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">環境之監控應包括測定空氣ä¸æ‰€å«ä¹‹å¾®ç²’物質與è¨å‚™ã€è¨æ–½è¡¨é¢åŠç©ºæ°£ä¸ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之微生物，以åŠç„¡èŒä½œæ¥å ´æ‰€ä¹‹äººå“¡å¯èƒ½é€ æˆä¹‹æ±¡æŸ“。微粒物質得用é©ç•¶ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之微粒計數器測定之，生èŒæ•¸å¾—用è½èŒæ³•ã€ç©ºæ°£å–樣法或表é¢æ“¦æ‹å–樣法 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">測定之。測定時應分別於該環境之使用ä¸åŠéžä½¿ç”¨ä¸é€²è¡Œã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=56"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 56 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">為利於第四åå…«æ¢è‡³ç¬¬äº”å五æ¢æ‰€åˆ—之å„é …é‹ä½œï¼Œç©ºèª¿è¨æ–½ä¸Šä¹‹é©ç•¶éƒ¨ä½ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">åŠç©ºèª¿å®¤å…§ï¼Œæ‡‰å‚™æœ‰å–樣點以供安è£å„測é‡å„€å™¨ç‚ºåŽŸå‰‡ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=57"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 57 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">ç©ºæ°£èª¿ç¯€ç³»çµ±ä¹‹ç¢ºæ•ˆé »çŽ‡æ‡‰ä¾è—¥å» 所在地之環境而定，至少æ¯å¹´ä¸€æ¬¡ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=58"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 58 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">空氣調節系統之確效數據應彙整æˆæª”，é€æ¬Šè²¬å–®ä½æ ¸å®šã€‚確效時如發ç¾æœ‰ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">異常ç¾è±¡ï¼Œæ‡‰ç«‹å³è™•ç†æ”¹å–„；如為污染有關事宜，應å³åœæ¢æœ‰é—œä¹‹è£½é€ å·¥ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">作，迄改善後å†å¾©å·¥ã€‚異常ç¾è±¡å‡æ‡‰ç´å…¥æª”案以便追蹤檢討。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 三 ç·¨ 人員</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=59"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 59 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» å„部門應é…ç½®è¶³å¤ ä¹‹å°ˆæ¥åŠä½œæ¥äººå“¡ä»¥åŸ·è¡Œã€ç£å°Žæ¯ä¸€æˆå“ä¹‹è£½é€ ã€ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">åŠ å·¥ã€åŒ…è£èˆ‡å„²å˜ã€‚æ¤ç‰äººå“¡åƒèˆ‡æŒ‡å®šå·¥ä½œä¹‹è³‡æ ¼åŠèƒ½åŠ›æ‡‰äºˆç¢ºèªã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=60"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 60 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本編所述之å“質管ç†äººå“¡ä¿‚å“質管制åŠå“質ä¿è‰å–®ä½ä¹‹æŠ€è¡“åŠå°ˆæ¥äººå“¡ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=61"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 61 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å°æ–¼æ–°é€²ä¹‹å°ˆæ¥èˆ‡ä½œæ¥äººå“¡æ‡‰è¨‚有書é¢è·å‰æ•™è‚²è¨“練計畫ã€æ•™è‚²å…§å®¹åŠè€ƒ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ ¸è¾¦æ³•ã€‚å°æ–¼ä¸èƒ½é€šéŽè€ƒæ ¸ä¹‹æ–°é€²äººå“¡ï¼Œäº¦æ‡‰è¨‚æœ‰åŠ å¼·æ•™è‚²åŠå†è€ƒæ ¸ä¹‹è¾¦ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">法。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=62"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 62 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å°æ–¼åœ¨è·äººå“¡æ‡‰è¨‚有書é¢å®šæœŸå†æ•™è‚²ä¹‹è¨ˆç•«ã€æ•™è‚²å…§å®¹åŠè€ƒæ ¸è¾¦æ³•ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=63"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 63 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å°æ–¼ç‰¹æ®Šä½œæ¥ (如無èŒä½œæ¥) ä¹‹äººå“¡æ‡‰è¨‚æœ‰ç‰¹å®šä¹‹æ•™è‚²è¨“ç·´èˆ‡è€ƒæ ¸è¾¦æ³•ï¼Œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">åˆæ ¼å¾Œæ–¹å¯åƒåŠ è©²é …ä½œæ¥ã€‚å°æ–¼å°ˆæ¥äººå“¡æ‡‰é…åˆå·¥ä½œæ€§è³ªå¯¦æ–½ç‰¹å®šå°ˆé•·ä¹‹ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æ•™è‚²è¨“ç·´èˆ‡è€ƒæ ¸ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=64"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 64 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">第å…å一至第å…å三æ¢æ‰€åˆ—之å„é …æ•™è‚²è¨“ç·´èˆ‡è€ƒæ ¸æ‡‰è¨‚æœ‰æ›¸é¢è¨ˆç•«èˆ‡è¾¦æ³• </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">，經權責單ä½æ ¸å®šå¾Œå¯¦æ–½ï¼Œä¿®æ”¹æ™‚亦åŒï¼›æ ¸å®šæ—¥æœŸåŠä¿®è¨‚日期å‡æ‡‰æ˜Žè¨˜æ–¼ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">其上。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=65"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 65 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å°æ–¼å“質管ç†äººå“¡æ‡‰å‚™æœ‰å…¶äººäº‹è³‡æ–™æª”，檔案ä¸æ‡‰åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 å¸ç¶“æ·ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 å—訓之çµæ¥è‰æ›¸æˆ–憑è‰ï¼Œå…¶å…§è¼‰æœ‰å¸å“¡åƒåŠ å—訓åˆæ ¼çµæ¥ä¹‹æ•˜è¿° (技 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">術員部份) 。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 æ¯æ¬¡å®Œæˆä¸€èª²ç¨‹æˆ–接å—特別訓練之紀錄。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› å†è€ƒæ ¸ç´€éŒ„。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=66"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 66 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">新進與å‡é·ä¹‹å“質管ç†äººå“¡æ‡‰æ–¼é©ç•¶æ™‚間，以é©ç•¶æ–¹æ³•å†è€ƒæ ¸å…¶èƒ½åŠ›ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=67"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 67 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">實施å„é …æ•™è‚²è¨“ç·´å¾Œï¼Œæ‡‰æœ‰æ›¸é¢ç´€éŒ„記載實施內容åŠçµæžœä»¥ä¾›è¿½è¹¤æª¢è¨Žã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 å›› ç·¨ 製程確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=68"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 68 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">製程確效為é‡å°ä¸€ç‰¹å®šç”¢å“之製程建立書é¢è‰æ“šä¹‹æŽªæ–½ï¼Œä»¥ç¢ºä¿è©²è£½ç¨‹èƒ½ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æŒçºŒç©©å®šçš„產製出符åˆæ—¢è¨‚è¦æ ¼èˆ‡å“質特性之產å“。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=69"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 69 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">執行製程確效å‰ï¼Œå…¶ä½¿ç”¨ä¹‹è¨æ–½èˆ‡è¨å‚™ç‰æ‡‰ä»¥å·²é€šéŽé©—è‰ç‚ºåŽŸå‰‡ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=70"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 70 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">執行製程確效å‰æ‡‰å‚™æœ‰ç¶“權責單ä½ä¸»ç®¡æ ¸å®šä¹‹æ›¸é¢ç¢ºæ•ˆè¨ˆç•«æ›¸ã€‚確效計畫 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">書ä¸é™¤æ‡‰åŒ…括第一編第七æ¢ä¹‹å„é …è¦å®šå¤–，應明示å„該製程之關éµæ€§åƒæ•¸ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ã€è©•ä¼°æ–¹æ³•ã€é 訂之確效åŠæ¸¬è©¦æ–¹æ³•ã€é 計è¦æ”¶é›†çš„數據種類åŠåˆæ ¼æ¨™æº– </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">範åœç‰ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=71"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 71 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">先期性確效包括è¨å‚™ä¹‹å®‰è£é©—è‰åŠæ€§èƒ½é©—è‰ï¼Œè£½ç¨‹ç¢ºæ•ˆã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=72"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 72 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">執行先期性確效作æ¥æ™‚應先驗è‰èˆ‡è©•ä¼°å„有關è¨å‚™èƒ½åœ¨è£½ç¨‹è¦å®šçš„æ“作上 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">下é™é©ç•¶çš„æ“作。本階段的確效事宜包括è¨å‚™ä¹‹è¨è¨ˆï¼Œè¨‚å®šæ ¡æ£ã€ç¶è·èˆ‡ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">調整之有關è¦å®šï¼Œç¢ºèªæœƒå½±éŸ¿è£½ç¨‹èˆ‡ç”¢å“之關éµæ€§è¨å‚™æŒ‡æ¨™ã€‚ç”±é€™äº›ä½œæ¥ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">所得之資料應使用於建立書é¢çš„製程æ¢ä»¶ï¼ŒåŒ…括è¨å‚™çš„æ ¡æ£ã€ç¶è·ã€ç›£æ¸¬ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">與控制。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=73"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 73 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">性能驗è‰çš„ç›®çš„æ˜¯ä»¥åš´æ ¼çš„æ¸¬è©¦ä¾†è‰æ˜Žè£½ç¨‹çš„有效性與å†ç¾æ€§ï¼Œåœ¨é€²å…¥ç¢º </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">效的性能驗è‰éšŽæ®µæ™‚，製程è¦æ ¼æ¥å·²å»ºç«‹è€Œä¸”本質上已é€éŽå¯¦é©—室或其他 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">試驗方法è‰æ˜Žç‚ºå¯æŽ¥å—者，而且è¨å‚™å·²åŸºæ–¼é©å®œçš„安è£é©—è‰åˆ¤å®šç‚ºå¯æŽ¥å— </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">者。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=74"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 74 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">先期性確效應能模擬實際的生產æ¢ä»¶ï¼Œå¿…è¦æ™‚應包括最差狀æ³åœ¨å…§ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=75"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 75 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">先期性確效一製程時，應先確定é¸æ“‡ä¾›è©•ä¼°ä¹‹æŒ‡æ¨™ä¸¦å°‡å…¶æŽ§åˆ¶ï¼Œç„¶å¾Œåœ¨æŽ§ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">制之製程æ¢ä»¶ä¸‹è£½é€ 數批產å“，測試是å¦ç¬¦åˆè¦æ ¼ã€‚至少有連續三批能符 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">åˆè¦æ ¼æ™‚，該製程å³é€šéŽç¢ºæ•ˆã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">é—œéµæ€§çš„製程指標應予以監控åŠè¨˜è¼‰ã€‚將監控éŽç¨‹æ‰€æ”¶é›†çš„æ•¸æ“šåŠ ä»¥åˆ†æž </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">，å¯å»ºç«‹å„個製程指標的變異性以åŠè¨å‚™èˆ‡è£½ç¨‹ä¹‹æŽ§åˆ¶æ˜¯å¦å¯ç¢ºä¿ç”¢å“符 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">åˆè¦æ ¼ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=76"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 76 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å°æ–¼å„種劑型之先期性製程確效應妥當é¸æ“‡èˆ‡å„è©²åŠ‘åž‹ç¢ºæ•ˆäº‹é …æœ‰é—œä¹‹é—œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">éµæ€§åƒæ•¸é€²è¡Œã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=77"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 77 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">ç„¡èŒè£½åŠ‘確效å‰æ‡‰åŸ·è¡Œä¸‹åˆ—é—œéµæ€§é©—è‰ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 與無èŒè£½åŠ‘作æ¥å ´æ‰€æœ‰é—œä¹‹ç©ºæ°£ä¾›æ‡‰åŠç©ºæ°£èª¿ç¯€ç³»çµ±ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 純淨水åŠæ³¨å°„用水供應系統。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 æ»…èŒè¨å‚™ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› ç„¡èŒè£½åŠ‘之充填åŠå¯†å°ç³»çµ±ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 清潔法與衛生事宜。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=78"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 78 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">ç„¡èŒè£½åŠ‘作æ¥å ´æ‰€ä¹‹ç’°å¢ƒç›£æŽ§æ‡‰äºˆç¢ºæ•ˆä»¥ç¢ºä¿èƒ½æŒçºŒç©©å®šçš„符åˆå„è©²å ´æ‰€ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之環境è¦æ±‚。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=79"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 79 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">ç„¡èŒè£½åŠ‘之滅èŒç¢ºæ•ˆæœ‰é—œäº‹å®œæ‚‰ä¾å…«å四年å二月二å二日衛署藥å—第八 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四○七八七三五號函「滅èŒéŽç¨‹ç¢ºæ•ˆæŒ‡å°Žæ‰‹å†Šã€ä¹‹è¦å®šé€²è¡Œã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=80"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 80 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» åœ¨å…¶å“質確ä¿ä¹‹ç¨‹åºä¸æ‡‰å»ºç«‹æœ‰å¯ä¾›å›žæº¯æ€§ç¢ºæ•ˆç”¨ä¹‹é—œéµæ€§æŒ‡æ¨™é …ç›® </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=81"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 81 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">已上市之產å“應就生產之連續批次執行回溯性確效。若å“質嚴é‡ä¸ç©©å®šé ˆ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">改變é…æ–¹ã€è£½ç¨‹ã€è£½é€ è¨å‚™ç‰æ™‚，應於變更時執行先期性確效。如å“質僅 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">呈ç¾è¼•å¾®ä¸ç©©å®šè€Œåªé ˆå°é…æ–¹ã€è£½ç¨‹ã€è£½é€ è¨å‚™ç‰ä½œè¼•å¾®ä¹‹ç•°å‹•æ™‚，得執 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行併行性確效。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=82"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 82 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» æ‡‰å»ºç«‹èƒ½éš¨æ™‚é€²è¡Œç¢ºæ•ˆä½œæ¥ä¹‹ç³»çµ±ï¼Œä»¥å› 應臨時在包è£ã€é…æ–¹ã€è¨å‚™ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">ã€æˆ–製程上有所改變而å°ç”¢å“之有效性或特性有所影響，以åŠå°ç”¢å“特性 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">有所改變之任何å¯èƒ½ç‹€æ³ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 五 ç·¨ 分æžç¢ºæ•ˆ</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=83"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 83 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">è—¥å» ä¹‹å“質管ç†éƒ¨é–€æ‡‰å‚™æœ‰ä¸‹åˆ—書é¢è³‡æ–™ä»¥é…åˆç¢ºæ•ˆä½œæ¥ï¼š </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 標準實驗室è¦ç¯„或基本æ“作è¦ç¯„。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 標準試驗法。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 å°ç…§æ¨™æº–å“之標定與管ç†æ¨™æº–作æ¥ç¨‹åºã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› è¨å‚™æ“作è¦ç¯„。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五 實驗室ç†è¨˜æœ¬ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å… è¨å‚™æ ¡æ£åŠç¶è·æ—¥èªŒç°¿ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七 分æžçµæžœå離è¦æ ¼æ™‚之處ç†æ–¹æ³•ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=84"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 84 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å„種分æžæ–¹æ³•ä¹‹ç³»çµ±é©ç•¶æ€§ã€æº–確度ã€ç²¾å¯†åº¦ã€æœ€ä½Žæª¢æ¸¬æ¿ƒåº¦ã€æœ€ä½Žå®šé‡ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">濃度ã€å°ˆä¸€æ€§ã€ç·šæ€§åŠå†ç¾æ€§ç‰ï¼Œå‡è¦–å„該分æžæ–¹æ³•ä¹‹æœ¬è³ªã€ç›®çš„èˆ‡éœ€è¦ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">分別建立，並視å„該分æžæ–¹æ³•åˆ†åˆ¥ç¢ºæ•ˆä¹‹ï¼›åŸ·è¡Œæ™‚並記錄æˆæª”。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=85"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 85 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">新購置之分æžå„€å™¨æ‡‰åŸ·è¡Œå®‰è£ã€æ“作與性能驗è‰ï¼Œå™¨å…·æ‡‰è¦–其本質必è¦æ™‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">執行之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=86"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 86 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å„種既有之儀器ã€å™¨å…·ã€è¨ˆé‡å™¨ã€åŠè¨˜éŒ„å™¨ä¹‹æ ¡æ£ï¼Œæ‡‰ä¾æ“šæ›¸é¢è¨ˆç•«é©ç•¶ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">定期執行之。該書é¢è¨ˆç•«ä¹‹å…§å®¹åŒ…括： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 ç‰¹åˆ¥æŒ‡ç¤ºäº‹é …ã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 時間表。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 準確度ã€ç²¾å¯†åº¦ç¯„åœã€‚ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">å›› ä¸èƒ½ç¬¦åˆæº–確度ã€ç²¾å¯†åº¦ç¯„åœä¹‹å› 應措施ç‰ã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=87"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 87 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å®‰å®šæ€§æœ‰é—œäº‹å®œå› å¦è¡Œè¦å®šï¼ŒæƒŸæœ‰é—œä¹‹æ†æº«æ†æ¿•è£ç½®æ‡‰ç¬¦åˆå®‰è£ã€æ“ä½œåŠ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">性能驗è‰æœ‰é—œè¦å®šã€‚ </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第 å… ç·¨ 附則</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=88"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 88 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">下列å„é …è—¥å“ä¸é©ç”¨æ–¼æœ¬åŸºæº–，其製程確效方法å¦è¨‚： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一 原料血漿åŠè¡€æ¶²è£½åŠ‘ä¸é–“產å“，無法以明確之批次紀錄記載者。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二 訂有經éŽç¢ºæ•ˆä¹‹ä¸é–“階段檢定基準之藥å“ä¸”ç¶“ä¸»ç®¡æ©Ÿé—œæ ¸å‡†ä¸é ˆåŸ·è¡Œ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;"> </span><span style="font-family: 細明體; font-size: 11pt;">確效者。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三 經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ˜Žä»¤å…¬å‘Šå…予執行確效之藥å“。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&lno=89"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 89 </span><span style="color: windowtext; text-decoration: none; text-underline: none;">æ¢</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">å„種確效åŠé©—è‰ä½œæ¥å®Œæˆå¾Œï¼Œå„åˆæ ¼äº‹é …應以é©ç•¶æ–¹æ³•åŠæŽªæ–½äºˆä»¥ç›£æŽ§ç¶ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">æŒã€‚當æ¤ç‰æ–¹æ³•æˆ–æŽªæ–½æœ‰é ˆæ›´æ”¹æ™‚ï¼Œæ‡‰ç”±ç¢ºæ•ˆæ¬Šè²¬å–®ä½å…ˆå°æ“¬æ”¹ç”¨ä¹‹ç›£æŽ§ </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">方法進行評估，如å¯èƒ½å°ç”¢å“å“質有顯著影響時，應進行å†ç¢ºæ•ˆã€‚ </span></p> </td> </tr> </tbody></table>2013-12-05
藥政管ç†é¡ž,è—¥å“優良調劑作æ¥æº–則法è¦å‘½ä»¤è—¥å“優良調劑作æ¥æº–則<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則ä¾è—¥äº‹æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第三å七æ¢ç¬¬ä¸€é …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱藥事人員，係指ä¾æ³•åŸ·æ¥ä¹‹è—¥å¸«åŠè—¥åŠ‘生。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱調劑，係指藥事人員自å—ç†è™•æ–¹ç®‹è‡³ç—…æ‚£å–å¾—è—¥å“間，所為之處方確èªã€è™•æ–¹ç™»éŒ„ã€ç”¨è—¥é©ç•¶æ€§è©•ä¼°ã€è—¥å“調é…或調製ã€å†æ¬¡æ ¸å°ã€ç¢ºèªå–藥者交付藥å“ã€ç”¨è—¥æŒ‡å°Žç‰ç›¸é—œä¹‹è¡Œç‚ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱藥事作æ¥è™•æ‰€ï¼Œä¿‚æŒ‡ç¶“è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†è¨ç«‹ä¹‹é†«ç™‚機構藥劑部門åŠè—¥å±€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱調劑處所，係指從事處方調劑ã€å˜æ”¾è™•æ–¹è—¥å“ã€èª¿åŠ‘器具ã€è¨å‚™åŠå…¶ä»–å¿…è¦ç‰©å“ä¹‹å ´æ‰€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱調é…，係指調劑作æ¥éŽç¨‹ä¸ï¼Œä¾è™•æ–¹ç®‹å…§å®¹é¸å–æ£ç¢ºè—¥å“ã€è¨ˆæ•¸æ£ç¢ºæ•¸é‡ã€æ›¸å¯«è—¥è¢‹æˆ–貼標籤ã€åŒ…è£ç‰éŽç¨‹ä¹‹è¡Œç‚ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則所稱調製，係指調劑作æ¥éŽç¨‹ä¸ï¼Œä¾é†«å¸«æ‰€é–‹å…·ä¹‹è™•æ–¹ç®‹ï¼Œæ”¹è®ŠåŽŸåŠ‘型或é…製新製å“之行為。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事人員於藥事作æ¥è™•æ‰€ï¼Œæ‡‰ä½©æˆ´åŸ·æ¥åŸ·ç…§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事作æ¥è™•æ‰€æ‡‰å…·å‚™æ´—滌è¨å‚™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">調劑處所應有å…平方公尺以上之作æ¥é¢ç©ï¼Œä¸¦æ‡‰èˆ‡å…¶ä»–作æ¥è™•æ‰€æ˜Žé¡¯å€éš”。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …å…平方公尺作æ¥é¢ç©ï¼Œä¹å一年å月二å一日å‰è¨ç«‹ä¹‹è—¥äº‹ä½œæ¥è™•æ‰€ï¼Œä¸é©ç”¨ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">調劑處所應ä¾éœ€è¦è¨ç½®è—¥å“專用冷è—冰箱，其內應置溫度計並ä¿æŒæ•´æ½”。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“應ä¾è²¯å˜æ¢ä»¶å˜æ”¾ï¼Œé¿å…å—到光線直接照射。</span> </p><p><span style="font-family: 新細明體,serif;">ç–«è‹—ã€è¡€æ¶²è£½åŠ‘ç‰ç‰¹æ®Šè—¥å“é ˆåˆ†å±¤åˆ†æ«ƒï¼Œä¾è¦å®šæ¨™ç¤ºåŠä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">庫å˜å ´æ‰€æ‡‰èˆ‡èª¿åŠ‘處所隔離，éžç¶“所屬藥事人員許å¯ï¼Œä¸å¾—無故進入。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å°æ–¼å·²è®Šè³ªæˆ–å·²éŽä¿å˜æœŸé™çš„è—¥å“，應予標示並明顯å€éš”置放，ä¾æ³•è™•ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事人員自藥å“拆å°è‡³èª¿åŠ‘之期間，應注æ„å°ˆæ¥åŒ…è£è—¥å“之包è£ææ–™åŠè²¯å˜ç’°å¢ƒï¼Œä¸¦æ¨™ç¤ºè—¥åã€å–®ä½å«é‡åŠä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">處方藥ä¸å¾—以開架å¼é™³åˆ—。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è—¥å“應於補充å‰ç¢ºèªå…¶èˆ‡å—補充之藥瓶標示相符，補充後應å†æ¬¡ç¢ºèªã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事人員å—ç†è™•æ–¹å¾Œï¼Œæ‡‰ç¢ºèªè™•æ–¹ä¹‹åˆæ³•æ€§ã€å®Œæ•´æ€§èˆ‡è™•æ–¹æœŸé™æœ‰æ•ˆæ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …確èªè™•æ–¹ï¼Œæ‡‰åŒ…括下列å„é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç—…患的姓åã€å¹´é½¡ã€æ€§åˆ¥åŠç—…å。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è™•æ–¹é†«å¸«å§“åã€ç®¡åˆ¶è—¥å“使用執照號碼ã€å…¶ç°½åæˆ–è“‹ç« ï¼Œæ‰€å±¬é†«ç™‚æ©Ÿæ§‹å稱地å€åŠé›»è©±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“之å稱ã€åŠ‘åž‹åŠå–®ä½å«é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥å“數é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€åŠ‘é‡åŠç”¨è—¥æŒ‡ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€é–‹ç«‹è™•æ–¹æ—¥æœŸã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€é€£çºŒè™•æ–¹æŒ‡ç¤ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬äºŒé …ç¬¬ä¸ƒæ¬¾æ‰€ç¨±é€£çºŒè™•æ–¹æŒ‡ç¤ºï¼ŒåŒ…å«é€£çºŒè™•æ–¹çš„調劑次數åŠæ™‚間間隔。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">交付藥å“之包è£æˆ–容器ä¸å¾—é‡è¤‡ä½¿ç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">為防æ¢å…’ç«¥å–å¾—è—¥å“，藥事人員必è¦æ™‚，應使用有安全瓶蓋之容器。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事人員應於藥å“容器包è£ä¸Šè¼‰æ˜Žä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç—…患之姓ååŠæ€§åˆ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“å稱。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è—¥å“å–®ä½å«é‡åŠæ•¸é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è—¥å“用法åŠç”¨é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€é†«ç™‚機構或藥局之å稱åŠåœ°å€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€èª¿åŠ‘者姓å。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€èª¿åŠ‘或交付日期。</span> </p><p><span style="font-family: 新細明體,serif;">ä¸‹åˆ—äº‹é …å¾—æ¨™ç¤ºæ–¼è—¥å“外包è£å®¹å™¨æˆ–列為醫師ã€è—¥äº‹äººå“¡è«®è©¢äº‹é …。</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è¦èªžã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¸»è¦é©æ‡‰ç—‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¸»è¦å‰¯ä½œç”¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€é†«ç™‚機構或藥局之電話號碼。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€è—¥å“外觀標記其他用藥指示。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事人員應確ä¿æ‰€æœ‰è—¥å“在病患治療期間內，å‡æœªè¶…éŽè—¥å“標示之ä¿å˜æœŸé™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事人員於交付藥å“時，應å†æ¬¡æ ¸å°æ¨™ç±¤å…§å®¹ã€è—¥å“種類ã€æ•¸é‡èˆ‡è™•æ–¹æŒ‡ç¤ºæ˜¯å¦æ£ç¢ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">藥事人員交付藥å“時，應確èªæ‰€äº¤ä»˜ä¹‹å°è±¡ç‚ºäº¤ä»˜è™•æ–¹ç®‹è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫師ä¾æœ¬æ³•ç¬¬ä¸€ç™¾é›¶äºŒæ¢ä¹‹è¦å®šå¾—親自為藥å“調劑者，準用本準則之有關è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則自發布日施行。</span> </p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p>2013-12-05
臨床試驗類,è—¥å“優良臨床試驗準則法è¦å‘½ä»¤è—¥å“優良臨床試驗準則<p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">總則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則ä¾è—¥äº‹æ³•ç¬¬å››å二æ¢ç¬¬äºŒé …è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則之主管機關為行政院衛生署。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則專用å詞定義如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è‡¨åºŠè©¦é©—：以發ç¾æˆ–è‰æ˜Žè—¥å“在臨床ã€è—¥ç†æˆ–其他藥å¸ä¸Šä¹‹ä½œç”¨ç‚ºç›®çš„ï¼Œè€Œæ–¼äººé«”åŸ·è¡Œä¹‹ç ”ç©¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€éžè‡¨åºŠè©¦é©—：éžæ–¼äººé«”執行之生物醫å¸ç ”究。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å—試者：åƒåŠ 臨床試驗而接å—試驗藥å“或å°ç…§è—¥å“之個人。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å—試者åŒæ„書：å—試者於å—告知並了解將åƒèˆ‡ä¹‹è‡¨åºŠè©¦é©—之相關訊æ¯ï¼Œä¸”åƒé…Œæ˜¯å¦åƒèˆ‡è©¦é©—ä¹‹æ‰€æœ‰å› ç´ å¾Œï¼Œè‡ªé¡˜ç°½ç½²é¡˜æ„åƒåŠ 試驗之文件。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€äººé«”試驗委員會：由具醫å¸èƒŒæ™¯ä¹‹å°ˆæ¥äººå“¡èˆ‡éžé†«å¸èƒŒæ™¯ä¹‹ç¤¾æœƒå…¬æ£äººå£«æ‰€å…±åŒçµ„æˆä¹‹å§”員會，其責任在ä¿è·å—試者之權利ã€å®‰å…¨èˆ‡ç¦ç¥‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è©¦é©—機構：執行臨床試驗之醫療機構。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€è©¦é©—主æŒäººï¼šè©¦é©—æ©Ÿæ§‹åŸ·è¡Œè‡¨åºŠè©¦é©—ä¹‹è² è²¬äººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è©¦é©—委託者：臨床試驗之發起åŠç®¡ç†è€…。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å—è¨—ç ”ç©¶æ©Ÿæ§‹ï¼šå’Œè©¦é©—å§”è¨—è€…ç· ç´„ä»¥æ‰¿æ“”è‡¨åºŠè©¦é©—ä¸€éƒ¨æˆ–å…¨éƒ¨å·¥ä½œä¹‹å€‹äººæˆ–æ©Ÿæ§‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€è©¦é©—è—¥å“：臨床試驗ä¸ç”¨ä¾†è©¦é©—之藥å“，或當åšåƒè€ƒä¹‹æ´»æ€§æˆåˆ†è£½åŠ‘或安慰劑。包括已上巿藥å“ä½¿ç”¨æ–¼èˆ‡å…¶æ ¸å‡†å…§å®¹ä¸åŒä¹‹ç”¨é€”ã€é…æ–¹ã€åŒ…è£ã€é©æ‡‰ç—‡ï¼Œæˆ–用於ç²å¾—æœ‰é—œæ ¸å‡†ç”¨é€”ä¹‹é€²ä¸€æ¥è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€è©¦é©—計畫書：記載臨床試驗之目的ã€è¨è¨ˆã€æ–¹æ³•ã€çµ±è¨ˆè€ƒé‡èˆ‡ç·¨åˆ¶ç‰äº‹é …之文件，並得載明試驗之相關背景åŠç†è«–。</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€ä¸»æŒäººæ‰‹å†Šï¼šæœ‰é—œè©¦é©—è—¥å“之臨床åŠéžè‡¨åºŠæ•¸æ“šä¹‹ç·¨è¼¯ç‰©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€è—¥å“ä¸è‰¯å應：使用藥å“後所發生之有害且未é 期之å應。æ¤é …å應與試驗藥å“間，應具有åˆç†ä¹‹å› 果關係。</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€ä¸è‰¯äº‹ä»¶ï¼šå—試者åƒåŠ 試驗後所發生之任何ä¸è‰¯æƒ…æ³ã€‚æ¤é …ä¸è‰¯æƒ…æ³èˆ‡è©¦é©—è—¥å“é–“ä¸ä»¥å…·æœ‰å› 果關係為必è¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€ç›²æ€§ï¼šä½¿åƒèˆ‡è©¦é©—之一方或多方ä¸çŸ¥è©¦é©—治療分é…之方å¼ã€‚單盲係指å—試者ä¸çŸ¥æ²»ç™‚分é…之方å¼ï¼Œé›™ç›²æ˜¯æŒ‡å—試者ã€è©¦é©—主æŒäººã€ç›£æ¸¬è€…，åŠåœ¨æŸäº›æƒ…æ³ä¸‹ï¼Œæ•¸æ“šåˆ†æžè€…亦ä¸æ¸…楚治療分é…之方å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">執行臨床試驗應符åˆèµ«çˆ¾è¾›åŸºå®£è¨€ä¹‹å€«ç†åŽŸå‰‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">臨床試驗進行å‰ï¼Œæ‡‰æ¬Šè¡¡å°å€‹åˆ¥å—試者åŠæ•´é«”社會之å¯èƒ½é¢¨éšªã€ä¸ä¾¿åŠé 期利益。é 期利益應超éŽå¯èƒ½é¢¨éšªåŠä¸ä¾¿ï¼Œå§‹å¾—進行試驗。</span> </p><p><span style="font-family: 新細明體,serif;">å—試者之權利ã€å®‰å…¨åŠç¦ç¥‰ç‚ºè—¥å“臨床試驗之最é‡è¦è€ƒé‡ï¼Œä¸”應å‹æ–¼ç§‘å¸åŠç¤¾æœƒä¹‹åˆ©ç›Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗委員會應確ä¿å—試者之權利ã€å®‰å…¨ï¼Œä»¥åŠç¦ç¥‰å—到ä¿è·ï¼Œä¸”å°æ–¼æ˜“å—傷害å—試者之臨床試驗，應特別留æ„。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰æ–¼è‡¨åºŠè©¦é©—進行å‰ï¼Œå–å¾—å—試者自願給予之å—試者åŒæ„書。</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººæˆ–由其指定之人員，應充分告知å—試者臨床試驗進行之資訊ã€å—試者åŒæ„書之內容åŠæ‰€æœ‰ç”±äººé«”è©¦é©—å§”å“¡æœƒæ‰€æ ¸å‡†èˆ‡è‡¨åºŠè©¦é©—ç›¸é—œä¹‹æ›¸é¢æ„見，並使其充分çžè§£å¾Œè¦ªç†ç°½å，並載明日期。</span> </p><p><span style="font-family: 新細明體,serif;">å‰äºŒé …之行為，å—試者為無行為能力人者，由法定代ç†äººä»£ç‚ºä¹‹ï¼›å—試者為é™åˆ¶è¡Œç‚ºèƒ½åŠ›äººè€…，應得法定代ç†äººä¹‹åŒæ„ï¼›å—試者雖éžç„¡è¡Œç‚ºèƒ½åŠ›æˆ–é™åˆ¶è¡Œç‚ºèƒ½åŠ›è€…ï¼Œä½†å› ç„¡æ„è˜æˆ–精神錯亂無法自行為之時，由有åŒæ„權之人為之。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …有åŒæ„權人為é…å¶åŠåŒå±…之親屬。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">在å—試者åƒåŠ 試驗與後續追蹤期間，試驗主æŒäººåŠè©¦é©—機構就å—試者任何與試驗相關之ä¸è‰¯å應，應æä¾›å—試者充分醫療照è·ã€‚試驗主æŒäººç™¼ç¾è©¦é©—期間å—試者有疾病需è¦é†«ç™‚ç…§è·æ™‚，應告知å—試者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è‹¥å—試者有轉介醫師且經å—試者åŒæ„，試驗主æŒäººæ‡‰é€šçŸ¥å…¶è½‰ä»‹é†«å¸«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººèˆ‡è©¦é©—相關人員ä¸å¾—強迫或ä¸ç•¶å½±éŸ¿å—試者åƒèˆ‡è‡¨åºŠè©¦é©—之æ„願。</span> </p><p><span style="font-family: 新細明體,serif;">臨床試驗進行ä¸ï¼Œè©¦é©—主æŒäººèˆ‡è©¦é©—相關人員亦ä¸å¾—強迫或ä¸ç•¶å½±éŸ¿å—試者繼續åƒèˆ‡è‡¨åºŠè©¦é©—之æ„願。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者得ä¸é™„ç†ç”±éš¨æ™‚退出臨床試驗。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形，試驗主æŒäººæ‡‰åœ¨å°Šé‡å—試者之權利åŠæ„願之æ¢ä»¶ä¸‹ï¼Œç›¡é‡ç¢ºèªå…¶é€€å‡ºè©¦é©—ä¹‹åŽŸå› ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者å°æ–¼å—試者å¯ç²å¾—之補助åŠä»˜æ¬¾æ–¹å¼ï¼Œä¸å¾—有強迫或ä¸ç•¶å½±éŸ¿å—試者之情形。</span> </p><p><span style="font-family: 新細明體,serif;">å—試者之補助，應按臨床試驗進行之進度ä¾æ¯”例給付之，ä¸å¾—於試驗完æˆå¾Œæ–¹ç‚ºçµ¦ä»˜ã€‚但å°é‡‘é¡è€…，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å—試者補助之付款方å¼ã€é‡‘é¡åŠä»˜æ¬¾é€²åº¦ï¼Œæ‡‰è¼‰æ˜Žæ–¼å—試者åŒæ„書åŠå…¶ä»–給與å—試者之書é¢è³‡æ–™ï¼›è£œåŠ©æŒ‰æ¯”例分é…付款之方å¼ï¼Œæ‡‰è©³ç´°èªªæ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者之身分åŠå…¶è‡¨åºŠè©¦é©—相關紀錄，應予ä¿å¯†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床試驗應有科å¸æ ¹æ“šï¼Œè©¦é©—計畫書之內容，應清楚詳盡。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">éžç¶“äººé«”è©¦é©—å§”å“¡æœƒä¹‹æ ¸å‡†ï¼Œä¸å¾—進行藥å“臨床試驗。</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗委員會於審查å—試者åŒæ„書ã€è©¦é©—計畫書åŠå…¶ä»–ç›¸é—œæ–‡ä»¶å¾Œï¼Œå¾—æ ¸å‡†è©¦é©—æ©Ÿæ§‹é€²è¡Œè‡¨åºŠè©¦é©—ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">所有åƒèˆ‡è©¦é©—執行之人員，應有符åˆå·¥ä½œè³‡æ ¼ä¹‹æ•™è‚²ã€è¨“ç·´åŠç¶“驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">所有臨床試驗之資料，應予記錄åŠä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">å—試者ä¿è·</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床試驗開始å‰ï¼Œè©¦é©—主æŒäººæ‡‰å–得人體試驗委員會å°å—試者åŒæ„書和æä¾›å—試者之任何其他書é¢è³‡æ–™ä¹‹æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …æ ¸å‡†ï¼Œæ‡‰ä»¥æ›¸é¢ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">若具有é‡è¦æ€§ä¹‹æ–°è³‡è¨Šå¯èƒ½å½±éŸ¿å—試者之åŒæ„時，應修訂å—試者åŒæ„書åŠæä¾›å—試者之任何其他書é¢è³‡æ–™ï¼Œä¸¦æ‡‰ç«‹å³å‘ŠçŸ¥å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人。</span> </p><p><span style="font-family: 新細明體,serif;">修訂後之å—試者åŒæ„書åŠæä¾›å—試者之任何其他書é¢è³‡æ–™ï¼Œæ‡‰å…ˆå¾—åˆ°äººé«”è©¦é©—å§”å“¡æœƒä¹‹æ ¸å‡†ï¼›ç¶“ä¸»ç®¡æ©Ÿé—œæ ¸å‡†é€²è¡Œä¹‹è‡¨åºŠè©¦é©—ï¼Œä¸¦æ‡‰å¾—åˆ°ä¸»ç®¡æ©Ÿé—œä¹‹æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …ä¹‹å‘ŠçŸ¥åŠç¬¬äºŒé …ä¹‹æ ¸å‡†ï¼Œçš†æ‡‰ä»¥æ›¸é¢ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者åŒæ„書åŠæä¾›å—試者之任何其他書é¢è³‡æ–™ï¼Œä¸å¾—æœ‰ä»»ä½•æœƒé€ æˆå—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人放棄其法定權利，或å…除試驗主æŒäººã€è©¦é©—機構ã€è©¦é©—委託者或其代ç†å•†è²¬ä»»ä¹‹è¨˜è¼‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">é•èƒŒå‰é …è¦å®šä¹‹è¨˜è¼‰ï¼Œç„¡æ•ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">有關試驗計畫之å£é åŠæ›¸é¢è³‡æ–™ï¼ŒåŒ…括å—試者åŒæ„書，皆應使用å£èªžåŒ–åŠéžæŠ€è¡“性之語言，且為å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人所能ç†è§£è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 20 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者åŒæ„書，應由å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人於åƒåŠ 試驗å‰ï¼Œè¦ªç†ç°½å並載明日期。</span> </p><p><span style="font-family: 新細明體,serif;">å–å¾—å—試者åŒæ„書å‰ï¼Œè©¦é©—主æŒäººæˆ–其指定之人員，應給予å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人充分時間與機會，以詢å•è‡¨åºŠè©¦é©—之細節。</span> </p><p><span style="font-family: 新細明體,serif;">關於臨床試驗計畫之所有å•é¡Œï¼Œæ‡‰çµ¦äºˆå—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人滿æ„之回ç”。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬äºŒé …ä¹‹äººå“¡æ‡‰æ–¼å—試者åŒæ„書簽å。</span> </p><p><span style="font-family: 新細明體,serif;">用以治療或處置緊急病æ³ä¹‹è‡¨åºŠè©¦é©—，é 期無法é å…ˆå–å¾—å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人åŒæ„，若於試驗計畫書ä¸è©³åˆ—緊急事件處ç†ç¨‹åºï¼Œå¾—æ–¼å–å¾—å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人書é¢åŒæ„å‰ï¼Œå…ˆé€²è¡Œè©¦é©—。但若能å–å¾—å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人書é¢åŒæ„時，應立å³ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 21 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人皆無法閱讀時，應由見è‰äººåœ¨å ´åƒèˆ‡æ‰€æœ‰æœ‰é—œå—試者åŒæ„書之討論。</span> </p><p><span style="font-family: 新細明體,serif;">見è‰äººæ‡‰é–±è®€å—試者åŒæ„書åŠæä¾›å—試者之任何其他書é¢è³‡æ–™ï¼Œä»¥è¦‹è‰è©¦é©—主æŒäººæˆ–其指定之人員已經確切地將其內容å‘å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人為解釋，並確定其充分了解所有資料之內容。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …æƒ…å½¢ï¼Œå—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人，ä»æ‡‰æ–¼å—試者åŒæ„書親ç†ç°½å並載明日期。但得以指å°ä»£æ›¿ç°½å。</span> </p><p><span style="font-family: 新細明體,serif;">見è‰äººæ–¼å®Œæˆç¬¬äºŒé …之行為，並確定å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人之åŒæ„完全出於其自由æ„願後，應於å—試者åŒæ„書簽å並載明日期。</span> </p><p><span style="font-family: 新細明體,serif;">試驗相關人員ä¸å¾—為見è‰äººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 22 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者åŒæ„書或æä¾›å—試者之其他書é¢è³‡æ–™æ‡‰èªªæ˜Žä»¥ä¸‹å…§å®¹ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è‡¨åºŠè©¦é©—ç‚ºä¸€ç¨®ç ”ç©¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è©¦é©—之目的。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€è©¦é©—治療åŠæ¯å€‹æ²»ç™‚之隨機分é…機率。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ²»ç™‚程åºï¼ŒåŒ…å«æ‰€æœ‰ä¾µå…¥æ€§è¡Œç‚ºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å—試者之責任。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è‡¨åºŠè©¦é©—ä¸å°šåœ¨è©¦é©—之部分。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å°å—試者或å°èƒšèƒŽã€å¬°å…’或哺乳ä¸å¹¼å…’之å¯é 期å±éšªæˆ–ä¸ä¾¿è™•ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€å¯åˆç†é 期之臨床利益。</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å…¶ä»–治療方å¼æˆ–療程，åŠå…¶å¯èƒ½ä¹‹é‡è¦å¥½è™•åŠé¢¨éšªã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€è©¦é©—相關æ害發生時，å—試者å¯å¾—到之補償或治療。</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€å¦‚有å¯ç²å¾—之補助，應告知åƒèˆ‡è‡¨åºŠè©¦é©—之å—試者。</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€å¦‚有應支付之費用，應告知åƒèˆ‡è‡¨åºŠè©¦é©—之å—試者。</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€å—試者為自願性åƒèˆ‡è©¦é©—，å¯ä¸åŒæ„åƒèˆ‡è©¦é©—或隨時退出試驗，而ä¸å—到處罰或æåŠå…¶æ‡‰å¾—之利益。</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€ç¶“由簽署å—試者åŒæ„書，å—試者å³åŒæ„其原始醫療紀錄å¯ç›´æŽ¥å—監測者ã€ç¨½æ ¸è€…ã€äººé«”試驗委員會åŠä¸»ç®¡æ©Ÿé—œæª¢é–±ï¼Œä»¥ç¢ºä¿è‡¨åºŠè©¦é©—éŽç¨‹èˆ‡æ•¸æ“šç¬¦åˆç›¸é—œæ³•å¾‹åŠæ³•è¦è¦æ±‚，並承諾絕ä¸é•åå—試者身分之機密性。</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€è¾¨èªå—試者身分之紀錄應ä¿å¯†ï¼Œä¸”在相關法律åŠæ³•è¦è¦æ±‚下將ä¸å…¬é–‹ã€‚如果發表試驗çµæžœï¼Œå—試者之身分ä»å°‡ä¿å¯†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€è‹¥æ–°è³‡è¨Šå¯èƒ½å½±éŸ¿å—試者繼續åƒèˆ‡è‡¨åºŠè©¦é©—之æ„願，å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人會被立å³å‘ŠçŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å七ã€é€²ä¸€æ¥ç²çŸ¥æœ‰é—œè©¦é©—之資訊和å—試者權利之è¯çµ¡äººï¼ŒåŠèˆ‡è©¦é©—相關之傷害發生時之è¯çµ¡äººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…«ã€å—試者終æ¢åƒèˆ‡è©¦é©—之å¯é 期情æ³åŠç†ç”±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åä¹ã€å—試者é 計åƒèˆ‡è‡¨åºŠè©¦é©—之時間。</span> </p><p><span style="font-family: 新細明體,serif;">二åã€å¤§ç´„å—試者人數。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 23 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人於åƒåŠ 臨床試驗執行å‰ï¼Œæ‡‰æ”¶åˆ°å·²ç°½ååŠè¼‰æ˜Žæ—¥æœŸä¹‹å—試者åŒæ„書之副本åŠå…¶ä»–應æä¾›å—試者之書é¢è³‡æ–™ã€‚但用以治療或處置緊急病æ³ä¹‹è‡¨åºŠè©¦é©—，é 期無法é å…ˆå–å¾—å—試者或有åŒæ„權之人åŒæ„者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å—試者åƒåŠ 臨床試驗期間，若åŒæ„書或其他文件有修æ£ï¼Œå—試者ã€æ³•å®šä»£ç†äººæˆ–有åŒæ„權之人，應收到已簽ååŠè¼‰æ˜Žæ—¥æœŸä¹‹å—試者åŒæ„書之更新副本åŠå…¶ä»–ä¿®æ£æ–‡ä»¶ä¹‹å‰¯æœ¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 24 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">法定代ç†äººæˆ–有åŒæ„權之人ä¸å¾—代ç†å—試者åŒæ„åƒèˆ‡éžä»¥æ²»ç™‚為目的之臨床試驗。但符åˆä¸‹åˆ—所有æ¢ä»¶è€…，ä¸åœ¨æ¤é™ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç„¡æ³•ç”±æœ‰èƒ½åŠ›ç°½ç½²å—試者åŒæ„書之å—試者é”æˆè©¦é©—目標之臨床試驗。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è‡¨åºŠè©¦é©—å°å—試者之å¯é 期å±éšªå¾ˆä½Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å°å—è©¦è€…åˆ©ç›Šä¹‹è² é¢å½±éŸ¿å¾ˆå°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ³•å¾‹æœªç¦æ¢ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€äººé«”試驗委員會之書é¢æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …但書之情形，應é¸æ“‡è©¦é©—è—¥å“所治療疾病之病患åƒèˆ‡è©¦é©—。å—試者應特別嚴密監測，如有éŽåº¦ä¸é©æƒ…形，應å³é€€å‡ºè‡¨åºŠè©¦é©—。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">人體試驗委員會</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 25 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗機構為審查藥å“臨床試驗，應è¨äººé«”試驗委員會，組æˆäººå“¡æ‡‰å…·å‚™å¯©æŸ¥åŠè©•ä¼°è—¥å“臨床試驗之科å¸ã€é†«å¸æˆ–倫ç†è³‡æ ¼åŠç¶“驗。</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗委員會之委員至少五人，其ä¸è‡³å°‘一ä½ç‚ºéžç§‘å¸èƒŒæ™¯è€…，且至少一ä½ç‚ºéžè©¦é©—機構æˆå“¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗委員會應建立並éµå®ˆæ›¸é¢ä½œæ¥ç¨‹åºï¼Œä¸”應ä¿å˜æ´»å‹•ä¹‹æ›¸é¢ç´€éŒ„åŠæœƒè°ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗委員會之組æˆåŠé‹ä½œï¼Œæ‡‰ç¬¦åˆä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 26 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人體試驗委員會之決è°ï¼Œæ‡‰ä¾å‰æ¢ç¬¬å››é …之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 27 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">委員未親自åƒèˆ‡äººé«”試驗委員會之審查åŠè¨Žè«–，ä¸å¾—åƒèˆ‡æ±ºè°æˆ–æ出æ„見。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 28 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººå¾—æ供任何有關試驗之資料，但ä¸å¾—åƒèˆ‡äººé«”試驗委員會之審è°ã€æ±ºè°æˆ–æ出æ„見。</span> </p><p><span style="font-family: 新細明體,serif;">人體試驗委員會得邀請éžå§”員之專家給予特定專æ¥ä¸Šä¹‹å”助。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 29 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人體試驗委員會應ä¿å˜æ›¸é¢ä½œæ¥ç¨‹åºã€å§”å“¡åå–®ã€å§”å“¡è·æ¥åŠè¯ç¹«åå–®ã€é€å¯©æ–‡ä»¶ã€æœƒè°ç´€éŒ„ã€ä¿¡ä»¶ã€åŠå…¶ä»–臨床試驗相關資料至試驗çµæŸå¾Œä¸‰å¹´ï¼Œä¸”å¯ä¾›ä¸»ç®¡æ©Ÿé—œéš¨æ™‚調閱。</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººã€è©¦é©—委託者或主管機關得å‘人體試驗委員會索å–書é¢ä½œæ¥ç¨‹åºåŠå…¨é«”委員å單，人體試驗委員會ä¸å¾—拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">試驗主æŒäºº</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 30 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰ç¬¦åˆä¸»ç®¡æ©Ÿé—œè¦å®šä¹‹è³‡æ ¼åŠèƒ½åŠ›ï¼Œä¸¦å…·å‚™é©ç•¶åŸ·è¡Œè‡¨åºŠè©¦é©—之經驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 31 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰å®Œå…¨ç†Ÿæ‚‰è©¦é©—è—¥å“於試驗計畫書ã€æœ€æ–°ç‰ˆä¸»æŒäººæ‰‹å†Šã€è—¥å“資訊，åŠå…¶ä»–由試驗委託者æ供之藥å“資訊ä¸æ述之使用方法。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 32 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰æ˜Žçžä¸¦éµå®ˆæœ¬æº–則åŠç›¸é—œæ³•è¦ä¹‹è¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººåŠè©¦é©—機構應接å—è©¦é©—å§”è¨—è€…ä¹‹ç›£æ¸¬èˆ‡ç¨½æ ¸ï¼Œä¸¦æŽ¥å—ä¸»ç®¡æ©Ÿé—œæˆ–å…¶æŒ‡å®šæ©Ÿæ§‹ä¹‹æŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 34 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰ä¿ç•™å…¶æŽˆæ¬Šè‡¨åºŠè©¦é©—相關責任之試驗相關人員å單。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 35 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰è‰æ˜Žå…¶èƒ½åœ¨è©¦é©—計畫書è¦å®šä¹‹æ™‚é–“å…§å‹Ÿé›†è¶³å¤ ä¹‹å—試者。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 36 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººåœ¨è©¦é©—期間內，應有充分時間以執行與完æˆè©¦é©—。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 37 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰æœ‰å……分之åˆæ ¼è©¦é©—相關人員åŠè¨æ–½ï¼Œä»¥é©ç•¶ä¸¦å®‰å…¨çš„執行試驗。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 38 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰ç¢ºä¿æ‰€æœ‰è©¦é©—相關人員å°è©¦é©—計畫書åŠç ”究藥å“充分了解，以åŠå…¶æ–¼è‡¨åºŠè©¦é©—ä¸ä¹‹è²¬ä»»èˆ‡å·¥ä½œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 39 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗計畫書åŠä¸»æŒäººæ‰‹å†Šè‹¥åœ¨è‡¨åºŠè©¦é©—期間更新，試驗主æŒäººåŠè©¦é©—機構應主動æ供人體試驗委員會更新版本。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">試驗委託者</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">通則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 40 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è©¦é©—å§”è¨—è€…æ‡‰è² è²¬ç”„é¸è©¦é©—主æŒäººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 41 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者與試驗主æŒäººåŠè©¦é©—機構é”æˆå”è°åŸ·è¡Œè©¦é©—å‰ï¼Œè©¦é©—委託者應æ供試驗計畫書與最新版主æŒäººæ‰‹å†Šäºˆè©¦é©—主æŒäººåŠè©¦é©—機構，且應給予試驗主æŒäººå……分之時間檢閱試驗計畫書åŠç›¸é—œè³‡è¨Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 42 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應ç²å¾—試驗主æŒäººåŠè©¦é©—機構å°æ–¼ä»¥ä¸‹äº‹é …之åŒæ„：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€éµå®ˆæœ¬æº–則åŠç›¸é—œæ³•è¦ä¹‹è¦å®šï¼Œä¸¦ä¾æ“šè©¦é©—委託者åŠäººé«”試驗委員會åŒæ„之試驗計畫書，進行試驗。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€éµå®ˆæ•¸æ“šç´€éŒ„åŠå ±å‘Šä¹‹ç¨‹åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æŽ¥å—ç›£æ¸¬ï¼Œç¨½æ ¸åŠæŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¾è©¦é©—委託者指定之期間ä¿å˜è©¦é©—主æŒäººåŠè©¦é©—機構應建檔之必è¦æ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">試驗委託者ã€è©¦é©—主æŒäººåŠè©¦é©—機構，應在試驗計畫書或其他文件上共åŒç°½ç« ，以確èªæ¤å”è°ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 43 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者得移轉部分或全部與試驗相關的權利與義務於å—è¨—ç ”ç©¶æ©Ÿæ§‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">但關於ç¶è·è©¦é©—數據的å“質與完整性之最終責任，ä»æ‡‰ç”±è©¦é©—å§”è¨—è€…è² è²¬ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …委託，應以書é¢ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">æ–¼ç¬¬ä¸€é …ç§»è½‰ä¹‹æ¬Šåˆ©ç¾©å‹™ç¯„åœå…§ï¼Œå—è¨—ç ”ç©¶æ©Ÿæ§‹æº–ç”¨æœ¬æº–å‰‡æœ‰é—œè©¦é©—å§”è¨—è€…ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 44 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者得è¨ç«‹ç¨ç«‹æ•¸æ“šç›£æ¸¬å§”員會，以定期評估安全性數據ã€é‡è¦ç™‚效指標ç‰è‡¨åºŠè©¦é©—之進展。</span> </p><p><span style="font-family: 新細明體,serif;">ç¨ç«‹æ•¸æ“šç›£æ¸¬å§”員會得建è°è©¦é©—委託者繼續ã€ä¿®æ£æˆ–終æ¢æ¤é …試驗。</span> </p><p><span style="font-family: 新細明體,serif;">ç¨ç«‹æ•¸æ“šç›£æ¸¬å§”員會應建立書é¢æ¨™æº–作æ¥ç¨‹åºï¼Œä¸¦ä¿ç•™æ‰€æœ‰æœƒè°ä¹‹æ›¸é¢ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 45 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應任用åˆæ ¼ã€é©ç•¶ï¼Œä»¥åŠèƒ½å°è©¦é©—相關醫療å•é¡Œæä¾›æ„見之醫療人員。必è¦æ™‚，亦å¯æŒ‡æ´¾å¤–部顧å•æ“”任上述工作。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 46 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床試驗開始å‰ï¼Œè©¦é©—委託者應定義åŠåˆ†é…所有試驗相關之責任與功能。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 47 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è©¦é©—å§”è¨—è€…æ‡‰è² è²¬è©¦é©—ä¸»æŒäººæˆ–è©¦é©—æ©Ÿæ§‹å› è©¦é©—æ‰€ç”Ÿä¹‹è³ å„Ÿè²¬ä»»æˆ–æŠ•ä¿è²¬ä»»ä¿éšªã€‚ä½†å› è©¦é©—ä¸»æŒäººæˆ–試驗機構之醫療ç–失所致者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 48 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººã€è©¦é©—機構或試驗委託者之試驗相關人員ä¸éµå¾žè©¦é©—計畫書或本準則之è¦å®šæ™‚，試驗委託者應採å–迅速之措施以確ä¿å…¶éµå¾žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººã€è©¦é©—機構ä¸éµå¾žå‰é …措施者，試驗委託者應ä¾ç¬¬ä¸€ç™¾åå…æ¢ä¹‹è¦å®šè™•ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">å“質ä¿è‰åŠå“質管制</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 49 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應以書é¢æ¨™æº–作æ¥ç¨‹åºè¦å®šä¸¦æŒçºŒåŸ·è¡Œå“質ä¿è‰åŠå“質管制系統，以確ä¿è©¦é©—進行åŠæ•¸æ“šä¹‹ç”¢ç”Ÿã€ç´€éŒ„èˆ‡å ±å‘Šçš†éµå®ˆè©¦é©—計畫書與本準則之è¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 50 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è©¦é©—å§”è¨—è€…æ‡‰è² è²¬å–得試驗機構之åŒæ„ï¼Œç›´æŽ¥ç›£æ¸¬å’Œç¨½æ ¸è©¦é©—ç›¸é—œå ´æ‰€ã€åŽŸå§‹è³‡æ–™ã€æ–‡ä»¶åŠå ±å‘Šï¼Œä¸¦å¯æŽ¥å—ä¸»ç®¡æ©Ÿé—œæŸ¥æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 51 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者與試驗主æŒäººã€è©¦é©—機構或任何其他åƒèˆ‡æ¤è‡¨åºŠè©¦é©—之人員所訂定之å”è°ï¼Œçš†æ‡‰ä»¥æ›¸é¢ç‚ºä¹‹ï¼Œä¸¦å¾—作為試驗計畫書之一部分。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 52 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應任用åˆæ ¼é©ç•¶ä¹‹äººå“¡è¨è¨ˆè©¦é©—è¨ˆç•«æ›¸ä¹‹å…§å®¹ï¼Œè£½ä½œå€‹æ¡ˆå ±å‘Šã€è¦åŠƒåˆ†æžã€æœŸä¸å ±å‘ŠåŠè‡¨åºŠè©¦é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">數據處ç†åŠä¿å˜</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 53 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">數據處ç†ä¹‹æ‰€æœ‰æ¥é©Ÿæ‡‰åŸ·è¡Œå“質管制，以確ä¿æ‰€æœ‰æ•¸æ“šä¹‹å¯ä¿¡åº¦åŠå…¶è™•ç†ä¹‹æ£ç¢ºæ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 54 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應任用åˆæ ¼é©ç•¶ä¹‹äººå“¡ï¼Œè² 責以下工作：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç›£ç£è©¦é©—之執行。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è™•ç†èˆ‡é©—è‰è©¦é©—數據。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€çµ±è¨ˆåˆ†æžã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 55 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床試驗使用電å資料處ç†ç³»çµ±æˆ–é 端電å資料處ç†ç³»çµ±æ™‚ï¼Œè©¦é©—å§”è¨—è€…æ‡‰åŸ·è¡Œä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¢ºä¿é›»å資料處ç†ç³»çµ±ç¬¦åˆè©¦é©—委託者å°è³‡æ–™å®Œæ•´æ€§ã€ç²¾ç¢ºåº¦ã€å¯ä¿¡åº¦åŠä¸€è‡´æ€§ä¹‹è¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€éµå¾ªä¸¦ä¿å˜ç³»çµ±ä¹‹æ¨™æº–作æ¥ç¨‹åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¢ºä¿ç³»çµ±å°è³‡æ–™æ›´æ£ä¹‹è¨è¨ˆä¿å˜åŽŸæœ‰ç´€éŒ„，且ä¸å°‡åŽŸè¼¸å…¥è³‡æ–™åˆªé™¤ã€‚系統應分別ä¿å˜ç¨½æ ¸è·¯å¾‘ã€è³‡æ–™è·¯å¾‘與修æ£è·¯å¾‘。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æ‡‰æœ‰å®‰å…¨ç¨‹åºä»¥é˜²æ¢æœªç¶“授權者使用系統或數據。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¿æœ‰æŽˆæ¬Šä¿®æ£è©¦é©—數據之人員å單。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ä¿ç•™é©ç•¶ä¹‹è³‡æ–™å‚™ä»½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ç¢ºä¿ç›²æ€§è¨è¨ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 56 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">資料於處ç†éŽç¨‹ä¸ç¶“éŽè½‰æ›è€…，原始觀察資料應能與轉æ›å¾Œè³‡æ–™é€²è¡Œæ¯”較。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 57 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應建立清楚之身分代碼，以確èªæ¯ä½å—試者</span> <span style="font-family: 新細明體,serif;">之試驗數據。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 58 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者或其他數據所有者，應ä¿å˜æ‰€æœ‰è©¦é©—å§”è¨—è€…æ‡‰è² è²¬èˆ‡è©¦é©—ç›¸é—œä¹‹å¿…è¦æ–‡ä»¶ï¼Œè‡³è©¦é©—è—¥å“æ–¼æˆ‘åœ‹æ ¸å‡†ä¸Šå¸‚å¾Œè‡³å°‘äºŒå¹´ã€‚ä½†å…¶ä»–æ³•è¦è¦å®šä¹‹ä¿å˜æœŸé–“長於二年者，從其è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 59 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者終æ¢è©¦é©—è—¥å“ä¹‹è‡¨åºŠç ”ç™¼å·¥ä½œæ™‚ï¼Œæ‡‰é€šçŸ¥æ‰€æœ‰è©¦é©—ä¸»æŒäººã€è©¦é©—機構åŠä¸»ç®¡æ©Ÿé—œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形，試驗委託者應ä¿å˜ç¬¬äº”åå…«æ¢ä¹‹å¿…è¦æ–‡ä»¶è‡³è©¦é©—æ£å¼åœæ¢å¾Œè‡³å°‘二年。但其他法è¦è¦å®šä¹‹ä¿å˜æœŸé–“長於二年者，從其è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 60 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗相關資料之權利移轉，應通知主管機關。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 61 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應書é¢é€šçŸ¥è©¦é©—主æŒäººåŠè©¦é©—機構紀錄ä¿å˜ä¹‹å¿…è¦æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">è©¦é©—ç›¸é—œç´€éŒ„ç„¡é ˆç¹¼çºŒä¿å˜è€…，試驗委託者應書é¢é€šçŸ¥è©¦é©—主æŒäººåŠè©¦é©—機構。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">試驗藥å“之管ç†</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 62 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">籌畫試驗計畫時，試驗委託者應有充分之éžè‡¨åºŠæˆ–è‡¨åºŠç ”ç©¶ä¹‹å®‰å…¨æ€§åŠæœ‰æ•ˆæ€§è³‡æ–™ï¼Œä»¥æ”¯æŒå—試者於試驗期間內能承å—其給藥方å¼åŠåŠ‘é‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 63 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">發ç¾èˆ‡è©¦é©—è—¥å“有關之é‡å¤§æ–°è³‡è¨Šæ™‚，試驗委託者應立å³æ›´æ–°ä¸»æŒäººæ‰‹å†Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 64 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗藥å“ã€å°ç…§è—¥å“åŠå®‰æ…°åŠ‘之特性應åˆæ–¼è—¥å“ç™¼å±•ä¹‹éšŽæ®µï¼Œä¸”å…¶è£½é€ ã€è™•ç†åŠå„²å˜ï¼Œæ‡‰ç¬¦åˆè—¥å“å„ªè‰¯è£½é€ è¦ç¯„，其代碼åŠæ¨™ç±¤ï¼Œæ‡‰å¾—以ä¿è·ç›²æ€§è¨è¨ˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 65 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應決定試驗藥å“之儲å˜æº«åº¦ã€å„²å˜æ¢ä»¶ã€å„²å˜æ™‚é–“ã€æº¶åŠ‘åŠæ³¨å°„器æ，並通知監測者ã€è©¦é©—主æŒäººã€è—¥å¸«ã€å€‰å„²åŠå…¶ä»–相關人員。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 66 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗藥å“應以é©ç•¶åŒ…è£ï¼Œé¿å…é‹é€èˆ‡å„²å˜æœŸé–“之污染與變質。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 67 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">盲性試驗之藥å“代碼系統，應能於緊急情æ³æ™‚迅速辨別所使用之藥å“，而ä¸æœƒç ´å£žç›²æ€§è¨è¨ˆä¹‹åŠŸèƒ½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 68 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床發展éŽç¨‹ä¸è©¦é©—è—¥å“或å°ç…§è—¥å“之é…方有é‡å¤§æ”¹è®Šè€…，應於新é…方使用於臨床試驗å‰ï¼Œå®Œæˆæ–°é…方是å¦æœƒæ˜Žé¡¯æ”¹è®Šè—¥å“安定性ã€æº¶é›¢çŽ‡ã€ç”Ÿé«”å¯ç”¨çŽ‡åŠå…¶ä»–藥動å¸ç‰¹æ€§ä¹‹ç ”究評估。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 69 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è©¦é©—æœªç¶“æ ¸å‡†ï¼Œè©¦é©—å§”è¨—è€…ä¸å¾—æ供試驗主æŒäººåŠè©¦é©—機構試驗藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 70 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者所訂定之書é¢ç¨‹åºä¸ï¼Œæ‡‰åŒ…æ‹¬ä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è©¦é©—主æŒäººèˆ‡è©¦é©—機構應éµå®ˆè©¦é©—è—¥å“處ç†åŠä¿å˜ç¨‹åºä¹‹æ–‡å—。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è—¥å“之處ç†ã€è²¯å˜ã€ç™¼è—¥ã€è‡ªå—試者處å–回餘藥ã€å°‡é¤˜è—¥æ¸é‚„試驗委託者之程åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 71 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者å°æ–¼è©¦é©—è—¥å“之處ç†ï¼Œæ‡‰åŸ·è¡Œä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æº–時交付試驗藥å“予試驗主æŒäººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¿ç•™é‹é€ã€æŽ¥æ”¶ã€é…ç½®ã€å›žæ”¶åŠéŠ·æ¯€è©¦é©—è—¥å“之文件紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€éµå¾ªä¸¦ä¿å˜è©¦é©—è—¥å“之回收系統åŠå…¶ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€éµå¾ªä¸¦ä¿å˜é¤˜è—¥é…置系統åŠå…¶è‰æ˜Žæ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç¢ºä¿è©¦é©—è—¥å“於使用期間之安定性。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ä¿å˜è¶³å¤ 之試驗藥å“樣å“，必è¦æ™‚å¾—å†è©³ç´°ç¢ºèªå…¶ç‰¹æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ä¿å˜å„批次樣å“分æžåŠç‰¹æ€§ä¹‹ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">為å–得延長藥å“儲å˜æ™‚間之許å¯è€Œä¿ç•™å‰é …第å…款åŠç¬¬ä¸ƒæ¬¾ä¹‹æ¨£å“者，其樣å“應ä¿ç•™è‡³å®‰å®šæ€§è©¦é©—數據分æžå®Œæˆæ™‚。但法è¦è¦å®šè¼ƒé•·æœŸé–“者，從其è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 72 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應æŒçºŒé€²è¡Œè©¦é©—è—¥å“之安全性評估。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">監測</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 73 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應確ä¿è©¦é©—æ–¼é©ç•¶ä¹‹ç›£æ¸¬ä¸‹åŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 74 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">監測之目的如下：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç¢ºä¿å—試者之權利åŠç¦ç¥‰å—到ä¿è·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¢ºä¿æ‰€å ±å‘Šä¹‹è©¦é©—數據準確ã€å®Œæ•´ï¼Œä¸”å¯è‡ªåŽŸå§‹è³‡æ–™ä¸æŸ¥è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¢ºä¿è©¦é©—之執行符åˆå·²æ ¸å‡†è©¦é©—計畫書åŠå…¶ä¿®æ£æ›¸ã€æœ¬æº–則åŠç›¸é—œæ³•è¦ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 75 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">監測者之é¸æ“‡åŠå…¶è³‡æ ¼æ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç›£æ¸¬è€…應由試驗委託者指派。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç›£æ¸¬è€…應有é©ç•¶ä¹‹è¨“練，且應有足以é©ç•¶ç›£æ¸¬è©¦é©—的科å¸åŠè‡¨åºŠçŸ¥è˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç›£æ¸¬è€…ä¹‹è³‡æ ¼æ‡‰æœ‰æ›¸é¢è‰æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç›£æ¸¬è€…應熟知試驗藥å“ã€è©¦é©—計畫書ã€å—試者åŒæ„書åŠå…¶ä»–給與å—試者之書é¢è³‡æ–™ã€è©¦é©—委託者之標準作æ¥ç¨‹åºã€æœ¬æº–則åŠç›¸é—œæ³•è¦ä¹‹è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 76 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應決定é©ç•¶ä¹‹ç›£æ¸¬ç¯„åœåŠæ€§è³ªã€‚監測範åœèˆ‡æ€§è³ªä¹‹æ±ºå®šæ‡‰è€ƒé‡è©¦é©—之目標ã€ç›®çš„ã€è¨è¨ˆã€è¤‡é›œæ€§ã€ç›²æ€§ã€è¦æ¨¡åŠç™‚效指標。</span> </p><p><span style="font-family: 新細明體,serif;">試驗開始å‰ã€è©¦é©—期間åŠè©¦é©—å¾Œï¼Œæ‡‰é€²è¡Œå¯¦åœ°ç›£æ¸¬ã€‚ä½†è©¦é©—å§”è¨—è€…å¾—å¢žåŠ è©¦é©—ä¸»æŒäººè¨“練或會è°ç‰ç›£æ¸¬ç¨‹åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">監測者é¸æ“‡é©—è‰æ•¸æ“šæ™‚，得以統計抽樣方å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 77 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">監測者應ä¾è©¦é©—委託者之è¦æ±‚，進行下列措施，以確ä¿è©¦é©—æ£ç¢ºåŸ·è¡ŒåŠç´€éŒ„：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç›£æ¸¬è€…應擔任試驗委託者åŠè©¦é©—主æŒäººé–“之主è¦æºé€šè¯ç¹«è€…。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç›£æ¸¬è€…應確èªè©¦é©—主æŒäººæœ‰é©ç•¶ä¹‹è³‡æ ¼èˆ‡è³‡æºï¼Œä¸¦ä¸”在試驗éŽç¨‹ä¸ä»ç¶æŒå…¶é©ç•¶æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç›£æ¸¬è€…應確èªè©¦é©—相關人員åŠå¯¦é©—室ã€å„€å™¨ç‰è©¦é©—相關è¨å‚™ï¼Œå¯é©ç•¶ã€å®‰å…¨åŠæ£ç¢ºåœ°åŸ·è¡Œè©¦é©—，並且在試驗éŽç¨‹ä»ç¶æŒå…¶é©ç•¶æ€§ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç›£æ¸¬è€…應確èªè©¦é©—è—¥å“符åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">符åˆå„²è—時間與æ¢ä»¶ä¹‹è¦æ±‚，且試驗éŽç¨‹ä¸æœ‰å……分試驗藥å“之供給。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">試驗藥å“僅æ供於符åˆè³‡æ ¼ä¹‹å—試者，且其使用劑é‡ç¬¦åˆè©¦é©—計畫書之è¦å®šã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æä¾›å—試者æ£ç¢ºä½¿ç”¨ã€è™•ç†ã€å„²è—åŠæ¸é‚„試驗藥å“之必è¦èªªæ˜Žã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è©¦é©—å ´æ‰€è©¦é©—è—¥å“之接收ã€ä½¿ç”¨åŠæ¸é‚„，應有管制且有é©ç•¶ç´€éŒ„。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">è©¦é©—å ´æ‰€æœªä½¿ç”¨è©¦é©—è—¥å“之處ç†ï¼Œæ‡‰ç¬¦åˆç›¸é—œæ³•è¦ä¹‹è¦å®šä¸”符åˆè©¦é©—委託者授權之æ¥é©Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ç¢ºèªè©¦é©—主æŒäººéµå®ˆç¶“å¯©æŸ¥æ ¸å‡†ä¹‹è©¦é©—è¨ˆç•«æ›¸åŠå…¶ä¿®æ£æ›¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€ç¢ºèªå—試者於åƒèˆ‡è©¦é©—å‰çš†å·²ç°½ç½²å—試者åŒæ„書。</span> </p><p><span style="font-family: 新細明體,serif;">七ã€ç¢ºèªè©¦é©—主æŒäººæ”¶åˆ°æœ€æ–°ç‰ˆä¸»æŒäººæ‰‹å†Šï¼ŒåŠæ£ç¢ºåŸ·è¡Œè©¦é©—所需之試驗資料與試驗æ料。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€ç¢ºèªè©¦é©—主æŒäººèˆ‡è©¦é©—相關人員已被充分告知試驗計畫之å„é …ç´°ç¯€ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€ç¢ºèªè©¦é©—主æŒäººèˆ‡è©¦é©—相關人員ä¾ç…§è©¦é©—計畫書åŠè©¦é©—委託者與試驗主æŒäººåŠè©¦é©—機構間之書é¢å”è°ï¼ŒåŸ·è¡Œå…¶è¢«æŒ‡å®šä¹‹è·å‹™ï¼Œä¸”未將è·å‹™æŒ‡æ´¾æœªæŽˆæ¬Šäººå“¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åã€ç¢ºèªè©¦é©—主æŒäººåƒ…收ç´ç¬¦åˆè³‡æ ¼ä¹‹å—試者。</span> </p><p><span style="font-family: 新細明體,serif;">å一ã€å ±å‘Šå—試者之收ç´é€Ÿåº¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å二ã€ç¢ºèªæ£ç¢ºã€å®Œæ•´ä¿å˜åŽŸå§‹æ•¸æ“šã€æª”案與其他試驗紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">å三ã€ç¢ºèªè©¦é©—主æŒäººæ供所有必è¦ä¹‹å ±å‘Šã€é€šå ±è³‡æ–™ã€ç”³è«‹æ›¸èˆ‡é€å¯©è³‡æ–™ï¼Œä¸”以上文件皆為æ£ç¢ºã€å®Œæ•´ã€å³æ™‚ã€å—跡清晰ã€è¼‰æ˜Žæ—¥æœŸä¸¦å¯èªè‰æ¤è©¦é©—。</span> </p><p><span style="font-family: 新細明體,serif;">åå››ã€æ ¸å°å€‹æ¡ˆå ±å‘Šè¡¨ä¹‹ç™»éŒ„ã€åŽŸå§‹è³‡æ–™ã€æª”案與其他試驗相關紀錄之æ£ç¢ºæ€§èˆ‡å®Œæ•´æ€§ã€‚監測者應確èªä»¥ä¸‹äº‹é …：</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">試驗計畫書所需之數據已æ£ç¢ºç™»éŒ„æ–¼å€‹æ¡ˆå ±å‘Šè¡¨ï¼Œä¸”èˆ‡åŽŸå§‹è³‡æ–™ä¸€è‡´ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">æ¯ä½å—試者有任何治療劑é‡æˆ–治療方å¼ä¹‹è®Šæ›´è€…，應é©ç•¶åœ°è¨˜éŒ„。</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">ä¸è‰¯äº‹ä»¶ã€ä½µç”¨è—¥å“與併發症，å‡ä¾ç…§è©¦é©—è¨ˆç•«æ›¸ç™»éŒ„æ–¼å€‹æ¡ˆå ±å‘Šè¡¨ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">å››</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">å—試者未回診ã€æœªåšä¹‹æª¢é©—與檢查，å‡å·²æ¸…æ¥šç™»éŒ„æ–¼å€‹æ¡ˆå ±å‘Šè¡¨ã€‚</span> </p><p><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">五</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">所有退出試驗之å—è©¦è€…å·²ç™»éŒ„æ–¼å€‹æ¡ˆå ±å‘Šè¡¨ï¼Œä¸¦è¼‰æ˜Žå…¶åŽŸå› ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å五ã€é€šçŸ¥è©¦é©—主æŒäººå€‹æ¡ˆå ±å‘Šè¡¨ç™»éŒ„上之錯誤ã€éºæ¼æˆ–ä¸æ¸…楚處，並確定試驗主æŒäººå·²ç‚ºæ›´æ£ã€æ–°å¢žæˆ–刪除，且在更改處註明日期ã€èªªæ˜ŽåŽŸå› åŠç°½å，或由經授權之試驗相關人員代試驗主æŒäººç°½å。簽署授權å單應建檔。</span> </p><p><span style="font-family: 新細明體,serif;">åå…ã€æ ¸å°æ˜¯å¦æ‰€æœ‰ä¸è‰¯äº‹ä»¶å‡å·²ä¾ç¬¬ä¸€ç™¾é›¶å…æ¢ä¹‹è¦å®šé€šå ±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å七ã€ç¢ºèªè©¦é©—主æŒäººä¿å˜è©¦é©—之必è¦è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">åå…«ã€èˆ‡è©¦é©—主æŒäººæºé€šä¸ç¬¦åˆè©¦é©—計畫書ã€æ¨™æº–作æ¥ç¨‹åºã€æœ¬æº–則與相關法è¦è¦å®šä¹‹è™•ï¼Œä¸¦æŽ¡å–é©ç•¶æŽªæ–½é¿å…å…¶å†ç™¼ç”Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 78 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">監測者應éµå®ˆè©¦é©—委託者建立之書é¢æ¨™æº–作æ¥ç¨‹åºï¼ŒåŠè©¦é©—委託者為監測特定試驗而指定之程åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 79 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç›£æ¸¬å ±å‘Šæ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€ç›£æ¸¬è€…應於æ¯æ¬¡è©¦é©—å ´æ‰€ä¹‹è¨ªè¦–æˆ–è©¦é©—ç›¸é—œä¹‹æºé€šå¾Œï¼Œå‘試驗委託者æ出書é¢å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å ±å‘Šæ‡‰åŒ…å«æ—¥æœŸã€åœ°é»žã€ç›£æ¸¬è€…姓åã€åŠè©¦é©—主æŒäººæˆ–其他è¯çµ¡äººä¹‹å§“å。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å ±å‘Šæ‡‰æ‘˜è¦æ述監測者檢閱之部分ã€é‡å¤§ç™¼ç¾ã€å離åŠç¼ºå¤±ã€çµè«–ã€æŽ¡å–或將採å–之措施，åŠç‚ºç¢ºä¿éµå®ˆè©¦é©—而建è°ä¹‹æŽªæ–½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€è©¦é©—委託者應指定代表記錄ã€æª¢é–±åŠè¿½è¹¤ç›£æ¸¬å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å…</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">ç¨½æ ¸</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 80 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">è©¦é©—å§”è¨—è€…ä¹‹ç¨½æ ¸ç‚ºç¨ç«‹ä¹‹åˆ¶åº¦ï¼Œä¸”ä¸åœ¨ç›£æ¸¬åŠå“質管制功能內，其目的為評估試驗之執行且確ä¿å…¶éµå®ˆè©¦é©—計畫書ã€æ¨™æº–作æ¥ç¨‹åºã€æœ¬æº–則åŠç›¸é—œæ³•è¦ä¹‹è¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 81 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¨½æ ¸è€…ä¹‹ä»»ç”¨æ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è©¦é©—委託者應任用臨床試驗åŠæ•¸æ“šæ”¶é›†ç³»çµ±ä»¥å¤–ä¹‹äººå“¡é€²è¡Œç¨½æ ¸ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ç¨½æ ¸è€…所å—訓練應足以é©ä»»åŸ·è¡Œç¨½æ ¸ï¼Œä¸¦ä»¥æ›¸é¢è‰æ˜Žç¨½æ ¸è€…之資æ·ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 82 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ç¨½æ ¸ç¨‹åºæ‡‰ç¬¦åˆä¸‹åˆ—è¦å®šï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ‡‰ç¨½æ ¸ä¹‹éƒ¨åˆ†ã€å¦‚ä½•ç¨½æ ¸ã€ç¨½æ ¸æ¬¡æ•¸åŠç¨½æ ¸å ±å‘Šä¹‹å…§å®¹åŠå½¢å¼ï¼Œæ‡‰ä¾ç…§è©¦é©—委託者之標準作æ¥ç¨‹åºåŸ·è¡Œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è©¦é©—å§”è¨—è€…ç¨½æ ¸ä¹‹è¨ˆç•«åŠç¨‹åºï¼Œæ‡‰ä¾æ“šè©¦é©—之é‡è¦æ€§ã€å—試者人數ã€è©¦é©—之種類åŠè¤‡é›œæ€§ã€å—試者風險，åŠå…¶ä»–æ出之å•é¡Œè¨‚定。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ç¨½æ ¸è€…之觀察和發ç¾ï¼Œæ‡‰ä»¥æ›¸é¢è¨˜éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ç‚ºç¶è·ç¨½æ ¸åŠŸèƒ½ä¹‹ç¨ç«‹æ€§åŠå…¶åƒ¹å€¼ï¼Œä¸»ç®¡æ©Ÿé—œä¸å¾—è¦æ±‚æä¾›å®šæœŸç¨½æ ¸å ±å‘Šã€‚ä½†è‰æ˜Žæœ‰åš´é‡é•å本準則之è¦å®šæˆ–å› æ‡‰å¸æ³•ç¨‹åºï¼Œä¸»ç®¡æ©Ÿé—œå¾—è¦æ±‚å€‹åˆ¥ç¨½æ ¸å ±å‘Šäº”ã€è©¦é©—委託者應æä¾›ç¨½æ ¸æ†‘è‰ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å…</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">臨床試驗之申請與審查</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 83 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">申請臨床試驗應具申請書，並æ出下列文件：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è©¦é©—計畫書。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å—試者åŒæ„書。</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å—試者招募廣告或其他收集æ¥é©Ÿä¹‹æ–‡ä»¶ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€çµ¦èˆ‡å—試者之書é¢è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€ä¸»æŒäººæ‰‹å†Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€è©¦é©—è—¥å“之ç¾æœ‰å®‰å…¨æ€§è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">七ã€å—試者之補助與補償說明。</span> </p><p><span style="font-family: 新細明體,serif;">å…«ã€è©¦é©—主æŒäººæœ€æ–°å¸æ·æ–‡ä»¶æˆ–其他å¯è‰æ˜Žå…¶è³‡æ ¼ä¹‹è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ä¹ã€å…¶ä»–經人體試驗委員指定而必è¦è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 84 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人體試驗委員會宜於一個月內完æˆè‡¨åºŠè©¦é©—ä¹‹å¯©æŸ¥ï¼Œå°±ä»¥ä¸‹å››é …å¯©æŸ¥çµæžœä¹‹ä¸€åšæˆå¯©æŸ¥æ±ºå®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€ä¿®æ£å¾Œè¤‡å¯©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€ä¸æ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€ä¸æ¢æˆ–終æ¢åŽŸæ ¸å‡†ä¹‹è¨ˆç•«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 85 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">審查決定應以書é¢ç‚ºä¹‹ï¼Œä¸¦è¼‰æ˜Žä¸‹åˆ—äº‹é …ï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è©¦é©—å稱。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è©¦é©—機構åŠè©¦é©—主æŒäººã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€æ‰€å¯©æŸ¥ä¹‹è³‡æ–™åŠç‰ˆæœ¬ç·¨è™Ÿã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€å¯©æŸ¥çµæžœåŠå…¶ç†ç”±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å¹´ã€æœˆã€æ—¥ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 86 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人體試驗委員會應審查試驗主æŒäººä¹‹è³‡æ ¼ã€å¸ç¶“æ·åŠå…¶ä»–相關資料。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 87 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">äººé«”è©¦é©—å§”å“¡æœƒæ‡‰æ ¹æ“šå—試者所承å—之風險，定期評估進行ä¸ä¹‹è‡¨åºŠè©¦é©—。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è©•ä¼°æ¯å¹´è‡³å°‘應進行一次。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 88 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¾å—試者以外具有åŒæ„權之人åŒæ„，而進行臨床試驗時，人體試</span> <span style="font-family: 新細明體,serif;">驗委員會應確定試驗計畫書åŠå…¶ä»–文件資料充分æåŠç›¸é—œä¹‹å€«ç†è€ƒé‡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">七</span> <span style="font-family: 新細明體,serif;">ç« </span> <span style="font-family: 新細明體,serif;">臨床試驗之進行</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">一</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">試驗計畫書</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 89 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººåŠè©¦é©—機構應ä¾ç¶“試驗委託者ã€äººé«”試驗委員會åŠä¸»ç®¡æ©Ÿé—œåŒæ„之試驗計畫書執行臨床試驗。試驗主æŒäººåŠè©¦é©—機構應與試驗委託者共åŒç°½ç½²è©¦é©—計畫書或å¦è¡Œç°½è¨‚書é¢å¥‘約，以確èªé›™æ–¹ä¹‹åŒæ„。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 90 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæœªå–得試驗委託者åŒæ„åŠäººé«”è©¦é©—å§”å“¡æœƒæ ¸å‡†å‰ï¼Œä¸æ‡‰å離或變更試驗計畫書之執行。但為åŠæ™‚é¿å…å—試者éå—傷害或僅為行政事務之改變者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">為åŠæ™‚é¿å…å—試者éå—傷害所為之å離或變更，試驗主æŒäººæ‡‰æ–¼ä¸ƒæ—¥å…§å°‡å離或變更之內容åŠå…¶åŽŸå› ，或試驗計畫書修æ£æ¡ˆï¼Œæ交人體試驗委員會ã€è©¦é©—å§”è¨—è€…ï¼›ç¶“ä¸»ç®¡æ©Ÿé—œæ ¸å‡†é€²è¡Œä¹‹è‡¨åºŠè©¦é©—ï¼Œæ‡‰åŒæ™‚æ交主管機關。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 91 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæˆ–經其指定之人員，應記錄åŠè§£é‡‹åŸ·è¡Œè©¦é©—計畫書之å差。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">二</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">試驗藥å“</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 92 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæˆ–è©¦é©—æ©Ÿæ§‹æ‡‰è² è²¬è©¦é©—è—¥å“之點收åŠä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººæˆ–試驗機構得指派專責藥師或é©ç•¶äººå“¡è² 責部分或全部試驗藥å“之點收åŠä¿å˜ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 93 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººã€è©¦é©—機構ã€è¢«æŒ‡å®šä¹‹å°ˆè²¬è—¥å¸«æˆ–é©ç•¶äººå“¡ï¼Œæ‡‰ä¿ç•™ä¸‹åˆ—紀錄：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€è©¦é©—è—¥å“é‹é€è‡³è‡¨åºŠè©¦é©—機構之點收。</span> </p><p><span style="font-family: 新細明體,serif;">二ã€è©¦é©—è—¥å“之å˜è²¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å—試者使用之試驗藥å“。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€æœªä½¿ç”¨è©¦é©—è—¥å“æ¸é‚„試驗委託者或å¦å¤–處置之方å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …資料應載明日期ã€æ•¸é‡ã€æ‰¹åºè™Ÿã€æœ‰æ•ˆæ—¥æœŸï¼ŒåŠè©¦é©—è—¥å“å’Œå—試者之代碼。</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰ä¿ç•™æ–‡ä»¶ç´€éŒ„，說明其æä¾›å—試者之劑é‡å’Œè©¦é©—計畫書è¦å®šç›¸ç¬¦ï¼Œä¸”使用之試驗藥å“數é‡èˆ‡ç”±è©¦é©—委託者收到之數é‡ç›¸å»åˆã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 94 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗藥å“應ä¾è©¦é©—委託者è¦æ±‚之方å¼å„²å˜ï¼Œä¸¦æ‡‰ç¬¦åˆç›¸é—œæ³•è¦ä¹‹è¦æ±‚。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 95 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗藥å“åƒ…å¾—ä½¿ç”¨æ–¼ç¶“æ ¸å‡†ä¹‹è‡¨åºŠè©¦é©—è¨ˆç•«ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 96 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæˆ–試驗主æŒäººæŒ‡å®šä¹‹äººå“¡ï¼Œæ‡‰å‘å—試者解釋如何æ£ç¢ºä½¿ç”¨è©¦é©—è—¥å“，並應於臨床試驗ä¸æ¯éš”一段é©ç•¶æ™‚間，檢查å—試者是å¦éµå®ˆèªªæ˜Žã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 97 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰éµå¾žè‡¨åºŠè©¦é©—之隨機分é…程åºã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …隨機分é…程åºè‹¥å¯è§£ç¢¼ï¼Œæ‡‰åƒ…ä¾æ“šè©¦é©—計畫書è¦å®šè§£ç¢¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">若臨床試驗採盲性è¨è¨ˆï¼Œè€Œè©¦é©—è—¥å“有任何æ早解碼之情æ³ï¼Œè©¦é©—主æŒäººæ‡‰ç«‹å³å°è©¦é©—委託者解釋，並作書é¢ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">三</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">ç´€éŒ„èˆ‡å ±å‘Š</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 98 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰ç¢ºä¿å€‹æ¡ˆå ±å‘Šè¡¨å’Œæ‰€æœ‰éœ€è¦å‘è©¦é©—å§”è¨—è€…å ±å‘Šè³‡æ–™ä¹‹ç²¾ç¢ºåº¦ã€å®Œæ•´æ€§ã€æ˜“讀性åŠæ™‚間性。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 99 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å€‹æ¡ˆå ±å‘Šè¡¨ä¸ä¹‹è³‡æ–™ï¼Œæ‡‰èˆ‡åŽŸå§‹è³‡æ–™ç›¸åŒã€‚å¦‚æœ‰å·®ç•°ï¼Œæ‡‰è§£é‡‹å…¶åŽŸå› ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 100 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å€‹æ¡ˆå ±å‘Šè¡¨ä¹‹ä»»ä½•ä¿®æ£ï¼Œæ‡‰è¨˜éŒ„其修æ£æ—¥æœŸåŠä¿®æ£åŽŸå› ，且ä¸å¾—覆蓋原先之紀錄。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …è¦å®šï¼Œé©ç”¨æ–¼æ›¸é¢è³‡æ–™èˆ‡é›»å資料之修æ£ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰æŒ‡å®šä»£è¡¨è¨˜éŒ„å€‹æ¡ˆå ±å‘Šè¡¨ä¹‹ä¿®æ£ï¼Œä¸”ä¿®æ£å…§å®¹æ‡‰ç¶“試驗主æŒäººåŒæ„。</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººæ‡‰ä¿ç•™ä¿®æ£ç´€éŒ„。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 101 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººåŠè©¦é©—機構應盡善良管ç†äººä¹‹æ³¨æ„，妥善ä¿ç®¡æ‰€æœ‰è‡¨åºŠè©¦é©—相關é‡è¦æ–‡ä»¶ï¼Œä¸¦é˜²æ¢éå—æ„å¤–ä¹‹ç ´å£žæˆ–æ早銷毀。</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …文件，應ä¿å˜è‡³è©¦é©—è—¥å“於我國ç²å‡†ä¸Šå¸‚後至少二年。但其他法è¦è¦å®šä¹‹ä¿å˜æœŸé–“長於二年者，從其è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 102 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">臨床試驗之財務計畫，應由試驗委託者和試驗機構或試驗主æŒäººè¨‚定書é¢å¥‘約。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 103 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">監測者ã€ç¨½æ ¸è€…ã€äººé«”試驗委員會或主管機關得è¦æ±‚檢視任何與試驗相關之資料。但檢視å—試者個人之身分資料å‰ï¼Œæ‡‰å…ˆç¢ºèªå·²å–å¾—å—試者書é¢åŒæ„。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 104 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">主管機關得è¦æ±‚試驗主æŒäººå‘其所屬機構æ出書é¢å ±å‘Šï¼Œèªªæ˜Žè‡¨åºŠè©¦é©—進度。</span> </p><p><span style="font-family: 新細明體,serif;">試驗主æŒäººåŠè©¦é©—機構æ¯å¹´æ‡‰å°‡è‡¨åºŠè©¦é©—進度å‘人體試驗委員會æ出定期摘è¦å ±å‘Šã€‚å¿…è¦æ™‚，人體試驗委員會得è¦æ±‚縮çŸå®šæœŸæ‘˜è¦å ±å‘Šä¹‹é–“隔期間。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 105 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">發生é‡å¤§å½±éŸ¿è‡¨åºŠè©¦é©—åŸ·è¡Œæˆ–å¢žåŠ å—試者風險之情形，試驗主æŒäººæ‡‰ç«‹å³å‘試驗委託者ã€äººé«”試驗委員會åŠä¸»ç®¡æ©Ÿé—œæ出書é¢å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 106 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å—試者發生任何嚴é‡ä¸è‰¯äº‹ä»¶ï¼Œè©¦é©—主æŒäººæ‡‰ç«‹å³é€šçŸ¥è©¦é©—委託者，並儘快æ供詳細書é¢å ±å‘Šã€‚發生未é 期之嚴é‡è—¥å“ä¸è‰¯å應，試驗主æŒäººæ‡‰ç«‹å³é€šçŸ¥äººé«”試驗委員會。但若試驗計畫書或其他文件明確排除者，ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">試驗委託者ç²çŸ¥æœªé 期之æ»äº¡æˆ–å±åŠç”Ÿå‘½ä¹‹åš´é‡è—¥å“ä¸è‰¯å應，應於ç²çŸ¥æ—¥èµ·ä¸ƒæ—¥å…§é€šå ±ä¸»ç®¡æ©Ÿé—œæˆ–其委託機構，並在ç²çŸ¥æ—¥èµ·å五日內æ供詳細書é¢è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">試驗委託者ç²çŸ¥æœªé 期之æ»äº¡æˆ–å±åŠç”Ÿå‘½ä»¥å¤–之嚴é‡è—¥å“ä¸è‰¯å應，應於ç²çŸ¥æ—¥èµ·åäº”æ—¥å…§é€šå ±ä¸»ç®¡æ©Ÿé—œæˆ–å…¶å§”è¨—æ©Ÿæ§‹ï¼Œä¸¦æ供詳細書é¢è³‡æ–™ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …ä¹‹å£é åŠæ›¸é¢å ±å‘Šï¼Œæ‡‰ä»¥å—試者代碼代表å—試者之身分，ä¸å¾—顯示å—試者之姓åã€èº«åˆ†è‰çµ±ä¸€ç·¨è™Ÿã€ä½å€æˆ–其他å¯è¾¨èªå—試者身分之資訊。嚴é‡ä¸è‰¯äº‹ä»¶èˆ‡åš´é‡è—¥å“ä¸è‰¯åæ‡‰ä¹‹é …ç›®ç”±ä¸»ç®¡æ©Ÿé—œå…¬å‘Šä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 107 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">發生與試驗藥å“安全性評估相關之ä¸è‰¯å應或異常實驗室檢查值時，試驗主æŒäººæ‡‰æ–¼è©¦é©—計畫書è¦å®šä¹‹æ™‚é–“å…§å‘試驗委託者æ出書é¢å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 108 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">發生æ»äº¡ç—…例時，試驗委託者ã€äººé«”試驗委員會與主管機關得è¦æ±‚試驗主æŒäººæ出驗å±å ±å‘Šã€æœ€çµ‚醫療紀錄åŠå…¶ä»–任何é¡å¤–資訊。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 109 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">以下情形發生時，試驗委託者應立刻通知試驗主æŒäººã€è©¦é©—機構åŠä¸»ç®¡æ©Ÿé—œï¼š</span> </p><p><span style="font-family: 新細明體,serif;">一ã€å¯èƒ½å±å®³å—試者安全之新發ç¾ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å½±éŸ¿è©¦é©—執行之新發ç¾ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€å½±éŸ¿äººé«”試驗委員會åŒæ„試驗繼續進行之新發ç¾ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 110 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者應å‘主管機關æå‡ºæœ€æ–°å®‰å…¨æ€§å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 111 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗完æˆæˆ–æ早終æ¢æ™‚，試驗主æŒäººåŠè©¦é©—機構應æ供試驗委託者åŠä¸»ç®¡æ©Ÿé—œå…¶æ‰€è¦æ±‚ä¹‹ä»»ä½•å ±å‘Šï¼Œä¸¦æ供人體試驗委員會試驗çµæžœæ‘˜è¦ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形，試驗委託者應å‘主管機關æå‡ºå®Œæ•´è©³ç›¡ä¹‹è‡¨åºŠè©¦é©—å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …å ±å‘Šä¹‹æ ¼å¼ç”±ä¸»ç®¡æ©Ÿé—œå…¬å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å››</span> <span style="font-family: 新細明體,serif;">節</span> <span style="font-family: 新細明體,serif;">試驗之ä¸æ¢èˆ‡çµ‚æ¢</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 112 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗ä¸æ¢æˆ–終æ¢æ™‚，試驗主æŒäººåŠè©¦é©—機構應立å³é€šçŸ¥å—試者，並確ä¿å—試者有é©ç•¶ä¹‹æ²»ç™‚åŠè¿½è¹¤ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …情形，試驗主æŒäººåŠè©¦é©—機構應將試驗ä¸æ¢æˆ–終æ¢ä¹‹äº‹ç”±ï¼Œä»¥æ›¸é¢é€šçŸ¥ä¸»ç®¡æ©Ÿé—œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 113 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººåŠè©¦é©—機構未事先ç²å¾—試驗委託者之åŒæ„，而ä¸æ¢æˆ–</span> <span style="font-family: 新細明體,serif;">終æ¢è‡¨åºŠè©¦é©—者，試驗主æŒäººåŠè©¦é©—機構應立å³é€šçŸ¥è©¦é©—委託者與人體試驗委員會，並æ出詳細書é¢å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 114 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗委託者ä¸æ¢æˆ–終æ¢è‡¨åºŠè©¦é©—者，試驗委託者應立å³é€šçŸ¥è©¦é©—主æŒäººã€è©¦é©—機構ã€äººé«”試驗委員會åŠä¸»ç®¡æ©Ÿé—œï¼Œä¸¦æ出詳細書é¢å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 115 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">人體試驗委員會終æ¢æˆ–æš«åœè©¦é©—者，試驗主æŒäººåŠè©¦é©—機構應立å³é€šçŸ¥è©¦é©—委託者，並æ出詳細書é¢å ±å‘Šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 116 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">試驗主æŒäººæˆ–試驗機構é‡å¤§æˆ–æŒçºŒé•å試驗計畫書，試驗委託者應終æ¢å…¶ç¹¼çºŒåƒèˆ‡è‡¨åºŠè©¦é©—，並立å³é€šçŸ¥ä¸»ç®¡æ©Ÿé—œã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">五</span> <span style="font-family: 新細明體,serif;">節</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">多機構åˆä½œè‡¨åºŠè©¦é©—</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 117 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">進行多機構åˆä½œè‡¨åºŠè©¦é©—時，所有試驗主æŒäººæ‡‰éµå®ˆç¶“試驗委託者所åŒæ„，並經人體試驗委員會åŠä¸»ç®¡æ©Ÿé—œæ‰€æ ¸å‡†ä¹‹è©¦é©—計畫書。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 118 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">進行多機構åˆä½œè‡¨åºŠè©¦é©—時，å°æ–¼ä¾è©¦é©—計畫書收集é¡å¤–數據之試驗主æŒäººï¼Œè©¦é©—委託者應æ供能ç²å¾—é¡å¤–æ•¸æ“šä¹‹è£œå……å€‹æ¡ˆå ±å‘Šè¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 119 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">多機構åˆä½œè‡¨åºŠè©¦é©—進行å‰ï¼Œæ‡‰ä»¥æ›¸é¢è¨˜è¼‰è©¦é©—主æŒäººåŠå…¶ä»–åƒèˆ‡ä¹‹è©¦é©—主æŒäººä¹‹è²¬ä»»åˆ†é…åŠå”調方å¼ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 120 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">進行多機構åˆä½œè‡¨åºŠè©¦é©—時，所有試驗主æŒäººæ‡‰éµå¾žä¸€è‡´ä¹‹æ¨™æº–評估臨床çµæžœã€å¯¦é©—室çµæžœåŠå¡«å¯«å€‹æ¡ˆå ±å‘Šè¡¨ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 121 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">進行多機構åˆä½œè‡¨åºŠè©¦é©—æ™‚ï¼Œè©¦é©—å§”è¨—è€…æ‡‰åŠ å¼·è©¦é©—ä¸»æŒäººé–“之æºé€šã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span> <span style="font-family: 新細明體,serif;">å…«</span> <span style="font-family: 新細明體,serif;">ç« </span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">附則</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 122 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則施行å‰å·²ä¾è—¥å“優良臨床試驗è¦ç¯„進行藥å“臨床試驗者，於本準則施行後，應ä¾æœ¬æº–則之è¦å®šè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 123 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本準則自發布日施行。</span> </p>2013-12-05
臨床試驗類,è—¥å“臨床試驗基準,è—¥å“臨床試驗一般基準行政解釋藥å“臨床試驗一般基準<div class="WordSection1"><p style="line-height: 21.45pt; text-autospace: ; 127pt: ;"><b><span style="font-family: arial unicode ms,sans-serif; font-size: 16pt;">è—¥å“臨床試驗一般基準</span></b> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 18.8pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">1. </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">目的</span></b> </p><p style="line-height: 19.85pt; text-autospace: ;"> </p><p style="line-height: 15.05pt; margin: 0cm 7pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">為æ昇國內臨床試驗水準，使執行臨床試驗有éµå¾ªåŽŸå‰‡ï¼Œæœ¬ç½²ä¹ƒåƒè€ƒï¼©ï¼£ï¼¨ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">International Conference on Harmonization</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）藥å“ç ”ç™¼ç–ç•¥ä¸æœ‰é—œäººé«”用藥的臨床試驗åŠè—¥å“è‡¨åºŠç ”ç™¼ç¨‹åº</span> </p><p style="line-height: 4.3pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">之通則，特制訂本基準。</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.3pt; text-autospace: ;"> </p><p style="line-height: 14.8pt; margin: 0cm 5pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">本基準之目的，在於藉推廣å°ä¸€èˆ¬æ€§åŽŸå‰‡èˆ‡æ–¹æ³•çš„了解åŠç›¸é—œå詞的定義，以便於評估åŠæŽ¥å—臨床試驗資料。</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.45pt; text-autospace: ;"> </p><p style="line-height: 15pt; margin: 0cm 5pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 8.5pt;">為求簡化，文ä¸ã€Œè—¥å“ã€ä¿‚指「試驗用藥å“ã€ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 8.5pt;">investigational product</span><span style="font-family: arial unicode ms,sans-serif; font-size: 8.5pt;">）或「醫藥產å“ã€ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 8.5pt;">medicinal product</span><span style="font-family: arial unicode ms,sans-serif; font-size: 8.5pt;">）或「藥劑ã€ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 8.5pt;">pharmaceutical</span><span style="font-family: arial unicode ms,sans-serif; font-size: 8.5pt;">），亦包括疫苗（</span><span style="font-family: arial,sans-serif; font-size: 8.5pt;">vaccines</span><span style="font-family: arial unicode ms,sans-serif; font-size: 8.5pt;">）ã€ç”Ÿç‰©è£½åŠ‘產å“（</span><span style="font-family: arial,sans-serif; font-size: 8.5pt;">biological</span> </p><p style="line-height: 4.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">product</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）。</span> </p><p style="line-height: 18.8pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">2. </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">通則</span></b> </p><p style="line-height: 18.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">2.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å—試驗者之ä¿è·æŽªæ–½</span></b> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.1pt; text-autospace: ;"> </p><p style="line-height: 15.85pt; margin: 0cm 5pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å°å—試驗者ä¿è·ä¹‹åŽŸå‰‡åŠåŸ·è¡Œç´°å‰‡ï¼Œå‡æ‡‰ç¬¦åˆæœ¬ç½²åˆ¶è¨‚之「藥å“優良臨床試驗è¦ç¯„ã€ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Good Clinical Practice</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）。æ¤åŽŸå‰‡æºæ–¼èµ«çˆ¾è¾›åŸºå®£è¨€ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Declaration of Helsinki</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">），且應用於所有人體</span> <span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">用藥之試驗。</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.5pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.85pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">在進行任何臨床試驗之å‰ï¼Œå¿…é ˆæœ‰è¶³å¤ ä¹‹éžè‡¨åºŠè©¦é©—（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">non-clinical</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）或早期人體試驗之çµæžœï¼Œ</span> <span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">顯示該藥å“在進行臨床試驗å‰ï¼Œå…·å¯æŽ¥å—之安全性。本署制訂之「藥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„〠ä¸ï¼Œèªªæ˜Žæœ‰é—œè©¦é©—所需的動物藥ç†è©¦é©—åŠæ¯’性試驗之目的åŠæ™‚間。</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.35pt; text-autospace: ;"> </p><p style="line-height: 15.9pt; margin: 0cm 2pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">在藥å“ç ”ç™¼éŽç¨‹ä¸ï¼Œå…¶å‹•ç‰©æ¯’性åŠè‡¨åºŠè³‡æ–™ï¼Œéœ€ç”±å°ˆå®¶ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">qualified experts</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）評估å°å—試驗</span> <span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">者安全性的影響。æ¤è©•ä¼°çµæžœï¼Œæ‡‰åæ˜ æ–¼æœªä¾†ä¹‹ç ”ç©¶è¨ˆç•«ï¼Œè‹¥æœ‰å¿…è¦æ™‚，ç¾éšŽæ®µé€²è¡Œä¸ä¹‹è©¦é©—， 亦應åŠæ™‚予以é©åº¦ä¿®æ£ï¼Œä»¥ç¶è·å—試驗者之安全。å—試驗者之ä¿è·è²¬ä»»ç”±è©¦é©—主æŒäººã€è©¦é©—委託</span> </p><p style="line-height: 4.9pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">者åŠäººé«”試驗委員會（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Institutional Review Board</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">∕</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Ethics Committee</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">，</span><span style="font-family: arial,sans-serif; font-size: 10pt;">IRB</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">∕</span><span style="font-family: arial,sans-serif; font-size: 10pt;">EC</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）共åŒåˆ†æ“”。</span> </p><p style="line-height: 4.3pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">本署制訂之「藥å“優良臨床試驗è¦ç¯„ã€ä¸ï¼Œèªªæ˜Žæœ‰é—œè²¬ä»»æ¸å±¬å•é¡Œã€‚</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 11pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">2.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è¨è¨ˆåŠåˆ†æžä¹‹ç§‘å¸æ–¹æ³•</span></b> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">臨床試驗之è¨è¨ˆã€åŸ·è¡ŒåŠåˆ†æžå‡éœ€éµå¾ªç§‘å¸åŽŸå‰‡ï¼Œä»¥é”ç ”ç©¶ç›®çš„ï¼Œä¸”éœ€é©ç•¶åœ°å ±å‘Šã€‚一個åˆ</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">ç†åŒ–çš„è—¥å“ç ”ç™¼ï¼Œå…¶ç²¾é«“åœ¨æ–¼ï¼šæ出é‡è¦çš„å•é¡Œï¼Œä¸¦ç”±é©ç•¶çš„è©¦é©—åŠ ä»¥è§£ç”。所有試驗的主è¦ç›®</span> </p><p style="line-height: 4.55pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">的，å‡é ˆæ¸…楚詳盡地陳述。</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection2"><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">臨床試驗之分類，å¯æŒ‰è‡¨åºŠç ”ç™¼éšŽæ®µï¼Œæˆ–æ ¹æ“šå¦‚è¡¨ä¸€æ‰€åˆ—ä¹‹ç ”ç©¶ç›®çš„è€Œå®šï¼ˆè©²è¡¨åƒ…ä¾›åƒè€ƒï¼‰ã€‚</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">è—¥å“è©¦é©—é ˆé€£çºŒåœ°é€²è¡Œï¼Œå…¶ç«‹æ„為：先å‰è©¦é©—çš„çµæžœï¼Œæ‡‰å½±éŸ¿å¾ŒçºŒè©¦é©—的計畫。試驗ç²å¾—的資料ï¹</span> </p><p style="line-height: 5.45pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">亦常導致修æ£åŽŸå…ˆçš„è—¥å“ç ”ç™¼ç–ç•¥ï¼Œä¾‹å¦‚ï¼šä¸€é …æ²»ç™‚ç¢ºèªè©¦é©—（</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">therapeutic confirmatory study</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）</span> </p><p style="line-height: 4.3pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">çš„çµæžœï¼Œå¯èƒ½é¡¯ç¤ºé ˆé€²è¡Œäººé«”è—¥ç†å¸è©¦é©—。</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.6pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">表一：ä¾ç›®çš„分類之臨床試驗</span></b> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: auto;" clear="all" /></span><div class="WordSection3"><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 11.8pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 27pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗類型</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 16.7pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">人體藥ç†</span> </p><p style="line-height: 18.8pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Human</span> </p><p style="line-height: 4.8pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">Pharmacology</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 11.65pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">治療探索</span> </p><p style="line-height: 4.85pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Therapeutic</span> </p><p style="line-height: 4.65pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">Exploratory</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 16.65pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">治療確èª</span> </p><p style="line-height: 4.85pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Therapeutic</span> </p><p style="line-height: 4.65pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">Confirmatory</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 14.65pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">治療使用</span> </p><p style="line-height: 5.45pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">（</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">Therapeutic Use</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）</span> </p><span style="font-family: times new roman,serif; font-size: 12pt;"><br clear="all" /></span><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 11.8pt; text-autospace: ;"> </p><p style="line-height: 0.05pt; text-autospace: ;"> </p><table style="border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 13.4pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 13.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.35pt; text-autospace: ; 35pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç ”ç©¶ç›®çš„</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 13.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.35pt; text-autospace: ; 56pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç ”ç©¶å¯¦ä¾‹</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 13.4pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 23.6pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 23.6pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è©•ä¼°è€å—性</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 23.6pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 23.6pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 18pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">定義åŠæ述藥動å¸åŠè—¥æ•ˆ</span> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">劑é‡è€å—性試驗</span> </li> </ul> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"></td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 17.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 17.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å¸</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 17.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">單劑é‡åŠå¤šåŠ‘é‡ä¹‹è—¥å‹•åŠè—¥</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 17.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 18.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 18.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">探討藥å“代è¬åŠè—¥å“交互</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 18.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.35pt; text-autospace: ; 30pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">效å¸è©¦é©—</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 18.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 17.75pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 17.75pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">作用</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 17.75pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“交互作用試驗</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 17.75pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 18.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 18.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">估算活性</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 18.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 18.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 37.3pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 37.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">探討目標é©æ‡‰ç—‡</span> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">用替代指標ã€è—¥ç†æŒ‡æ¨™æˆ–其他</span> </li> </ul> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 37.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"></td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 37.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">估算後續試驗劑é‡</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.4pt; text-autospace: ; 30pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">臨床目標於明確界定æ—群進</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.45pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 8.45pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">確èªè©¦é©—之è¨è¨ˆã€æŒ‡æ¨™</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.45pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 9.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.4pt; text-autospace: ; 30pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è¡ŒçŸæœŸæ€§çš„åˆæœŸè©¦é©—</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.45pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 8.45pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">endpoints</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）åŠæ–¹æ³•ä¹‹æ ¹</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.45pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.3pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 9.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">劑é‡ï¼ç™‚效å應的探索試驗</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">æ“š</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.7pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 8.7pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.7pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 37.75pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 37.75pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial,sans-serif; font-size: 10pt;"> </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">顯示</span><span style="font-family: arial,sans-serif; font-size: 10pt;">/</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">確èªç™‚效</span> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é©ç•¶ä¸”有åˆé©å°ç…§çµ„之試驗</span> </li> </ul> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 37.75pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"></td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 37.75pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.4pt; text-autospace: ; 30pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">以建立療效</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.7pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 8.7pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">建立安全性資料</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.7pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.3pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 9.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">隨機，平行之劑é‡å應試驗</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">æä¾›é©ç•¶ä¾æ“šä»¥è©•ä¼°æ•ˆç›Š</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial,sans-serif; font-size: 10pt;"> </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è©•ä¼°æ»äº¡çŽ‡</span><span style="font-family: arial,sans-serif; font-size: 10pt;">/</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">罹病率çµæžœä¹‹è©¦</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">/</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">風險之關係，以支æŒæ˜¯å¦</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.65pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 8.65pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.4pt; text-autospace: ; 30pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é©—</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.65pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">æ ¸å‡†è—¥å“</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">臨床安全性試驗</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 9.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">建立劑é‡ï¼ç™‚效å應之關</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">大è¦æ¨¡çš„簡單試驗</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.1pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ä¿‚</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.1pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 8.3pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 8.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom" rowspan="2"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">比較性試驗</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 8.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 9.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 9.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 9.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 37.3pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 37.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">深入çžè§£åœ¨ä¸€èˆ¬æˆ–特定æ—</span> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">比較性療效試驗</span> </li> </ul> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 37.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"></td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 37.3pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 18pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">群或環境ä¸ä¹‹æ•ˆç›Š</span><span style="font-family: arial,sans-serif; font-size: 10pt;">/</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">風險</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial,sans-serif; font-size: 10pt;"> </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è©•ä¼°æ»äº¡çŽ‡</span><span style="font-family: arial,sans-serif; font-size: 10pt;">/</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">罹病率çµæžœä¹‹è©¦</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 17.55pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 17.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">的關係</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 17.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.4pt; text-autospace: ; 30pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é©—</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 17.55pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 18.45pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 18.45pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">確èªè¼ƒå°‘發生之藥å“ä¸è‰¯</span> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å…¶ä»–æŒ‡æ¨™ä¹‹è©¦é©—ç ”ç©¶</span> </li> </ul> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 18.45pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"></td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 18.45pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 18pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å應</span> </p> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">大è¦æ¨¡çš„簡單試驗</span> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 18pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> <tr style="height: 17.9pt;"> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 140pt; padding-right: 0cm; height: 17.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">進一æ¥ä¿®æ£åŠ‘é‡</span> <ul> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“經濟å¸è©¦é©—</span> </li> </ul> </li> </ul> </td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 157pt; padding-right: 0cm; height: 17.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"></td> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 0cm; width: 0cm; padding-right: 0cm; height: 17.9pt; padding-top: 0cm;border-color: #f0f0f0;" valign="bottom"> <p style="text-autospace: ;"> </p> </td> </tr> </tbody></table></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection4"><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 13.65pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3. </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç ”ç™¼æ–¹æ³•</span></b> </p><p style="line-height: 18.25pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">本部份包括與藥å“ç ”ç™¼è¨ˆç•«åŠå…¶å€‹åˆ¥ç ”究試驗相關之è°é¡ŒåŠå…¶è€ƒé‡ã€‚</span> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç ”ç™¼è¨ˆç•«ä¹‹è€ƒé‡</span></b> </p><p style="line-height: 18.7pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">éžè‡¨åºŠç ”究</span></b> </p><p style="line-height: 18.25pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é‡å°è‡¨åºŠè©¦é©—，決定éžè‡¨åºŠè©¦é©—的性質åŠå…¶åŸ·è¡Œæ™‚間的主è¦è€ƒé‡å› ç´ å¦‚ä¸‹ï¼š</span> </p><p style="line-height: 18.7pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.35pt; text-autospace: ; punctuation-wrap: simple; 14pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">a)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">個別å—試驗者的建è°çµ¦è—¥æœŸé–“以åŠçµ¦è—¥ç¸½åŠ‘é‡ </span></p><p style="line-height: 18.65pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.35pt; text-autospace: ; punctuation-wrap: simple; 14pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">b)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗用藥å“特性（如：長åŠè¡°æœŸã€ç”Ÿç‰©è£½åŠ‘產å“） </span></p><p style="line-height: 18.55pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.35pt; text-autospace: ; punctuation-wrap: simple; 13pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">c)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">臨床處置所é‡å°ä¹‹ç–¾ç—…æˆ–ç‹€æ³ </span></p><p style="line-height: 18.65pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.35pt; text-autospace: ; punctuation-wrap: simple; 14pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">d)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">特定æ—群之使用（如：有生育能力之婦女） </span></p><p style="line-height: 18.65pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.4pt; text-autospace: ; punctuation-wrap: simple; 14pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">e)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">給藥途徑 </span></p><p style="line-height: 19.2pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">支æŒè‡¨åºŠè©¦é©—所需之éžè‡¨åºŠè³‡è¨Šï¼Œå‡è¨˜è¼‰æ–¼æœ¬ç½²åˆ¶è¨‚之「藥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„ã€ä¸ã€‚</span> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.1.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">安全性試驗</span></b> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.05pt; text-autospace: ;"> </p><p style="line-height: 14.85pt; margin: 0cm 3pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">首次於人體進行之試驗，應先仔細檢閱其先å‰çš„éžè‡¨åºŠè³‡è¨Šï¼Œå¦‚：藥動å¸ã€è—¥ç†å¸ã€åŠæ¯’物å¸ï¼Œå†æ±ºå®šæŠ•äºˆåŠ‘é‡ã€‚早期éžè‡¨åºŠè©¦é©—ç ”ç©¶æ‡‰æä¾›è¶³å¤ è³‡è¨Šï¼Œä»¥æ±ºå®šäººé«”çš„èµ·å§‹åŠ‘é‡åŠå®‰å…¨çš„æœ</span> </p><p style="line-height: 4.6pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">藥期間，並æ供藥å“之生ç†åŠæ¯’ç†ä½œç”¨çš„資訊。</span> </p><p style="line-height: 18.85pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.1.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥ç†å¸åŠè—¥å‹•å¸çš„試驗</span></b> </p><p style="line-height: 19.35pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">臨床試驗之探索（</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">exploration</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）åŠç ”發的基礎與方å‘，是建立於éžè‡¨åºŠç ”究之藥動å¸åŠè—¥ç†</span> </p><p style="line-height: 4.3pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å¸çš„資料，包括如：</span> </p><p style="line-height: 18.65pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.4pt; text-autospace: ; punctuation-wrap: simple; 14pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">a)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">主è¦æ•ˆç”¨çš„è—¥ç†å¸åŸºç¤Žï¼ˆä½œç”¨æ©Ÿåˆ¶ï¼‰ </span></p><p style="line-height: 18.5pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.4pt; text-autospace: ; punctuation-wrap: simple; 14pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">b)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">劑é‡ï¼å應或濃度ï¼å應之關係，以åŠä½œç”¨æ™‚é–“ </span></p><p style="line-height: 18.6pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 13.4pt; text-autospace: ; punctuation-wrap: simple; 13pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">c)<span style="font: 7pt times new roman;"> </span></span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">臨床å¯èƒ½çµ¦è—¥é€”徑之試驗 </span></p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: auto;" clear="all" /></span><div class="WordSection5"><p style="line-height: 19.5pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 9.5pt;">d) </span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">全身性之一般藥ç†å¸ï¼ŒåŒ…括主è¦å™¨å®˜ç³»çµ±ä¸Šä¹‹è—¥ç†ä½œç”¨åŠç”Ÿç†å應</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection6"><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">e) </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å¸æ”¶ã€åˆ†ä½ˆã€ä»£è¬åŠæŽ’泄之試驗</span> </p><p style="line-height: 18.8pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗藥å“之å“質</span></b> </p><p style="line-height: 19.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">應詳述用於人體試驗之製劑é…方（</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">formulation</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）的特性，包括任何å¯å¾—之生體å¯ç”¨çŽ‡è³‡è¨Šã€‚</span> </p><p style="line-height: 5.05pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">該製劑é…方應é©åˆç”¨æ–¼è©²è—¥å“ç ”ç™¼çš„éšŽæ®µã€‚ç†æƒ³ä¸ï¼Œè£½åŠ‘é…方應é©ç”¨æ–¼ä¸€ç³»åˆ—檢測劑é‡ç¯„åœä¹‹è©¦</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">驗。在藥å“ç ”ç™¼éŽç¨‹ä¸ï¼Œæ‡‰æ¸¬è©¦è—¥å“çš„ä¸åŒè£½åŠ‘é…方，並由生體相ç‰æ€§æˆ–其他方法，建立ä¸åŒè£½</span> </p><p style="line-height: 4.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">劑é…方的相關性，å°è§£é‡‹æ•´å€‹ç ”發計畫ä¸æ‰€å¾—之臨床試驗çµæžœæ˜¯ç›¸ç•¶é‡è¦çš„。</span> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.3 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è‡¨åºŠç ”ç™¼çš„éšŽæ®µ</span></b> </p><p style="line-height: 19.15pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">臨床藥å“ç ”ç™¼é€šå¸¸æŒ‰æ™‚é–“å…ˆå¾Œè¢«æ述為四個階段（第一階段至第四階段）。然而很é‡è¦çš„是</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">é ˆèªçŸ¥ï¼Œä¾ç ”發階段作為臨床試驗的分類基準是ä¸æ°ç•¶çš„ï¼Œå› ç‚ºåŒä¸€é¡žåž‹çš„試驗有å¯èƒ½ç™¼ç”Ÿæ–¼ä¸</span> </p><p style="line-height: 4.8pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">åŒéšŽæ®µï¼ˆè¦‹åœ–一）。一般èªç‚ºï¼Œä¾</span><span style="font-family: arial,sans-serif; font-size: 10pt;"> 2.2 </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">節ä¸æ‰€è¿°ä¹‹ç ”究目的分類為較佳的方法。åŒæ™‚äº¦é ˆçžè§£ï¹</span> </p><p style="line-height: 5.15pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">階段的概念是一種æ述方法，而éžè¦å®šã€‚æ¤å¤–，æ¤æ¦‚念並ä¸è¡¨ç¤ºé ˆä¾å›ºå®šçš„ç ”ç©¶é †åºï¼›å› 為å°æŸ</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">äº›ç ”ç™¼ä¸çš„è—¥å“而言，æ¤éšŽæ®µé †åºéžä½†ä¸å¿…è¦è€Œä¸”ä¸æ°ç•¶ã€‚舉例來說，雖然人體藥ç†è©¦é©—通常都</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">在第一階段進行，但也有許多人體藥ç†è©¦é©—也在其他三個階段ä¸é€²è¡Œï¼Œä½†å»è¢«æ¨™ç¤ºç‚ºç¬¬ä¸€éšŽæ®µè©¦</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">驗。圖一顯示出æ¤äºŒç¨®åˆ†é¡žæ–¹æ³•çš„相似但具ä¸åŒä¹‹ç›¸é—œç¨‹åº¦ã€‚由圖上標示點的分佈，å¯çœ‹å‡ºè©¦é©—</span> </p><p style="line-height: 4.55pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é¡žåž‹èˆ‡ç ”ç™¼éšŽæ®µä¸¦éžåŒç¾©ã€‚</span> </p><p style="line-height: 18.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 116pt: ;"><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">圖一：藥å“ç ”ç™¼éšŽæ®µèˆ‡è©¦é©—é¡žåž‹ä¹‹ç›¸é—œæ€§</span></b> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 19.55pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">註：æ¤çŸ©é™£åœ–形按新藥產å“ç ”ç™¼æ¯ä¸€éšŽæ®µä¹‹ç›®çš„ï¼Œèªªæ˜Žç ”ç™¼éšŽæ®µèˆ‡è©¦é©—é¡žåž‹ä¹‹é—œä¿‚ã€‚å¯¦å¿ƒåœ“</span> </p><p style="line-height: 6.25pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.85pt; margin: 0cm 4pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">圈（â—）標示å„階段最常進行的試驗類型，空白圓圈（○）則表示å„階段å¯èƒ½ä½†è¼ƒå°‘進行的試驗 類型，而æ¯å€‹åœ“圈都代表一單ç¨ä¹‹è©¦é©—。為了說明單ç¨è©¦é©—ä¹‹ç ”ç™¼ï¼Œæ¯ä¸€å€‹åœ“圈都å¯ä»¥è™›ç·šè¯çµè‡³é™„圖上之圓柱，æ¤åœ“柱說明æ¯ä¸€ç¨ç«‹è©¦é©—之組æˆåŠç ”ç™¼é †åºã€‚</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.35pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.85pt; margin: 0cm 4pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç†æƒ³ä¸çš„è—¥å“ç ”ç™¼ï¼Œç‚ºä¸€é‚輯性的é€æ¥ç ”發程åºï¼Œå³æ—©æœŸè¼ƒå°åž‹è©¦é©—之çµæžœæ”¯æŒåŠè¦åŠƒå¾ŒçºŒè¼ƒå¤§è¦æ¨¡ã€ç¢ºå®šæ€§çš„試驗。å°ææ˜‡æ–°è—¥ç ”ç™¼æ•ˆçŽ‡è€Œè¨€ï¼Œåœ¨æ—©æœŸå³ç¢ºèªè©¦é©—用藥å“çš„ç‰¹æ€§ï¼Œä¸¦æ“šæ¤ è¦åŠƒç ”發計畫，是相當é‡è¦çš„。</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.5pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.9pt; margin: 0cm 4pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">åˆæœŸè©¦é©—ä¸åƒ…æä¾›çŸæœŸå®‰å…¨æ€§åŠè€å—性之早期評估資訊，而且æ供藥動å¸åŠè—¥æ•ˆå¸è³‡æ–™ï¼Œä»¥æ±ºå®šåˆæœŸæ²»ç™‚探索試驗之é©ç•¶åŠ‘é‡ç¯„åœä»¥åŠçµ¦è—¥æ™‚間。後續之確èªè©¦é©—，通常為è¦æ¨¡è¼ƒå¤§ã€è©¦é©— 期間較長且包括更多ä¸åŒçš„å—試驗者æ—群。劑é‡ï¼åæ‡‰è³‡æ–™é ˆç”±ä¸åŒç ”發階段ç²å¾—，從早期的è€å—性試驗，到çŸæœŸè—¥æ•ˆå¸è©¦é©—ï¼Œåˆ°å¤§åž‹çš„ç™‚æ•ˆè©¦é©—ã€‚ç ”ç™¼éŽç¨‹ä¸ï¼Œæ–°ç²å¾—的資料，å¯èƒ½æœƒé¡¯ç¤ºé ˆ 進行æŸäº›é€šå¸¸åœ¨è¼ƒæ—©éšŽæ®µé€²è¡Œçš„試驗，例如：後期試驗所得之血ä¸è—¥å“濃度資料，å¯èƒ½é¡¯ç¤ºéœ€è¦é€²è¡Œè—¥å“間交互作用試驗；åˆå¦‚è—¥å“ä¸è‰¯å應，å¯èƒ½å»ºè°éœ€è¦æ›´é€²ä¸€æ¥åŠ‘é‡è³‡æ–™ï¼Œæˆ–進行å¦å¤–çš„</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection7"><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">éžè‡¨åºŠè©¦é©—。除æ¤ä¹‹å¤–，為申請藥å“新的銷售許å¯ï¼Œå¦‚é‡å°æ–°é©æ‡‰ç—‡ï¼Œå¯è€ƒæ…®é€²è¡Œç¬¬ä¸€æˆ–第二階</span> </p><p style="line-height: 4.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">段的藥動å¸æˆ–治療探索試驗。</span> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.3.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">第一階段（最典型的試驗為人體藥ç†å¸ï¼‰</span></b> </p><p style="line-height: 20pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.4pt; margin: 0cm 5pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">第一階段始於新試驗藥å“首次用於人體。雖然一般èªç‚ºäººé«”è—¥ç†è©¦é©—屬於第一階段，但亦å¯èƒ½æ–¼å…¶ä»–ç ”ç™¼éšŽæ®µåŸ·è¡Œã€‚æ¤éšŽæ®µä¹‹ç ”究通常並無治療性之目的，而å¯èƒ½é€²è¡Œæ–¼è‡ªé¡˜ä¹‹å¥åº·å—試驗 者或æŸäº›ç‰¹å®šå—試驗者æ—群，如輕微高血壓患者。具顯著潛在毒性之藥å“，如細胞毒性藥å“ï¼Œé€šå¸¸ä»¥ç—…æ‚£é€²è¡Œç ”ç©¶ã€‚æ¤éšŽæ®µä¹‹ç ”究å¯ç‚ºé–‹æ”¾æ€§ã€ä¸¦ä»¥åŸºç·šå°ç…§æˆ–隨機盲性，以æ高效度。</span> </p><p style="line-height: 18.75pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">åœ¨ç¬¬ä¸€éšŽæ®µé€²è¡Œä¹‹ç ”ç©¶é€šå¸¸åŒ…æ‹¬ä»¥ä¸‹ä¸€å€‹æˆ–æ•¸å€‹å±¤é¢ï¼š</span> </p><p style="line-height: 18.9pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">a) </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">åˆæœŸå®‰å…¨æ€§åŠè€å—性之估算</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.1pt; text-autospace: ;"> </p><p style="line-height: 14.8pt; margin: 0cm 5pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">在åˆæœŸåŠå¾ŒçºŒçµ¦äºˆæ–°è—¥æ–¼äººé«”，通常是欲決定後續臨床試驗所需è€å—性的劑é‡ç¯„åœï¼Œä¸¦åŒæ™‚確定å¯é 期的ä¸è‰¯å應性質。æ¤è©¦é©—常包括單劑é‡åŠå¤šåŠ‘é‡çµ¦äºˆã€‚</span> </p><p style="line-height: 18.95pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">b) </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">藥動å¸ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Pharmacokinetics</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）之評估</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.2pt; text-autospace: ;"> </p><p style="line-height: 17.25pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">åœ¨æ•´å€‹ç ”ç™¼è¨ˆç•«éŽç¨‹ä¸å°‡æŒçºŒäº†è§£è—¥å“之å¸æ”¶ã€åˆ†ä½ˆã€ä»£è¬ã€æŽ’泄的性質。第一階段試驗的é‡è¦ç›®æ¨™å³åœ¨çžè§£è—¥å‹•å¸çš„基本特性。藥動å¸å¯ç”±ä¸åŒè©¦é©—或經療效ã€å®‰å…¨æ€§åŠè€å—性試驗所得 資料進行評估。藥動å¸å°è©•ä¼°è—¥å“清除ã€åŠé ä¼°è—¥å“本身或其代è¬ç‰©ä¹‹ç´¯ç©ã€ä»¥åŠæ½›åœ¨è—¥å“交互作用éžå¸¸é‡è¦ã€‚有些藥動å¸ç ”究會在較晚的階段進行，以解決較特定的å•é¡Œã€‚例如，許多å£æœè—¥ å“，特別是控制釋出的藥å“ï¼Œç ”ç©¶é£Ÿç‰©å°ç”Ÿé«”å¯ç”¨çŽ‡ä¹‹ä½œç”¨æ˜¯ç›¸ç•¶é‡è¦çš„。æ¤å¤–，應考é‡ç²å¾—次 </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">æ—群（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">subpopulations</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）的藥動å¸è³‡æ–™ï¼Œå¦‚è€äººã€å…’ç«¥ã€å©¦å¥³ã€æ¸…除力衰弱之病患（腎或è‚è¡°ç«ï¼‰</span> <span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">åŠäººç¨®çš„次æ—群（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">ethnic subgroups</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）。藥å“間的交互作用å°è¨±å¤šè—¥å“而言很é‡è¦ï¼Œé€šå¸¸é€™äº›è©¦</span> <span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">驗在第一階段以後æ‰é€²è¡Œï¼Œä½†å‹•ç‰©æˆ–生物體外試驗的代è¬ï¼Œæˆ–潛在交互作用çµæžœï¼Œäº¦å¯å¼•å°Žè©²é …試驗較早進行。</span> </p><p style="line-height: 19.15pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">c) </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">藥效å¸ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 10pt;">Pharmacodynamics</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）之評估</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.2pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.85pt; margin: 0cm 5pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">視藥å“åŠè©¦é©—指標之ä¸åŒï¼Œè—¥æ•ˆå¸è©¦é©—åŠè¡€ä¸è—¥å“濃度與å應的相關試驗，å¯é€²è¡Œæ–¼è‡ªé¡˜ä¹‹å¥åº·å—試驗者或病患。當試驗於病患時，若有é©ç•¶é‡æ¸¬æ–¹æ³•ï¼Œè—¥æ•ˆå¸è³‡æ–™å¯æä¾›å°æ´»æ€§åŠå¯èƒ½ç™‚ 效之早期é 估，並å¯æŒ‡å¼•å¾ŒçºŒè©¦é©—的劑é‡åŠçµ¦è—¥ç”¨æ³•ã€‚</span> </p><p style="line-height: 18.95pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">d) </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“活性之早期測é‡</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.05pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.85pt; margin: 0cm 5pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“活性或潛在治療效益的åˆæœŸè©¦é©—，å¯æ–¼é€²è¡Œç¬¬ä¸€éšŽæ®µè©¦é©—時作為次è¦è©¦é©—目標。通常這類試驗都會在較晚的階段ä¸é€²è¡Œï¼Œä½†è‹¥åœ¨æ¤æ—©æœŸéšŽæ®µï¼Œè—¥å“活性於çŸæœŸç”¨è—¥ä¹‹ç—…æ‚£ä¸å·²å¯æ¸¬é‡å‡º 時，則在第一階段進行亦屬é©ç•¶ã€‚</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: auto;" clear="all" /></span><div class="WordSection8"><p style="line-height: 19.05pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.3.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">第二階段（最典型的試驗為治療探索）</span></b> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection9"><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">一般èªç‚ºç¬¬äºŒéšŽæ®µèµ·å§‹æ–¼ä»¥ç—…人進行療效探索為主è¦ç›®æ¨™çš„試驗。åˆæœŸç™‚效探索試驗å¯ä½¿ç”¨</span> </p><p style="line-height: 6.2pt; text-autospace: ;"> </p><p style="line-height: 15.85pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">å„種試驗è¨è¨ˆï¼ŒåŒ…括使用åŒæ¥å°ç…§çµ„（</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">concurrent controls</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）åŠåŸºç·šç‹€æ³ï¼ˆ</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">baseline status</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）之</span> <span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">比較，後續試驗則通常為隨機ã€åŒæ¥å°ç…§çµ„的試驗，以å°æŸä¸€é©æ‡‰ç—‡çš„療效和安全性進行評估。 ç¬¬äºŒéšŽæ®µçš„è©¦é©—é€šå¸¸åŸ·è¡Œæ–¼ä¸€ç¾¤ç”±åš´æ ¼æ¢ä»¶ç¯©é¸å‡ºåŒè³ªæ€§é«˜çš„ç—…æ‚£æ—群，並進行嚴密監測作æ¥ã€‚</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.5pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.4pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">æ¤éšŽæ®µä¹‹å¦ä¸€é‡è¦ç›®çš„為決定第三階段試驗所使用之劑é‡åŠæ²»ç™‚方法。æ¤éšŽæ®µä¸ï¼Œæ—©æœŸçš„試 驗通常採用é€æ¥åŠ‘é‡å¢žåŠ çš„è¨è¨ˆï¼Œä»¥é€²è¡ŒåŠ‘é‡ï¼å應åˆæ¥ä¹‹ä¼°ç®—，後期試驗則å¯ç¶“平行劑é‡ï¼å應è¨è¨ˆï¼ˆäº¦å¯å»¶è‡³ç¬¬ä¸‰éšŽæ®µåŸ·è¡Œï¼‰ï¼Œä»¥ç¢ºèªè©²é©æ‡‰ç—‡ä¹‹åŠ‘é‡ï¼å應關係。劑é‡ï¼å應確èªè©¦é©—å¯ åœ¨ç¬¬äºŒæˆ–ç¬¬ä¸‰éšŽæ®µé€²è¡Œã€‚ç¬¬äºŒéšŽæ®µæ‰€ç”¨çš„åŠ‘é‡ï¼Œé€šå¸¸ï¼ˆä½†éžçµ•å°ï¼‰ä½Žæ–¼ç¬¬ä¸€éšŽæ®µæ‰€ç”¨çš„最高劑é‡ã€‚</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.35pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.85pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">第二階段臨床試驗的目的還包括：評估其他å¯èƒ½è©¦é©—指標ã€æ²»ç™‚方法（包括併用藥å“）ã€ç›® 標æ—群（如輕微或嚴é‡ç–¾ç—…）ç‰ï¼Œä»¥ä¾›ç¬¬äºŒéšŽæ®µå¾ŒçºŒè©¦é©—或第三階段試驗之需。為é”æˆä¸Šè¿°ç›®çš„，å¯è—‰ç”±æŽ¢ç´¢åˆ†æžã€ç ”究數據的å集åˆæˆ–在試驗ä¸çš„多é‡æŒ‡æ¨™ä¾†é”æˆä¸Šè¿°ç›®çš„。</span> </p><p style="line-height: 19.05pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.3.3 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç¬¬ä¸‰éšŽæ®µï¼ˆæœ€å…¸åž‹çš„ç ”ç©¶ç¨®é¡žç‚ºæ²»ç™‚ç¢ºèªï¼‰</span></b> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.1pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.9pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">一般èªç‚ºç¬¬ä¸‰éšŽæ®µèµ·å§‹æ–¼ä¸»è¦ç›®çš„為顯示或確èªæ²»ç™‚效益之試驗。第三階段試驗主è¦ç›®çš„， 為確èªæ–¼ç¬¬äºŒéšŽæ®µä¸æ‰€å¾—è—¥å“用於目標é©æ‡‰ç—‡åŠå—試驗者是安全åŠæœ‰æ•ˆçš„åˆæ¥è‰æ“šã€‚這些試驗的目的在æä¾›æ ¸å‡†è—¥å“上市之é©ç•¶ä¾æ“šã€‚第三階段試驗å¯æ›´é€²ä¸€æ¥åœ°æŽ¢ç´¢åŠ‘é‡ï¼å應關係，或探討 å°‡æ¤è—¥å“使用於更多æ—群ã€æˆ–用於疾病之ä¸åŒéšŽæ®µã€æˆ–與ä¸åŒè—¥å“åˆä½µä½¿ç”¨ã€‚å°éœ€é•·æœŸçµ¦è—¥çš„è—¥å“而言，雖然第二階段å¯é€²è¡Œé•·æœŸçµ¦è—¥ä¹‹è‡¨åºŠè©¦é©—，但æ¤é¡žè‡¨åºŠè©¦é©—通常於第三階段進行，第三 階段所執行之試驗æ供完整資訊，以支æŒè—¥å“çš„é©ç•¶ä½¿ç”¨èªªæ˜Žã€‚</span> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.3.4 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">第四階段（å„類型的試驗ï¼æ²»ç™‚用途）</span></b> </p><p style="line-height: 19.15pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">第四階段試驗起始於藥å“æ ¸å‡†ä¸Šå¸‚ä¹‹å¾Œã€‚æ²»ç™‚ç”¨é€”ä¹‹è©¦é©—ä¹‹ç›®çš„è¶…å‡ºæ–¼å…ˆå‰è—¥å“的安全性ã€</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">療效ã€åŠåŠ‘é‡å®šç¾©ã€‚第四階段的試驗å‡åœ¨è—¥å“æ ¸å‡†ä¸Šå¸‚å¾Œé€²è¡Œï¼Œä¸”èˆ‡å·²æ ¸å‡†ä¹‹é©æ‡‰ç—‡ç›¸é—œï¼ˆä¸åŒ</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">於例行之上市後監測）。æ¤é¡žè©¦é©—é›–éžç”³è«‹æ ¸å‡†ä¹‹å¿…é ˆï¼Œä½†å°è—¥å“最佳用法是相當é‡è¦çš„。æ¤é¡ž</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">ç ”ç©¶åŒ…æ‹¬å„類型，但å‡é ˆå…·æœ‰æ£ç¢ºç§‘å¸ç›®çš„。常進行的試驗包括：與其他藥å“交互作用ã€åŠ‘é‡ï¼</span> </p><p style="line-height: 4.85pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å應或安全性試驗，以åŠç”¨ä¾†ä½è‰åœ¨æ ¸å‡†é©æ‡‰ç—‡ä½¿ç”¨ä¹‹è©¦é©—，如æ»äº¡çŽ‡</span><span style="font-family: arial,sans-serif; font-size: 10pt;">/</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">罹病率試驗ã€æµè¡Œç—…å¸</span> </p><p style="line-height: 4.3pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗。</span> </p><p style="line-height: 18.95pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.3.5 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">èˆ‡åŽŸæ ¸å‡†ç”¨é€”ç„¡é—œä¹‹æ‡‰ç”¨ç ”ç™¼</span></b> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">è—¥å“é¦–æ¬¡æ ¸å‡†å¾Œï¼Œè—¥å“ç ”ç™¼æœƒç¹¼çºŒé€²è¡Œè©¦é©—æ–¼æ–°é©æ‡‰ç—‡æˆ–ä¿®æ£é©æ‡‰ç—‡ã€æ–°çš„劑é‡æ–¹å¼ã€æ–°çš„</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">給藥途徑或應用於其他å—試驗者æ—群。若進行的試驗，是新劑é‡ã€æ–°è£½åŠ‘é…æ–¹ã€æ–°è¤‡æ–¹æˆ–新組åˆï¼Œ</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">則å¯èƒ½é ˆå¦é€²è¡Œäººé«”è—¥ç†å¸è©¦é©—ï¼Œè€Œé ˆæ“¬æ–°çš„ç ”ç™¼è¨ˆç•«ã€‚æŸäº›è©¦é©—，å¯å› åŽŸæœ‰ç ”ç™¼è¨ˆç•«æ‰€ç²å¾—之</span> </p><p style="line-height: 4.5pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">資料或治療之使用而得以å…除。</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: auto;" clear="all" /></span><div class="WordSection10"><p style="line-height: 19.65pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 9.5pt;">3.1.4 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">特別考é‡</span></b> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection11"><p style="line-height: 13.35pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç ”ç™¼è¨ˆç•«æ‡‰è€ƒæ…®æŸäº›ç‰¹åˆ¥æƒ…æ³æˆ–æ—群。</span> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.4.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“代è¬ç‰©çš„試驗</span></b> </p><p style="line-height: 18.4pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">應確èªä¸»è¦æ´»æ€§ä»£è¬ç‰©ï¼ŒåŒæ™‚值得進行更詳細的藥動å¸è©¦é©—。進行æ¤ä»£è¬ç‰©è©•ä¼°è©¦é©—之時</span> </p><p style="line-height: 4.55pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">間，決定於å„個藥å“的特性。</span> </p><p style="line-height: 19pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.4.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“交互作用</span></b> </p><p style="line-height: 19.15pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">若以代è¬ç‰©å‰–æžã€éžè‡¨åºŠè©¦é©—çµæžœæˆ–類似藥å“之資訊顯示有藥å“交互作用的å¯èƒ½æ€§ï¼Œå‰‡å»ºè°</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">æ–¼è‡¨åºŠç ”ç™¼éŽç¨‹ä¸é€²è¡Œè—¥å“交互作用試驗。經常一起æœç”¨çš„è—¥å“，其藥å“交互作用之試驗通常必</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">é ˆåœ¨éžè‡¨åºŠéšŽæ®µé€²è¡Œï¼Œè‹¥å¯è¡Œï¼Œäº¦å¯æ–¼è‡¨åºŠéšŽæ®µé€²è¡Œï¼›ç‰¹åˆ¥æ˜¯å°æ–¼æŸäº›å·²çŸ¥æœƒæ”¹è®Šå…¶ä»–è—¥å“å¸æ”¶</span> </p><p style="line-height: 4.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">或代è¬ï¼Œæˆ–本身之代è¬åŠæŽ’泄會å—其他藥å“影響者。</span> </p><p style="line-height: 18.9pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.1.4.3 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">特別的æ—群</span></b> </p><p style="line-height: 18.7pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å› å…¶å…·æœ‰ç¨ç‰¹çš„風險</span><span style="font-family: arial,sans-serif; font-size: 10pt;">/</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">æ•ˆç›Šæˆ–å› é 期æ¤æ—群與一般æˆäººç›¸æ¯”較，應修æ£å…¶åŠ‘é‡æˆ–用藥時間，</span> </p><p style="line-height: 6pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.9pt; margin: 0cm 1pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">故在藥å“ç ”ç™¼éŽç¨‹ä¸ï¼Œå¿…é ˆè€ƒæ…®æŸäº›æ—群å¯èƒ½éœ€è¦é€²è¡Œä¸€äº›ç‰¹åˆ¥çš„試驗。å°æ–¼è…Žæˆ–è‚功能ä¸è‰¯çš„ 病患，進行藥動å¸è©¦é©—以評估藥å“代è¬æˆ–排泄之潛在變化影響，也是很é‡è¦ã€‚æ¤å¤–ï¼Œæ‡‰ç‰¹åˆ¥æ³¨æ„ </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">關於弱勢æ—群（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">vulnerable populations</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）之å—試åŒæ„書åŠç¨‹åºç‰ç›¸é—œçš„倫ç†è€ƒé‡ã€‚</span> </p><p style="line-height: 18.8pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">a. </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å•å©¦ä¹‹è©¦é©—</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.05pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.4pt; margin: 0cm 1pt 0pt 36pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">一般而言，除éžè—¥å“欲用於å•å©¦ï¼Œå¦å‰‡æ‡‰å°‡å•å©¦æŽ’除於試驗之外。è¬ä¸€å—試驗者於 給藥期間懷å•ï¼Œè‹¥èƒ½å®‰å…¨åœ°çµ‚æ¢æ²»ç™‚，則通常應終æ¢æ²»ç™‚，且å°æ‡·å•ã€èƒšèƒŽã€åŠå©ç«¥ä¹‹å¾ŒçºŒè©•ä¼°æ˜¯éžå¸¸é‡è¦çš„。åŒæ¨£çš„，若æ¤è—¥å“欲用於å•å©¦ï¼Œè€Œå°‡å•å©¦åŒ…括於試驗ä¸ï¼Œå‰‡å° 懷å•ã€èƒšèƒŽã€åŠå©ç«¥ä¹‹å¾ŒçºŒè©•ä¼°äº¦éžå¸¸é‡è¦ã€‚</span> </p><p style="line-height: 18.85pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">b. </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">哺育ä¸å©¦å¥³ä¹‹è©¦é©—</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.2pt; text-autospace: ;"> </p><p style="line-height: 14.8pt; margin: 0cm 1pt 0pt 36pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">儘å¯èƒ½é€²è¡Œè—¥å“排泄或æ¯ä¹³ä¸ä»£è¬ç‰©ä¹‹æª¢æ¸¬ï¼›ç•¶å“ºè‚²ä¸å©¦å¥³åƒèˆ‡è©¦é©—計畫時，應監測藥å“å°å¬°å¹¼å…’之作用。</span> </p><p style="line-height: 18.8pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ; 18pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">c. </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">兒童之試驗</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.15pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.4pt; text-autospace: ; punctuation-wrap: simple; 36pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">ç ”ç©¶é€²è¡Œä¹‹è¦æ¨¡é ˆæ±ºå®šæ–¼å°è©²è—¥å“之ç¾æœ‰çžè§£ï¼ŒåŠç”±æˆäººæˆ–ä¸åŒå¹´é½¡å±¤å…’童之既有 資料外æ’之å¯èƒ½æ€§ã€‚æŸäº›è—¥å“åœ¨å…¶ç ”ç™¼éšŽæ®µä¹‹æ—©æœŸå¯ç”¨æ–¼å…’童；若藥å“將會用於兒童ï¹æ‡‰é¸æ“‡åˆé©ä¹‹å¹´é½¡å±¤æ—ç¾¤åŠ ä»¥è©•ä¼°ã€‚ç•¶è‡¨åºŠç ”ç™¼è¨ˆç•«åŒ…æ‹¬å…’ç«¥æ™‚ï¼Œä¸€èˆ¬æ‡‰å¾žè¼ƒå¤§å…’ç«¥é–‹ 始進行，å†å»¶ä¼¸æ–½è¡Œæ–¼è¼ƒå°å…’童或嬰兒。</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: auto;" clear="all" /></span><div class="WordSection12"><p style="line-height: 19.75pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 9.5pt;">3.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">個別臨床試驗之考é‡</span></b> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection13"><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">臨床試驗之目的ã€è¨è¨ˆã€åŸ·è¡Œã€åˆ†æžåŠå ±å‘Šæ™‚，應éµå¾ªä»¥ä¸‹ä¹‹é‡è¦åŽŸå‰‡ã€‚在試驗開始å‰ï¼Œæ¯</span> </p><p style="line-height: 4.6pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">一部份å‡é ˆè©³è¼‰æ–¼è©¦é©—計畫書。</span> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">目的</span></b> </p><p style="line-height: 5pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">é ˆæ¸…æ¥šé™³è¿°è©¦é©—ä¹‹ç›®çš„ï¼Œç›®çš„å¯åŒ…括åŒæ™‚或分別探索或確èªå®‰å…¨æ€§ã€ç™‚效ã€è—¥å‹•å¸è©•ä¼°ï¼Œä»¥</span> </p><p style="line-height: 4.6pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">åŠè—¥ç†å¸ã€ç”Ÿç†å¸ã€ç”Ÿç‰©åŒ–å¸ä¹‹æ•ˆæžœã€‚</span> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è¨è¨ˆ</span></b> </p><p style="line-height: 5pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">試驗è¨è¨ˆä¹‹é¸æ“‡ï¼Œæ‡‰ä»¥èƒ½æä¾›æ‰€éœ€è³‡è¨Šç‚ºåŽŸå‰‡ã€‚ä¸€äº›å¸¸è¦‹çš„ç ”ç©¶è¨è¨ˆåŒ…括平行ã€äº¤å‰ã€è¤‡å› </span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">åã€åŠ‘é‡é€æ¥æ昇ã€åŠå›ºå®šåŠ‘é‡å應。應é©ç•¶é¸å–å°ç…§çµ„åŠé©ç•¶å—試驗者的人數以é”æˆè©¦é©—目的；</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">亦應詳細陳述主è¦åŠæ¬¡è¦æŒ‡æ¨™åŠå…¶åˆ†æžè¨ˆç•«ã€‚æ‡‰è©³åŠ é™³è¿°è‡¨åºŠå¾µè±¡æˆ–ç—‡ç‹€æ”¹è®Šä¹‹ä¸è‰¯å應與實驗</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">室檢驗的監測方法。試驗計畫書應列出å°ææ—©åœæ¢è‡¨åºŠè™•ç½®çš„å—試驗者之特殊處ç†ç¨‹åºå’Œè¿½è¹¤æ–¹</span> </p><p style="line-height: 4.6pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">法。</span> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.2.1 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å—試驗者之é¸æ“‡</span></b> </p><p style="line-height: 5pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">é¸æ“‡å—試驗者æ—ç¾¤æ™‚ï¼Œæ‡‰è€ƒæ…®ç ”ç™¼éšŽæ®µåŠå…¶è©¦é©—çš„é©æ‡‰ç—‡ï¼ˆå¦‚æ£å¸¸å¥åº·ä¹‹å—試驗者ã€ç™Œç—‡æ‚£</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">者ã€æˆ–æ—©æœŸç ”ç™¼éšŽæ®µä¹‹ç‰¹åˆ¥æ—群），先å‰çš„éžè‡¨åºŠæˆ–臨床èªçŸ¥äº¦é ˆåˆ—入考é‡ã€‚早期試驗å¯é€éŽåš´</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">æ ¼ä¹‹ç¯©é¸æ¢ä»¶ï¼Œä»¥é™ä½Žç—…患群或å¥åº·å—試驗者之變異性。然而，隨藥å“ç ”ç™¼ä¹‹é€²è¡Œï¼Œå—試驗者æ—</span> </p><p style="line-height: 4.6pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">群應é€æ¥æ“´å¤§ç¯„åœï¼Œä»¥åæ˜ é©æ‡‰ç—‡çš„目標æ—群。</span> </p><p style="line-height: 6.2pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.7pt; margin: 0cm 3pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">è¦–ç ”ç™¼éšŽæ®µåŠå®‰å…¨æ€§è€ƒé‡ï¼Œæœ‰å¯èƒ½é ˆåœ¨åš´å¯†ç›£æ¸¬çš„環境之下進行試驗（如ä½é™¢ç—…患）。按一般性原則，å—試驗者ä¸å¾—åŒæ™‚åƒåŠ 一個以上之試驗，但若有é©ç•¶ç†ç”±ï¼Œå¯æœ‰ä¾‹å¤–。å—試驗者在無 é©ç•¶æ™‚間終æ¢è‡¨åºŠè™•ç½®ï¼Œä»¥ä¿è·å—試驗者安全åŠæŽ’除藥å“之殘餘效應時，ä¸æ‡‰é‡è¤‡æ”¶ç´æ–¼è‡¨åºŠè©¦é©—。原則上，具生育能力之婦女在åƒåŠ 臨床試驗時應使用高效果之é¿å•æŽªæ–½ï¼›ç”·æ€§å—試驗者，應 考é‡è©¦é©—用藥å“å°å…¶æ€§ä¼´ä¾¶æˆ–å嗣之å±å®³ã€‚當有跡象顯示（如試驗ä¸åŒ…å«å¯èƒ½å°Žè‡´éºå‚³åŸºå› çªè®Š</span> </p><p style="line-height: 4.85pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">或å°ç”Ÿæ®–系統具毒性之藥å“時），應於試驗ä¸æä¾›é©ç•¶ä¹‹é¿å•æŽªæ–½ã€‚</span> </p><p style="line-height: 4.9pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.2.2 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å°ç…§çµ„之é¸æ“‡</span></b> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">試驗需有åˆé©ä¹‹å°ç…§çµ„ï¼›å°ç…§çµ„å¯ç‚ºå®‰æ…°åŠ‘ã€ç„¡æ²»ç™‚ã€æ´»æ€§å°ç…§çµ„或試驗用藥å“之ä¸åŒåŠ‘é‡</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">組。å°ç…§çµ„之é¸æ“‡äº¦å—試驗者數目的影響。æŸäº›è©¦é©—使用回溯性（外部）å°ç…§çµ„是å¯è¡Œçš„，但必</span> </p><p style="line-height: 4.65pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é ˆå°‡éŒ¯èª¤æŽ¨è«–çš„å¯èƒ½æ€§æ¸›è‡³æœ€ä½Žã€‚</span> </p><p style="line-height: 4.9pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.2.3 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å—試驗者數目</span></b> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">試驗è¦æ¨¡å¤§å°å—ç ”ç©¶ç–¾ç—…ã€è©¦é©—目的ã€æŒ‡æ¨™ä¹‹å½±éŸ¿ã€‚樣本數之統計評估應基於é 期治療效果ã€</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">數據之變異ã€èª¤å·®æ©ŸçŽ‡èˆ‡æ—群å集ã€æˆ–次級指標期望所ç²å¾—之資訊。在æŸäº›æƒ…æ³ä¸‹ï¼Œç‚ºç¢ºç«‹è—¥å“</span> </p><p style="line-height: 4.65pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">安全性，å¯èƒ½éœ€è¦è¼ƒå¤§ä¹‹è³‡æ–™åº«ã€‚</span> </p><p style="line-height: 4.9pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.2.4 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å應變數</span></b> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">å應變數應具å‰çž»æ€§åœ°æ–¼è©¦é©—å‰å®šç¾©ï¼Œä¸¦æ述其觀察方法和é‡åŒ–方法；客觀之觀察方法應於</span> </p><p style="line-height: 5.25pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">é©æ™‚é©åœ°å„˜å¯èƒ½ä½¿ç”¨ã€‚試驗指標是用於評估與藥動å¸åƒæ•¸ã€è—¥æ•ˆå¸ã€ç™‚效åŠå®‰å…¨æ€§ç‰ç›¸é—œä¹‹è—¥æ•ˆ</span> </p><p style="line-height: 6.2pt; text-autospace: ;"> </p><p style="line-height: 14.85pt; margin: 0cm 3pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">çš„å應變數。主è¦æŒ‡æ¨™æ‡‰èƒ½åæ˜ ç›¸é—œçš„è‡¨åºŠæ•ˆæžœï¼Œä¸”å¸¸æ˜¯æ ¹æ“šè©¦é©—çš„ä¸»è¦ç›®çš„而é¸å®šã€‚次級指標係評估藥å“其他的效果，å¯èˆ‡ä¸»è¦æŒ‡æ¨™ç›¸é—œæˆ–ä¸ç›¸é—œã€‚試驗指標åŠå…¶åˆ†æžè¨ˆç•«ï¼Œæ‡‰äº‹å…ˆæ–¼è©¦é©—計</span> </p><p style="line-height: 4.7pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">畫書ä¸ç¢ºå¯¦èªªæ˜Žã€‚</span> </p><p style="line-height: 6.2pt; text-autospace: ;"> </p><p style="line-height: 14.9pt; margin: 0cm 3pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">替代指標（</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">surrogate endpoint</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）與臨床上é‡è¦çµæžœç›¸é—œï¼Œä½†ä¸¦éžç›´æŽ¥æ¸¬é‡è‡¨åºŠæ•ˆç›Šã€‚é©ç•¶</span> <span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">時，替代指標å¯ä½œç‚ºä¸»è¦æŒ‡æ¨™ï¼ˆç•¶æ¤æ›¿ä»£æŒ‡æ¨™çžè§£ç¨‹åº¦è¶³ä»¥é 測臨床çµæžœï¼‰ã€‚所有客觀åŠä¸»è§€æŒ‡</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection14"><p style="line-height: 12.75pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">標的測é‡æ–¹æ³•å‡æ‡‰ç¶“確èªï¼Œä¸¦è¦æ±‚準確度ã€ç²¾ç¢ºåº¦ã€å¯é‡è¤‡æ€§ã€å¯ä¿¡åº¦åŠéˆæ•åº¦ï¼ˆæ•æ„Ÿæ€§éš¨æ™‚é–“</span> </p><p style="line-height: 4.6pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">而改變）。</span> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.2.5 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é™ä½Žæˆ–è©•ä¼°å差的方法</span></b> </p><p style="line-height: 4.35pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗計畫書說明å—試驗者之臨床處置指派åŠç›²æ€§ä½œæ¥çš„方法。</span> </p><p style="line-height: 18.8pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">a. </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">隨機指派</span> </p><p style="line-height: 19.15pt; text-autospace: ;"> </p><p style="line-height: 12.75pt; text-autospace: ; 56pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">當進行å°ç…§æ€§è©¦é©—時，隨機指派為臨床處置指派的較佳方法，以確ä¿å—試組的比較</span> </p><p style="line-height: 4.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 36pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">性，並å¯é™ä½Žé¸æ“‡æ€§å差發生之å¯èƒ½æ€§ã€‚</span> </p><p style="line-height: 18.9pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">b. </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">盲性作æ¥</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 10.2pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 15.85pt; text-autospace: ; punctuation-wrap: simple; 36pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">盲性作æ¥ç‚ºä¸€é™ä½Žè©¦é©—çµæžœå差的é‡è¦æ–¹æ³•ã€‚單盲試驗係指以安慰劑或其他掩飾方 å¼ï¼Œä½¿å—試驗者ä¸çŸ¥é“所接å—的治療方法為何。雙盲試驗則是連åƒèˆ‡æ²»ç™‚ã€è‡¨åºŠè©•ä¼°åŠåˆ†æžè³‡æ–™çš„試驗主æŒäººæˆ–試驗委託者亦ä¸çŸ¥é“å—試驗者所被指派的臨床處置。</span> </p><p style="line-height: 18.85pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 18pt: ;"><span style="font-family: arial,sans-serif; font-size: 10pt;">c. </span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">é †å¾žæ€§</span> </p><p style="line-height: 18.5pt; text-autospace: ;"> </p><p style="line-height: 13.35pt; text-autospace: ; 56pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗計畫書應說明å—試驗者使用試驗藥å“的方法與評估確實用藥的紀錄。</span> </p><p style="line-height: 19.15pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.3 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">執行</span></b> </p><p style="line-height: 4.3pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗應ä¾æ¤åŸºæº–執行，並應éµå¾ªæœ¬ç½²åˆ¶è¨‚之「藥å“優良臨床試驗è¦ç¯„ã€ã€‚</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 12.9pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.4 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">分æž</span></b> </p><p style="line-height: 4.95pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ; 20pt: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">試驗計畫書ä¸æ‡‰æ˜Žåˆ—é©ç”¨æ–¼æ¤è©¦é©—目的åŠè©¦é©—è¨è¨ˆä¹‹åˆ†æžè¨ˆç•«ï¼Œåˆ†æžè¨ˆç•«æ‡‰è€ƒæ…®å—試驗者指</span> </p><p style="line-height: 5.3pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">派方法ã€å應變數的測é‡æ–¹æ³•ã€æ‰€å°‡é€²è¡Œæª¢å®šçš„å‡è¨ã€åŠè™•ç†å¸¸è¦‹å•é¡Œï¼ˆå¦‚ææ—©ä¸æ¢è©¦é©—或é•å</span> </p><p style="line-height: 4.65pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">試驗計畫書）的分æžæ–¹æ³•ã€‚試驗計畫書應æ述所採用的統計方法ï¹åŒ…括試驗ä¸ä»»ä½•æœŸä¸åˆ†æžçš„時</span> </p><p style="line-height: 4.6pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">間點。</span> </p><p style="line-height: 6.2pt; text-autospace: ;"> </p><p style="text-justify: inter-ideograph; text-align: justify; line-height: 16.45pt; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">臨床試驗çµæžœä¹‹åˆ†æžæ‡‰éµå¾ªäº‹å‰ç–åŠƒä¹‹è©¦é©—è¨ˆç•«æ›¸ï¼Œä¸¦æ‡‰æ–¼è©¦é©—å ±å‘Šä¸èªªæ˜Žä»»ä½•åŠæ‰€æœ‰æœªéµ 循計畫書之處。試驗一般都é 期å¯é †åˆ©å®Œæˆï¼Œç„¶è€Œåœ¨æŸäº›è©¦é©—，ææ—©çµæŸä¹‹å¯èƒ½æ€§äº¦è¢«è¨±å¯ã€‚è‹¥æœ‰ä¸Šè¿°æƒ…å½¢ï¼Œé ˆåœ¨è©¦é©—è¨ˆç•«æ›¸ä¸è©³ç´°èªªæ˜Žæ‡‰æœ‰çš„統計考é‡ï¼Œå¦‚ï¼šçµ±è¨ˆæ•´é«”çš„é¡¯è‘—æ°´æº–èˆ‡èª¿æ•´è™•ç† æ•ˆæ‡‰ä¹‹ä¼°å€¼çš„å¯èƒ½æ€§ã€‚所有臨床試驗å‡éœ€æœé›†å®‰å…¨æ€§è³‡æ–™ï¼Œæ¤è³‡æ–™ä¸¦èˆ‡ä¾åš´é‡ç¨‹åº¦åˆ†é¡žä¹‹ä¸è‰¯å</span> </p><p style="line-height: 4.65pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">應åŠå¯èƒ½ä¹‹å› 果關係，é©ç•¶è¡¨åˆ—。</span> </p><p style="line-height: 4.9pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial,sans-serif; font-size: 10pt;">3.2.5 </span></b><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">å ±å‘Š</span></b> </p><p style="line-height: 5.85pt; text-autospace: ;"> </p><p style="line-height: 15pt; margin: 0cm 4pt 0pt 0cm; text-autospace: ; punctuation-wrap: simple;"><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">è‡¨åºŠè©¦é©—å ±å‘Šä¹‹æ ¼å¼åŠå…§å®¹ï¼Œè«‹åƒé–±</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;"> ICH </span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">之「</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">Guideline for the format and content of the clinical and statistical sections of new drug applications</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">ã€åŠæœ¬ç½²å³å°‡å…¬ä½ˆä¹‹ã€Œè‡¨åºŠè©¦é©—å ±å‘Šä¹‹</span> </p><p style="line-height: 4.4pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">æ ¼å¼åŠå…§å®¹åŸºæº–ã€ã€‚</span> </p><p style="line-height: 10pt; text-autospace: ;"> </p><p style="line-height: 12.6pt; text-autospace: ;"> </p><p style="line-height: 13.4pt; text-autospace: ;"><b><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">åƒè€ƒæ–‡ç»</span></b> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: auto;" clear="all" /></span><div class="WordSection15"><p style="line-height: 19.4pt; text-autospace: ;"> </p><p style="line-height: 12.7pt; text-autospace: ;"><span style="font-family: arial,sans-serif; font-size: 9.5pt;">1. </span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">行政院衛生署（</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">1996</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">）</span><span style="font-family: arial,sans-serif; font-size: 9.5pt;">.</span><span style="font-family: arial unicode ms,sans-serif; font-size: 9.5pt;">è—¥å“優良臨床試驗è¦ç¯„（å°åŒ—）</span> </p></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: always;" clear="all" /></span><div class="WordSection16"><ol> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">行政院衛生署（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">1997</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）</span><span style="font-family: arial,sans-serif; font-size: 10pt;">.</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“è‡¨åºŠè©¦é©—ç”³è«‹é ˆçŸ¥ï¼ˆå°åŒ—）</span> </li></ol><p style="line-height: 4.65pt; text-autospace: ;"> </p><ol> <li><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">行政院衛生署（</span><span style="font-family: arial,sans-serif; font-size: 10pt;">1998</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">）</span><span style="font-family: arial,sans-serif; font-size: 10pt;">.</span><span style="font-family: arial unicode ms,sans-serif; font-size: 10pt;">è—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„（å°åŒ—）</span> </li></ol><p style="line-height: 6.6pt; text-autospace: ;"> </p><ol> <li><span style="line-height: 157%; font-family: arial,sans-serif; font-size: 10pt;">ICH Harmonized Tripartite Guideline: General Considerations for Clinical Trials. Recommended for Adoption at Step 4 of the ICH Process on 17 July 1997 by the ICH Steering Committee. </span></li></ol></div><span style="font-family: times new roman,serif; font-size: 12pt;"><br style="page-break-before: auto;" clear="all" /></span><p style="text-autospace: ;"><span style="font-family: calibri;"> </span></p>2013-12-05
臨床試驗類,è—¥å“臨床試驗å—試者åŒæ„書範本行政解釋藥å“臨床試驗å—試者åŒæ„書修æ£æ¡ˆç”³è«‹è¡¨ã€é€å¯©è³‡æ–™æŸ¥æª¢è¡¨åŠå¡«å¯«ç¯„例å„1份詳如附件2013-12-05
臨床試驗類,è—¥å“臨床試驗å—試者åŒæ„書範本行政解釋藥å“臨床試驗å—試者åŒæ„書範本詳如附件2013-12-05
臨床試驗類,è—¥å“臨床試驗å—試者招募原則行政解釋藥å“臨床試驗å—試者招募原則詳如附件2013-12-05
臨床試驗類,è—¥å“臨床試驗計畫書主è¦å¯©æŸ¥äº‹é …行政解釋藥å“臨床試驗計畫書主è¦å¯©æŸ¥äº‹é …詳如附件2013-12-05https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4564&type=0
藥政管ç†é¡ž,åš´é‡è—¥ç‰©ä¸è‰¯åæ‡‰é€šå ±è¾¦æ³•æ³•å¾‹åš´é‡è—¥ç‰©ä¸è‰¯åæ‡‰é€šå ±è¾¦æ³•<p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法ä¾è—¥äº‹æ³•</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">第四å五æ¢ä¹‹ä¸€è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱之藥物係指本法第四æ¢æ‰€ç¨±ä¹‹è—¥ç‰©ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">å› è—¥ç‰©æ‰€å¼•èµ·ä¹‹åš´é‡è—¥ç‰©ä¸è‰¯å應發生時，醫療機構ã€è—¥å±€ã€è—¥å•†æ‡‰ä¾æœ¬è¾¦æ³•å¡«å…·é€šå ±æ›¸ï¼Œé€£åŒç›¸é—œè³‡æ–™ï¼Œå‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæˆ–å…¶å§”è¨—æ©Ÿæ§‹é€šå ±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法所稱之嚴é‡è—¥ç‰©ä¸è‰¯åæ‡‰ï¼Œä¿‚æŒ‡å› ä½¿ç”¨è—¥ç‰©è‡´ç”Ÿä¸‹åˆ—å„款情形之一者：</span> </p><p><span style="font-family: 新細明體,serif;">一ã€æ»äº¡ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">二ã€å±åŠç”Ÿå‘½ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">三ã€é€ æˆæ°¸ä¹…性殘疾。</span> </p><p><span style="font-family: 新細明體,serif;">å››ã€èƒŽå¬°å…’先天性畸形。</span> </p><p><span style="font-family: 新細明體,serif;">五ã€å°Žè‡´ç—…人ä½é™¢æˆ–延長病人ä½é™¢æ™‚間。</span> </p><p><span style="font-family: 新細明體,serif;">å…ã€å…¶ä»–å¯èƒ½å°Žè‡´æ°¸ä¹…性傷害需åšè™•ç½®è€…。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構åŠè—¥å±€æ‡‰æ–¼å¾—知å‰æ¢ç¬¬ä¸€æ¬¾åŠç¬¬äºŒæ¬¾ä¹‹åš´é‡è—¥ç‰©ä¸è‰¯å應之日起七日內，ä¾ç¬¬ä¸‰æ¢è¦å®šè¾¦ç†é€šå ±ï¼Œä¸¦å‰¯çŸ¥æŒæœ‰è—¥ç‰©è¨±å¯è‰ä¹‹è—¥å•†ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …é€šå ±è³‡æ–™å¦‚æœªæª¢é½Šï¼Œæ‡‰æ–¼å五日內補齊。</span> </p><p><span style="font-family: 新細明體,serif;">ç¬¬ä¸€é …é€šå ±è³‡æ–™å¦‚éœ€æŒæœ‰è—¥ç‰©è¨±å¯è‰ä¹‹è—¥å•†æ供產å“相關資料，藥商ä¸å¾—拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">æŒæœ‰è—¥ç‰©è¨±å¯è‰ä¹‹è—¥å•†æ–¼å¾—知嚴é‡è—¥ç‰©ä¸è‰¯å應之日起å五日內，ä¾ç¬¬ä¸‰æ¢è¦å®šè¾¦ç†é€šå ±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">醫療機構ã€è—¥å±€åŠè—¥å•†ä¾æœ¬è¾¦æ³•è¾¦ç†é€šå ±ï¼Œå¾—以郵寄ã€å‚³çœŸæˆ–網路ç‰æ–¹å¼ç‚ºä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">å‰é …é€šå ±æ–¹å¼ï¼Œæ–¼ç·Šæ€¥æ™‚，得先行以å£é æ–¹å¼é€šå ±ï¼Œä¸¦æ‡‰æ–¼æœŸé™å…§å®Œæˆæ›¸é¢é€šå ±ã€‚</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæˆ–其委託機構，於必è¦æ™‚，得å‘醫療機構ã€è—¥å±€åŠè—¥å•†è«‹æ±‚æ供嚴é‡è—¥ç‰©ä¸è‰¯å應病人之就醫紀錄ã€çµ¦è—¥ç´€éŒ„或產å“資料，醫療機構ã€è—¥å±€åŠè—¥å•†ä¸å¾—拒絕。</span> </p><p><span style="font-family: 新細明體,serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體,serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體,serif;">本辦法自發布日施行。</span> </p>2013-12-05
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹å« ursodeoxycholic acidæˆåˆ†è—¥å“ä¹‹ä»¿å–®åŠ è¨»ç›¸é—œäº‹å®œè©³å¦‚é™„ä»¶2013-12-16
藥政管ç†é¡ž,藥事法行政解釋「Rosiglitazoneæˆåˆ†è—¥å“之風險評估暨管控計畫書ã€å…¬å‘Šé™„件1詳如附件2013-12-16
藥政管ç†é¡ž,藥事法行政解釋「Rosiglitazoneæˆåˆ†è—¥å“之風險評估暨管控計畫書ã€å…¬å‘Šé™„件2詳如附件2013-12-16
藥政管ç†é¡ž,藥事法行政解釋「Rosiglitazoneæˆåˆ†è—¥å“之風險評估暨管控計畫書ã€å…¬å‘Šé™„件3詳如附件2013-12-16
藥政管ç†é¡ž,藥物回收作æ¥å¯¦æ–½è¦é»žè¡Œæ”¿è§£é‡‹101å¹´8月17æ—¥_衛生ç¦åˆ©éƒ¨å…¬å‘Š__ä¿®æ£ã€Œè—¥ç‰©å›žæ”¶ä½œæ¥å¯¦æ–½è¦é»žã€è©³å¦‚附件2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4630&type=0
罕見疾病類,罕見疾病防治åŠè—¥ç‰©æ³•è¡Œæ”¿è§£é‡‹991208_ä¿®æ£ç½•è¦‹ç–¾ç—…防治åŠè—¥ç‰©æ³•æ¢æ–‡è©³å¦‚附件2013-12-16
化å¸è£½é€ 管制類,è—¥ç‰©è£½é€ /å§”è¨—è£½é€ ,è—¥ç‰©è£½é€ å·¥å» è¨å» 標準,è—¥ç‰©è£½é€ æ¥è€…檢查辦法,生物藥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•,è—¥å“å§”è¨—è£½é€ å¯¦æ–½è¦é»ž,è—¥ç‰©å§”è¨—è£½é€ åŠæª¢é©—作æ¥æº–å‰‡è¡Œæ”¿è§£é‡‹å‡¡é ˜æœ‰è—¥å“è¼¸å…¥æˆ–è£½é€ ä¹‹è¨±å¯è‰ï¼Œå…¶æœ‰æ•ˆæœŸé–“屆滿，ä»æ¬²ç¹¼çºŒè¼¸å…¥æˆ–è£½é€ å„該藥å“者，應å‘本署申請展延有效期間。<p><span style="font-family: 新細明體, serif;">一ã€æŸ¥å‰ç”±å…§æ”¿éƒ¨</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">或本署</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">æ ¸æ›ç™¼ä¹‹è—¥å“許å¯è‰ï¼Œè¿„ä»Šå·²æœ‰ä¸€éƒ¨ä»½ä¹‹æœ‰æ•ˆæ—¥æœŸå°‡ç¶“å±†æ»¿ï¼Œå¦‚æ¬²ç¹¼çºŒè¼¸å…¥æˆ–è£½é€ å„該藥å“者，應å³å‘æœ¬ç½²ç”³è«‹å±•å»¶æœ‰æ•ˆæœŸé–“ï¼Œå—£å¾Œä¸¦é ˆåˆ‡å¯¦ä¾ç…§è—¥ç‰©è—¥å•†ç®¡ç†æ³•æ–½è¡Œç´°å‰‡ç¬¬äº”åå››æ¢ä¹‹è¦å®šï¼Œæ–¼æœ‰æ•ˆæœŸé–“屆滿å‰ä¸‰å€‹æœˆæ出申請，å¦å‰‡æ‡‰äºˆæ’¤éŠ·åŽŸè¨±å¯è‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€èŒ²ç‚ºä¾¿åˆ©è¾¦ç†ç”³è«‹è—¥ç‰©è¨±å¯è‰å±•å»¶æœ‰æ•ˆæœŸé–“之工作計，特補充è¦å®šæ‡‰æŒ‰æ¯ä¸€ç¨®è—¥ç‰©ï¼Œåˆ†åˆ¥å„填申請書一份，該申請書應é€ç¶“縣</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">市</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">或直轄市衛生局</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">藥政æ¥å‹™ä¸»ç®¡èª²ã€ç§‘</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">æŸ¥æ ¸ç¬¦åˆåŠ 蓋戳記åŠä¸»ç®¡äººå“¡è·ç« 後å†é€æœ¬ç½²è¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€è—¥å•†å¦‚在åœæ¥æœŸé–“，其藥物許å¯è‰æœ‰æ•ˆæœŸé–“屆滿，ä»æ¬²ç¹¼çºŒä½¿ç”¨è€…，應於期é™ä¹‹å…§å‚™æ–‡åˆ—明å„該藥物å稱ã€è¨±å¯å—號，å‘æœ¬ç½²å‚™æ¡ˆï¼Œä¿Ÿæ ¸å‡†å¾©æ¥æ™‚補辦展延有效期間手續。</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€å‡¡å±¬ä¸è—¥è£½åŠ‘</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">包括以ä¸è—¥åŽŸæ–™ç‚ºä¸»è€…</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">è—¥å“，應按æ¯ä¸€ç¨®ï¼ŒåŠ 附「ä¸è—¥è£½åŠ‘申請æ›ç™¼è¨±å¯è‰è³‡æ–™è¡¨ã€å„一份。</span> </p><p><span style="font-family: 新細明體, serif;">五ã€ç¸£</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">市</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">åŠç›´è½„å¸‚è¡›ç”Ÿå±€æŸ¥æ ¸è—¥å•†ç”³è«‹è—¥ç‰©è¨±å¯è‰å±•å»¶æœ‰æ•ˆæœŸé–“案件，發ç¾å…¶è—¥å•†æ¥å·²æ‡æ¥æˆ–å—撤銷許å¯åŸ·ç…§è™•åˆ†è€…，應追繳其所有藥物許å¯è‰ï¼Œä¸¦å ±ä¸Šç´šè¡›ç”Ÿä¸»ç®¡æ©Ÿé—œã€‚å¦‚å…¶è—¥ç‰©å› é•åè¦å®š</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">或涉嫌案件</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">ä»å¾…繼續查處而未çµæ¡ˆè€…，應在藥商原é€ç”³è«‹æ›¸å·¦é‚Šã€Œè¡›ç”Ÿå±€åŠ è“‹ç« æˆ³æˆ–è¨»æ˜Žäº‹é …ã€æ¬„內載明案情，以便åƒè¾¦ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å…ã€æª¢é™„「藥物輸入</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">è£½é€ </span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">許å¯è‰å±•å»¶æœ‰æ•ˆæœŸé–“申請書ã€åŠã€Œä¸è—¥è£½åŠ‘申請æ›ç™¼è¨±å¯è‰è³‡æ–™è¡¨ã€æ ¼å¼å„一份。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋公告Gonadotropin-releasing hormone促進劑類治療å‰åˆ—腺癌藥å“ä»¿å–®åŠ åˆŠè¦èªžç›¸é—œäº‹å®œè©³å¦‚附件2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4638&type=0
藥政管ç†é¡ž,藥事法行政解釋公告申請本署藥物ã€å«è—¥åŒ–粧å“查驗登記暨變更案件，請檢附產å“仿單ã€æ¨™ç±¤ä¹‹é›»å圖åƒæª”案相關事宜<p><span style="font-family: 新細明體, serif;">一ã€è‡ªæ°‘國</span><span style="font-family: calibri;">98</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">æ—¥èµ·ï¼Œå» å•†ç”³è«‹è—¥ç‰©æˆ–å«è—¥åŒ–粧å“之查驗登記暨涉åŠä»¿å–®ã€æ¨™ç±¤ã€å¤–ç›’åŠè—¥ç‰©å¤–觀變更之案件時，請檢附產å“仿單ã€æ¨™ç±¤ã€å¤–ç›’åŠè—¥ç‰©å¤–觀之電å圖åƒæª”案。以利藥物資料公開之推動與執行。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å‰è¿°é›»å圖åƒæª”案è¦æ ¼éœ€æ±‚如下列：</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">藥物ã€å«è—¥åŒ–粧å“之仿單ã€æ¨™ç±¤åŠå¤–ç›’é›»å圖åƒï¼š</span> </p><p><span style="font-family: 新細明體, serif;">１ã€ä¾ç…§é–±è®€é †åºæŽƒææˆæ¯å¼µè§£æžåº¦è‡³å°‘</span><span style="font-family: calibri;">300dpi</span><span style="font-family: 新細明體, serif;">之</span><span style="font-family: calibri;">JPEG</span><span style="font-family: 新細明體, serif;">圖åƒæª”案，色彩管ç†ä½¿ç”¨</span><span style="font-family: calibri;">sRGB</span><span style="font-family: 新細明體, serif;">色域空間。</span> </p><p><span style="font-family: 新細明體, serif;">ï¼’ã€</span><span style="font-family: calibri;">JPEG</span><span style="font-family: 新細明體, serif;">圖åƒæª”命å為阿拉伯數å—</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">碼：å‰</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">碼為è‰åˆ¥ã€ä¸</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">碼為è‰è™Ÿã€æœ«</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">ç¢¼ç‚ºå¼µæ•¸é †åº</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">以藥å“為例：衛署藥輸å—第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔åè¨ç‚º</span><span style="font-family: calibri;">020123450001</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">020123450002&hellip;</span><span style="font-family: 新細明體, serif;">；以醫療器æ為例：衛署醫器輸å—第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔åè¨ç‚º</span><span style="font-family: calibri;">060123450001</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">060123450002&hellip;)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">３ã€ä»¥è¨±å¯è‰å—號為單ä½è¨ç«‹è³‡æ–™å¤¾ï¼Œå…¶å…§éƒ¨è¨ç«‹å…©å€‹å資料夾將</span><span style="font-family: calibri;">&rdquo;</span><span style="font-family: 新細明體, serif;">仿單</span><span style="font-family: calibri;">&rdquo;</span><span style="font-family: 新細明體, serif;">åŠ</span><span style="font-family: calibri;">&rdquo;</span><span style="font-family: 新細明體, serif;">標籤ã€å¤–ç›’</span><span style="font-family: calibri;">&rdquo;</span><span style="font-family: 新細明體, serif;">之圖åƒæª”分別å˜æ”¾ï¼Œä¸¦ç‡’製æˆå…‰ç¢Ÿæª¢é™„於申請案件ä¸ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">藥物外觀電å圖åƒï¼Œä½¿ç”¨å°æœ‰</span><span style="font-family: calibri;">50mm</span><span style="font-family: 新細明體, serif;">å°ºè¦</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">實體比例</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">：</span><span style="font-family: calibri;">1)</span><span style="font-family: 新細明體, serif;">çš„ç°è‰²ç´™ä½œç‚ºèƒŒæ™¯ç´™ï¼Œæ‹æ”è¦æ ¼å¦‚後：</span> </p><p><span style="font-family: 新細明體, serif;">１ã€ç´™å¼µã€å°ºè¦ã€è—¥å“æ‹æ”比例皆為</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">：</span><span style="font-family: calibri;">1(</span><span style="font-family: 新細明體, serif;">ä¸å¯ç¸®å°æ”¾å¤§é¡é </span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">ï¼’ã€è£½æˆ</span><span style="font-family: calibri;">JPEG</span><span style="font-family: 新細明體, serif;">檔案後，æ¯å¼µåœ–åƒè§£æžåº¦é ˆæœ‰</span><span style="font-family: calibri;">180dpi</span><span style="font-family: 新細明體, serif;">以上，色彩管ç†ä½¿ç”¨</span><span style="font-family: calibri;">sRGB</span><span style="font-family: 新細明體, serif;">色域空間。</span> </p><p><span style="font-family: 新細明體, serif;">３ã€é ˆèƒ½å€åˆ¥è—¥å“æ£åé¢ï¼Œè—¥å“擺放以尺è¦</span><span style="font-family: calibri;">25mm</span><span style="font-family: 新細明體, serif;">處為ä¸é»ž</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">圖例如附件</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">ï¼”ã€éŒ 劑以尺è¦ä¸é»žç‚ºåŸºæº–，æ£åé¢å·¦å³æ“ºæ”¾</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">é•·åœ“æŸ±å½¢éŒ åŠ‘é™¤å¤–</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">５ã€é•·åœ“æŸ±å½¢éŒ åŠ‘ä¹‹ä¸é»žèˆ‡å°ºè¦ä¸é»žå°é½Šï¼Œä¾æ£åé¢ä¸Šä¸‹æ“ºæ”¾ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">ï¼–ã€è† 囊上下蓋接åˆè™•èˆ‡å°ºè¦ä¸é»žæˆä¸€ç›´ç·šï¼Œä¾åºä¸Šä¸‹æ“ºæ”¾ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">ï¼—ã€æª”案命å為阿拉伯數å—</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">碼：å‰</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">碼為è‰åˆ¥ã€ä¸</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">碼為è‰è™Ÿã€æœ«</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">ç¢¼ç‚ºå¼µæ•¸é †åº</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">以藥å“為例：衛署藥輸å—第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔åè¨ç‚º</span><span style="font-family: calibri;">020123450001</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">020123450002&hellip;</span><span style="font-family: 新細明體, serif;">；以醫療器æ為例：衛署醫器輸å—第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔åè¨ç‚º</span><span style="font-family: calibri;">060123450001</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">060123450002&hellip;)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">８ã€å®Œæˆä¹‹é›»å圖åƒæª”以光碟燒錄後附於申請案件ä¸ã€‚</span><span style="font-family: calibri;"></font></p></span></p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋公告å«Buflomedilæˆåˆ†è—¥å“之療效åŠå®‰å…¨æ€§å†è©•ä¼°ç›¸é—œäº‹å®œè©³å¦‚附件2013-12-16
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藥政管ç†é¡ž,藥事法行政解釋公告å«sibutramineæˆåˆ†è—¥å“安全å†è©•ä¼°æœªç²é€šéŽï¼Œå»¢æ¢è©²æˆåˆ†è—¥å“許å¯è‰ç›¸é—œäº‹å®œè©³å¦‚附件2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4646&type=0
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藥政管ç†é¡ž,藥事法行政解釋公告å«æ°«é›¢å幫浦抑制劑〈proton pump inhibitors,PPI〉æˆåˆ†è—¥å“ä»¿å–®åŠ åˆŠæ³¨æ„äº‹é …ç›¸é—œäº‹å®œè©³å¦‚é™„ä»¶2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4650&type=0
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藥政管ç†é¡ž,藥事法行政解釋公告氫離å幫浦抑制劑〈proton pump inhibitors,PPIs〉藥å“ä»¿å–®åŠ åˆŠè¦èªžç›¸é—œäº‹å®œè©³å¦‚附件2013-12-16
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查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記,指示藥å“審查基準,胃腸製劑,眼用製劑,解熱鎮痛劑,綜åˆæ„Ÿå†’è—¥,瀉藥,鎮咳祛痰劑,驅蟲劑,鎮暈劑,抗éŽæ•åŠ‘,指示藥å“審查基準-一般皮膚外用劑,西藥åŠé†«ç™‚器æ查驗登記審查費收費標準,藥物資料公開辦法,æ–°åž‹æµæ„Ÿç–«è‹—查驗登記指引,æ ¸é†«æ”¾å°„æ€§è—¥å“審查基準,生物相似性藥å“查驗登記技術性資料審查é‡é»žè¡¨,æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記療效åŠå®‰å…¨æ€§ä¹‹è€ƒé‡é‡é»ž,原料藥主檔案(DMF)æ ¸å‚™åŠåœ‹ç”¢åŽŸæ–™è—¥æŸ¥é©—登記精實é€å¯©æ–‡ä»¶è³‡æ–™,新藥查驗登記精簡審查程åº,新藥查驗登記優先審查機制,國產創新藥å“查驗登記專案試辦計畫行政解釋公告藥物或å«è—¥åŒ–粧å“許å¯è‰æŒæœ‰è€…，授權他人輸入å„該產å“，應å‘æœ¬ç½²å ±å‚™<p><span style="font-family: 新細明體, serif;">為é…åˆé€šé—œè‡ªå‹•åŒ–作æ¥ï¼Œä¸¦æ¸›å°‘æµ·é—œå¯©æ ¸æŽˆæ¬Šæ–‡ä»¶æ™‚åˆ¤æ–·ä¸Šä¹‹å›°æ“¾æˆ–éŒ¯èª¤ï¼Œå ±å‚™ç¨‹åºï¼Œè¦å®šå¦‚下：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å‡¡è—¥ç‰©è¨±å¯è‰æˆ–å«è—¥åŒ–粧å“許å¯è‰ä¹‹æŒæœ‰è€…，授權他人輸人å„該產å“時，å‡æ‡‰æª¢å…·ã€ŒæŽˆæ¬Šè¼¸å…¥è—¥ç‰©æˆ–å«è—¥åŒ–粧å“å ±å‚™ç”³è«‹æ›¸ã€ï¼Œå¡«å¦¥è—¥ç‰©è¨±å¯è‰æˆ–å«è—¥åŒ–粧å“許å¯è‰ä¹‹å—號ã€è¢«æŽˆæ¬Šè€…之藥商許å¯åŸ·ç…§å—號ã€è¢«æŽˆæ¬Šè€…之公å¸æˆ–å·¥å» å稱ã€è¢«æŽˆæ¬Šè€…營利事æ¥ç™»è¨˜è‰çµ±ä¸€ç·¨è™Ÿã€æŽˆæ¬Šæ—¥æœŸç‰è³‡æ–™ï¼Œé€£åŒä¸Šè¿°è‰ç…§ä¹‹å½±å°æœ¬å„ä¹™ä»½ï¼Œç”³è«‹æœ¬ç½²æ ¸å‚™ï¼Œç¶“æœ¬ç½²æ ¸å‡†ç°½å¯©æ–‡ä»¶ç·¨è™Ÿï¼ˆå四碼）後，供為輸入通關使用。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€çŸæœŸæŽˆæ¬Šã€å–®æ¬¡æŽˆæ¬Šã€æŽˆæ¬Šçµ‚æ¢æˆ–授權變更，å‡æ‡‰ä¾ç…§å‰é …è¦å®šç”³è«‹æœ¬ç½²æ ¸å‚™ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€è¼¸å…¥ç®¡åˆ¶è—¥å“者，應請é€æ‰¹æª¢å…·æŽˆæ¬Šè¼¸å…¥ä¹‹ç›¸é—œè³‡æ–™ï¼Œå‘本署管制藥å“管ç†å±€ï¼Œç”³è«‹è¼¸å…¥åŒæ„書，並以輸入åŒæ„書編號（å四碼），作為簽審文件編號，ä¾ç®¡åˆ¶è—¥å“管ç†æ¢ä¾‹ç›¸é—œè¦å®šï¼Œè¾¦ç†è¼¸å…¥é€šé—œäº‹å®œã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å«é›™ç£·é…¸é¹½é¡ž(Bisphosphonates)æˆåˆ†è—¥å“å†è©•ä¼°çµæžœç›¸é—œäº‹å®œå…¬å‘ŠPDF檔詳如附件2013-12-16
藥政管ç†é¡ž,藥事法行政解釋世界衛生組織函告有關「日本政府宣佈ä¸é©ç”¨è—¥å“4,4'-DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE一種ã€ä»¤å¸ŒçŸ¥ç…§è½‰é£åŠ 強注æ„。<p><span style="font-family: 新細明體, serif;">一ã€å‡†ä¸–界衛生組織本年三月二å一日函，為日本政府æ供有關</span><span style="font-family: calibri;">4,4'- DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE </span><span style="font-family: 新細明體, serif;">è—¥å“ä¸é©ç”¨ä¹‹å ±å‘Šï¼Œç•¥ä»¥ã€Œä¸€ä¹ä¸ƒâ—‹å¹´å一月日本å¥åº·ç¦åˆ©éƒ¨è£½è—¥çµ„接ç²å…¶å°ˆé–€æ供藥å“å作用之一ä¹äºŒæ‰€é†«é™¢ä¸ä¹‹ä¸€æ‰€é†«é™¢å ±å‘Šï¼Œé—œæ–¼</span><span style="font-family: calibri;"> 4,4'- DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE </span><span style="font-family: 新細明體, serif;">è—¥å“所引起如脂肪éŽå¤šç—‡……ç‰ç‰æ–°çš„å作用，æ¤é¡žå應並經作動物實驗è‰å¯¦ã€‚åˆæ¤é …å ±å‘Šç¶“é€šçŸ¥å„製藥商後å‡è¡¨é‡è¦–，並決定將市é¢ä¸Šæ¤é¡žè—¥å“刪除，åŒæ™‚å°‡æ¤ä½œç”¨ä¹‹å ±å‘Šæ供政府。日本政府接ç²è£½è—¥å•†åŠè—¥äº‹å¯©è°å§”員會ç‰ä¹‹å ±å‘Šå¾Œï¼Œå·²æ±ºå®šä¸å†æ ¸å‡†æ¤é …è—¥å“之許å¯è‰ï¼Œå„è—¥å•†äº¦æ±ºå®šåœ¨å·²æ ¸å‡†ä¹‹ç”¢å“目錄ä¸å°‡è©²è—¥åˆªåŽ»ã€‚ã€ç‰ç”±ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€èŒ²ç‚ºç¶è·åœ‹æ°‘å¥åº·èµ·è¦‹ï¼Œæª¢ç™¼ä¸–界衛生組織來函之影å°æœ¬ä¸€ä»½ï¼Œå¸Œå³è½‰é£å„有關醫療團體å°è©²è—¥å“</span><span style="font-family: calibri;"> 4,4'- DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE </span><span style="font-family: 新細明體, serif;">åŠ å¼·æ³¨æ„使用。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å¸æ³•é™¢é‡‹å—第376號解釋文<span style="font-family: 新細明體, serif;">化å¸åˆæˆéº»é†‰è—¥å“é¡žåŠå…¶è£½åŠ‘為麻醉藥å“管ç†æ¢ä¾‹æ‰€ç¨±éº»é†‰è—¥å“之一種，為åŒæ¢ä¾‹ç¬¬äºŒæ¢ç¬¬å››æ¬¾æ‰€æ˜Žå®šã€‚安éžä»–命係以化å¸åŽŸæ–™åˆæˆè€Œå…·æœ‰æˆç™®æ€§ä¹‹è—¥å“，行政院衛生署ä¸è¯æ°‘國七åä¹å¹´å月ä¹æ—¥è¡›ç½²è—¥å—第ä¹â—‹å››ä¸€å››äºŒè™Ÿå…¬å‘Šï¼Œå°‡å®‰éžä»–命列入麻醉藥å“管ç†æ¢ä¾‹æ‰€ç¨±åŒ–å¸åˆæˆéº»é†‰è—¥å“類，係在公告確定其列為管ç†ä¹‹é …目，並éžå¢žåˆ—處罰è¦å®šæˆ–å¢žåŠ äººæ°‘ä¹‹ç¾©å‹™ï¼Œèˆ‡æ†²æ³•ä¸¦ç„¡ç‰´è§¸ã€‚</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å¸æ³•é™¢é‡‹å—第404號解釋文<span style="font-family: 新細明體, serif;">憲法第å五æ¢è¦å®šäººæ°‘之工作權應予ä¿éšœï¼Œæ•…人民得自由é¸æ“‡å·¥ä½œåŠè·æ¥ï¼Œä»¥ç¶æŒç”Ÿè¨ˆã€‚惟人民之工作與公共ç¦ç¥‰æœ‰å¯†åˆ‡é—œä¿‚，為增進公共利益之必è¦ï¼Œå°æ–¼äººæ°‘從事工作之方法åŠæ‡‰å…·å‚™ä¹‹è³‡æ ¼æˆ–其他è¦ä»¶ï¼Œå¾—以法律為é©ç•¶ä¹‹é™åˆ¶ï¼Œæ¤è§€æ†²æ³•ç¬¬äºŒå三æ¢è¦å®šè‡ªæ˜Žã€‚醫師法為強化專æ¥åˆ†å·¥ã€ä¿éšœç—…人權益åŠå¢žé€²åœ‹æ°‘å¥åº·ï¼Œä½¿ä¸åŒé†«è¡“é ˜åŸŸä¹‹é†«å¸«æ供專精之醫療æœå‹™ï¼Œå°‡é†«å¸«å€åˆ†ç‚ºé†«å¸«ã€ä¸é†«å¸«åŠç‰™é†«å¸«ã€‚醫療法第四å一æ¢è¦å®šé†«ç™‚æ©Ÿæ§‹ä¹‹è² è²¬é†«å¸«æ‡‰ç£å°Žæ‰€å±¬é†«äº‹äººå“¡ä¾å„該醫事專門è·æ¥æ³•è¦è¦å®šåŸ·è¡Œæ¥å‹™ï¼Œå‡å±¬å¢žé€²å…¬å…±åˆ©ç›Šæ‰€å¿…è¦ã€‚ä¸é†«å¸«ä¹‹é†«ç™‚行為應ä¾ä¸åœ‹å‚³çµ±ä¹‹é†«è¡“為之，若ä¸é†«å¸«ä»¥ã€Œé™é†«å¸«æŒ‡ç¤ºä½¿ç”¨ã€ä¹‹è¥¿è—¥è£½åŠ‘或西藥æˆè—¥è™•æ–¹ï¼Œç‚ºäººæ²»ç—…，顯éžä»¥ä¸åœ‹å‚³çµ±é†«è¡“為醫療方法，有é•é†«å¸«å°ˆæ¥åˆ†é¡žä¹‹åŽŸå‰‡åŠç—…人å°ä¸é†«å¸«ä¹‹ä¿¡è³´ã€‚行政院衛生署七å一年三月å八日衛署醫å—第三七○一å…七號函釋：「三ã€ä¸é†«å¸«å¦‚使用『é™é†«å¸«æŒ‡ç¤ºä½¿ç”¨ã€ä¹‹è¥¿è—¥è£½åŠ‘ï¼Œæ ¸ç‚ºé†«å¸«æ¥å‹™ä¸Šä¹‹ä¸æ£ç•¶è¡Œç‚ºï¼Œæ‡‰ä¾é†«å¸«æ³•ç¬¬äºŒå五æ¢è¦å®šè«–處。四ã€è¥¿è—¥æˆè—¥ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•ä¹‹è¦å®šï¼Œå…¶ä¸å¾…醫師指示，å³å¯ä¾›æ²»ç™‚疾病。故使用西藥æˆè—¥ç‚ºäººæ²»ç—…ï¼Œæ ¸éžä¸é†«å¸«ä¹‹æ¥å‹™ç¯„åœã€‚ã€è¦åœ¨é—¡é‡‹ä¸é†«å¸«ä¹‹æ¥å‹™ç¯„åœï¼Œç¬¦åˆé†«å¸«æ³•åŠé†«ç™‚法之立法æ„旨，與憲法ä¿éšœå·¥ä½œæ¬Šä¹‹è¦å®šï¼Œå°šç„¡ç‰´è§¸</span>2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=535&type=0
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署å…å五年三月八日衛署藥å—第一○一四一五號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">以「æèŠã€è£½æˆä¹‹è€å˜é£²æ–™ï¼ŒæŒ‰é£Ÿå“管ç†ï¼Œå‡†äºˆè£½å”®ï¼ŒæƒŸåŒæ™‚摻用其他ä¸è—¥æ或藥å“者，應ä¾è—¥å“管ç†ï¼Œå¾©è«‹ã€€æŸ¥ç…§ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：復貴處å…å五年一月二å三日衛四å—第○七一一七號函。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋市售åŠå˜åº«èˆŠåŒ…è£è—¥å“，ä»æ‡‰æ–¼å…å二年三月底å‰å…¨éƒ¨æ¸…點收回，一律改æ›æ–°åŒ…è£ï¼Œé•è€…按其情節ä¾æ³•è™•ç†<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">62.01.31.</span><span style="font-family: 新細明體, serif;">çœè—¥èª¿ç¸½å—第</span><span style="font-family: calibri;">008</span><span style="font-family: 新細明體, serif;">號申請書已悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥æ›è‰å¾Œä¹‹èˆŠåŒ…è£è—¥å“，原è¦å®šåœ¨æ–°è¨±å¯è‰ç”Ÿæ•ˆä¸€å¹´å…§æœªå”®å®Œè€…，應自第二年起æ›æ–°åŒ…è£ã€‚而藥å“許å¯è‰è‡ªäº”å八年開始æ›ç™¼ä»¥ä¾†ï¼Œè¿„å·²æ·æ™‚數載；å³</span> <span style="font-family: 新細明體, serif;">貴會å…åå¹´ä¹æœˆé–“建è°è—¥å“舊包è£å‡†äºˆç¹¼çºŒä½¿ç”¨ä¸€å¹´ï¼Œäº¦é€¾è¶Šé™æœŸã€‚å» å•†æ¥è€…，ç†æ‡‰æ—©æ—¥å®Œæˆæ”¹æ›æ–°åŒ…è£ï¼Œè©Žç›®å‰å¸‚售藥å“，發ç¾ä»æœ‰ç¹¼çºŒä½¿ç”¨èˆŠåŒ…è£ï¼Œå½±éŸ¿è—¥æ”¿ç®¡ç†è‡³é‰…ã€‚èŒ²ç‚ºåŠ å¼·æª¢è‚…å½åŠ£ç¦è—¥ï¼Œç¶è·åœ‹æ°‘å¥åº·ï¼Œæ‰€è«‹å†äºˆå±•å»¶èˆŠåŒ…è£è—¥å“收回期é™ä¸€ç¯€ï¼Œæœªä¾¿åŒæ„。ä»æ‡‰åˆ‡å¯¦ç…§æœ¬ç½²</span><span style="font-family: calibri;">61.12.27.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;"> 16490</span><span style="font-family: 新細明體, serif;">號令辦ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€å‰¯æœ¬æŠ„é€è‡ºç£å€è£½è—¥å·¥æ¥åŒæ¥å…¬æœƒã€è‡ºåŒ—市藥å“調製商æ¥åŒæ¥å…¬æœƒï¼ŒæŠ„發臺ç£çœæ”¿åºœè¡›ç”Ÿè™•ã€è‡ºåŒ—市政府衛生局ã€æœ¬ç½²è—¥æ”¿è™•ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋æˆå…¬å‘Šå«Gadoliniumæˆåˆ†é¡¯å½±åŠ‘è—¥å“安全性å†è©•ä¼°çµæžœç›¸é—œäº‹å®œè©³å¦‚附件2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹æœ‰é—œè£½é€ è—¥å“標明有效期é™ä¸€æ¡ˆå¾©å¸ŒçŸ¥ç…§<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.7.22.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">02074</span><span style="font-family: 新細明體, serif;">號呈件å‡æ‚‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è£½é€ è—¥å“ï¼Œé™¤æŠ—ç”Ÿç´ åŠç”Ÿç‰©è£½åŠ‘é ˆåœ¨åŒ…è£ä¸ŠåˆŠè¼‰æœ‰æ•ˆæœŸé–“外，其他藥å“尚無註明有效期é™ä¹‹è¦å®šï¼Œä½†ä»é ˆæ¨™æ˜Žè£½é€ 年月日或批號ç‰ï¼Œä»¥åˆ©æŸ¥æ ¸ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院ä¹åäºŒå¹´äº”æœˆä¸ƒæ—¥é™¢æŽˆç ”ç®¡å—第09200104262號函（公文書橫å¼æ›¸å¯«æŽ¨å‹•æ–¹æ¡ˆï¼‰<p><span style="font-family: 新細明體, serif;">一ã€è—¥å“ã€é†«ç™‚器æã€å«è—¥åŒ–粧å“和化粧å“è‰²ç´ ç”³è«‹æ›¸è¡¨æ–°è¦æ ¼ï¼š</span><span style="font-family: calibri;">A4</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">80</span><span style="font-family: 新細明體, serif;">ç£…æ¨¡é€ ç´™ï¼Œé•·äºŒåä¹ï¼Žä¸ƒå…¬åˆ†ï¼Œå¯¬äºŒå一公分，內容為白底黑å—ç›´å¼æ©«æ›¸é›»è…¦æ£æ¥·åˆ—å°ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€è¡Œæ”¿é™¢è¡›ç”Ÿç½²è—¥å“ã€é†«ç™‚器æã€å«è—¥åŒ–粧å“ã€åŒ–粧å“è‰²ç´ è¨±å¯è‰æ–°è¦æ ¼ç‚ºï¼š</span><span style="font-family: calibri;">A4</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">150</span><span style="font-family: 新細明體, serif;">ç£…æ¨¡é€ ç´™ï¼Œé•·äºŒåä¹ï¼Žä¸ƒå…¬åˆ†ï¼Œå¯¬äºŒå一公分，內容文為直å¼æ©«æ›¸é›»è…¦æ£æ¥·åˆ—å°ï¼Œä¸‹æ–¹åŠ 蓋本署關防，è‰æ›¸èƒŒé¢ç‚ºè®Šæ›´äº‹é …記錄。å„類許å¯è‰é¡è‰²å€åˆ†å¦‚下：藥å“許å¯è‰ç‚ºé»ƒè‰²ã€å¤–銷專用藥å“許å¯è‰ç‚ºè‰ç¶ 色ã€ç´°èŒå¸å…疫製å“許å¯è‰ç‚ºæ·ºç¶ 色ã€å«è—¥åŒ–粧å“許å¯è‰ç‚ºç²‰ç´…色ã€ç¬¬ä¸€ç‰ç´šé†«ç™‚器æ許å¯è‰ç‚ºæ·ºæ©˜è‰²ã€ç¬¬äºŒã€ä¸‰ç‰ç´šé†«ç™‚器æ許å¯è‰ç‚ºæ©˜è‰²ã€å¤–銷醫療器æ許å¯è‰ç‚ºæ·ºæ·ºæ©˜è‰²ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署93å¹´2月25日衛署藥å—第0930300018號函<p><span style="font-family: 新細明體, serif;">主　　旨：修æ£ã€Œè—¥å±€è¨ç½®ä½œæ¥æ³¨æ„äº‹é …ã€å¦‚附件，並自å³æ—¥èµ·å¯¦æ–½ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€ã€Œè—¥å±€è¨ç½®ä½œæ¥æ³¨æ„äº‹é …ã€ç¶“本署ä¹å一年å月二å一日衛署藥å—第○ä¹ä¸€â—‹â—‹å…四七一ä¹è™Ÿå…¬å‘Šï¼Œä¹å二年五月å…日衛署藥å—第○ä¹äºŒâ—‹ä¸‰ä¸€å…五五○號修æ£å…¬å‘Šåœ¨æ¡ˆã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€ä¹å一年å月二å一日公告å‰å·²è¨ç«‹ä¹‹è—¥å±€ï¼Œå¾—繼續ä¾åŽŸç”³è«‹ä¹‹è¦å®šè¾¦ç†ï¼Œä¸é©ç”¨è©²æ³¨æ„äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">附　　件：</span> <span style="font-family: 新細明體, serif;">藥局è¨ç½®ä½œæ¥æ³¨æ„äº‹é …</span> </p><p><span style="font-family: 新細明體, serif;">一ã€è—¥å±€è¨ç«‹ï¼Œæ‡‰ä¾è—¥äº‹æ³•ä¹‹è¦å®šï¼Œç”±è—¥å¸«æˆ–藥劑生親自主æŒï¼Œä¾æ³•åŸ·è¡Œè—¥å“調劑ã€ä¾›æ‡‰åŠå…¼ç‡Ÿè—¥å“零售æ¥å‹™ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€è—¥å±€è¨ç½®ç¸½é¢ç©éœ€æœ‰å八平方公尺以上，其空間應有調劑處所ã€å€™è—¥å€ã€å—ç†è™•æ–¹ç®‹èˆ‡éžè™•æ–¹è—¥å“供應å€åŠè—¥äº‹è«®è©¢æœå‹™å€ï¼Œä½†ä¸åŒ…å«å»æ‰€åŠå€‰åº«ç‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€è—¥å±€è¨ç½®ä¹‹èª¿åŠ‘處所，至少應有å…平方公尺之作æ¥é¢ç©ï¼Œå…¶ç’°å¢ƒè¨æ–½æ‡‰ç¬¦åˆå„ªè‰¯è—¥å“調劑作æ¥è¦ç¯„（</span><span style="font-family: calibri;">GDP</span><span style="font-family: 新細明體, serif;">）之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€è—¥å±€ä¸å¾—在醫療機構內，以隔間方å¼è¨ç½®ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">五ã€è—¥å±€ç”³è«‹è¨ç«‹ï¼Œå¦‚與其他營æ¥ã€åŸ·æ¥å–®ä½æˆ–機構åŒä¸€æ¨“層或åŒä¸€é–€ç‰Œåœ°å€ï¼Œæ‡‰å…·å‚™å„自ç¨ç«‹å‡ºå…¥é–€æˆ¶åŠæ˜Žé¡¯å€éš”之æ¢ä»¶ï¼Œä¸”藥事æœå‹™ä½œæ¥æ‡‰ç¨ç«‹é€²è¡Œï¼Œæ°‘眾進出互ä¸å½±éŸ¿ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å…ã€è—¥å±€è¨ç«‹æ‡‰æœ‰æ˜Žé¡¯å¸‚招，如屬å¥ä¿ç‰¹ç´„藥局，應有全民å¥åº·ä¿éšªé†«äº‹æœå‹™æ©Ÿæ§‹æ¨™èªŒã€‚</span> </p><p><span style="font-family: 新細明體, serif;">七ã€ï¼ˆåˆªé™¤ï¼‰</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署96å¹´1月23日衛署藥å—第0950064131號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關貴公å¸å‡½è«‹é‡‹ç¤ºé†«ç™‚院所直接購買</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">度酒精，å†ç”±è—¥å¸«æˆ–藥劑生自行稀釋為</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">消毒酒精，作為肌膚ã€æ‰‹éƒ¨åŠå™¨çš¿ã€å™¨æ¢°ç‰æ¸…æ½”ã€æ¶ˆæ¯’ã€æŠ—èŒä¹‹ç”¨é€”，是å¦é•å藥事法或其他相關法è¦ä¹‹ç–‘義乙案，復請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´å…¬å¸</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">08</span><span style="font-family: 新細明體, serif;">æ—¥ç¥å—第</span><span style="font-family: calibri;">0951208302</span><span style="font-family: 新細明體, serif;">號函，兼復生發貿易股份有é™å…¬å¸</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">11</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">27</span><span style="font-family: 新細明體, serif;">日發å—第</span><span style="font-family: calibri;">0951127102</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ¡ˆå…§</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">度酒精，ä¸ä»¥äººç”¨è—¥å“列管，其管ç†è«‹åƒç…§è²¡æ”¿éƒ¨å…¬å¸ƒä¹‹ã€Œæœªè®Šæ€§é…’精管ç†è¾¦æ³•ã€ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€æœ‰é—œ</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">酒精製劑之管ç†ï¼š</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">作為醫療用途，如殺èŒã€æ¶ˆæ¯’ã€æ‰‹è¡“å‰æ¶ˆæ¯’ç‰ç”¨é€”之</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">消毒酒精製劑，應以藥å“列管。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">若作為一般手部ã€çš®è†šæ¸…潔用途（éžé†«ç™‚用途），å«</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">酒精產å“，得以一般商å“列管，惟ä¸å¾—宣稱醫療效能（如：殺èŒã€æ¶ˆæ¯’ç‰ï¼‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">酒精基於醫療作æ¥æ¶ˆæ¯’抗èŒç¨‹åºä¹‹ç”¨ï¼Œæ‡‰ç”±é†«ç™‚之人員管控，其由醫院藥局以</span><span style="font-family: calibri;">95%</span><span style="font-family: 新細明體, serif;">酒精調é…，應無ä¸å¯ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署97å¹´1月2日衛署藥å—第0960053982號函<p><span style="font-family: 新細明體, serif;">主</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">旨：檢陳轄內○○藥å“有é™å…¬å¸è²©å”®ä¹‹ã€Œ</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三åˆä¸€â—‹â—‹éŒ ã€ç”¢å“（本</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">署藥物食å“檢驗局檢驗çµæžœæª¢å‡º</span><span style="font-family: calibri;">7-Keto-dehydroepiandrosterone</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> Synephrine</span><span style="font-family: 新細明體, serif;">åŠ</span><span style="font-family: calibri;">Caffeine</span><span style="font-family: 新細明體, serif;">ç‰æˆåˆ†ï¼‰ï¼Œå‡½è«‹é‡‹ç¤ºå…¶ç”¢å“屬性ç‰ä¹™æ¡ˆï¼Œå¾©è«‹ã€€</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´å±€</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">14</span><span style="font-family: 新細明體, serif;">日北市衛藥食å—第</span><span style="font-family: calibri;">09639071000</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥æ¡ˆå…§ã€Œ</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三åˆä¸€â—‹â—‹éŒ ã€ç”¢å“，æ¥ç¶“本署藥物食å“檢驗局檢驗çµæžœï¼šæª¢å‡º</span><span style="font-family: calibri;">7-Keto-dehydroepiandrosterone</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">Synephrine</span><span style="font-family: 新細明體, serif;">åŠ</span><span style="font-family: calibri;">Caffeine</span><span style="font-family: 新細明體, serif;">ç‰æˆåˆ†ï¼Œç¶“查本署目</span> <span style="font-family: 新細明體, serif;">å‰å°æ–¼å«</span><span style="font-family: calibri;">dehydroepiandrosterone</span><span style="font-family: 新細明體, serif;">æˆåˆ†å£æœåŠ‘型之管ç†ï¼Œç¶“審慎評估，ä¸ä»¥äººç”¨è—¥å“列管，ä¸å¾—宣稱醫療效能；惟本件被檢出å«</span><span style="font-family: calibri;">Caffeine</span><span style="font-family: 新細明體, serif;">åŠ</span><span style="font-family: calibri;">Synephrine</span><span style="font-family: 新細明體, serif;">，ä¾æ¡ˆå…§æœ¬ç½²è—¥ç‰©é£Ÿå“檢驗局</span><span style="font-family: calibri;">96.11.12</span><span style="font-family: 新細明體, serif;">藥檢åƒå—第</span><span style="font-family: calibri;">0960000920</span><span style="font-family: 新細明體, serif;">è™Ÿå ±å‘Šæ›¸è¨˜è¼‰ã€Œ</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三åˆä¸€â—‹â—‹éŒ ã€æ¨™ç¤ºå«ç¶ 茶èƒå–物（</span><span style="font-family: calibri;">Green tea extract</span><span style="font-family: 新細明體, serif;">）åŠæŸ‘橘èƒå–物ã€</span><span style="font-family: calibri;">Citrus aurantium extract 200mg</span><span style="font-family: 新細明體, serif;">（</span><span style="font-family: calibri;">Octopamin 150mg Synephrine 50mg</span><span style="font-family: 新細明體, serif;">）】，是å¦ç‚ºèŒ¶è‘‰åŠæŸ‘橘（</span><span style="font-family: calibri;">Citrus aurantium</span><span style="font-family: 新細明體, serif;">）ä¸ä¹‹å¤©ç„¶ä¾†æºæˆåˆ†ä¸æ˜Žã€‚倘若係天然來æºä¹‹å¾®é‡å˜åœ¨ä¸”未經純化精製者，ä¸ä»¥è—¥å“列管，ä¸å¾—å®£ç¨±é†«ç™‚æ•ˆèƒ½ï¼›è‹¥ä¿‚å¤–åŠ è€…ï¼Œä¾å…¶ä½œç”¨ï¼Œå‰‡ä»¥è—¥å“列管。</span> </p><p><span style="font-family: 新細明體, serif;">三ã€æª¢é‚„「</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三åˆä¸€â—‹â—‹éŒ ã€ç”¢å“檢體乙份。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署96å¹´6月12日衛署藥å—第0960321599號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關乙類æˆè—¥æ˜¯å¦æ‡‰é–‹æ”¾ç”±ç¶²è·¯å¹³å°éŠ·å”®ä¹™æ¡ˆï¼Œè«‹ã€€æƒ 賜å“見。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€ä¾æ“šâ—‹â—‹æ•¸ä½æ•´åˆè‚¡ä»½æœ‰é™å…¬å¸</span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">日康å—第</span><span style="font-family: calibri;">960601</span><span style="font-family: 新細明體, serif;">號函辦ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å› 乙類æˆè—¥ä¿‚安全性較高之藥å“，作用緩和，無ç©è“„性，è€ä¹…儲å˜ï¼Œä½¿ç”¨ç°¡ä¾¿ï¼Œä¸¦æ˜Žç¤ºå…¶æ•ˆèƒ½ã€ç”¨é‡ã€ç”¨æ³•ï¼Œæ¨™æ˜Žæˆè—¥è¨±å¯è‰å—號，其使用ä¸å¾…醫師指示，å³ä¾›æ²»ç™‚疾病之用者。為便於民眾自主å¥åº·ç®¡ç†ï¼Œæ˜¯æ•…，民國</span><span style="font-family: calibri;">81</span><span style="font-family: 新細明體, serif;">å¹´ä¿®æ£ä¹‹æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘管ç†è¾¦æ³•ç¬¬</span><span style="font-family: calibri;">16</span><span style="font-family: 新細明體, serif;">æ¢è¦å®šï¼Œä¹™é¡žæˆè—¥å¾—由百貨店ã€é›œè²¨åº—åŠé¤æ—…æœå‹™å•†å…¼ç‡Ÿé›¶å”®ï¼Œè‡ªç«‹æ³•åŽŸæ„è§€ä¹‹ï¼Œå› ç•¶æ™‚ä¸¦ç„¡ç¶²è·¯éŠ·å”®å¹³å°ä¹‹æ¦‚念，故應僅開放由實體店é¢è²©è³£ä¹™é¡žæˆè—¥ï¼Œç„¶è€Œæ™‚代進æ¥ï¼Œè™›æ“¬é€šè·¯äº¦ç‚ºå¸‚å ´ç¶“ç‡Ÿè¡ŒéŠ·ä¹‹ä¸€ï¼Œå¾—å¦é–‹æ”¾ç¶²è·¯å¹³å°éŠ·å”®ä¹™é¡žæˆè—¥ï¼Œè«‹ã€€æƒ 賜å“見。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署96å¹´8月10日衛署藥å—第0960031183號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關貴局檢é€è½„內○○ä¼æ¥æœ‰é™å…¬å¸éŠ·å”®ä¹‹ã€Œâ—‹â—‹æ¢…ã€ç”¢å“（經本署藥物食å“檢驗局檢驗çµæžœæª¢å‡ºå«</span><span style="font-family: calibri;">Sennoside 3.8mg/pack</span><span style="font-family: 新細明體, serif;">），函請釋疑其é•è¦æƒ…事應ä¾è—¥äº‹æ³•æŠ‘或食å“衛生管ç†æ³•ç›¸é—œè¦å®šè™•è¾¦ä¹™æ¡ˆï¼Œå¾©è«‹ã€€æŸ¥ç…§ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´å±€</span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">7</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">10</span><span style="font-family: 新細明體, serif;">日北市衛藥食å—第</span><span style="font-family: calibri;">09635313400</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ¡ˆå…§è²´å±€å‡½æ•˜ã€Ž……ä¾æ¡ˆå…§ç”¢å“標示使用已超éŽå·²è¶…éŽè©²å…¬å‘Šé™é‡ï¼ŒæƒŸæ¡ˆå…§ç”¢å“為一般梅å之醃漬食å“物並éžå¤§ç½²å‡½é‡‹ä¹‹ã€ŒèŒ¶åŒ…ã€ï¼Œè¬¹è«‹å¤§ç½²é‡‹ç–‘，本案將應ä¾è—¥äº‹æ³•æŠ‘或食å“衛生管ç†æ³•ç›¸é—œè¦å®šè™•è¾¦ã€‚ã€ä¹™ç¯€ï¼Œä¾æ“š</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">「番瀉（</span><span style="font-family: calibri;">Cassia angustifolia Vahl</span><span style="font-family: 新細明體, serif;">）ã€å…¶è‘‰èˆ‡èŽ¢éƒ¨ä½å¯ä¾›ç‚ºèŒ¶åŒ…ã€è†³é£Ÿèª¿ç†åŒ…或經èƒå–後作為飲料ã€éŒ ç‹€ã€è† 囊狀ã€ç²‰æœ«ç‹€ã€é¡†ç²’ç‹€ç‰é£Ÿå“之原料，惟其番瀉葉甘（</span><span style="font-family: calibri;">Sennoside</span><span style="font-family: 新細明體, serif;">）之æ¯æ—¥ä½¿ç”¨åŠ‘é‡ç‚º</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">毫克以下。且產å“應標示番瀉葉甘å«é‡ã€æ¯æ—¥å»ºè°é£Ÿç”¨é‡ï¼ŒåŠç›¸é—œä¹‹è¦èªžã€‚</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">本署</span><span style="font-family: calibri;">91</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">11</span><span style="font-family: 新細明體, serif;">日衛署藥å—第</span><span style="font-family: calibri;">0910020787</span><span style="font-family: 新細明體, serif;">號公告：「番瀉葉茶包之管ç†ç”¢å“標示或檢出å«ç•ªç€‰è‘‰ç”˜ï¼ˆ</span><span style="font-family: calibri;">Sennoside</span><span style="font-family: 新細明體, serif;">）æ¯æ—¥ä½¿ç”¨åŠ‘é‡ç‚º</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">毫克以上者，應以藥å“管熅…ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)Sennosides</span><span style="font-family: 新細明體, serif;">列屬本署</span><span style="font-family: calibri;">93</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">15</span><span style="font-family: 新細明體, serif;">日衛署藥å—第</span><span style="font-family: calibri;">0930309289</span><span style="font-family: 新細明體, serif;">號公告「指示藥å“審查基準瀉劑ã€ä¹‹æœ‰æ•ˆæˆåˆ†ä¹‹å“é …ã€‚ç¶œä¸Šï¼Œæ¡ˆå…§ç”¢å“應以藥å“管ç†ï¼Œé¡¯ç„¡ç–‘義，éžå› 醃漬食å“物與本署公告之「茶包ã€ï¼Œæœ‰æ‰€æ›´è¿ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€è‹¥å°±æ¡ˆå…§æ‰€è¿°ï¼Œè©²ç”¢å“係由「黃金梅（一般梅å醃漬製æˆï¼‰ã€ã€ã€Œä¹³é…¸èŒã€ã€ã€Œè—¤é»ƒæžœï¼ˆç¾…夢果）ã€ã€ã€Œæ˜Žæ—¥è‘‰ã€ã€ã€Œæ™®æ´±èŒ¶ã€ç‰åŽŸæ–™æ‰€è£½æˆï¼Œè€Œç„¡å¦å¤–æ·»åŠ ä½¿ç”¨ã€Œç•ªç€‰ï¼ˆè‘‰æˆ–èŽ¢ï¼‰ç²‰æœ«æˆ–å…¶èƒå–物ã€ï¼Œå‰‡ç”¢å“應ä¸è‡´æª¢å‡ºç•ªç€‰ç”˜æˆåˆ†ã€‚è‹¥æ¥è€…表示番瀉甘確為來自產å“åŽŸæ–™ï¼Œè€Œç„¡æ·»åŠ ã€Œç•ªç€‰ï¼ˆè‘‰æˆ–èŽ¢ï¼‰ç²‰æœ«æˆ–å…¶èƒå–物ã€ï¼Œå»ºè«‹æ¥è€…舉è‰èªªæ˜Žä¿‚來自何種原料。</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€æª¢é‚„原附之「○○梅ã€æª¢é«”乙份。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署96å¹´9月7日衛署藥å—第0960332676號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">æœ‰é—œã€€è²´å» å‡½è©¢è—¥äº‹æ³•åŠå…¶æ–½è¡Œç´°å‰‡ä¸ã€Œè‡ªè£½ç”¢å“ã€ä¹‹æ„義乙案，復如說明段，請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©ã€€è²´å» </span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">8</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">27</span><span style="font-family: 新細明體, serif;">日永釋藥å—第</span><span style="font-family: calibri;">096082701</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€è—¥å“ä¹‹è£½é€ ã€è¼¸å…¥æ‡‰ä¾è—¥äº‹æ³•ç¬¬</span><span style="font-family: calibri;">39</span><span style="font-family: 新細明體, serif;">æ¢ä¹‹è¦å®šï¼Œç”³è«‹æœ¬ç½²æŸ¥é©—ç™»è¨˜ï¼Œç¶“æ ¸å‡†ç™¼çµ¦è—¥å“許å¯è‰å¾Œï¼Œå§‹å¾—è£½é€ è¼¸å…¥ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€å¾©ä¾è—¥äº‹æ³•ç¬¬</span><span style="font-family: calibri;">16</span><span style="font-family: 新細明體, serif;">æ¢ã€ç¬¬</span><span style="font-family: calibri;">18</span><span style="font-family: 新細明體, serif;">æ¢è¦å®šï¼Œè—¥å“è£½é€ æ¥è€…係指經營藥å“ä¹‹è£½é€ ã€åŠ 工與其產å“批發ã€è¼¸å‡ºåŠè‡ªç”¨åŽŸæ–™è¼¸å…¥ä¹‹æ¥è€…，藥å“è£½é€ æ¥è€…，得兼營自製產å“之零售æ¥å‹™ï¼Œäº¦å³æ‰€ç¨±ã€Œè‡ªè£½ç”¢å“ã€ä¿‚該æ¥è€…ä¾è—¥äº‹æ³•ç¬¬</span><span style="font-family: calibri;">39</span><span style="font-family: 新細明體, serif;">æ¢è¦å®šæ ¸å‡†ç™¼çµ¦è¨±å¯è‰ï¼Œç¶“æ ¸å‡†è£½å”®ä¹‹è—¥å“æˆå“。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署96å¹´10月30日衛署藥å—第0960045629號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關「○○西藥房ã€å¸‚招是å¦ç¬¦åˆè¦å®šä¹™æ¡ˆï¼Œå¾©å¦‚說明段，請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©ã€€è²´å±€</span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">10</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">日雲衛藥å—第</span><span style="font-family: calibri;">0964000552</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å¸‚招所載之文å—係屬表見自由之範疇，其é™åˆ¶é ˆç¬¦åˆæ³•å¾‹ä¿ç•™åŠæ¯”例原則ç‰ï¼Œå¾©æŸ¥è—¥äº‹æ³•åŠå…¶æŽˆæ¬Šä¹‹æ³•è¦ï¼Œå°šç„¡å°±å¸‚招所載之文å—內容有所é™åˆ¶ï¼Œåƒ…藥局è¨ç½®ä½œæ¥æ³¨æ„äº‹é …ç¬¬</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">點è¦å®šã€Œè—¥å±€è¨ç«‹æ‡‰æœ‰æ˜Žé¡¯å¸‚招，如屬å¥ä¿ç‰¹ç´„藥局，應有全民å¥åº·ä¿éšªé†«äº‹æœå‹™æ©Ÿæ§‹æ¨™èªŒã€‚ã€ï¼Œåˆå…ˆæ•˜æ˜Žã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€è‹¥å…¶å¸‚招內容涉虛å½ä¸å¯¦æˆ–引人錯誤，為é¿å…誤導消費者，宜請　貴局視實際情æ³è¼”導藥商改善。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署96å¹´11月20日衛署藥å—第0960321933號令<p><span style="font-family: 新細明體, serif;">ä¾åœ°æ–¹åˆ¶åº¦æ³•ç¬¬å››æ¢ç¬¬äºŒé …之è¦å®šï¼Œè‡ºåŒ—縣å‡æ ¼ç‚ºæº–直轄市之後準用本署主管法è¦æœ‰é—œæ–¼ç›´è½„市è¦å®šè€…如後附，並自ä¸è¯æ°‘國ä¹åå…年五月二å五日生效。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">法è¦å稱</span> <span style="font-family: 新細明體, serif;">æ¢ã€é …ã€æ¬¾ã€ç›®</span> <span style="font-family: 新細明體, serif;">藥事法</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;">66</span><span style="font-family: 新細明體, serif;">æ¢ç¬¬</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">é …ã€ç¬¬</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">é …ã€ç¬¬</span><span style="font-family: calibri;">66</span><span style="font-family: 新細明體, serif;">æ¢ä¹‹</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">ã€ç¬¬</span><span style="font-family: calibri;">102</span><span style="font-family: 新細明體, serif;">æ¢ç¬¬</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">é …</span> <span style="font-family: 新細明體, serif;">藥事法施行細則</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;">38</span><span style="font-family: 新細明體, serif;">æ¢ã€ç¬¬</span><span style="font-family: calibri;">44</span><span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">化粧å“衛生管ç†æ¢ä¾‹</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;">24</span><span style="font-family: 新細明體, serif;">æ¢ç¬¬</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">é …ã€ç¬¬</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">é …</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署八å四年七月二å四日衛署藥å—第八四○四四å…â—‹ä¹è™Ÿå‡½<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關「é’è‰æ¹¯ã€å»£å‘Šä¹™æ¡ˆï¼ŒæŸ¥ä»¥æ°‘é–“é’è‰è—¥ä½œæˆèŒ¶åŒ…，得ä¸ä»¥è—¥å“管ç†ï¼ŒæƒŸä¸å¾—宣稱療效，復請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：復貴處八å四年七月å三日</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å…«å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">衛四å—第○五五○三八號函。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署97å¹´2月13日衛署藥å—第0970002523號函<p><span style="font-family: 新細明體, serif;">主　　旨：有關於「新世代產æ¥</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">法（è‰æ¡ˆï¼‰ã€ï¼Œæœ¬ç½²æ„見，ä»è«‹ã€€åƒæŽ¡ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©ã€€è²´éƒ¨</span><span style="font-family: calibri;">97</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">14</span><span style="font-family: 新細明體, serif;">日經授工å—第</span><span style="font-family: calibri;">09600669950</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æœ‰é—œç”¢æ¥ç™¼å±•åŸºæœ¬æ³•è‰æ¡ˆä¹‹æ³•å¾‹ä½éšŽï¼Œè«‹åƒè€ƒè¡Œæ”¿é™¢æ³•è¦å§”員會</span><span style="font-family: calibri;">92</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">17</span><span style="font-family: 新細明體, serif;">æ—¥å¬é–‹æ³•è¦è«®è©¢æœƒè°ï¼Œé—œæ–¼ã€ŒåŸºæœ¬æ³•ã€åˆ¶å®šä¹‹å¿…è¦æ€§ã€æ³•å¾‹ä½éšŽåŠè¦ç¯„效力疑義案所作æˆä¹‹æœƒè°çµè«–辦ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€ç”¢æ¥æ•´é«”æ€ç¶ç•¶ç„¶æœ‰å…¶å¿…è¦ï¼Œç„¶ç”¢æ¥ä¹‹ç™¼å±•ï¼Œå¸¸å› 涉åŠå±¤é¢ä¸åŒè€Œæœ‰ä¸åŒç®¡è½„，並éžæŸä¸€éƒ¨æœƒæ‰€èƒ½ç¨ç«‹å®Œæˆã€‚經查　貴部所擬之「新世代產æ¥</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">法ã€è‰æ¡ˆï¼Œäº¦å°‡ç”¢æ¥æ•´é«”與個別之特性，列為å„該法案é‡è¦å…§å®¹ï¼Œç‚ºé”事權統一ã€å°ˆæ¥åˆ†å·¥ä»¥åŠç°¡åŒ–行政æµç¨‹ç‰é …目的，本案建請ä»ä»¥ã€€è²´éƒ¨ä½œç‚ºç›¸é—œæ³•å¾‹æ¡ˆä¹‹ä¸»ç®¡æ©Ÿé—œï¼Œå†ç”±ã€€è²´éƒ¨æœƒåŒç›®çš„事æ¥ä¸»ç®¡æ©Ÿé—œï¼Œå°±å€‹åˆ¥ç”¢æ¥ä¹‹ç‰¹æ®Šæ€§ï¼Œå…±åŒæ“¬å®šç”¢æ¥ç™¼å±•ç–略，å”åŒå»ºç«‹åˆä½œæ©Ÿåˆ¶ï¼Œä»¥åˆ©è¡Œæ”¿è³‡æºä¹‹çµ±æ•´èˆ‡é‹ç”¨ã€‚如涉åŠæ©Ÿé—œè§’色之é‡æ–°å®šä½å•é¡Œï¼Œä¸¦è«‹è¡¡é…Œå„æ©Ÿé—œä¹‹ç‰¹æ€§ï¼Œæ•´é«”åŠ ä»¥å¯©æ…Žè€ƒé‡ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署97å¹´4月30日衛署藥å—第0970304896號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關å°ç£æŸæœ—è—¥å“股份有é™å…¬å¸ã€Œè‚ç´ éˆ‰æ³¨å°„æ¶²</span><span style="font-family: calibri;">5000</span><span style="font-family: 新細明體, serif;">國際單ä½ï¼å…¬æ’®ï¼ˆè¡›ç½²è—¥è¼¸å—第</span><span style="font-family: calibri;">018198</span><span style="font-family: 新細明體, serif;">號）ã€è—¥å“抽驗事宜，權責å€åˆ†åŠç®¡è½„çˆè°ä¹™æ¡ˆï¼Œè«‹ã€€æŸ¥ç…§ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€é—œæ–¼è—¥äº‹æ³•ç¨½æŸ¥åŠå–ç· ä¹‹ç›¸é—œäº‹é …ï¼Œæ‡‰ç”±è—¥å•†ç™»è¨˜åœ°ä¹‹ç›´è½„å¸‚æˆ–ç¸£ï¼ˆå¸‚ï¼‰è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œç®¡è½„ï¼Œæœ‰ç®¡è½„æ¬Šä¹‹åœ°æ–¹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¾—ä¾è¡Œæ”¿ç¨‹åºæ³•ä¹‹ç›¸é—œè¦å®šï¼Œè«‹æ±‚行為或物å“儲放地之地方衛生主管機關å”助辦ç†ï¼Œéžæœ‰æ£ç•¶ç†ç”±ä¸èƒ½å”助者ä¸å¾—拒絕。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€è‡³è¡Œç‚ºæˆ–物å“儲放地之地方衛生主管機關èªæœ‰å¿…è¦æ™‚，得請求有管轄權之地方衛生主管機關陪åŒé…åˆè¾¦ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署七å四年å…月一日衛署藥å—第五一七å…○三號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">艾葉æ‰è£½æˆè‰¾çµ¨æ‰€ä½œæˆä¹‹è£½å“，而使用於é‡ç¸è€…，應以藥å“管ç†ï¼Œè«‹ã€€æŸ¥ç…§ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：覆貴局七å四年二月å一日七四高市衛四å—第○三三五一號函。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署ä¹å一年三月å一日衛署藥å—第○ä¹ä¸€â—‹â—‹äºŒâ—‹ä¸ƒå…«ä¸ƒè™Ÿå…¬å‘Š<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">為有效管ç†å«ç•ªç€‰è‘‰ï¼ˆ</span><span style="font-family: calibri;">sennosides</span><span style="font-family: 新細明體, serif;">）產å“，é‡ç”³ç”¢å“標示或檢出å«ç•ªç€‰è‘‰ï¼ˆ</span><span style="font-family: calibri;">sennosides</span><span style="font-family: 新細明體, serif;">），æ¯æ—¥ä½¿ç”¨åŠ‘é‡ç‚ºå二毫克以上者，應以藥å“管ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">ä¾ã€€ã€€æ“šï¼šè—¥äº‹æ³•ç¬¬å…æ¢ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> <span style="font-family: 新細明體, serif;">番瀉葉茶包之管ç†ï¼Œç”¢å“標示或檢出å«ç•ªç€‰è‘‰ï¼ˆ</span><span style="font-family: calibri;">sennosides</span><span style="font-family: 新細明體, serif;">），æ¯æ—¥ä½¿ç”¨åŠ‘é‡ç‚ºå二毫克以上者，應以藥å“管ç†ã€‚上述處ç†åŽŸå‰‡ï¼Œå‰ç¶“本署八å八年七月二å八日衛署藥å—第八八○三七五七○號函知å„縣ã€å¸‚衛生局在案，特å†å…¬å‘Šå‘¨çŸ¥ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署ä¹å二年å一月四日署授藥å—第○ä¹äºŒâ—‹â—‹â—‹äºŒä¸‰äº”一號公告<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">公告處方內容å«ç´°è¾›ä¹‹ä¸è—¥è—¥å“許å¯è‰ï¼Œæ‡‰è‡ªå…¬å‘Šæ—¥èµ·ä¸€å€‹æœˆå…§ï¼Œå‘本署申請變更類別為ä¸é†«å¸«è™•æ–¹ç”¨è—¥åŠæ‡‰æ¨™ç¤ºæ³¨æ„äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">ä¾ã€€ã€€æ“šï¼šè—¥äº‹æ³•ç¬¬å…«æ¢ã€ç¬¬å››åå…«æ¢åŠå…¶æ–½è¡Œç´°å‰‡ç¬¬ä¸‰æ¢ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å…¬å‘Šäº‹é …ï¼š</span> <span style="font-family: 新細明體, serif;">一ã€åŽŸæ ¸å®šç‚ºã€Œæˆè—¥ã€ä¹‹ä¸è—¥è—¥å“許å¯è‰ï¼Œæ‡‰æª¢é™„左列資料辦ç†è®Šæ›´æ‰‹çºŒï¼š</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">變更登記申請書乙份：類別變更為「ä¸é†«å¸«è™•æ–¹ç”¨è—¥ã€ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">åŽŸæ ¸å‡†ä¸¦è“‹æœ‰é¨Žç¸«ç« ä¹‹æ¨™ç±¤ã€ä»¿å–®æ ¸å®šæœ¬ä¹™ä»½ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">標籤ã€ä»¿å–®åŠå¤–盒擬稿二份。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€åŽŸæ ¸å®šç‚ºã€Œä¸é†«å¸«è™•æ–¹ç”¨è—¥ã€ä¹‹ä¸è—¥è—¥å“許å¯è‰ï¼Œæ‡‰è‡ªè¡Œæ–¼æ¨™ç±¤ã€ä»¿å–®åŠå¤–盒，以粗黑å—é«”æˆ–åŠ ç´…æ¡†æ¨™ç¤ºã€Œæœ¬è£½åŠ‘å«é¦¬å…œéˆ´é…¸ï¼Œå¤§é‡é•·æœŸæœç”¨å¯èƒ½å°Žè‡´è…Žè¡°ç«ç‰å‰¯ä½œç”¨ã€ä¹‹æ³¨æ„äº‹é …ã€‚ä¸éœ€å‘æœ¬ç½²å ±å‚™ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署ä¹å年七月åä¹æ—¥è¡›ç½²è—¥å—第○ä¹â—‹â—‹â—‹å››ä¸ƒäºŒäº”å…號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關å°ç«¯å‡½è©¢è—¥äº‹æ³•ç¬¬å…æ¢ç¬¬ä¸€é …第一款所稱「公定之國家處方集ã€åŠç¬¬äº”åæ¢ç¬¬å…æ¢ç¬¬ä¸€é …第三款所稱「國民處方é¸é›†ã€ç‚ºä½•ï¼Ÿ</span> </p><p><span style="font-family: 新細明體, serif;">ç›®å‰æœ¬ç½²èªå®šä¹‹ã€Œå…¬å®šä¹‹åœ‹å®¶è™•æ–¹é›†ã€åŒ…括美國：</span><span style="font-family: calibri;">PDR</span><span style="font-family: 新細明體, serif;">（</span><span style="font-family: calibri;">Physician</span><span style="font-family: 新細明體, serif;">’</span><span style="font-family: calibri;">s Desk Reference</span><span style="font-family: 新細明體, serif;">）ã€è‹±åœ‹ï¼š</span><span style="font-family: calibri;">British National Formula</span><span style="font-family: 新細明體, serif;">，</span><span style="font-family: calibri;">ABPI</span><span style="font-family: 新細明體, serif;">ã€æ—¥æœ¬ï¼šæ—¥æœ¬é†«è—¥å“集（</span><span style="font-family: calibri;">Drugs in Japan</span><span style="font-family: 新細明體, serif;">）ã€ç‘žå£«ï¼š</span><span style="font-family: calibri;">Arzneimitte-Kompendium der Schweiz</span><span style="font-family: 新細明體, serif;">ã€åŠ 拿大：</span><span style="font-family: calibri;">Compendium of Pharmaceuticals and Specialities</span><span style="font-family: 新細明體, serif;">ã€æ³•åœ‹ï¼š</span><span style="font-family: calibri;">Dictionarie Vidale</span><span style="font-family: 新細明體, serif;">ã€æ¾³æ´²ï¼š</span><span style="font-family: calibri;">MIM</span><span style="font-family: 新細明體, serif;">’</span><span style="font-family: calibri;">s</span><span style="font-family: 新細明體, serif;">ã€å¾·åœ‹ï¼š</span><span style="font-family: calibri;">Rote List</span><span style="font-family: 新細明體, serif;">ã€æ¯”利時：</span><span style="font-family: calibri;">Repertoire Commente Des Medicaments</span><span style="font-family: 新細明體, serif;">ã€ç‘žå…¸ï¼š</span><span style="font-family: calibri;">FASS</span><span style="font-family: 新細明體, serif;">（</span><span style="font-family: calibri;">Farmacevtiska specialiteteri Sverige</span><span style="font-family: 新細明體, serif;">），以上書ç±å¯è‡³é†«å¸å°ˆæ¥æ›¸å±€æ´½è³¼ï¼›å¦æœ¬ç½²æ–¼ä¸ƒå七年出版「國民處方é¸é›†ã€ï¼Œè©²æ›¸ç±æœªå†å‡ºç‰ˆï¼Œå°ç«¯è‹¥æœ‰éœ€è¦ï¼Œå¯æ´½è¡›ç”Ÿç½²è—¥æ”¿è™•æŸ¥è©¢ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：復å°ç«¯ä¹å年七月å一日未列å—號號函。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署ä¹å年二月二å一日衛署ä¸æœƒå—第○ä¹â—‹â—‹â—‹ä¸€ä¸€ä¸ƒäºŒä¸ƒè™Ÿå…¬å‘Š<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">公告å«å»£é˜²å·±ã€é’木香ã€é—œæœ¨é€šã€å¤©ä»™è—¤åŠé¦¬å…œéˆ´ç‰ä¸è—¥æ之ä¸è—¥è—¥å“許å¯è‰ï¼Œæ‡‰æ–¼ä¹å一年二月二åå…«æ—¥å‰è®Šæ›´ç‚ºä¸é†«å¸«è™•æ–¹ç”¨è—¥åŠæ¨™ç¤ºæ³¨æ„äº‹é …ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">ä¾ã€€ã€€æ“šï¼šè—¥äº‹æ³•ç¬¬å…«æ¢ã€ç¬¬å››åå…«æ¢åŠè—¥äº‹æ³•æ–½è¡Œç´°å‰‡ç¬¬ä¸‰æ¢ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å…¬å‘Šäº‹é …ï¼š</span> <span style="font-family: 新細明體, serif;">一ã€åŽŸæ ¸ç‚ºã€Œæˆè—¥ã€ä¹‹ä¸è—¥è—¥å“許å¯è‰ï¼Œæ‡‰æª¢é™„左列資料辦ç†è®Šæ›´æ‰‹çºŒï¼š</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">變更登記申請書乙份：類別變更為「ä¸é†«å¸«è™•æ–¹ç”¨è—¥ã€ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">è—¥å“許å¯è‰æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">åŽŸæ ¸å‡†ä¸¦è“‹æœ‰é¨Žç¸«ç« ä¹‹æ¨™ç±¤ã€ä»¿å–®æ ¸å®šæœ¬ä¹™ä»½ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">查驗登記申請書æ£æœ¬ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">標籤ã€ä»¿å–®åŠå¤–盒擬稿二份。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€åŽŸæ ¸å®šç‚ºã€Œä¸é†«å¸«è™•æ–¹ç”¨è—¥ã€ä¹‹ä¸è—¥è—¥å“許å¯è‰ï¼Œæ‡‰è‡ªè¡Œæ–¼æ¨™ç±¤ã€ä»¿å–®åŠå¤–盒，以粗黑å—é«”æˆ–åŠ ç´…æ¡†æ¨™ç¤ºã€Œæœ¬è£½åŠ‘å«é¦¬å…œéˆ´é…¸ï¼Œå¤§é‡é•·æœŸæœç”¨å¯èƒ½å°Žè‡´è…Žè¡°ç«ç‰å‰¯ä½œç”¨ã€ä¹‹æ³¨æ„äº‹é …ã€‚ä¸éœ€å‘æœ¬ç½²å ±å‚™ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署ä¹å年五月åå…日衛署藥å—第○ä¹â—‹â—‹â—‹äºŒä¸‰äº”å…四號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">貴局函詢抽驗自屈臣æ°ç™¾ä½³è‚¡ä»½æœ‰é™å…¬å¸ä¹‹ã€Œä¹¾æ´—潔手å‡è† ã€ç”¢å“，是å¦å±¬ã€Œä¹™é¡žæˆè—¥ã€ç®¡ç†ä¹™æ¡ˆï¼Œå¾©å¦‚說明段二，請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´å±€ä¹å年四月å七日北市衛四å—第ä¹â—‹äºŒä¸€äº”å…七二○○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ¡ˆå…§è£½å“「乾洗潔手å‡è† “</span><span style="font-family: calibri;">Antibacterial Hand Gel</span><span style="font-family: 新細明體, serif;">”ã€å«</span><span style="font-family: calibri;">Alcohol denatured</span><span style="font-family: 新細明體, serif;">æˆåˆ†ï¼Œä¸¦å®£ç¨±</span><span style="font-family: calibri;">Antibacterial Hand Gel</span><span style="font-family: 新細明體, serif;">，應以藥å“列管。ä¾æ“šæœ¬ç½²å…«åä¹å¹´å››æœˆäº”日衛署藥å—第八ä¹â—‹ä¸€å…ä¹å…○號函，函知å„縣市衛生局，å«æœ‰ä»¥</span><span style="font-family: calibri;">Ethyl alcohol</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">Isopropyl alcohol</span><span style="font-family: 新細明體, serif;">為主æˆåˆ†ä¹‹çš®è†šå¤–用製劑（乾洗手製å“ï¼‰ï¼Œç¶“æœ¬ç½²æ ¸å®šåˆ—å±¬ã€Œä¹™é¡žæˆè—¥ã€ç®¡ç†ã€‚æ“šæ¤ï¼Œæœ¬æ¡ˆç”¢å“應å¯æ¯”照列屬「乙類æˆè—¥ã€ç®¡ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€æª¢é‚„所附檢體。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署八åä¹å¹´å月二å四日衛署藥å—第○八ä¹â—‹â—‹äºŒäºŒå››ä¸‰å…號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關貴局函詢貴轄進昌藥局除經營藥局æ¥å‹™å¤–，並以「藥å“供貨ä¸å¿ƒã€ä¹‹æ–¹å¼ä¾›æ‡‰è¨ºæ‰€åŠå…¶ä»–藥局，是å¦é•å藥事法或藥師法ç‰ç›¸é—œæ³•è¦ä¹™æ¡ˆï¼Œå¾©å¦‚說明段，請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´å±€å…«åä¹å¹´å月åå…日八ä¹é›²è¡›å››å—第一ä¹å››ä¸€â—‹è™Ÿå‡½ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŒ‰ã€Œè—¥å“供貨ä¸å¿ƒã€å¾žäº‹è—¥å“批發，應屬藥事法所稱之西藥販賣æ¥è€…，ä¾è—¥äº‹æ³•æ‡‰ç”³è«‹åœ°æ–¹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ç™»è¨˜ï¼Œå¦è¨å°ˆä»»è—¥å¸«é§åº—管ç†ï¼ŒæƒŸäºŒè€…è¨æ–¼åŒå€æ™‚，商å“應有明顯å€éš”。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署八å八年七月二å八日衛署藥å—第八八○三七五七○號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">有關番瀉葉茶包之管ç†ï¼ŒèŒ²é‡æ–°è¦å®šå¦‚åŽï¼Œè«‹ã€€æŸ¥ç…§ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€ç•ªç€‰è‘‰èŒ¶åŒ…之管ç†ï¼Œå»£å‘Šå„ªå…ˆè™•ç†ï¼Œå»£å‘Šå¦‚宣稱「減肥ã€ï¼Œå‰‡ä»¥é£Ÿå“衛生管ç†æ³•è™•ç½°ã€‚產å“部分，如未標示主æˆåˆ†ï¼Œåƒ…稱減肥茶，以食å“衛生管ç†æ³•è™•ç†ï¼›å¦‚標示番瀉葉ã€èŽ¢æžœæˆ–麘者，則ä¾æ¨™ç¤ºä¹‹å«é‡ã€ç”¨æ³•ã€ç”¨é‡åˆ¤å®šï¼Œæ¯æ—¥ä½¿ç”¨åŠ‘é‡ä»¥ç•ªç€‰è‘‰éº˜ï¼ˆ</span><span style="font-family: calibri;">Sennosides</span><span style="font-family: 新細明體, serif;">）計為å二毫克以上者，以藥å“管ç†ï¼Œæ¯æ—¥ä½¿ç”¨åŠ‘é‡æœªé”å二毫克，則ä¸ä»¥è—¥å“管ç†ï¼›å¦‚衛生局èªæœ‰å¿…è¦é€é©—時，檢驗çµæžœäº¦ä¾æ¤åŽŸå‰‡åˆ¤å®šã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€ä¸Šè¿°è™•ç†åŽŸå‰‡ï¼Œæ¥ç¶“本署藥物食å“å”èª¿æœƒå ±ç¬¬äºŒå次會è°è¨Žè«–確定。食å“使用，則ä¸å¾—宣稱醫療效能，且應符åˆé£Ÿå“衛生管ç†æ³•åŠç›¸é—œæ³•ä»¤ä¹‹è¦å®šã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署八åå…å¹´ä¹æœˆäºŒå二日衛署藥å—第八å…○四二三○ä¹è™Ÿå‡½<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">關於貴局函請釋示西藥販賣æ¥è€…ä¾è™•æ–¹è²©å”®ç®¡åˆ¶è—¥å“應ä¾ä½•é …法æ¢è¦ç¯„處罰乙案，復請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´å±€å…«åå…年七月ä¹æ—¥åŒ—市衛四å—第八å…二三å…三三一○○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€è¥¿è—¥è²©è³£æ¥è€…ä¾é†«å¸«è™•æ–¹ä¾›æ‡‰ç®¡åˆ¶è—¥å“，應屬調劑範åœï¼Œè€Œè¥¿è—¥è²©è³£æ¥è€…並未列有調劑營æ¥é …目，應ä¾é•å藥事法第二å七æ¢ä¹‹è¦å®šè¾¦ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署八åå…å¹´å一月å四日衛署藥å—第八å…â—‹å…一二○å…號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">貴署檢é€ã€Œæºèƒšã€äºŒç“¶ã€ã€Œè‚功能改善劑</span><span style="font-family: calibri;">LAENNEC INJ.</span><span style="font-family: 新細明體, serif;">ã€å£¹ç›’åŠã€Œæ€¡å²èƒŽç›¤ç²¾è¯æ¶²ã€å£¹ç›’，囑予鑑定乙節。復請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´ç½²å…«å四年å月ä¹æ—¥å£«æª¢æœƒå…«å…åµä¹äº”å…五å—第二一ä¹äº”○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€èƒŽç›¤ç´ 製å“之管ç†ï¼Œå¦‚為牛ã€ç¾Šå‹•ç‰©ä¹‹èƒŽç›¤èƒå–精製（åˆç¨±æŠ½å‡ºç‰©ï¼‰ï¼Œå‰‡ä»¥è—¥å“列管；若為牛ã€ç¾Šå‹•ç‰©ä¹‹èƒŽç›¤ç›´æŽ¥ç£¨ç²‰è£½æˆï¼Œä¸”ä¸æ·»åŠ 其他藥å“æˆåˆ†è€…，則以食å“管ç†ï¼ŒæƒŸä¸å¾—宣稱療效；å¦è‹¥ä»¥ã€Œäººã€ä¹‹èƒŽç›¤èƒå–精製或直接磨粉製æˆï¼Œå‡ä»¥è—¥å“åˆ—ç®¡ã€‚æ˜¯ä»¥è‹¥ç¶“æ ¸å±¬è—¥å“管ç†ï¼Œå‰‡é ˆç”³é ˜è—¥å“許å¯è‰å¾Œï¼Œå§‹å¾—è£½é€ æˆ–è¼¸å…¥ï¼›é•è€…，ä¾å½è—¥æˆ–ç¦è—¥è«–處。</span> </p><p><span style="font-family: 新細明體, serif;">三ã€ç¶“查å‰é–‹æª¢é«”，</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">「æºèƒšã€è£½å“，係自「人ã€ä¹‹èƒŽç›¤èƒå–精製，且標示涉åŠç™‚效詞å¥ï¼Œæ‡‰ä»¥è—¥å“管ç†ï¼Œèˆ‡æœ¬ç½²å…«å四年三月三å一日衛署食å—ç¬¬å…«å››â—‹ä¸€å››å…«å…«â—‹è™Ÿæ‰€æ ¸å‡†ä¹‹å…§å®¹ä¸ç¬¦ï¼Œä½µäºˆæ•˜æ˜Žï¼›</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">日本產製è‚臟機能改善劑「</span><span style="font-family: calibri;">LAENNEC INJ. 2ML</span><span style="font-family: 新細明體, serif;">×</span><span style="font-family: calibri;">10 AMP.</span><span style="font-family: 新細明體, serif;">ã€æ³¨å°„劑，係屬藥å“ï¼›</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">「怡å²èƒŽç›¤ç²¾è¯æ¶²ã€è£½å“，ä¾å…¶ä½¿ç”¨é ˆçŸ¥ï¼Œå°‡ã€Œ</span><span style="font-family: calibri;">LANNEC INJ.</span><span style="font-family: 新細明體, serif;">ã€</span><span style="font-family: calibri;">2ML</span><span style="font-family: 新細明體, serif;">×</span><span style="font-family: calibri;">2AMP.</span><span style="font-family: 新細明體, serif;">æ³¨å°„åŠ‘åŠ å…¥</span><span style="font-family: calibri;">120ML</span><span style="font-family: 新細明體, serif;">液體瓶è£ä¸ï¼Œæ–晃å‡å‹»ä½¿ç”¨ä¹‹ï¼Œä¿‚屬藥å“管ç†ï¼Œè©²æ¶‰æ¡ˆä¸‰ç¨®è—¥å“，å‡æœªç¶“æœ¬ç½²æ ¸å‡†è—¥å“登記，ä»è«‹æŸ¥æ˜Žå…¶ä¾†æºäºˆä»¥å¯©é…Œã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署八åå…å¹´å…月å四日衛署藥å—第八å…○二七八五二號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">關於輸入åŠç¶“銷管制藥å“之藥商，得å¦ä¾é†«å¸«è™•æ–¹è²©å”®ä¾›æ‡‰è©²è—¥å•†è¼¸å…¥ç¶“銷之管制藥å“，復請　查照。</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å¾©è²´å±€å…«åå…年五月å三日北市衛四å—第八å…二二å…ä¹äºŒäº”○○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€ä¾è—¥äº‹æ³•ç¬¬å五æ¢ä¹‹è¦å®šï¼Œè¥¿è—¥è²©è³£æ¥è€…，係指經營西藥批發ã€é›¶å”®ã€è¼¸å…¥åŠè¼¸å‡ºä¹‹æ¥è€…；西藥之調劑，係為åŒæ³•ç¬¬åä¹æ¢è—¥å±€ä¹‹æ¥å‹™ç¯„åœã€‚管制藥å“係屬醫師處方藥å“，ä¾åŒæ³•ç¬¬äº”åæ¢ç¬¬ä¸€é …å‰æ®µï¼Œé ˆç”±é†«å¸«è™•æ–¹ä¹‹è—¥å“，éžç¶“醫師處方，ä¸å¾—調劑供應；復據該æ¢ä½†æ›¸è¦å®šï¼ŒåŒæ¥è—¥å•†ä¹‹æ‰¹ç™¼ã€è²©è³£ï¼Œå‰‡ä¸åœ¨æ¤é™ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€ç¶œä¸Šï¼Œè¥¿è—¥è²©è³£æ¥è€…，ä¸å¾—ä¾é†«å¸«è™•æ–¹ã€Œè²©å”®ã€ç®¡åˆ¶è—¥å“。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋行政院衛生署å…å四年四月二日衛署藥å—第å…二八一五號函<p><span style="font-family: 新細明體, serif;">主　　旨：</span> <span style="font-family: 新細明體, serif;">樟腦åŠå…¶ç³»åˆ—å“為「ä¸è¯è—¥å…¸ã€æ‰€æ”¶è¼‰ï¼Œä½†äº¦ç‚ºä¸€èˆ¬å·¥æ¥åŽŸæ–™ï¼Œéžä»¥é†«è—¥ä¹‹ç›®çš„è€ŒåŠ å·¥æˆ–è²©è³£è€…ï¼Œä¸å®œæ¯”照藥å“管ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">說　　明：復貴處å…å四年三月七日衛四å—第一二五一一號函。</span> </p>2013-12-16
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記,指示藥å“審查基準,胃腸製劑,眼用製劑,解熱鎮痛劑,綜åˆæ„Ÿå†’è—¥,瀉藥,鎮咳祛痰劑,驅蟲劑,鎮暈劑,抗éŽæ•åŠ‘,指示藥å“審查基準-一般皮膚外用劑,西藥åŠé†«ç™‚器æ查驗登記審查費收費標準,藥物資料公開辦法,æ–°åž‹æµæ„Ÿç–«è‹—查驗登記指引,æ ¸é†«æ”¾å°„æ€§è—¥å“審查基準,生物相似性藥å“查驗登記技術性資料審查é‡é»žè¡¨,æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記療效åŠå®‰å…¨æ€§ä¹‹è€ƒé‡é‡é»ž,原料藥主檔案(DMF)æ ¸å‚™åŠåœ‹ç”¢åŽŸæ–™è—¥æŸ¥é©—登記精實é€å¯©æ–‡ä»¶è³‡æ–™,新藥查驗登記精簡審查程åº,新藥查驗登記優先審查機制,國產創新藥å“查驗登記專案試辦計畫法è¦å‘½ä»¤è¡Œæ”¿é™¢è¡›ç”Ÿç½²å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準<p><span style="font-family: 新細明體, serif;">所</span> <span style="font-family: 新細明體, serif;">有</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">æ–‡</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">æ–°è—¥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">藥事法è¦å®šä¹‹æ–°è—¥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">æˆåˆ†ã€æ–°ç™‚效複方或新使用途徑製劑之藥å“</span><span style="font-family: calibri;">)</span></p> </td> <td style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">國內新è¨å·¥å» ã€æ–°åŠ‘åž‹è¨ç«‹æŸ¥æ ¸</span> </p> </td> <td style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">æ–°è—¥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">監視新藥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">期ä¸ã€æœŸæ»¿</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">ã€æ–°åŠ‘åž‹ã€æ–°åŠ‘é‡ã€æŽ§é‡‹åŠ‘åž‹ç‰è£½åŠ‘之藥å“</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">35,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內新è¨å·¥å» ã€æ–°åŠ‘åž‹è¨ç«‹æŸ¥æ ¸</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">一般製劑</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">éžå±¬æ–°è—¥ä¸€ã€äºŒä¹‹è—¥å“</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內新è¨å·¥å» ã€æ–°åŠ‘åž‹è¨ç«‹æŸ¥æ ¸</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">å››</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">生物製劑ã€é¡žæ¯’ç´ åŠèŒæ¶²ç‰ã€åŸºå› 工程製劑</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span><span style="font-family: calibri;">(一)</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體, serif;">血液製劑ã€æŠ—æ¯’ç´ ã€ç–«è‹—。</span> </p> <p><span><span style="font-family: calibri;">(二)</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體, serif;">åˆ©ç”¨åŸºå› å·¥ç¨‹è£½é€ ä¹‹è—¥å“</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內新è¨å·¥å» ã€æ–°åŠ‘åž‹è¨ç«‹æŸ¥æ ¸</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">臨床試驗</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">è¨ˆç•«æ›¸å¯©æ ¸</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">15,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">å…</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">生體å¯ç”¨çŽ‡ï¼ç”Ÿé«”</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">相ç‰æ€§</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">è¨ˆç•«æ›¸å¯©æ ¸</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">5,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">七</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">原料藥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">ä¾›è—¥å» è£½é€ è—¥å“之原料</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">30,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">å…«</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">自用原料輸入</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">åœ‹å…§è—¥å» è¼¸å…¥è‡ªç”¨ä¹‹å ±å‚™</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">ä¹</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">新醫療器æ</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">å«æ–°é†«ç™‚效能</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">é ˆæª¢é™„è‡¨åºŠã€å®‰å…¨æ€§è©¦é©—å ±å‘Šç‰ä¹‹æ–°é†«ç™‚器æ。</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">åˆ—ç®¡æŸ¥æ ¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">é ˆæŸ¥é©—æˆ–ä¸é ˆæŸ¥é©—之判定</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內醫療器æå» ï¼§ï¼</span><span style="font-family: calibri;">P</span><span style="font-family: 新細明體, serif;">æŸ¥æ ¸</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr style="height: 27.75pt;"> <td valign="top" style="border-top: #f0f0f0; height: 27.75pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; height: 27.75pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: #f0f0f0; padding-right: 1.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國外醫療器æå·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; height: 27.75pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: #f0f0f0; padding-right: 1.4pt; width: 139.25pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一○</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">一般醫療器æ</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">列管之醫療器æ</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">åˆ—ç®¡æŸ¥æ ¸</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">é ˆæŸ¥é©—æˆ–ä¸é ˆæŸ¥é©—之判定</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內醫療器æå» ï¼§</span><span style="font-family: calibri;">M</span><span style="font-family: 新細明體, serif;">ï¼°æŸ¥æ ¸</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國外醫療器æå·¥å» è³‡æ–™å‚™æŸ¥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">新發明或新化粧å“</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">å«è—¥åŒ–粧å“ã€åŒ–粧å“è‰²ç´ </span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">é ˆæª¢é™„ç ”ç©¶å ±å‘Šã€å«é…æ–¹ç¦å¿Œä¹‹å®‰å…¨è©¦é©—å ±å‘Š</span> </p> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">è‡¨åºŠå ±å‘Šä¹‹æ–°åŒ–ç²§å“</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å«è—¥åŒ–粧å“ã€åŒ–粧å“è‰²ç´ </span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">å«è—¥å“æˆåˆ†ä¹‹åŒ–粧å“ã€åŒ–粧å“ç”¨è‰²ç´ </span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">8,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">一般化粧å“</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">å«è—¥å“æˆåˆ†ä¹‹åŒ–粧å“備查</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">3,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一四</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">è—¥å“變更</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">æ–°é©æ‡‰ç—‡ã€æ–°ç”¨æ³•ç”¨é‡ã€æ–°é¡žåˆ¥æˆ–新賦形劑</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">12,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">å§”è¨—è£½é€ ã€ç§»è½‰ã€åˆä½µã€ç”¢åœ°è®Šè®Šæ›´ã€é·å» </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">ä»¥å» æ¬¡è¨ˆ</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">8,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">其化變更或委託包è£ã€è¨±å¯è‰ã€æ¨™ä»¿éºå¤±è£œç™¼</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">5,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">醫療器æ變更</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">å¢žåŠ æ–°é©ç”¨ç”¨ç¯„åœ</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">12,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">移轉ã€åˆä½µã€ç”¢åœ°è®Šæ›´ã€é·å» </span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">ä»¥å» æ¬¡è¨ˆ</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">ã€å¢žåŠ è¦æ ¼</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">8,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">其他變更或許å¯è‰ã€æ¨™ä»¿éºå¤±è£œç™¼</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">5,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一å…</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">化粧å“變更</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">å«è—¥åŒ–粧å“ã€åŒ–粧å“è‰²ç´ è¨±å¯è‰ã€ä¸€èˆ¬åŒ–粧å“備查函內容變更ã€åŒ–粧å“分è£æˆ–改è£å‚™æŸ¥ã€‚</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">3,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一七</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">展延</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">åŽŸæ ¸å‡†è¨±å¯è‰ã€å‚™æŸ¥å‡½æœ‰æ•ˆæœŸé–“展延</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">3,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一八</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">產地è‰æ˜Žã€ï¼§ï¼ï¼°è—¥å» ã€é†«ç™‚器æ英文è‰æ˜ŽåŠæŸ¥é©—登記函詢案件</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體, serif;">æ¢</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署å—ç†è—¥ç‰©ã€åŒ–粧å“查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å–®ä½ï¼šæ–°å°å¹£</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">å…ƒ</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">å—ç†é¡žåˆ¥</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範åœ</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一ä¹</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">é ˜è‰è²»ç”¨</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p>2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6089&type=0
查驗登記類,西藥åŠé†«ç™‚器æ查驗登記審查費收費標準法è¦å‘½ä»¤è¥¿è—¥åŠé†«ç™‚器æ查驗登記審查費收費標準<table width="614" style="border-collapse: collapse; width: 460.4pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;border: white 1pt solid;"> <p><span style="font-family: 標楷體;">第一æ¢ã€€æœ¬æ¨™æº–ä¾è—¥äº‹æ³•ç¬¬ä¸€ç™¾é›¶å››æ¢ä¹‹äºŒç¬¬äºŒé …è¦å®šè¨‚定之。 </span></p> </td> </tr> <tr> <td style="border-top: #f0f0f0; border-right: white 1pt solid; border-bottom: white 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: white 1pt solid; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;"> <p><span style="font-family: 標楷體;">ç¬¬äºŒæ¢ è¥¿è—¥åŠé†«ç™‚器æ辦ç†æŸ¥é©—登記者，æ¯ä»¶æ‡‰ç¹³ç´ä¹‹å¯©æŸ¥è²»å¦‚下： </span></p> <p><span style="font-family: 標楷體;">一ã€æ–°è—¥ </span></p> <p><span style="font-family: 標楷體;">（一）新æˆåˆ†è£½åŠ‘之藥å“查驗登記，新臺幣å…åè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（二）新療效複方或新使用途徑製劑之藥å“查驗登記，新臺幣五è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）國內新è¨å·¥å» 或新劑型è¨ç«‹æŸ¥æ ¸ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆå››ï¼‰åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（五）新劑型ã€æ–°ä½¿ç”¨åŠ‘é‡ã€æ–°å–®ä½å«é‡æˆ–控釋劑型ã€ç›¸åŒæˆåˆ†ç›¸åŒæŠ•èˆ‡é€”徑ä¸åŒåŠ‘é‡ä¹‹æ–°æˆåˆ†æ–°è—¥ç‰è£½åŠ‘產å“之查驗登記，新臺幣三è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">二ã€ä¸€èˆ¬è£½åŠ‘ </span></p> <p><span style="font-family: 標楷體;">（一）監視藥å“之å¸åè—¥å“查驗登記，新臺幣三è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（二）éžå±¬ç›£è¦–è—¥å“之å¸åè—¥å“查驗登記，新臺幣二è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）國內新è¨å·¥å» 或新劑型è¨ç«‹æŸ¥æ ¸ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚<span style="text-decoration: underline;"> </span></span></p> <p><span style="font-family: 標楷體;">ï¼ˆå››ï¼‰åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（五）外銷專用藥å“查驗登記，新臺幣二è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">三ã€ç”Ÿç‰©è—¥å“ </span></p> <p><span style="font-family: 標楷體;">（一）血液製劑ã€æŠ—æ¯’ç´ æˆ–ç–«è‹—æŸ¥é©—ç™»è¨˜ï¼Œæ–°è‡ºå¹£å…åè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆäºŒï¼‰åˆ©ç”¨åŸºå› å·¥ç¨‹è£½é€ ä¹‹è—¥å“查驗登記，新臺幣å…åè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體; text-decoration: underline; text-underline: none;">（三）國內新è¨å·¥å» 或新劑型è¨ç«‹æŸ¥æ ¸ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆå››ï¼‰åœ‹å¤–è£½è—¥å·¥å» è³‡æ–™å‚™æŸ¥ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（五）</span><span style="font-family: 標楷體;">已審查éŽä¹‹ç”Ÿç‰©è—¥å“，其ä¸åŒåŠ‘é‡åŒ…è£ã€ä¸åŒç”¢åœ°ä¹‹æŸ¥é©—登記，新臺幣三è¬äº”åƒå…ƒã€‚</span> </p> <p><span style="font-family: 標楷體;">å››ã€è‡¨åºŠè©¦é©— </span></p> <p><span style="font-family: 標楷體;">ï¼ˆä¸€ï¼‰è‡¨åºŠè©¦é©—è¨ˆç•«æ›¸å¯©æ ¸ï¼Œæ–°è‡ºå¹£ä¸€è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆäºŒï¼‰è‡¨åºŠè©¦é©—å ±å‘Šæ›¸æŸ¥æ ¸ï¼Œæ–°è‡ºå¹£ä¸€è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）銜接性試驗評估，新臺幣一è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（四）臨床試驗相關函詢，新臺幣一åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">五ã€ç”Ÿé«”å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©— </span></p> <p><span style="font-family: 標楷體;">（一）生體å¯ç”¨çŽ‡è©¦é©—è¨ˆç•«æ›¸å¯©æ ¸ï¼Œæ–°è‡ºå¹£äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（二）生體相ç‰æ€§è©¦é©—è¨ˆç•«æ›¸å¯©æ ¸ï¼Œæ–°è‡ºå¹£äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）éžç›£è¦–æˆåˆ†ä¹‹ç”Ÿé«”å¯ç”¨çŽ‡è©¦é©—å ±å‘Šæ›¸å¯©æ ¸ï¼Œæ–°è‡ºå¹£ä¸€è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（四）éžç›£è¦–æˆåˆ†ä¹‹ç”Ÿé«”相ç‰æ€§è©¦é©—å ±å‘Šæ›¸å¯©æ ¸ï¼Œæ–°è‡ºå¹£ä¸€è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（五）éžç›£è¦–æˆåˆ†å£æœåŠ‘åž‹è—¥å“之溶離率曲線比å°å ±å‘Šæ›¸å¯©æ ¸ï¼Œæ–°è‡ºå¹£äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">å…ã€åŽŸæ–™è—¥ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆä¸€ï¼‰ä¾›è—¥å» è£½é€ è—¥å“之原料藥查驗登記，新臺幣三è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（二）輸入自用原料藥備查，新臺幣一åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（三）輸入試製藥å“原料藥備查，新臺幣一åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">七ã€é†«ç™‚器æ </span></p> <p><span style="font-family: 標楷體;">（一）新原ç†ã€æ–°çµæ§‹ã€æ–°ææ–™ã€æ–°æ•ˆèƒ½æˆ–經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå¯©æŸ¥èªå®šå±¬æ–°é†«ç™‚器æ之查驗登記，新臺幣三è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（二）一般åŠå¤–銷專用醫療器æ查驗登記，新臺幣一è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）醫療器æåˆ—ç®¡æŸ¥æ ¸ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（四）國內醫療器æè£½é€ å·¥å» æŸ¥æ ¸æˆ–å…¶å¾ŒçºŒç¨½æ ¸ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（五）國外醫療器æè£½é€ å·¥å» å“è³ªç³»çµ±æ–‡ä»¶å¯©æŸ¥æˆ–å…¶å¾ŒçºŒç¨½æ ¸ï¼Œæ–°è‡ºå¹£äºŒè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（å…）優良醫療器æè£½é€ å·¥å» èªå¯ç™»éŒ„å¢žåŠ ç™»éŒ„å“é …æˆ–é·å» 之變更，新臺幣二è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（七）優良醫療器æè£½é€ å·¥å» èªå¯ç™»éŒ„之其他變更，新臺幣八åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（八）第一ç‰ç´šé«”外診斷試劑備查函，新臺幣一åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（ä¹ï¼‰ç¬¬ä¸‰ç‰ç´šé«”外診斷試劑查驗登記（新增å“é …ï¼‰ï¼Œæ–°è‡ºå¹£äº”è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（å）第三ç‰ç´šé«”外診斷試劑查驗登記（類似å“é …ï¼‰ï¼Œæ–°è‡ºå¹£ä¸‰è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（å一）醫療器æåŠæˆå“備查，新臺幣一åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">å…«ã€è—¥å“ç™»è¨˜äº‹é …è®Šæ›´ </span></p> <p><span style="font-family: 標楷體;">（一）新é©æ‡‰ç—‡ã€æ–°ç”¨æ³•ç”¨é‡ã€æ–°é¡žåˆ¥æˆ–新賦形劑變更，新臺幣一è¬äºŒåƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆäºŒï¼‰å§”è¨—è£½é€ ã€ç§»è½‰ã€åˆä½µã€ç”¢åœ°æˆ–é·å» 變更，新臺幣八åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）å‰ç›®ä»¥å¤–之其它變更，新臺幣五åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ä¹ã€é†«ç™‚器æç™»è¨˜äº‹é …è®Šæ›´ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆä¸€ï¼‰å¢žåŠ æ–°é©ç”¨ç¯„åœè®Šæ›´ï¼Œæ–°è‡ºå¹£ä¸€è¬äºŒåƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆäºŒï¼‰å¢žåŠ è¦æ ¼ã€ç§»è½‰ã€åˆä½µã€ç”¢åœ°æˆ–é·å» 變更，新臺幣八åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）其它變更或申請委託包è£ï¼Œæ–°è‡ºå¹£äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（四）許å¯è‰ã€æ¨™ç±¤æˆ–仿單之éºå¤±è£œç™¼ï¼Œæ–°è‡ºå¹£äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">åã€è—¥ç‰©åŽŸæ ¸å‡†è¨±å¯è‰æœ‰æ•ˆæœŸé–“展延，新臺幣三åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">å一ã€è‰æ˜Žæ›¸åŠå‚™æŸ¥å‡½ </span></p> <p><span style="font-family: 標楷體;">（一）ä¸æ–‡ç”¢åœ°è‰æ˜Žæ›¸ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（二）英文產地è‰æ˜Žæ›¸ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（三）ä¸æ–‡å„ªè‰¯è—¥å“è£½é€ è‰æ˜Žæ›¸ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（四）英文優良藥å“è£½é€ è‰æ˜Žæ›¸ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（五）ä¸æ–‡å„ªè‰¯é†«ç™‚器æè£½é€ è‰æ˜Žæ›¸ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（å…）英文優良醫療器æè£½é€ è‰æ˜Žæ›¸ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（七）ä¸æ–‡å‚™æŸ¥å‡½è‰æ˜Žï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">（八）英文備查函è‰æ˜Žï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">å二ã€è—¥ç‰©è¨±å¯è‰é ˜è‰ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">å三ã€æ¡ˆä»¶å‡½è©¢ï¼Œæ–°è‡ºå¹£ä¸€åƒäº”百元。 </span></p> <p><span style="font-family: 標楷體;">åå››ã€åœ‹å¤–è—¥å“è£½é€ å·¥å» å¯¦åœ°æŸ¥æ ¸ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆä¸€ï¼‰å·¥å» è³‡æ–™ç¶“è¡›ç”Ÿç½²å‡†äºˆå‚™æŸ¥è€…ï¼Œ 新臺幣五åè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆäºŒï¼‰å·¥å» è³‡æ–™æœªç¶“è¡›ç”Ÿç½²å‡†äºˆå‚™æŸ¥è€…ï¼Œæ–°è‡ºå¹£äº”åå…è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">å五ã€åœ‹å¤–醫療器æè£½é€ å·¥å» å¯¦åœ°æŸ¥æ ¸ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆä¸€ï¼‰å¯¦åœ°æŸ¥æ ¸æˆ–å…¶å¾ŒçºŒç¨½æ ¸ï¼Œæ–°è‡ºå¹£äº”åè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ï¼ˆäºŒï¼‰å¢žåŠ ç™»éŒ„å“é …ä¹‹æŸ¥æ ¸ï¼Œæ–°è‡ºå¹£äº”åè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">（三）é·å» ä¹‹æŸ¥æ ¸ï¼Œæ–°è‡ºå¹£äº”åè¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">å‰é …第八款第二目åŠç¬¬ä¹æ¬¾ç¬¬äºŒç›®ä¹‹è®Šæ›´ç”³è«‹ï¼Œæ¯ä»¶ä»¥ä¸€å» 次為é™ã€‚ </span></p> <p><span style="font-family: 標楷體;">ç¬¬ä¸€é …ç¬¬å一款è‰æ˜Žæ›¸åŠå‚™æŸ¥å‡½ä¹‹ç”³è«‹ï¼Œæ¯ä»¶ä»¥ä¸€å¼äº”份為é™ã€‚ </span></p> <p><span style="font-family: 標楷體;">ç¬¬ä¸€é …ç¬¬å四款，æ¯ä»¶æ¯å¢žåŠ 一劑型之收費如下： </span></p> <p><span style="font-family: 標楷體;">一ã€éžç„¡èŒè£½åŠ‘之åŒä¸€å» 房ã€ç©ºèª¿ã€æ°´ç³»çµ±ï¼ŒåŠ 收新臺幣三è¬äº”åƒå…ƒã€‚</span> </p> <p><span style="font-family: 標楷體;">二ã€éžç„¡èŒè£½åŠ‘之åŒä¸€å» 房ä¸åŒç©ºèª¿æˆ–æ°´ç³»çµ±ï¼ŒåŠ æ”¶æ–°è‡ºå¹£äº”è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">三ã€ç„¡èŒè£½åŠ‘之åŒä¸€å» 房ä¸åŒç©ºèª¿æˆ–æ°´ç³»çµ±ï¼ŒåŠ æ”¶æ–°è‡ºå¹£å…«è¬å…«åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">å››ã€éžç„¡èŒè£½åŠ‘之åŒä¸€å» 房ä¸åŒç©ºèª¿ç³»çµ±ä¸”ä¸åŒæ°´ç³»çµ±ï¼ŒåŠ 收新臺幣七è¬å…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">五ã€ç„¡èŒè£½åŠ‘之åŒä¸€å» 房ä¸åŒç©ºèª¿ç³»çµ±ä¸”ä¸åŒæ°´ç³»çµ±ï¼ŒåŠ 收新臺幣åè¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">å…ã€éžç„¡èŒè£½åŠ‘之ä¸åŒå» æˆ¿ï¼ŒåŠ æ”¶æ–°è‡ºå¹£åè¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">七ã€ç„¡èŒè£½åŠ‘之ä¸åŒå» æˆ¿ï¼ŒåŠ æ”¶æ–°è‡ºå¹£åè¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ç¬¬ä¸€é …ç¬¬å五款，æ¯ä»¶æ¯å¢žåŠ 一醫療器æå“é …è£½ç¨‹ä¹‹æ”¶è²»å¦‚ä¸‹ï¼š </span></p> <p><span style="font-family: 標楷體;">一ã€åŒä¸€å» æˆ¿ï¼ŒåŠ æ”¶æ–°è‡ºå¹£ä¸‰è¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">二ã€ä¸åŒå» æˆ¿ï¼ŒåŠ æ”¶æ–°è‡ºå¹£åè¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ç¬¬ä¸€é …ç¬¬å五款，æ¯ä»¶æ¯å¢žåŠ 一ä¸åŒæ»…èŒè£½ç¨‹ï¼ŒåŠ 收新臺幣åè¬äº”åƒå…ƒã€‚ </span></p> <p><span style="font-family: 標楷體;">ç¬¬ä¸€é …ç¬¬ä¸€æ¬¾ç¬¬ä¸€ç›®ã€ç¬¬ä¸‰æ¬¾ç¬¬ä¸€ç›®åŠç¬¬äºŒç›®</span><span style="font-family: 標楷體;">自ä¸è¯æ°‘國ä¹åå…年一月一日施行。</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: white 1pt solid; border-bottom: white 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: white 1pt solid; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;"> <p><span style="font-family: 標楷體;">ç¬¬ä¸‰æ¢ è¾¦ç†æœ¬æ¨™æº–第二æ¢ç¬¬å四款åŠç¬¬åäº”æ¬¾ä¹‹æŸ¥æ ¸äººå“¡è‡¨å ´è²»ï¼Œæ‡‰æ¯”ç…§åœ‹å¤–å‡ºå·®æ—…è²»å ±æ”¯è¦é»žæ‰€å®šæ¨™æº–，由ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‘è¢«æŸ¥æ ¸è€…æ”¶å–。 </span></p> </td> </tr> <tr> <td style="border-top: #f0f0f0; border-right: white 1pt solid; border-bottom: white 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: white 1pt solid; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;"> <p><span style="font-family: 標楷體;">第四æ¢ã€€æœ¬æ¨™æº–</span><span style="font-family: 標楷體;">除已å¦å®šæ–½è¡Œæ—¥æœŸè€…外，</span><span style="font-family: 標楷體;">自發布日施行。 </span></p> <p><span style="font-family: 標楷體;"> </span></p> </td> </tr> </tbody></table><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å«diclofenacæˆåˆ†è—¥å“之仿單修訂事宜diclofenac皮膚外用劑型仿單<p><b><span style="font-family: 標楷體; font-size: 14pt;">修訂Diclofenacæˆåˆ†è—¥å“（皮膚外用劑型）之仿單內容ï¼åŒ…括用法用é‡ã€ç¦å¿Œã€è¦èªžã€æ³¨æ„äº‹é …ã€å‰¯ä½œç”¨ã€è—¥ç‰©äº¤äº’作用ã€ç‰¹æ®Šæ—群åŠéŽé‡</span></b><span style="font-family: 標楷體; font-size: 13pt;">(</span><span style="font-family: 標楷體; font-size: 13pt;">劃線為新增部分)</span></p><p><span style="font-family: 標楷體; font-size: 14pt;">ã€ç”¨æ³•ç”¨é‡ã€‘ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">å¢žåŠ ã€Žæœ¬è£½åŠ‘ä¸å»ºè°ä½¿ç”¨æ–¼12æ²ä»¥ä¸‹ä¹‹å…’ç«¥ã€ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">ã€æ³¨æ„äº‹é …ã€‘ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">1. </span><span style="font-family: 標楷體; font-size: 14pt;">本製劑åªèƒ½ç”¨æ–¼å®Œæ•´çš®è†šï¼Œä¸å¯ç”¨æ–¼è£‚開的皮膚或開放性傷å£ã€‚本製劑ä¸è¦èˆ‡çœ¼ç›åŠé»è†œæŽ¥è§¸ã€‚本å“僅供外用，ä¸å¯å£æœã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">2. </span><span style="font-family: 標楷體; font-size: 14pt;">é ˆç½®æ–¼å°å©æŽ¥è§¸ä¸åˆ°ä¹‹è™•ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">3. </span><span style="font-family: 標楷體; font-size: 14pt;">é¿å…陽光直射，宜ä¿å˜æ–¼é™°æ¶¼ä¹‹è™•ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">4. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">懷å•:å°šæœªæœ‰ç ”ç©¶å ±å‘Šé¡¯ç¤ºé—œæ–¼å•å©¦ä½¿ç”¨æœ¬è£½åŠ‘ä¹‹å®‰å…¨æ€§ï¼Œå› æ¤æœ¬è£½åŠ‘於懷å•æœŸé–“ä¸æ‡‰ä½¿ç”¨ã€‚由於å¯èƒ½é€ æˆå宮無力（Uterine inertia）和/或胎兒動脈導管éŽæ—©é–‰åˆï¼Œå› æ¤åœ¨æ‡·å•ç¬¬ä¸‰æœŸä½¿ç”¨æœ¬è£½åŠ‘為ç¦å¿Œã€‚å‹•ç‰©ç ”ç©¶å°šæœªé¡¯ç¤ºä»»ä½•ç›´æŽ¥æˆ–é–“æŽ¥å°æ–¼åœ¨æ‡·å•æœŸé–“胚胎/胎兒發展ã€åˆ†å¨©æˆ–產後發展的ä¸è‰¯å½±éŸ¿ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">5. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">授乳:</span><span style="font-family: 標楷體; color: black; font-size: 14pt; text-decoration: underline;">本製劑</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">是å¦åˆ†æ³Œè‡³äººé¡žä¹³æ±ä¸å°šå±¬æœªçŸ¥ï¼Œå› æ¤æœ¬è£½åŠ‘於授乳期間ä¸å»ºè°ä½¿ç”¨ã€‚若為ä¸å¾—已使用，本製劑ä¸å¾—用於乳房部ä½æˆ–大é¢ç©æŠ•äºˆï¼Œæ›´ä¸å¯é•·æœŸä½¿ç”¨ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">6. </span><span style="font-family: 標楷體; font-size: 14pt;">除éžé†«å¸«æˆ–藥師ã€è—¥åŠ‘生指示，本製劑勿使用於大é¢ç©ä¹‹é«”表或皮膚深部感染。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">7. </span><span style="font-family: 標楷體; font-size: 14pt;">請勿超éŽå»ºè°åŠ‘é‡ï¼Œè‹¥æœ‰å‰¯ä½œç”¨ç”¢ç”Ÿï¼Œæ‡‰ç«‹å³åœè—¥å°±é†«ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">8. </span><span style="font-family: 標楷體; font-size: 14pt;">使用後自覺狀æ³æœªæ”¹å–„或更惡化，應立å³åœè—¥ä¸¦å°±é†«ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">9. </span><span style="font-family: 標楷體; font-size: 14pt;">除éžé†«å¸«æˆ–藥師ã€è—¥åŠ‘生指示，éžé¡žå›ºé†‡æŠ—發炎藥劑ä¸å¯é€£çºŒä½¿ç”¨è¶…éŽäºŒæ˜ŸæœŸã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">ã€è¦èªžã€‘ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">1.</span><span style="font-family: 標楷體; font-size: 14pt;">癬類或其他皮膚感染症，應使用抗感染劑，單ç¨ä½¿ç”¨éžé¡žå›ºé†‡æŠ—發炎藥劑會使病情惡化。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">2.</span><span style="font-family: 標楷體; font-size: 14pt;">皮膚的黴èŒæ„ŸæŸ“有時ä¸æ˜“與其他皮膚炎å€åˆ†ï¼Œèª¤ç”¨éžé¡žå›ºé†‡æŠ—ç™¼ç‚Žè—¥åŠ‘æœƒä½¿ç—…æƒ…æƒ¡åŒ–ä¸¦é€ æˆæ—¥å¾Œè¨ºæ–·åŠæ²»ç™‚之困難。 </span></p><p class="Default"><span style="font-family: 標楷體; font-size: 14pt;">3.</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">使用本å“，ä»æœ‰æ¥µå°‘數引起è‚åŠŸèƒ½ç•°å¸¸ä¹‹å ±å‘Šã€‚</span><span style="font-family: 標楷體; font-size: 14pt;"> </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">ã€ç¦å¿Œã€‘ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">1. </span><span style="font-family: 標楷體; font-size: 14pt;">Diclofenac sodium, Acetylsalicylic acid</span><span style="font-family: 標楷體; font-size: 14pt;">åŠå…¶ä»–éžé¡žå›ºé†‡æŠ—發炎藥物，或å°Propylene glycol有éŽæ•å應者ç¦ç”¨æœ¬è—¥ã€‚ </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">2. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">懷å•ç¬¬ä¸‰æœŸç¦ç”¨æœ¬è—¥ã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;"> </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">ã€å‰¯ä½œç”¨ã€‘</span> </p><p><span style="font-size: 14pt;">1. </span><span style="font-family: 標楷體; font-size: 14pt;">å¶æœ‰æ”癢ã€ç¼ç†±æ„Ÿã€å±€éƒ¨ç™¼ç´…ã€éŽæ•æ€§çš®è†šç‚Žã€‚</span> </p><p><span style="font-size: 14pt;">2. Diclofenac </span><span style="font-family: 標楷體; font-size: 14pt;">局部治療期間發生全身å應與出ç¾å‰¯ä½œç”¨çš„å¯èƒ½æ€§è¼ƒå£æœçµ¦èˆ‡çš„機率å°ã€‚å‡å¦‚長期大é¢ç©ä½¿ç”¨æœ¬è£½åŠ‘，ä¸èƒ½å®Œå…¨æŽ’除全身性å應的å¯èƒ½æ€§ã€‚</span> </p><p><span style="font-size: 14pt;">3. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">ä¸è‰¯å應ä¾å™¨å®˜ç³»çµ±åˆ†é¡žå’Œç™¼ç”Ÿé »çŽ‡è©³åˆ—æ–¼ä¸‹è¡¨ã€‚ç™¼ç”Ÿé »çŽ‡ä¹‹å®šç¾©ç‚º</span><span style="font-size: 14pt; text-decoration: underline;">: </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">極常見</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/10)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">ã€å¸¸è¦‹</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/100 ~ < 1/10)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">ã€ä¸å¸¸è¦‹</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/1,000 ~ < 1/100)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">ã€ç½•è¦‹</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/10,000 ~ < 1/1,000)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">ã€æ¥µç½•è¦‹</span><span style="font-size: 14pt; text-decoration: underline;">(< 1/10,000)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">。在å„çµ„ç™¼ç”Ÿé »çŽ‡ä¸ï¼Œä¾ä¸è‰¯å應的嚴é‡åº¦é™å†ªæŽ’列。</span><span style="text-decoration: underline;"> </span></p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; padding-top: 0cm;border: black 1pt solid;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">感染和寄生蟲感染</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">:</span> <span style="font-family: 標楷體; font-size: 14pt;">膿皰性發疹</span> </p> </td> </tr> <tr> <td valign="top" style="border-bottom: black 1pt solid; border-left: black 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: black 1pt solid; padding-top: 0cm;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">å…疫系統的異常</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">éŽæ•</span><span style="font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">包å«è•éº»ç–¹</span><span style="font-size: 14pt;">)</span><span style="font-family: 標楷體; font-size: 14pt;">ã€è¡€ç®¡æ€§æ°´è…«</span> </p> </td> </tr> <tr> <td valign="top" style="border-bottom: black 1pt solid; border-left: black 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: black 1pt solid; padding-top: 0cm;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">呼å¸é“ã€èƒ¸éƒ¨åŠç¸±è†ˆçš„異常</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">氣喘</span> </p> </td> </tr> <tr> <td valign="top" style="border-bottom: black 1pt solid; border-left: black 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: black 1pt solid; padding-top: 0cm;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">皮膚和皮下組織的異常</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">常見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">皮膚炎</span><span style="font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">包å«æŽ¥è§¸æ€§çš®è†šç‚Ž</span><span style="font-size: 14pt;">)</span><span style="font-family: 標楷體; font-size: 14pt;">ã€ç´…ç–¹ã€ç´…æ–‘ã€æ¿•ç–¹ã€æ”癢</span> </p> <p><span style="font-family: 標楷體; font-size: 14pt;">罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">水泡性皮膚炎</span> </p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">å…‰æ•æ„Ÿå應</span> </p> </td> </tr> </tbody></table><p><span style="font-family: 標楷體; font-size: 14pt;">ã€äº¤äº’作用】</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;">è‡³ä»Šæœªæœ‰æœ¬è£½åŠ‘çš„äº¤äº’ä½œç”¨å ±å‘Šã€‚</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;">ã€éŽé‡ã€‘</span> </p><p><span style="font-size: 14pt;">Diclofenac </span><span style="font-family: 標楷體; font-size: 14pt;">局部使用的全身性å¸æ”¶ä½Žï¼Œä¸æ˜“發生éŽé‡ã€‚如使用ä¸ç•¶åŠç„¡æ„çš„éŽé‡ï¼ˆå¦‚用於兒童），å¯èƒ½ç”¢ç”Ÿé¡¯è‘—的全身性å應，æ¤æ™‚è¦æŽ¡å–一般的éž</span><span style="font-family: 標楷體; font-size: 14pt;">類固醇抗發炎藥ä¸æ¯’救治措施以治療éŽé‡ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å«diclofenacæˆåˆ†è—¥å“之仿單修訂事宜公告PDF檔詳如附件2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å«diclofenacæˆåˆ†è—¥å“之仿單修訂事宜增修全身性Diclofenacæˆåˆ†è—¥å“<p><b><span style="font-family: 標楷體; font-size: 13pt;">修訂Diclofenacæˆåˆ†è—¥å“（å£æœã€æ³¨å°„åŠæ “劑劑型）之仿單內容ï¼åŒ…括ç¦å¿Œã€è¦èªžã€æ³¨æ„äº‹é …ã€å‰¯ä½œç”¨ã€è—¥ç‰©äº¤äº’作用ã€ç‰¹æ®Šæ—群åŠéŽé‡</span></b><span style="font-family: 標楷體; font-size: 13pt;">(</span><span style="font-family: 標楷體; font-size: 13pt;">劃線為新增部分)</span></p><p><span style="font-family: 標楷體;">ã€ç¦å¿Œã€‘ </span></p><p><span style="font-family: 標楷體;">1.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">å°DiclofenacéŽæ•ä¹‹æ‚£è€…。 </span></p><p><span style="font-family: 標楷體;">2.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">消化性潰ç˜æ‚£è€…。 </span></p><p><span style="font-family: 標楷體;">3.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">é‡ç—‡ä¹‹è¡€æ¶²ç•°å¸¸æ‚£è€…。 </span></p><p><span style="font-family: 標楷體;">4.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">é‡ç—‡ä¹‹è‚障害患者。 </span></p><p><span style="font-family: 標楷體;">5.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">é‡ç—‡ä¹‹è…Žéšœå®³æ‚£è€…。 </span></p><p><span style="font-family: 標楷體;">6.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">æœç”¨aspirin或其他éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥ä¹‹å¾Œæ›¾ç™¼ç”Ÿæ°£å–˜ã€è•éº»ç–¹æˆ–其他éŽæ•å應者。æ¤é¡žç—…人曾有嚴é‡(極少數為致æ»æ€§)é¡žéŽæ•å應(anaphylactic-like reaction)ç™¼ç”Ÿä¹‹å ±å‘Šã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">7.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">æ–¼å† ç‹€å‹•è„ˆç¹žé“(CABG)手術期間投予作為æ¢ç—›ä¹‹ç”¨ã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">8.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">懷å•ç¬¬ä¸‰æœŸå©¦å¥³ç¦ç”¨æœ¬è—¥ã€‚ </span></p><p><span style="font-family: 標楷體;">ã€æ³¨æ„äº‹é …ã€‘ </span></p><p><span style="font-family: 標楷體;">1.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用消炎鎮痛劑治療，乃為å°ç—‡ç™‚法éžåŽŸå› 療法。 </span></p><p><span style="font-family: 標楷體;">2.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用於治療慢性疾患（慢性風濕性關節炎ã€åƒµç›´æ€§è„Šé«“ç‚Žï¼‰æ™‚æ‡‰è€ƒæ…®ä»¥ä¸‹äº‹é …ï¼š </span></p><p><span style="font-family: 標楷體;">（1ï¼‰é•·æœŸæŠ•èˆ‡æ™‚ï¼Œé ˆå®šæœŸä½œè‡¨åºŠæª¢æŸ¥ï¼ˆå°¿æª¢æŸ¥ã€è¡€æ¶²æª¢æŸ¥ã€è‚功能檢查）é‡æœ‰ç•°å¸¸ç¾è±¡ç™¼ç”Ÿæ™‚ï¼Œå‰‡é ˆæŽ¡å–減é‡æˆ–åœè—¥ç‰é©ç•¶æŽªæ–½ã€‚ </span></p><p><span style="font-family: 標楷體;">（2）考慮éžè—¥ç‰©æ€§ç™‚法。 </span></p><p><span style="font-family: 標楷體;">3. </span><span style="font-family: 標楷體;">ä½¿ç”¨æ–¼æ²»ç™‚æ€¥æ€§ç–¾æ‚£æ™‚ï¼Œæ‡‰è€ƒæ…®ä»¥ä¸‹äº‹é …ï¼š </span></p><p><span style="font-family: 標楷體;">（1）å°æ–¼æ€¥æ€§ç‚Žç—‡é ˆè€ƒæ…®å…¶ç—…ç—›åŠç™¼ç†±ç¨‹åº¦è€Œçµ¦è—¥ã€‚ </span></p><p><span style="font-family: 標楷體;">（2）原則上應é¿å…長期使用åŒä¸€é¡žè—¥å“。 </span></p><p><span style="font-family: 標楷體;">（3ï¼‰å¦‚æœ‰åŽŸå› ç™‚æ³•å‰‡æ‡‰æŽ¡ç”¨ã€‚ </span></p><p><span style="font-family: 標楷體;">4. </span><span style="font-family: 標楷體;">é ˆä»”ç´°è§€å¯Ÿæ‚£è€…ä¹‹ç‹€æ³ï¼Œç•™æ„有å¦å‰¯ä½œç”¨ç™¼ç”Ÿã€‚ </span></p><p><span style="font-family: 標楷體;">5. </span><span style="font-family: 標楷體;">本藥å¯èƒ½é®è”½æ„ŸæŸ“症狀之顯ç¾ï¼Œå› æ¤ç”¨æ–¼æ²»ç™‚æ„ŸæŸ“æ‰€å¼•èµ·ä¹‹ç‚Žç—‡æ™‚ï¼Œå¿…é ˆåˆä½µä½¿ç”¨é©ç•¶ä¹‹æŠ—èŒåŠ‘，åŒæ™‚仔細觀察，慎é‡æŠ•èˆ‡ã€‚ </span></p><p><span style="font-family: 標楷體;">6. </span><span style="font-family: 標楷體;">儘é‡é¿å…與其它消炎ã€éŽ®ç—›åŠ‘åˆä½µä½¿ç”¨ã€‚ </span></p><p><span style="font-family: 標楷體;">7. </span><span style="font-family: 標楷體;">å°å°å…’åŠé«˜é½¡æ‚£è€…，尤其注æ„有å¦å‰¯ä½œç”¨å‡ºç¾ï¼Œä¸¦ä»¥æœ€ä½Žä¹‹æœ‰æ•ˆåŠ‘é‡ä¾†æ…Žé‡æŠ•äºˆã€‚ </span></p><p><span style="font-family: 標楷體;">8. </span><span style="font-family: 標楷體;">diclofenac</span><span style="font-family: 標楷體;">å¯èƒ½å°Žè‡´èƒŽå…’動脈導管éŽæ—©é–‰åˆï¼Œå› æ¤æ–¼æ‡·å•å¾ŒæœŸæ‡‰é¿å…使用。 </span></p><p><span style="font-family: 標楷體;">9. </span><span style="font-family: 標楷體;">å°ä»¥ä¸‹æ‚£è€…é ˆæ…Žé‡æŠ•èˆ‡ï¼š </span></p><p><span style="font-family: 標楷體;">（1）患有è‚障礙或曾有該病å²ä¹‹æ‚£è€…。 </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext;">（2）曾有éŽæ•æ€§ç—…å²ä¹‹æ‚£è€…。</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">從未接觸éŽdiclofenac的病人亦有å¯èƒ½ç™¼ç”Ÿé¡žéŽæ•å應(Anaphylactoid Reactions)。具有aspirin三症狀(aspirin triad)的病人ä¸å¯æŠ•äºˆdiclofenac治療。這種複åˆç—‡ç‹€ä¸»è¦ç™¼ç”Ÿåœ¨æ‚£æœ‰é¼»ç‚Ž(無論具有鼻æ¯è‚‰èˆ‡å¦)的氣喘病人，或是使用aspirin或其他éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥ä¹‹å¾Œæœƒç™¼ç”Ÿåš´é‡è€Œå¯èƒ½è‡´æ»ä¹‹æ”¯æ°£ç®¡ç—™æ”£çš„病人。一旦類éŽæ•å應發生，應立å³å°±é†«è¨ºæ²»ã€‚ </span></p><p><span style="font-family: 標楷體;">（3）支氣管氣喘之患者。</span><span style="font-family: 標楷體; text-decoration: underline;">氣喘病人å¯èƒ½å…·æœ‰aspirinæ•æ„Ÿæ€§æ°£å–˜ã€‚æ¤é¡žç—…人投予aspirin曾出ç¾åš´é‡è€Œå¯èƒ½è‡´æ»çš„支氣管痙攣。由於aspirin與其他éžé¡žå›ºé†‡æ¶ˆç‚Žè—¥åœ¨æ¤é¡žç—…人ä¸æ›¾æœ‰äº¤å‰åæ‡‰æ€§çš„å ±å‘Šï¼Œå› æ¤æ¤é¡žaspirinéŽæ•ç—…人ä¸å¯ä½¿ç”¨diclofenac，而å°æ–¼åŽŸæ‚£æœ‰æ°£å–˜ä¹‹ç—…人也應謹慎投予。 </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">10. </span><span style="font-family: 標楷體; text-decoration: underline;">皮質類固醇藥物治療：diclofenacä¸èƒ½å–代皮質類固醇或治療皮質類固醇ä¸è¶³ã€‚貿然åœç”¨çš®è³ªé¡žå›ºé†‡å¯èƒ½é€ æˆçš®è³ªé¡žå›ºé†‡å應性疾病的惡化。長期接å—皮質類固醇治療的病人，若決定åœè—¥ï¼Œæ‡‰ç·©æ…¢æ¸›ä½ŽåŠ‘é‡ã€‚ </span></p><p><span style="font-family: 標楷體;">11.</span><span style="font-family: 標楷體; text-decoration: underline;"> diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">抗發炎åŠé€€ç‡’çš„è—¥ç†ä½œç”¨æœƒé™ä½Žåˆ©ç”¨é€™äº›è¨ºæ–·å¾µè±¡ä¾†åµæ¸¬æ„Ÿ 染性併發症發生於一些本來推論為éžæ„ŸæŸ“性疼痛情形的機會。 </span></p><p><span style="font-family: 標楷體;">12.</span><span style="font-family: 標楷體; text-decoration: underline;">實驗室檢驗：由於嚴é‡çš„胃腸é“æ½°ç˜åŠå‡ºè¡€å¯èƒ½æ²’有é è¦ç—‡ç‹€ï¼Œé†«å¸«æ‡‰ç›£æ¸¬æ˜¯å¦æœ‰èƒƒè…¸å‡ºè¡€çš„徵象或症狀。長期使用éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥çš„病人，應定期åšå…¨è¡€çƒè¨ˆæ•¸(CBC)åŠç”ŸåŒ–檢查。若è‚功能或腎功能檢驗異常的情形ç¶æŒæˆ–惡化，應立å³åœè—¥ã€‚ </span></p><p><span style="font-family: 標楷體;">ã€è¦èªžã€‘ </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">1. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">心血管作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">æ “å¡žæ€§å¿ƒè¡€ç®¡äº‹ä»¶</span></i><i><span style="font-family: arial, sans-serif; text-decoration: underline;"> (Cardiovascular Thrombotic Events)</span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">使用éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æ²»ç™‚å¯èƒ½ä½¿ç™¼ç”Ÿåš´é‡è€Œå¯èƒ½è‡´æ»ä¹‹æ “塞性心血管事件ã€å¿ƒè‚Œæ¢—塞與ä¸é¢¨çš„å±éšªæ€§å¢žåŠ 。å°æ–¼æ‚£æœ‰å¿ƒè¡€ç®¡ç–¾ç—…或具有心血管疾病å±éšªå› å的病人應使用最低有效劑é‡ï¼Œä¸¦ä½œç‚ºæœŸæœ€çŸçš„治療。病人應被告知嚴é‡å¿ƒè¡€ç®¡æ¯’性的徵象與症狀，åŠè¬ä¸€ç™¼ç”Ÿæ™‚所應採å–çš„æ¥é©Ÿã€‚</span><span style="text-decoration: underline;"> </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">沒有一致的è‰æ“šè‰æ˜ŽåŒæ™‚使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">aspirin</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">èƒ½å¤ æ¸›å°‘ä½¿ç”¨éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æ™‚çš„åš´é‡æ “塞性心血管事件風險。而åŒæ™‚使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">aspirin</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">與</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">ç¢ºå¯¦æœƒå¢žåŠ åš´é‡èƒƒè…¸é“事件的å±éšªæ€§ã€‚</span><span style="text-decoration: underline;"> </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">兩個大型å°ç…§æ€§è‡¨åºŠè©¦é©—ä¸ï¼Œç™¼ç¾é¸æ“‡æ€§</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">COX-2</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">之éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥åœ¨</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">CABG</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">手術後</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">10-14</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">天用於æ¢ç—›ï¼Œæœƒå¢žåŠ 其心肌梗塞和ä¸é¢¨ä¹‹ç™¼ç”ŸçŽ‡ã€‚</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">高血壓</span></i><i><span style="text-decoration: underline;"> </span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">投予éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療å¯èƒ½å°Žè‡´æ–°çš„高血壓發病或使原有的高血壓惡化。使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">thiazides</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">利尿劑或環利尿劑的病人，在æœç”¨éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æœŸé–“å°é€™äº›åˆ©å°¿åŠ‘çš„å應å¯èƒ½æœƒæ¸›å¼±ã€‚å°æ–¼é«˜è¡€å£“之病人應謹慎投予</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">，治療期間應密切監測血壓。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">充血性心衰ç«èˆ‡æ°´è…«</span></i><i><span style="text-decoration: underline;"> </span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">有些病人接å—éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療後曾發生體液滯留åŠæ°´è…«çš„ç¾è±¡ã€‚å°æ–¼é«”液滯留或心衰ç«ä¹‹ç—…人應謹慎投予。</span><span style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">2. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">胃腸é“作用ï¼èƒƒè…¸æ½°ç˜ã€å‡ºè¡€åŠç©¿å”之å±éšªæ€§</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">å¯èƒ½å¼•èµ·èƒƒã€å°è…¸æˆ–大腸發炎ã€å‡ºè¡€ã€æ½°ç˜åŠç©¿å”ç‰åš´é‡è€Œå¯èƒ½è‡´æ»ä¹‹è…¸èƒƒé“ä¸è‰¯å應。接å—éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æ²»ç™‚的病人隨時å¯èƒ½å‡ºç¾é€™äº›åš´é‡çš„ä¸è‰¯äº‹ä»¶ï¼Œä¸”ä¸ä¸€å®šæœ‰é è¦ç—‡ç‹€ã€‚å°æ–¼æœ‰æ¶ˆåŒ–性潰ç˜ç–¾ç—…或胃腸é“出血病å²ä¹‹ç—…äººæ‡‰è¬¹æ…ŽæŠ•äºˆã€‚å…¶ä»–æœƒå¢žåŠ ä½¿ç”¨éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æ²»ç™‚時發生胃腸é“出血的å±éšªå› å包括åŒæ™‚使用å£æœçš®è³ªé¡žå›ºé†‡æˆ–抗å‡è¡€åŠ‘ã€é•·æœŸä½¿ç”¨éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥ã€å¸ç…™ã€å–é…’ã€å¹´é•·åŠæ•´é«”å¥åº·ç‹€æ³ä¸ä½³ç‰ã€‚為了é™ä½Žèƒƒè…¸é“ä¸è‰¯å應的潛在å±éšªï¼Œç—…人應使用最低有效劑é‡ï¼Œä¸¦ä½œç‚ºæœŸæœ€çŸçš„治療。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><b><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">3. </span></b><b><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">è‚臟作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">投予</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療期間å¯èƒ½ç™¼ç”Ÿä¸€ç¨®æˆ–多種è‚功能指數å‡é«˜çš„ç¾è±¡ã€‚æŒçºŒæ²»ç™‚時，這些檢驗值異常å¯èƒ½æœƒæƒ¡åŒ–ã€ä¿æŒä¸è®Šæˆ–僅為çŸæš«çš„ç¾è±¡ã€‚</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">ä¾æ“šä¸Šå¸‚å¾Œè—¥ç‰©å®‰å…¨ç›£æ¸¬å ±å‘Šï¼Œ</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">引起之è‚毒性不良å應包括è‚臟壞æ»ã€é»ƒç–¸ã€çŒ›ï¨†æ€§è‚炎（無論具有黃疸與å¦ï¼‰åŠè‚è¡°ç«ã€‚å…¶ä¸ä¸€äº›é€šå ±æ¡ˆï¦µå°Žè‡´æ»äº¡æˆ–è‚臟移æ¤ã€‚長期使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療的病人應定期檢測è‚臟轉氨酶（</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">transaminases</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">），ä¾æ“šï§¶åºŠè©¦é©—數據和上市後經驗，應於治ï§å¾Œçš„第</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">4</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">到第</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">8</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">週内進行檢測。然而，嚴é‡è‚毒性ä¸è‰¯å應å¯èƒ½ç™¼ç”Ÿåœ¨ä»¥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療的任何時間。</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;"> </span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">è‹¥è‚功能指數異常的情形ç¶æŒæˆ–惡化，或出ç¾èˆ‡è‚病一致的臨床徵象與症狀，或出ç¾å…¨èº«æ€§å應</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">如嗜伊性白血çƒå¢žå¤šã€çš®ç–¹ã€è…¹ç—›ã€è…¹ç€‰ã€è¤è‰²å°¿æ¶²ç‰</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">時應立å³åœè—¥ã€‚為了é™ä½Žè‚臟ä¸è‰¯å應的潛在å±éšªï¼Œç—…人應使用最低有效劑é‡ï¼Œä¸¦ä½œç‚ºæœŸæœ€çŸçš„治療。åŒæ™‚投予具有潛在è‚毒性的藥物</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">ä¾‹å¦‚æŠ—ç”Ÿç´ ã€æŠ—癲癇藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">æ²»ç™‚æ™‚é ˆç‰¹åˆ¥æ³¨æ„。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><b><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">4. </span></b><b><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">腎臟作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">長期投予éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥å¯èƒ½å°Žè‡´è…Žä¹³é 壞æ»åŠå…¶ä»–腎臟æ傷。å°æ–¼ç™¼ç”Ÿé€™é¡žå應的高å±éšªæ—群</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">年長者ã€è…ŽåŠŸèƒ½å—æã€å¿ƒè¡°ç«ã€è‚功能ä¸å…¨åŠä½¿ç”¨åˆ©å°¿åŠ‘與</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">ACE</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">抑制劑的病人</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">應謹慎投予。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">é‡ç—‡è…Žè‡Ÿç–¾ç—…</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">ç›®å‰ä¹‹å°ç…§æ€§è‡¨åºŠè©¦é©—ä¸å°šæœªæœ‰é—œæ–¼é‡ç—‡è…Žè‡Ÿç–¾ç—…病人使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenec</span><span style="font-family: 標楷體; text-decoration: underline;">çš„è³‡æ–™ï¼Œå› æ¤ä¸å»ºè°æ¤é¡žç—…äººä½¿ç”¨ã€‚è‹¥å¿…é ˆé–‹å§‹</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療，建è°æ‡‰è©²å¯†åˆ‡ç›£æ¸¬ç—…人的腎功能。</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">5. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">皮膚å應</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">å¯èƒ½å¼•ç™¼åš´é‡è€Œå¯èƒ½è‡´æ»çš„皮膚ä¸è‰¯å應，例如å‰è½æ€§çš®è†šç‚Žã€</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">å²è’‚文生æ°</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">-</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">強生症候群</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(SJS)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">和毒性表皮壞æ»æº¶è§£</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(TENS)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">。一旦出ç¾çš®ç–¹æˆ–其他éŽæ•å¾µè±¡æ™‚應立å³åœè—¥ã€‚</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">6. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">血液作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p><span style="font-family: 標楷體; text-decoration: underline;">接å—éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æ²»ç™‚的病人有時會發生貧血。長期使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療的病人若出ç¾ä»»ä½•è²§è¡€æˆ–å¤±è¡€çš„å¾µè±¡æˆ–ç—‡ç‹€ï¼Œæ‡‰é€²è¡Œè¡€ç´…ç´ åŠè¡€æ¯”容之檢測。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æœƒæŠ‘制血å°æ¿å‡é›†ï¼ŒæŸäº›ç—…人å¯èƒ½å‡ºç¾å‡ºè¡€æ™‚間延長的情形。患有å‡è¡€ç–¾ç—…或æ£åœ¨ä½¿ç”¨æŠ—å‡è¡€åŠ‘的病人應密切監測血å°æ¿åŠŸèƒ½ã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">ã€ä¸è‰¯å應】</span> </p><p><span style="font-family: 標楷體; text-decoration: underline;">使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療之病人較為常見的ä¸è‰¯å應為</span><span style="font-family: 標楷體; text-decoration: underline;">胃腸é“的影響，包括腹痛ã€ä¾¿ç¥•ã€è…¹ç€‰ã€æ¶ˆåŒ–ä¸è‰¯ã€è„¹æ°£ã€å¤§å‡ºè¡€</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">ç©¿å”ã€å¿ƒç¼ç†±æ„Ÿã€å™å¿ƒã€èƒƒè…¸é“æ½°ç˜</span><span style="font-family: arial, sans-serif; text-decoration: underline;">(</span><span style="font-family: 標楷體; text-decoration: underline;">胃</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">å二指腸</span><span style="font-family: arial, sans-serif; text-decoration: underline;">)</span><span style="font-family: 標楷體; text-decoration: underline;">與嘔å。其他å應包括腎功能異常ã€è²§è¡€ã€é 暈ã€æ°´è…«ã€è‚é…µç´ å‡é«˜ã€é ç—›ã€å»¶é•·å‡ºè¡€æ™‚é–“ã€æ”癢ã€ç´…ç–¹åŠè€³é³´ã€‚</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">æ›¾åœ¨æ²»ç™‚æœŸé–“è¢«å ±å‘ŠéŽçš„ä¸è‰¯å應包括：</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">全身：發燒ã€æ„ŸæŸ“ã€æ•—血症。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">心血管系統：充血性心衰ç«ã€é«˜è¡€å£“ã€å¿ƒæéŽé€Ÿã€æšˆåŽ¥ã€‚</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">消化系統：å£ä¹¾ã€é£Ÿé“ç‚Žã€èƒƒ</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">腸潰ç˜ã€èƒƒç‚Žã€èƒƒè…¸å‡ºè¡€ã€èˆŒé 發炎ã€åè¡€ã€è‚ç‚Žã€é»ƒç–¸ã€‚</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">血液åŠæ·‹å·´ç³»çµ±ï¼šç˜€è¡€ã€å—œä¼Šæ€§ç™½è¡€çƒå¢žå¤šã€ç™½è¡€çƒéŽä½Žã€é»‘便ã€ç´«æ–‘ã€ç›´è…¸å‡ºè¡€ã€å£è…”ç‚Žã€è¡€å°æ¿éŽä½Žã€‚</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">代è¬åŠç‡Ÿé¤Šï¼šé«”é‡æ”¹è®Šã€‚</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">神經系統：焦慮ã€è¡°å¼±ã€ç²¾ç¥žéŒ¯äº‚ã€æ†‚鬱ã€ä½œå¤¢ç•°å¸¸ã€</span><span style="font-family: 標楷體; text-decoration: underline;">ç倦ã€</span><span style="font-family: 標楷體; text-decoration: underline;">å¤±çœ ã€ç–²å€¦ã€ç·Šå¼µã€æ„Ÿè¦ºç•°å¸¸ã€å—œç¡ã€é¡«æŠ–ã€çœ©æšˆã€‚</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">呼å¸ç³»çµ±ï¼šæ°£å–˜ã€å‘¼å¸å›°é›£ã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">皮膚åŠé™„屬組織：禿髮ã€å…‰æ•æ„Ÿã€æŽ’æ±—å¢žåŠ ã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">特殊感官：視力模糊。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">泌尿系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">膀胱炎ã€æŽ’尿困難ã€è¡€å°¿ã€é–“質性腎炎ã€å°‘å°¿</span><span class="longtext1" style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">多尿ã€è›‹ç™½å°¿ã€è…Žè¡°ç«ã€‚</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">其他少見之ä¸è‰¯å應包括：</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">全身：éŽæ•å應ã€é£Ÿæ¬²æ”¹è®Šã€æ»äº¡ã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">心血管系統：心律ä¸æ•´ã€ä½Žè¡€å£“ã€å¿ƒè‚Œæ¢—å¡žã€å¿ƒæ‚¸ã€è¡€ç®¡ç‚Žã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">消化系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">çµè…¸ç‚Žã€å™¯æ°£ã€è‚è¡°ç«ã€èƒ°è‡Ÿç‚Žã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">血液åŠæ·‹å·´ç³»çµ±ï¼šé¡†</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">粒性白血çƒç¼ºä¹ã€æº¶è¡€æ€§è²§è¡€ã€å†ç”Ÿä¸è‰¯æ€§è²§è¡€ã€æ·‹å·´çµç—…變ã€å…¨è¡€çƒæ¸›å°‘。</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">代è¬åŠç‡Ÿé¤Šï¼šé«˜è¡€ç³–。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">神經系統：</span><span style="font-family: 標楷體; text-decoration: underline;">痙攣<span class="longtext1">ã€æ˜è¿·ã€å¹»è¦ºã€è…¦è†œç‚Žã€‚</span></span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">呼å¸ç³»çµ±ï¼š</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">呼å¸æŠ‘制ã€è‚ºç‚Žã€‚</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">皮膚åŠé™„屬組織：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">血管性水腫ã€æ¯’性表皮壞æ»æº¶è§£ã€å¤šå½¢æ€§ç´…斑，</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="font-family: arial, sans-serif; text-decoration: underline;"><br /></span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">å‰è½æ€§çš®è†šç‚Žã€</span><span style="font-family: 標楷體; text-decoration: underline;">å²è’‚文生æ°</span><span style="font-family: arial, sans-serif; text-decoration: underline;">-</span><span style="font-family: 標楷體; text-decoration: underline;">強生症候群ã€</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">è•éº»ç–¹ã€‚</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">特殊感官：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">çµè†œç‚Žã€è½è¦ºå—æ。 </span></p><p><span style="font-family: 標楷體;">ã€è—¥ç‰©äº¤äº’作用】 </span></p><p><b><span style="font-family: 標楷體;">1.<span style="text-decoration: underline;"> Aspirin</span></span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">由於å¯èƒ½å¢žåŠ ä¸è‰¯å應(包括腸胃é“出血)ç™¼ç”Ÿçš„é¢¨éšªï¼Œä¸€èˆ¬è€Œè¨€ä¸ </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">建è°åŒæ™‚使用aspirin與diclofenac進行治療。　 </span></p><p><span style="font-family: 標楷體;">2.</span><span style="font-family: 標楷體;">抗å‡è¡€åŠ‘：<span style="text-decoration: underline;">抗å‡è¡€åŠ‘(如warfarin)與éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥å°èƒƒè…¸é“出血的影響 </span></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">æ˜¯åŠ æˆæ€§çš„，åˆä½µä½¿ç”¨é€™å…©é¡žè—¥å“的病人發生嚴é‡èƒƒè…¸é“出血之風險較單ç¨ä½¿ç”¨ä»»ä¸€é¡žè—¥å“者為高。 </span></p><p><b><span style="font-family: 標楷體; text-decoration: underline;">3.ACE</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">抑制劑：</span></b><span style="font-family: 標楷體; text-decoration: underline;">éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æœƒæ¸›å¼±è¡€ç®¡å¼µåŠ›ç´ 轉æ›é…¶(angiotensin c onverting enzyme (ACE))抑制劑的é™è¡€å£“作用。åŒæ™‚投予éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥èˆ‡ACE抑制劑時應考慮二者間å¯èƒ½ç™¼ç”Ÿä¹‹äº¤äº’作用。 </span></p><p><span style="font-family: 標楷體;">4.</span><span style="font-family: 標楷體;">åˆ©å°¿åŠ‘ï¼šè‡¨åºŠç ”ç©¶æŒ‡å‡ºï¼Œæœ‰äº›ç—…äººåœ¨åŒæ™‚接å—éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥æ²»ç™‚時，會使得furosemideåŠthiazides的利鈉尿作用減弱。<span style="text-decoration: underline;">åˆä½µä½¿ç”¨æœŸé–“應密切觀察是å¦æœ‰è…Žè¡°ç«ä¹‹å¾µè±¡ï¼Œ</span>並確ä¿åˆ©å°¿åŠ‘之效用。 </span></p><p><span style="font-family: 標楷體;">5.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">鋰鹽：<span style="text-decoration: underline;">éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥å¯èƒ½æ高鋰鹽的血漿ä¸æ¿ƒåº¦åŠé™ä½Žå…¶è…ŽæŽ’除。åˆä½µä½¿ç”¨æœŸé–“應密切觀察是å¦æœ‰é‹°é¹½ä¸æ¯’之徵象。<b> </b></span></span></p><p><span style="font-family: 標楷體;">6.<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; text-decoration: underline;">Methotrexate</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥å¯èƒ½ä½¿methotrexateæ¯’æ€§å¢žåŠ ï¼Œåˆä½µä½¿ç”¨æœŸé–“é ˆç‰¹åˆ¥æ³¨æ„。<b> </b></span></p><p><span style="font-family: 標楷體;">7.<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; text-decoration: underline;">Cyclosporine</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">åˆä½µä½¿ç”¨diclofenac治療時å¯èƒ½æœƒå¢žåŠ cyclosporine之腎毒性，åŒæ™‚æŠ•äºˆæ™‚é ˆç‰¹åˆ¥æ³¨æ„。 </span></p><p><b></b></p><p><b><span style="font-family: 標楷體;">ã€ç‰¹æ®Šæ—群】 </span></b></p><ol> <li><span style="font-family: 標楷體;">å•å©¦åŠæŽˆä¹³å©¦äººä¹‹æŠ•èˆ‡ï¼šå°å•å©¦åŠæŽˆä¹³å©¦äººä¹‹å®‰å…¨æ€§å°šæœªå»ºç«‹ã€‚å°æ–¼å•å©¦åŠå¯èƒ½æ‡·å•ä¹‹å©¦å¥³æˆ–æŽˆä¹³ä¹‹å©¦äººï¼Œé ˆåˆ¤æ–·å…¶æ²»ç™‚æ•ˆç›Šè¶…éŽå±éšªæ€§æ™‚，方予投與。 </span></li> <li><span style="font-family: 標楷體;">懷å•æœ€å¾Œ3個月的婦女使用本å“é ˆç‰¹åˆ¥æ³¨æ„ï¼ˆå› å¯èƒ½é€ æˆå宮收縮無 </span></li></ol><p><span style="font-family: 標楷體;">力åŠ/或胎兒動脈閉鎖éŽæ—©ï¼‰ã€‚ </span></p><p><span style="font-family: 標楷體;">3. FDA Pregnancy Category</span><span style="font-family: 標楷體;">（懷å•ç”¨è—¥ç´šæ•¸ï¼‰ï¼šC</span> </p><p><b><span style="font-family: arial, sans-serif;">4. </span></b><span style="font-family: 標楷體; text-decoration: underline;">兒童使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">的安全性åŠæœ‰æ•ˆæ€§å°šæœªå»ºç«‹ã€‚</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">5. </span></b><span style="font-family: 標楷體; text-decoration: underline;">è‡¨åºŠç ”ç©¶ä¸è€å¹´èˆ‡å¹´è¼•å—試者之有效性或安全性並無整體差異，然而ä¸èƒ½æŽ’除æŸäº›è€å¹´äººæœƒå°éžé¡žå›ºé†‡é¡žæ¶ˆç‚Žè—¥çš„ä½œç”¨æ›´åŠ æ•æ„Ÿã€‚由於è€å¹´äººçš„腎功能å¯èƒ½è¼ƒå·®ï¼Œåœ¨ä½¿ç”¨</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">æ™‚é ˆç‰¹åˆ¥æ³¨æ„監測腎功能。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">ã€éŽé‡ã€‘</span> </p><p><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">éŽé‡ä¹‹ç—‡ç‹€é€šå¸¸ä¾·é™æ–¼å—œç¡ã€ç–²å€¦ã€å™å¿ƒã€å˜”ååŠä¸Šè…¹ç—›ï¼Œä¸€èˆ¬äºˆä»¥æ”¯æŒæ€§ç…§è·å¾Œå¯æ¢å¾©ã€‚</span><span style="font-family: 標楷體;">å¦å¯èƒ½ç™¼ç”Ÿèƒƒè…¸é“出血ã€é«˜è¡€å£“ã€æ€¥æ€§è…Žè¡°ç«ã€å‘¼å¸æŠ‘制和æ˜è¿·ã€‚<span style="text-decoration: underline;">æœè—¥éŽé‡æ™‚亦å¯èƒ½ç™¼ç”Ÿé¡žéŽæ•å應。</span></span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">若有</span><span style="font-family: arial, sans-serif;">diclofenac</span><span style="font-family: 標楷體;">éŽé‡ä¸¦å°Žè‡´é¡¯è‘—全身性副作用時，建è°æŽ¡å–催å或洗胃。<span style="text-decoration: underline;">強迫利尿措施ç†è«–上有助益，而é€æžæˆ–血液çŒæ´—的效用則尚未è‰å¯¦ã€‚</span>除支æŒæ€§æŽªæ–½å¤–，å£æœæ´»æ€§ç¢³å¯èƒ½å¹«åŠ©æ¸›ä½Ž</span><span style="font-family: arial, sans-serif;">diclofenac</span><span style="font-family: 標楷體;">çš„å¸æ”¶ã€‚å°æ–¼ä½µç™¼ç—‡å¦‚è…Žè¡°ç«ã€ç—™æ”£ã€èƒƒè…¸é“刺激åŠå‘¼å¸æŠ‘制ç‰ï¼Œæ‡‰çµ¦äºˆæ”¯æŒç™‚法與症狀處ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋事 由︰為ä¸åœ‹å‘³ç²¾å…¬å¸ç”³è«‹é€²å£ç›¤å°¼è¥¿æž—一案復請查照<p><span style="font-family: 新細明體, serif;">一ã€æœ¬å¹´å月å三日陸拾國貿貳發å—第</span><span style="font-family: calibri;">9980</span><span style="font-family: 新細明體, serif;">號函為ä¸åœ‹å‘³ç²¾å…¬å¸ç”³è«‹é€²å£ç›¤å°¼è¥¿æž—</span><span style="font-family: calibri;">(PENICILLIN G BALK)</span><span style="font-family: 新細明體, serif;">ä½œä»¥åŠ å·¥å‘³ç²¾ã€éº©é…¸ä¹‹ç”¨ä¸€äº‹æ•¬æ‚‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€é—œæ–¼æŠ—ç”Ÿç´ åŽŸæ–™æ›¾å¥‰è¡Œæ”¿é™¢</span><span style="font-family: calibri;">(50</span><span style="font-family: 新細明體, serif;">經å—</span><span style="font-family: calibri;">3517</span><span style="font-family: 新細明體, serif;">號</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">令示應é™ç”±è£½é€ è©²é …æŠ—ç”Ÿç´ ä¹‹è—¥å» è¼¸å…¥ï¼Œä¸¦ä¸å¾—è½‰è®“ã€‚æƒŸæ“šç¨±è©²é …ç›¤å°¼è¥¿æž—ä¿‚å±¬è£½é€ å‘³ç²¾å…¬å¸é€²å£æœ‰æ¡ˆï¼Œæƒ…形較為特殊，擬姑准比照å‰ä¾‹ç”±è¼¸å…¥ä¹‹ä»£ç†å•†èˆ‡ä½¿ç”¨è©²è—¥ä¹‹å‘³ç²¾è£½é€ å·¥å» è¯å以專案å‘本署æ出申請，åŒæ™‚附具切çµä»¥è¼¸å…¥è©²è—¥ä¿‚å°ˆä¾›å‘³ç²¾åŠ å·¥ä¹‹ç”¨ï¼Œå¦‚æœ‰è½‰å”®</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">讓</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">或作其他用途，願å—「藥物商管ç†æ³•ã€æœ‰é—œè¦å®šè™•åˆ†ï¼Œç¶“æ ¸å‡†å¾Œï¼Œå†äºˆè¾¦ç†è¼¸å…¥ï¼Œä»¥åˆ©é…åˆè—¥æ”¿ç®¡ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å‰è¦å®šæ‡‰ç¹³éŠ·ä¹‹æ„Ÿå†’å£æœæ¶²åŠå«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“藥類( å«å’–å•¡å› æˆåˆ†åœ¨äº”å公絲以下者ä¸åœ¨æ¤é™ )之藥å“許å¯è‰ï¼Œå°šæœ‰éƒ¨åˆ†è—¥å•†ä»æœªç¹³éŠ·ï¼ŒèŒ²å†é™æ–¼æœ¬(62)å¹´ 5月31æ—¥å‰å°‡æ˜¯é …è—¥å“許å¯è‰ç¹³éŠ·ï¼Œä¸¦ä¸å¾—ç¹¼çºŒè£½é€ ï¼Œå¦å‰‡é™¤äºˆæ’¤éŠ·è¨±å¯è‰å¤–，並應調查其有無é•è¦è£½å”®åŠåº«å˜æƒ…形。<span style="font-family: 新細明體, serif;">本案係ä¾æ“šæœ¬ç½²</span><span style="font-family: calibri;">61.5.24.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號令åŠ</span><span style="font-family: calibri;">61.7.11.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">06241</span><span style="font-family: 新細明體, serif;">號令è¦å®šï¼Œæ²»ç™‚感冒å£æœæ¶²åŠå«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“藥類å£æœæ¶²</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">å«å’–å•¡å› æˆåˆ†åœ¨äº”å公絲以下者ä¸åœ¨æ¤é™</span><span style="font-family: calibri;"> )</span><span style="font-family: 新細明體, serif;">，於</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">å¹´å二月底å‰æ‡‰ç¹³éŠ·æ˜¯é …è—¥å“許å¯è‰ï¼Œä¸å¾—ç¹¼çºŒè£½é€ ï¼Œä¸¦å®šæ–¼</span><span style="font-family: calibri;">(62)</span><span style="font-family: 新細明體, serif;">年七月一日起一律ç¦æ¢å‡ºå”®ï¼Œå±¬æ–¼ä¸è—¥è£½åŠ‘，ä»ç…§æœ¬ç½²</span><span style="font-family: calibri;">61.7.11.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">06241</span><span style="font-family: 新細明體, serif;">號令è¦å®šåˆ‡å¯¦è¾¦ç†ã€‚</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為「紅åƒç²¾ã€æ¨™ç¤ºç™‚效ç‰å—樣，應以藥å“管ç†ï¼Œå¾©å¸ŒçŸ¥ç…§<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.08.10.</span><span style="font-family: 新細明體, serif;">北市衛四å—第</span><span style="font-family: calibri;">13421</span><span style="font-family: 新細明體, serif;">號函開æˆä¼æ¥æœ‰é™å…¬å¸å‰¯æœ¬å·²æ‚‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥ä»¥ä¸è—¥è—¥æ製æˆä¹‹å„類露液茶ç‰è€Œæ¨™æ˜Žç”¨é‡ç”¨æ³•æ²»ç™‚效能åŠå«é‡è€…應以藥å“管ç†ï¼Œæ¥ç¶“本署</span><span style="font-family: calibri;">60.11.11.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">06112</span><span style="font-family: 新細明體, serif;">號令é£éµåœ¨å·ã€‚案內「紅åƒç²¾ã€ä¸€é …於外盒仿單上標示主è¦æˆåˆ†ã€æ•ˆèƒ½ã€ç”¨æ³•ç”¨é‡ç‰å—樣，ä»æ‡‰ä¾ç…§æœ¬ç½²å‰ä»¤æŒ‡ç¤ºä¾æ³•è™•ç†ã€‚</span> </p>2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1072&type=0
藥政管ç†é¡ž,藥事法行政解釋為「薄è·è†ã€åŠã€Œè–„è·ç’ã€æ‡‰å¦ç”³è«‹æŸ¥é©—ç™»è¨˜ä¸€æ¡ˆæ ¸å¾©çŸ¥ç…§ç”±<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">60.7.14.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">01961</span><span style="font-family: 新細明體, serif;">號呈暨附件å‡æ‚‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ‰€è«‹æ ¸ç¤ºã€Œè–„è·è†ã€åŠã€Œè–„è·ç’ã€æ‡‰å¦ç”³è«‹æŸ¥é©—ç™»è¨˜ä¸€ç¯€ï¼Œç¶“æ ¸è©²å…©ç¨®ç”¢å“所使用之原料，å‡å±¬è—¥å…¸è¨˜è¼‰è—¥å“，應ä¾ç…§ã€Œè—¥ç‰©è—¥å•†ç®¡ç†æ³•ã€ç¬¬å››å三æ¢ä¹‹è¦å®šè¾¦ç†æŸ¥é©—ç™»è¨˜ï¼Œç¶“æ ¸å‡†ç™¼çµ¦è¨±å¯è‰å¾Œï¼Œå§‹å¾—製售。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為工æ¥åŽŸæ–™è¡Œè²©è³£ã€Œé‡æ›¹ã€ç‰æ‡‰æ–¼åŒ…è£ä¸Šæ¨™æ˜Žã€Œå·¥æ¥ç”¨ã€æˆ–「化工用ã€å—樣一案希知照。<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.1.22.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">08292</span><span style="font-family: 新細明體, serif;">號函經濟部副本計é”。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ¡ˆå‡†ç¶“濟部</span><span style="font-family: calibri;">61</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;"> 2</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">10</span><span style="font-family: 新細明體, serif;">日經</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">å·¥å—第</span><span style="font-family: calibri;"> 04508</span><span style="font-family: 新細明體, serif;">號令臺ç£çœæ”¿åºœå»ºè¨å»³ã€è‡ºåŒ—市政府建è¨å±€å‰¯æœ¬ï¼šã€Œ</span><span style="font-family: calibri;">1.</span><span style="font-family: 新細明體, serif;">准行政院衛生署本</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;"> 1</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">22</span><span style="font-family: 新細明體, serif;">日衛署藥å—第</span><span style="font-family: calibri;">8292</span><span style="font-family: 新細明體, serif;">號函略以『é‡æ›¹ã€</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">碳酸</span> <span style="font-family: 新細明體, serif;">氫鈉</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『硼酸ã€ã€ŽçŸ³ç¢³é…¸ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">é…š</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『凡士林ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">石脂</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『硫苦ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">硫酸鎂</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『柳酸ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">水楊酸</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『樟腦ã€ã€Žç”˜æ²¹ã€ã€Žæ©„欖油ã€ã€Žç¡¼ç ‚ã€</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">硼酸鈉</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">ç‰å‡ç‚ºè—¥å…¸æ”¶è¼‰ä¹‹è—¥å“，其屬工æ¥ç´šåŽŸä½¿ç”¨æ–¼ã€Žå·¥æ¥ã€æˆ–『化工ã€è€…，應於包è£ä¸Šæ¨™æ˜Žã€Žå·¥æ¥ç”¨ã€æˆ–『化工用ã€ç‰å—樣，以資與藥å“有所å€åˆ¥ï¼Œè€Œåˆ©ç®¡ç†ç‰ç”±åˆ°éƒ¨ã€‚</span><span style="font-family: calibri;"> 2.</span><span style="font-family: 新細明體, serif;">為ç¶è·åœ‹æ°‘å¥åº·ï¼Œæ‡‰äºˆç…§è¾¦ã€‚</span><span style="font-family: calibri;"> 3.</span><span style="font-family: 新細明體, serif;">希éµç…§ä¸¦è½‰çŸ¥è£½é€ åŠè²©è³£æ¥è€…éµè¾¦ã€ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為世界衛生組織函稱有關「西德衛生部宣佈åˆæ¥ç‚ºæœŸä¸€å¹´è¦å®šã€žPHENTERMINâ€è—¥å“é ˆç”±é†«å¸«è™•æ–¹ä½¿ç”¨ä»¤å¸Œéµç…§è½‰é£çŸ¥ç…§ç”±<p><span style="font-family: 新細明體, serif;">一ã€å‡†ä¸–界衛生組織本年二月二å一日函節開</span><span style="font-family: calibri;">:</span><span style="font-family: 新細明體, serif;">「西德衛生部æ供有關</span><span style="font-family: calibri;">:PHENTERMIN(</span><span style="font-family: 新細明體, serif;">α</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體, serif;">α</span><span style="font-family: calibri;">-DIMETHYLPHENETHYLAMINE)</span><span style="font-family: 新細明體, serif;">è—¥å“資料稱</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體, serif;">接ç²ç”±æ–¼æœç”¨è©²é …</span><span style="font-family: calibri;">"PHENTERMIN"</span><span style="font-family: 新細明體, serif;">å¯èƒ½å¼•èµ·</span><span style="font-family: calibri;"> PRIMARY VASCULAR PULMONARY HYPERTENSION</span><span style="font-family: 新細明體, serif;">ç—…ä¾‹ä¹‹å ±å‘Šï¼Œä¹ƒæ±ºå®šè‡ª</span><span style="font-family: calibri;">1971</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;"> 2</span><span style="font-family: 新細明體, serif;">日開始實施åˆæ¥ä»¥ä¸€å¹´ç‚ºæœŸä¹‹è¦å®šï¼Œä½¿ç”¨ã€ž</span><span style="font-family: calibri;">PHENTERMIN</span><span style="font-family: 新細明體, serif;">”å¿…é ˆç”±é†«å¸«è™•æ–¹ä½¿ç”¨ã€‚åœ¨åœæ¢é…å”®å«æœ‰</span><span style="font-family: calibri;">AMINORE (2-AMINO-5-PHENYL-2-OXAZOLINE)</span><span style="font-family: 新細明體, serif;">特效æˆä»½ä¹‹é£Ÿæ…¾æŠ‘制劑之åŒæ™‚，亦應考慮其他以</span><span style="font-family: calibri;"> "AMPHETAMINE" </span><span style="font-family: 新細明體, serif;">或其è¡åŒ–物為主æˆä»½ä¹‹é£Ÿæ…¾æŠ‘制劑å°æ–¼å¾ªç’°äº¦å¯èƒ½æœ‰é¡žä¼¼å½±éŸ¿è€Œç™¼ç”Ÿã€ž</span><span style="font-family: calibri;">PRIMARY VASCULARPULMONARY HYPERTENSION</span><span style="font-family: 新細明體, serif;">〞情形。在è¦å®šå«ã€ž</span><span style="font-family: calibri;">PHENTERMIN</span><span style="font-family: 新細明體, serif;">〞藥å“é ˆç”±é†«å¸«è™•æ–¹ä½¿ç”¨ä¹‹ä¸€å¹´æœŸé–“å…§å°æ–¼æ˜¯å¦éœ€å†ç¹¼çºŒé™å®šå°‡åœ¨ä½œæ±ºå®šã€ç‰ç”±ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥ã€ž</span><span style="font-family: calibri;">PHENTERMIN</span><span style="font-family: 新細明體, serif;">〞與〞</span><span style="font-family: calibri;">DIETHYLPROPION</span><span style="font-family: 新細明體, serif;">〞之化å¸æ§‹é€ å¼æ¥µç‚ºç›¸ä¼¼ï¼Œå‡å±¬</span> <span style="font-family: 新細明體, serif;">〞</span><span style="font-family: calibri;">AMPHETAMINE TYPE</span><span style="font-family: 新細明體, serif;">〞之食慾抑制劑，為ç¶è·åœ‹æ°‘建康起見，凡使用上述食慾抑制劑</span><span style="font-family: calibri;">(APPETITE DEPRESSANTS)</span><span style="font-family: 新細明體, serif;">è—¥å“ï¼Œå¿…é ˆé™é†«å¸«è™•æ–¹ä½¿ç”¨ä¸¦æ‡‰åŠ 強注æ„。</span> </p><p><span style="font-family: 新細明體, serif;">三ã€éš¨ä»¤æª¢ç™¼ä¸–界衛生組織來函影本一份，令希éµç…§ä¸¦å¸Œè½‰é£å„有關醫療團體知照為è¦ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ä»¥è£½è—¥å» å•†å義å¯å¦å…¼è£½é£Ÿå“飲料疑義一案令覆知照由<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.10.6.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">27884</span><span style="font-family: 新細明體, serif;">號呈悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è—¥å“使用於診斷ã€æ²»ç™‚減輕或é 防人類疾病，關係國民å¥åº·è‡³é‰…ï¼Œå› æ¤è£½è—¥å·¥å» è¨ç½®æ¨™æº–è¦å®šï¼Œè£½è—¥å·¥å» å» å€æ‡‰é¸æ“‡æ–¼ç’°å¢ƒæ¸…æ½”ã€ç©ºæ°£æ–°é®®ä¹‹åœ°å¸¶ï¼Œä¸¦æ‡‰èˆ‡ä½å®…æˆ–å…¬å…±å ´æ‰€éš”é›¢ï¼Œäº¦å³è¡¨ç¤ºè£½é€ è—¥å“ä¸å¾—與其他事物發生摻雜。復查食å“範åœè‡³ç‚ºå»£æ³›ï¼Œå…¶è£½é€ éŽç¨‹å„有ä¸åŒï¼Œç‚ºé¡§æ…®è—¥å“å“質之安全計，藥å“與食å“ä¸å¾—在åŒä¸€å» å€å…§è£½é€ ，以å…環境被污染而影響藥å“å“質。</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ç‚ºåŠ å¼·æ¢ç—›æ¶ˆç‚Žé¡žåŠè·çˆ¾è’™é¡žåŽŸæ–™è—¥ç®¡ç†æ¡ˆï¼Œè«‹æŸ¥ç…§è¾¦ç†<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">PREDNISOLONE, PHENYLBUTAZONE, OXYPHENBUTAZONE, DEXAMETHAZONE</span><span style="font-family: 新細明體, serif;">ç‰æ¢ç—›æ¶ˆç‚Žé¡žè—¥å“åŠ</span><span style="font-family: calibri;">TESTOSTERONE, METHYLTESTOSTERONE</span><span style="font-family: 新細明體, serif;">è·çˆ¾è’™é¡žè—¥å“效果固稱良好，但如使用失當，亦å¯èƒ½ç™¼ç”Ÿå‰¯ä½œç”¨ã€‚邇來曾發ç¾å°‘æ•¸è—¥å•†æœªç¶“æ ¸å‡†æ“…å°‡è©²é …è—¥å“摻入製劑情事，除分別ä¾æ³•åš´è™•å¤–，å°è©²é …åŽŸæ–™è—¥ä¹‹è£½é€ ã€è¼¸å…¥åŠéŠ·å”®ï¼ŒäºŸæ‡‰åš´æ ¼åŠ 強管ç†ï¼Œä»¥åŠå¯èƒ½å°‘é‡æ”œå¸¶èµ°ç§äº¦æ‡‰æ³¨æ„查ç·ï¼Œä¿¾é˜²æ¢æµç‚ºä¸æ£ç•¶ç”¨</span> <span style="font-family: 新細明體, serif;">途，藉以ç¶è·åœ‹æ°‘å¥åº·ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æª¢é™„上述藥å“產銷</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">輸入åŠéŠ·å”®</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">數é‡æœˆå ±è¡¨åŠéŠ·å”®ç‹€æ³å ±å‘Šè¡¨æ ¼å¼å„一份，希å³åˆ†å‡½å„有關藥æ¥åœ˜é«”轉知會員切實éµç…§è¾¦ç†ï¼Œè‡ªæœ¬</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å…å三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">年七月å日起填é€å…æœˆä»½å ±è¡¨ï¼Œä¸¦ç”±åœ°æ–¹è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œåš´å¯†æŸ¥æ ¸ï¼Œé•è€…ä¾æ³•åš´ç©¶ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ç‚ºåŠ å¼·è—¥å“管ç†ç‰¹å†åˆ†åˆ¥è¦å®šå«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“藥類å£æœæ¶²åŠ‘之處ç†è¦é»žä»¤ä»°éµç…§<p><span style="font-family: 新細明體, serif;">一ã€æœ¬ç½²</span><span style="font-family: calibri;">61. 5.24.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">è™Ÿä»¤ç‚ºåŠ å¼·ç®¡ç†å«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“藥類å£æœæ¶²åŠ‘è—¥å“一案計é”，茲å†åˆ†åˆ¥è¦å®šæœ‰é—œè©²é¡žè—¥å“處ç†è¦é»žå¦‚次：</span> </p><p><span style="font-family: calibri;">1.</span><span style="font-family: 新細明體, serif;">治療感冒藥å“åŠä¸å±¬æ–¼ä¸‹åˆ—å„款之藥å“而å«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“之å£æœæ¶²ï¼Œå‡æ‡‰æŒ‰ç…§æœ¬ç½²</span><span style="font-family: calibri;">61.5.24.</span><span style="font-family: 新細明體, serif;">衛署藥å—</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號令之è¦å®šè™•è£¡ã€‚</span> </p><p><span style="font-family: calibri;">2.</span><span style="font-family: 新細明體, serif;">感冒糖漿製劑，原則上ä¸å†æ ¸å‡†ç™»è¨˜ï¼Œå‰ç¶“æ ¸å‡†è¨±å¯æœ‰æ¡ˆè€…，其å«ç³–é‡æ¿ƒåº¦æ‡‰åœ¨</span><span style="font-family: calibri;">55% </span><span style="font-family: 新細明體, serif;">以上</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">èˆ‡è©²é …æ¨™æº–ä¸ç¬¦è€…應申請變更登記並且ä¸å¾—使用糖精</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">，其最å°åŒ…è£ä¸å¾—少於二天份劑é‡ï¼Œ</span><span style="font-family: calibri;"> 60</span><span style="font-family: 新細明體, serif;">å…¬æ’®ä»¥ä¸Šè€…å‡†ç”±åŽŸå» å•†åœ¨å…¶è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“內製售，必è¦æ™‚本署å°æ–¼è©²é¡žè—¥å“æˆåˆ†å«é‡æŒ‰ç…§åœ‹ç”¢è—¥å“審查基準，é‡æ–°äºˆä»¥å¯©æŸ¥ã€‚</span><span style="font-family: calibri;"> 3.</span><span style="font-family: 新細明體, serif;">ç¶ä»–命åŠå¼·è‚é¡žå£æœæ¶²ï¼Œå…¶æ‰€å«å’–å•¡å› æˆåˆ†åœ¨</span><span style="font-family: calibri;">50MG</span><span style="font-family: 新細明體, serif;">以上者，ä¸å†æ ¸å‡†ç™»è¨˜ï¼Œå¦‚ä¿‚å‰ç¶“æ ¸å‡†æœ‰æ¡ˆè€…ï¼Œæ‡‰ä¾æœ¬ç½²</span><span style="font-family: calibri;">61. 5.24.</span><span style="font-family: 新細明體, serif;">衛署藥å—</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號令之è¦å®šç”³è«‹å°‡è©²æˆåˆ†å«é‡æ”¹ç‚º</span><span style="font-family: calibri;">50MG</span><span style="font-family: 新細明體, serif;">以下，至於所å«å’–å•¡å› æˆåˆ†åœ¨</span><span style="font-family: calibri;">20MG</span><span style="font-family: 新細明體, serif;">至</span><span style="font-family: calibri;">50MG</span><span style="font-family: 新細明體, serif;">範åœä»¥å…§è€…ï¼Œé ˆåœ¨ä»¿å–®ã€æ¨™ç±¤è¨»æ˜Žã€Œä¸å¾—連續æœç”¨ã€å—樣</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">以示è¦æƒ•</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。å„ç´šè¡›ç”Ÿæ©Ÿé—œæ‡‰åŠ å¼·æŠ½æŸ¥ä¸Šé …å£æœæ¶²åŠ‘。</span> </p><p><span style="font-family: calibri;">4.</span><span style="font-family: 新細明體, serif;">ä¸è—¥å£æœæ¶²åŽŸå‰‡ä¸Šä¸å†æ ¸å‡†ç™»è¨˜ï¼Œå¦‚係以å‰æ ¸å‡†ç™»è¨˜è¨±å¯æœ‰æ¡ˆè€…ï¼Œåƒ…å‡†ç”±åŽŸå» åœ¨å…¶è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“內製售，該局</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">處</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">åŠæ‰€å±¬è¡›ç”Ÿæ©Ÿé—œæ‡‰åŠ 強抽查是類藥å“æœ‰ç„¡æ“…è‡ªæ‘»å…¥è¥¿è—¥æˆ–å…¶ä»–è¶…è¶Šæ ¸å‡†ç™»è¨˜äº‹é …ã€‚</span> </p><p><span style="font-family: calibri;">5.</span><span style="font-family: 新細明體, serif;">å£æœæ¶²åŠ‘型多屬較易變質之藥å“，為求安全åŠä¾¿æ–¼ç®¡ç†è¨ˆï¼ŒèŒ²è¦å®šå—£å¾Œè£½å”®ä¹‹å£æœæ¶²è—¥å“，å‡æ‡‰æ¨™æ˜Žè£½é€ 年月日åŠæ‰¹è™Ÿã€‚</span> </p><p><span style="font-family: calibri;">6.</span><span style="font-family: 新細明體, serif;">ä¸è—¥èˆ‡è¥¿è—¥è¤‡åˆè£½åŠ‘，其以西藥</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">影響ä¸æ¨žç¥žç¶“é¡ž</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">摻入ä¸è—¥å›ºæœ‰æ–¹åŠ‘者，原則上ä¸å†æ ¸å‡†ç™»è¨˜ï¼Œå¦‚ä¿‚å‰ç¶“æ ¸å‡†ç™»è¨˜è¨±å¯æœ‰æ¡ˆè€…ï¼Œåƒ…å‡†ç”±åŽŸå» åœ¨å…¶è—¥å“許å¯è‰æœ‰æ•ˆæœŸé–“內製售。</span> <span style="font-family: 新細明體, serif;">以上第二款ã€ç¬¬å››æ¬¾ã€ç¬¬å…款所稱å‰å·²ç¶“æ ¸å‡†ç™»è¨˜è¨±å¯æœ‰æ¡ˆè€…，其製å“å‡é™å®šå„該藥å“許å¯è‰æœ‰æ•ˆæœŸé–“屆滿å…個月後，一律ä¸å¾—買賣或供使用。</span> </p>2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1087&type=0
藥政管ç†é¡ž,藥事法行政解釋為有關「藥å“與食å“ä¸å¾—在åŒä¸€å» å€å…§è£½é€ ã€ä¸€æ¡ˆè¦†è«‹æŸ¥ç…§ç”±<p><span style="font-family: 新細明體, serif;">一ã€è²´å±€</span><span style="font-family: calibri;">61.11.07.</span><span style="font-family: 新細明體, serif;">å·¥</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">三第</span><span style="font-family: calibri;">12734</span><span style="font-family: 新細明體, serif;">號函敬悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥é£Ÿå“å·¥å» å…¶è£½é€ éŽç¨‹ä¸å®¹æ˜“污染環境者甚多，然而何種食å“ä¸è‡´æ±¡æŸ“環境，殊難é€ä¸€åˆ—èˆ‰ï¼Œä¸¦ä¸”è£½è—¥å» èˆ‡é£Ÿå“å» ä¹‹ç®¡ç†å„有ä¸åŒï¼Œå‡æ‡‰è€ƒæ…®ï¼Œå› æ¤ä»æ‡‰ä½œè¼ƒç‚ºæ˜Žç¢ºç•Œåˆ†ç‚ºå®œã€‚至於</span> <span style="font-family: 新細明體, serif;">貴局所稱æ“有較大é¢ç©ä¹‹è£½è—¥å» ，其藥å“與食å“ä¹‹å·¥ä½œå ´æ‰€ä»¥åœç‰†å®Œå…¨éš”離，能符åˆå„別è¨å» 標準，並能é¿å…發生污染者，本署åŒæ„</span> <span style="font-family: 新細明體, serif;">è²´å±€æ„見，視為ä¸åœ¨åŒä¸€å» å€å…§è£½é€ 。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋生物製劑抽樣檢驗å°ç·˜æ¥å‹™ä»æš«ç”±è‡ºç£çœè¡›ç”Ÿè©¦é©—所ä¾ç…§è¦å®šç¹¼çºŒè¾¦ç†ã€‚至診斷用血清åŠèŒæ¶²ï¼Œå‡æ‡‰äºˆæª¢å®šåŠ è²¼å°ç·˜ï¼Œå…¶ç„¡æª¢å®šåŸºæº–者，å¯åƒç…§åŽŸè£½é€ å» ä¹‹æª¢å®š<span style="font-family: 新細明體, serif; font-size: 12pt;">復</span><span style="font-family: calibri, sans-serif; font-size: 12pt;">62.6.29.</span><span style="font-family: 新細明體, serif; font-size: 12pt;">衛四å—第</span><span style="font-family: calibri, sans-serif; font-size: 12pt;">22135</span><span style="font-family: 新細明體, serif; font-size: 12pt;">號函</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為西藥進å£é©—è‰äº‹å®œå¸Œä¾å¤–交部函復原則辦ç†ç‰¹å¾©çŸ¥ç…§ç”±<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">60</span><span style="font-family: 新細明體, serif;">貿</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">æ ¹æ¥å—第</span><span style="font-family: calibri;">0376</span><span style="font-family: 新細明體, serif;">號呈悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ¡ˆç¶“轉准外交部外</span><span style="font-family: calibri;">(60)</span><span style="font-family: 新細明體, serif;">é ˜ä¸‰å—第</span><span style="font-family: calibri;">020651</span><span style="font-family: 新細明體, serif;">號函開：『</span><span style="font-family: calibri;"> 1.</span><span style="font-family: 新細明體, serif;">關於進å£è¥¿è—¥ä¹‹æ–‡ä»¶é©—è‰äº‹ï¼Œæœ¬å¹´å月å…日衛署藥å—第</span><span style="font-family: calibri;">4079</span><span style="font-family: 新細明體, serif;">號函敬悉。</span><span style="font-family: calibri;"> 2.</span><span style="font-family: 新細明體, serif;">查我國西藥進å£å•†å‘無邦交國家進å£è¥¿è—¥ï¼Œå…¶æœ‰é—œè‰ä»¶å¦‚能由出å£åœ‹å®¶ä¹‹æœ€é«˜è¡›ç”Ÿæ©Ÿæ§‹é©—è‰ä¸¦ç¶“當地之公è‰äººå…¬è‰ï¼Œåœ¨æ‰‹çºŒä¸Šè‡ªè¼ƒç‚ºä¾¿æ·ï¼ŒæƒŸå•é¡Œåœ¨æˆ‘æœ‰é—œæ©Ÿé—œå¦‚ä½•èƒ½ç¢ºçŸ¥è©²é …é©—è‰åŠå…¬è‰ç‚ºä¸Šè¿°æ©Ÿé—œæ‰€å‡ºå…·ï¼›å¦‚有å½å†’情事發生，我方如何å¯ä½œæœ‰æ•ˆä¹‹æŸ¥è‰ã€‚</span><span style="font-family: calibri;"> 3.</span><span style="font-family: 新細明體, serif;">復查我在若干無邦交國家在商務簽è‰æ–¹é¢ï¼Œç‚ºä¾¿åˆ©ç•¶åœ°å» 商起見，除指定由</span> <span style="font-family: 新細明體, serif;">é§åœ¨é„°è¿‘åœ‹å®¶ä¹‹æˆ‘ä½¿é ˜é¤¨å…¼ç†å¤–，並酌情指定當地若干機構辦ç†æ¤é …手續。如義大利地å€ï¼Œé™¤ç”±è¥¿ç牙大使館兼ç†å¤–，æ¤é¡žå•†å‹™ç°½è‰äº¦å¯ç”±å¤–åœ‹å» å•†é€•å‘我「é æ±è²¿æ˜“ä¸å¿ƒã€</span><span style="font-family: calibri;">(CENTRO COMMERCIALE PER L`ESTREMO ORIENTE, VIA FADIO FILZI2, 20124 MILANO, ITALY. TEL. 635,070)</span><span style="font-family: 新細明體, serif;">申請辦ç†ï¼Œå³ç‚ºä¸€ä¾‹ã€‚為確ä¿æˆ‘進å£å» 商之æ£ç•¶åˆ©ç›Šï¼Œä¸¦æœŸè¿…速處裡起見，æ¤é¡žæ–‡ä»¶ä¼¼ä»ä»¥å…ˆç¶“我有關é§å¤–ä½¿é ˜é¤¨æˆ–æ”¿åºœæŒ‡å®šæ©Ÿæ§‹ä¹‹é©—è‰ç‚ºå®œã€‚本案我西藥進å£å» 商å‘與我無邦交國家進å£ä¹‹è©²ç‰åœ‹å®¶ç‚ºä½•æœ¬éƒ¨æ“šå ±å¾Œè‡ªå¯é€åœ‹æŒ‡ç¤ºæ‡‰å‘我何一é§å¤–ä½¿é ˜é¤¨æˆ–æ”¿åºœæŒ‡å®šä¹‹æ©Ÿæ§‹åŠå¦‚何申辨驗è‰äº‹å®œã€‚</span><span style="font-family: calibri;"> 4.</span><span style="font-family: 新細明體, serif;">相應復請查照為è·ã€ç‰ç™½ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€å—£å¾Œè¥¿è—¥é€²å£ç°½è‰äº‹å®œå‡ä¾ç…§å¤–交部函復原則辦ç†</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ç‚ºå¸Œè½‰çŸ¥è£½è—¥å» å¢žåŠ è£½é€ åŽŸæ–™è—¥å“或æç…‰ä¸è—¥äºŒé …藥劑時應先å‘æœ¬ç½²ç”³è«‹æ ¸å‡†å¾Œå§‹å¾—è£½é€ <span style="font-family: 新細明體, serif;">一ã€æŸ¥å…§æ”¿éƒ¨å‰æœƒåŒç¶“æ¿Ÿéƒ¨è¨‚å®šä¹‹è£½è—¥å·¥å» è¨å‚™æ¨™æº–åŠä¸è—¥è£½è—¥å·¥å» è¨å‚™æ¨™æº–，å°æ–¼åŽŸæ–™è—¥è£½é€ åŠä¸è—¥æ煉所需之è¨å‚™æ¨™æº–å°šç„¡è¦å®šï¼Œæœ¬ç½²æˆç«‹ä»¥ä¾†ï¼Œå°è£½è—¥å» ç”³è«‹è£½é€ è—¥å“許å¯ï¼Œå¿…å…ˆè¦–å…¶æœ‰ç„¡è©²é …åŠ‘åž‹è¨å‚™ï¼Œä½œç‚ºå¯©æ ¸æº–繩之一，已往å°è£½é€ 原料藥å“åŠä¸è—¥ä¹‹æç…‰æ¡ˆä»¶ï¼Œå› ç„¡è¦å®šæ¨™æº–ï¼Œè‡´æœªèƒ½åš´æ ¼åŸ·è¡Œã€‚èŒ²ç‚ºåŠ å¼·ç®¡ç†ä¸¦çŽå‹µåŽŸæ–™è—¥ä¹‹è£½é€ ，å³å¸Œå°‡è£½è—¥å» ç›®å‰å·²æ ¸å‡†æœ‰è©²å…©é …è—¥åŠ‘è£½é€ ä¹‹ç¾æ³ï¼ŒåŠå…¶è¨å‚™æƒ…å½¢åˆ†åˆ¥åˆ—å†Šå ±ç½²ï¼Œä»¥æ†‘æ ¸è¾¦åŠæ´¾å“¡æŸ¥æ ¸ï¼Œè—‰è³‡æ˜Žçžå¯¦æ³è€Œåˆ©ç ”究改進，並希轉知å„會員在è¨å» 標準未修æ£å‰ï¼Œå¦‚æœ‰è£½è—¥å» éœ€è¦å¢žåŠ è£½é€ è©²å…©é …</span> <span style="font-family: 新細明體, serif;">藥劑時，應先å‘æœ¬ç½²ç”³è«‹æ ¸å‡†å¾Œå§‹å¾—è£½é€ ã€‚</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為ä¾å¾®ç”Ÿç‰©å¸ã€å…ç–«å¸å¸ç†å¾žäº‹äººç”¨ç”Ÿç‰©è—¥å“è£½é€ æ¥è€…è² è²¬è£½é€ äººå“¡è¦å®šä¸€æ¡ˆï¼Œå¾©å¸ŒçŸ¥ç…§<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">31.10.04.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">32231</span><span style="font-family: 新細明體, serif;">號呈悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è—¥ç‰©è—¥å•†ç®¡ç†æ³•ç¬¬</span><span style="font-family: calibri;">28</span><span style="font-family: 新細明體, serif;">æ¢è¦å®šï¼šã€Œä¾å¾®ç”Ÿç‰©å¸ã€å…ç–«å¸ä¹‹å¸ç†ï¼Œå¾žäº‹äººç”¨ç”Ÿç‰©è—¥å“è£½é€ æ¥è€…，應è˜ç”¨åœ‹å…§å¤–大å¸æˆ–專科å¸æ ¡ä»¥ä¸Šé†«è—¥æˆ–生物å¸ç‰ç³»ç§‘ç•¢æ¥ï¼Œå…·æœ‰å¾®ç”Ÿç‰©å¸ã€å…ç–«å¸è—¥å“è£½é€ å°ˆé–€çŸ¥è˜ï¼Œä¸¦æœ‰äºŒå¹´ä»¥ä¸Šè£½é€ 經驗之技術人員，é§å» è² è²¬è£½é€ ã€‚ã€</span> </p><p><span style="font-family: 新細明體, serif;">三ã€è©²ä¸åœ‹è¡€æ¸…ç–«è‹—è£½é€ æ‰€è‚¡ä»½æœ‰é™å…¬å¸ç‚ºå¾žäº‹äººç”¨ç”Ÿç‰©è—¥å“è£½é€ æ¥è€…，應ä¾è¦å®šè˜ç”¨ä¸Šé …技術人員é§å» è² è²¬è£½é€ ï¼Œä¸¦æ‡‰ä¾è—¥ç‰©å» 商管ç†æ³•ç¬¬</span><span style="font-family: calibri;">23</span><span style="font-family: 新細明體, serif;">æ¢é ˜å¾—藥商許å¯åŸ·ç…§å¾Œæ–¹å‡†ç‡Ÿæ¥ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為函復纖ç¶ç´ æº¶è§£é…µç´ æ´»æ€§åŒ–åŠ‘ç²¾è£½å“ç‰æ‡‰å¦ä»¥è—¥å“管ç†ç”±<p><span style="font-family: 新細明體, serif;">一ã€è²´å»³</span><span style="font-family: calibri;">61.7.3.</span><span style="font-family: 新細明體, serif;">建一å—第</span><span style="font-family: calibri;">63271</span><span style="font-family: 新細明體, serif;">號代電敬悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è‡ºç£ç¶ åå—股份有é™å…¬å¸è£½é€ é³³æ¢¨é…¥ç´ ã€çº–ç¶ç´ æº¶è§£é…µç´ ã€æ´»æ€§åŒ–劑精製å“åŠæœ¨ç“œä¹³æ¶²æš¨å‰¯ç”¢ç‰©å¦‚使用於醫療用途者，應以藥å“管ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為查復育亨賓ç¦æ¢é€²å£æ¡ˆæ—¥æœŸæ–‡è™Ÿï¼Œå¸ŒçŸ¥ç…§<span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.11.04.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">35880</span><span style="font-family: 新細明體, serif;">號呈悉。</span> <span style="font-family: 新細明體, serif;">二ã€æŸ¥è‚²äº¨è³“</span><span style="font-family: calibri;">YOHIMBINE</span><span style="font-family: 新細明體, serif;">åŠè£½åŠ‘ç¦æ¢é€²å£ä¸€æ¡ˆï¼Œç¶“內政部</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">四一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">åˆçš“內衛å—第</span><span style="font-family: calibri;">16860</span><span style="font-family: 新細明體, serif;">號代電知照，並經該處四å一年八月五日肆壹未微臺衛三å—第</span><span style="font-family: calibri;">9196</span><span style="font-family: 新細明體, serif;">號令分行å„縣市局衛生院暨有關公會知照å„在案</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">詳見臺ç£çœæ”¿åºœå…¬å ±å››å一年秋å—第三å五期第</span><span style="font-family: calibri;">503</span><span style="font-family: 新細明體, serif;">é </span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為訂定「藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“ç”³è«‹æ ¸ç™¼è‰æ˜Žæ›¸æ³¨æ„è¦é»žã€<p><span style="font-family: 新細明體, serif;">一ã€æŸ¥ä¾ç…§æµ·é—œé€²å£ç¨…則第廿ä¹ç« ，有機化å¸ç”¢å“ç¾è¡Œç¨…則號別第二ä¹å››äº”號</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“稅率為</span><span style="font-family: calibri;">20</span><span style="font-family: 新細明體, serif;">ï¼…ï¼ŒæƒŸè©²ç« å¢žè¨»ç¬¬ä¸€é …è¦å®šï¼šä»¥åˆæˆè—¥å» è¼¸å…¥è‡ªç”¨ä¹‹è©²é …åŒ–å¸ç”¢å“，經本署è‰æ˜Žå±¬å¯¦ï¼Œå¾—減低稅率徵稅。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€èŒ²ç‚ºè¾¦ç†è©²é …è‰æ˜Žæœ‰æ‰€æº–繩計，特訂定「藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“ç”³è«‹æ ¸ç™¼è‰æ˜Žæ›¸æ³¨æ„è¦é»žã€ä¸€ç¨®ï¼Œä¸¦ç¶“分別徵得財政部</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">å°è²¡é—œå—第</span><span style="font-family: calibri;">10249</span><span style="font-family: 新細明體, serif;">號åŠç¶“濟部國際貿易局陸壹貿肆發å—第</span><span style="font-family: calibri;">241</span><span style="font-family: 新細明體, serif;">號函復åŒæ„在案。</span> </p><p><span style="font-family: 新細明體, serif;">三ã€æª¢ç™¼å‰é …注æ„è¦é»žä¸€ä»½ï¼Œä»¤å¸ŒçŸ¥ç…§</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體, serif;">並轉知éµç…§ã€‚</span> </p><p><span style="font-family: calibri;">***** </span><span style="font-family: 新細明體, serif;">è—¥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“ç”³è«‹æ ¸ç™¼è‰æ˜Žæ›¸æ³¨æ„è¦é»ž</span><span style="font-family: calibri;"> ***** </span></p><p><span style="font-family: 新細明體, serif;">一ã€è¡Œæ”¿é™¢è¡›ç”Ÿç½²</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">以下簡稱本署</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">為å—ç†è£½é€ æ¥è€…ä¾ç…§æµ·é—œé€²å£ç¨…則第二åä¹ç« 有機化å¸ç”¢å“ç¾è¡Œç¨…則第</span><span style="font-family: calibri;">2945</span><span style="font-family: 新細明體, serif;">號</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">å¢žè¨»ç¬¬ä¸€é …è¦å®šè¼¸å…¥å°ˆä¾›åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“ç”³è«‹æ ¸ç™¼è‰æ˜Žç‰¹å®šæœ¬è¦é»žã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å‡¡ç”³è«‹æ ¸ç™¼è¼¸å…¥å°ˆä¾›åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“者應填具申請書</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">æ ¼å¼å¦‚附表一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">åŠåˆ‡çµæ›¸</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">æ ¼å¼å¦‚附表二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">å„一份é€ç”±è‡ºç£å€è£½è—¥å·¥æ¥åŒæ¥å…¬æœƒæ ¸è½‰æœ¬ç½²ç”³è«‹æ ¸ç™¼è‰æ˜Žæ›¸ã€‚</span> <span style="font-family: 新細明體, serif;">å‰é …è‰æ˜Žæ›¸</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">æ ¼å¼å¦‚附表三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">æœ‰æ•ˆæœŸé–“ä»¥è‡ªæ ¸ç™¼æ—¥èµ·å…個月內為é™ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€ç¶“ä¾ç…§æœ¬è¦é»žä¹‹è¦å®šæ ¸å‡†è¼¸å…¥ä¹‹å°ˆä¾›åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“應以自用為é™ä¸å¾—轉讓或移作其他用途如有é•å除應ä¾æœ‰é—œæ³•ä»¤è¦å®šè™•åˆ†å¤–本署並得åœæ¢æ ¸ç™¼è©²é …è‰æ˜Žæ›¸ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€ç¶“æ ¸å‡†è¼¸å…¥å°ˆä¾›åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“本署得é£ç”±çœå¸‚地方衛生主管機關或逕行派員檢查å„è—¥å“è£½é€ æ¥è€…之實際使用情形。</span> </p><p><span style="font-family: 新細明體, serif;">五ã€æœ¬ç½²æ ¸ç™¼è‰æ˜Žä¹‹å°ˆä¾›åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“種類暫定如å¦è¡¨</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">如附表四</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ç‚ºè¨‚å®šè—¥å» ç”³è«‹è¼¸å…¥è‡ªç”¨åŽŸæ–™è—¥æŸ¥é©—ç™»è¨˜æ³¨æ„è¦é»žä¸€æ¡ˆå¸ŒçŸ¥ç…§ç”±<p><span style="font-family: 新細明體, serif;">茲為促進本國製藥工æ¥ä¹‹ç™¼å±•åŠä¾¿æ°‘èµ·è¦‹ï¼Œç‰¹å°‡è—¥å» ç”³è«‹è¼¸å…¥è‡ªç”¨åŽŸæ–™è—¥ä¹‹æŸ¥é©—ç™»è¨˜æ‰‹çºŒï¼Œäºˆä»¥ç°¡åŒ–ï¼Œåˆ¶å®šè—¥å» ç”³è«‹è¼¸å…¥è‡ªç”¨åŽŸæ–™è—¥æŸ¥é©—ç™»è¨˜æ³¨æ„è¦é»žä¸€ç¨®ï¼Œéš¨æ–‡æª¢é™„希轉知å„會員知照。</span> </p><p><span style="font-family: calibri;"> ***** </span><span style="font-family: 新細明體, serif;">行政院衛生署辦ç†è—¥å» 申請輸入自用原料藥查驗登記注æ„è¦é»ž</span><span style="font-family: calibri;"> ***** </span><span style="font-family: 新細明體, serif;">一ã€å‡¡è—¥å» 申請輸入自用原料藥之查驗登記案件除ä¾ç…§è—¥ç‰©è—¥å•†ç®¡ç†æ³•åŠå…¶ä»–有</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">關法令之è¦å®šå¤–，應按本è¦é»žè¾¦ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€ç”³è«‹è¼¸å…¥è‡ªç”¨åŽŸæ–™è—¥ç„¡é ˆæ·»ä»˜ã€Œå‡ºç”¢åœ‹å®¶è¨±å¯è£½å”®ä¹‹è‰æ˜Žæ–‡ä»¶ã€</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體, serif;">但第一次</span> </p><p><span style="font-family: 新細明體, serif;">申請時，應檢附出產國家之è‰æ˜Žè©²è£½è—¥å» 為åˆæ³•è—¥å» 之è‰æ˜Žæ–‡ä»¶ã€‚</span> <span style="font-family: 新細明體, serif;">ä¸Šé …è‰</span> </p><p><span style="font-family: 新細明體, serif;">明文件應逕由ä¸è¯æ°‘國派é§è©²åœ‹ä¹‹å•†æ¥ä»£è¡¨åœ˜æˆ–å…¬è‰åœ˜é«”之簽è‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€ç”³è«‹è¼¸å…¥è‡ªç”¨åŽŸæ–™è—¥æ¡ˆä»¶ä¹‹å¯©æŸ¥æš«ä»¥</span><span style="font-family: calibri;">(A)</span><span style="font-family: 新細明體, serif;">級審查，但如係新輸入之原料藥應以</span><span style="font-family: calibri;">(B)</span><span style="font-family: 新細明體, serif;">級程åºå¯©æŸ¥ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€è—¥å» 輸入之自用原料藥ä¸å¾—轉售，並應出具切çµ</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">切çµæ›¸æ ¼å¼é™„後</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">ä¿è‰å…¶å“質åˆæ–¼è¦å®šï¼Œå¦‚有é•å除ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•æœ‰é—œè¦å®šäºˆä»¥è™•åˆ†å¤–，並得åŠéŠ·å…¶è¨±å¯è‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">五ã€æœ¬ç½²å°æ–¼è—¥å» 輸入之自用原料藥得隨時予以抽驗，如有ä¸åˆè¦å®šæ‡‰ä¾æ³•è™•ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為清涼劑應列入æˆè—¥ç®¡ç†ï¼Œå¾©å¸ŒçŸ¥ç…§<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.3.2.</span><span style="font-family: 新細明體, serif;">北市衛四å—第</span><span style="font-family: calibri;">3042</span><span style="font-family: 新細明體, serif;">號為檢呈「å£èŠ³éœ²ã€æª¢é©—æˆç¸¾æ›¸è«‹é‘’æ ¸ä¸€æ¡ˆæ‚‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥æ¸…涼劑關係國民ä¿å¥é —為密切，應予列入æˆè—¥ç®¡ç†ã€‚本案「å£èŠ³éœ²ã€å±¬å£è…”清涼劑，自應比照辦ç†ã€‚希å³æŸ¥æ˜Žå¦‚有製售情事，應é£ä¹‹ç«‹å³åœæ¢ï¼Œä¸¦è²¬ä»¤è©²å•†æ–¼ä¸€å€‹æœˆå…§ä¾æ³•ç”³è«‹ç™»è¨˜ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為è¦å®šé£²æ–™ä¸æ‰€å«å’–å•¡å› (CAFFEIN)之é™é‡ç‚ºç™¾åˆ†ä¹‹0.02以下<p><span style="font-family: 新細明體, serif;">一ã€å’–å•¡å› </span><span style="font-family: calibri;"> (CAFFEIN)</span><span style="font-family: 新細明體, serif;">屬ä¸æ¨žç¥žç¶“興奮劑；如飲料ä¸å«é‡éŽé«˜ï¼Œå‰‡æ¥µæ˜“影響飲用者å¥åº·ã€‚茲è¦å®šå‡¡è£½å”®ä¹‹ç“¶è£ã€ç½è£æˆ–å°è£è€Œä¾›ç›´æŽ¥é£²ç”¨ä¹‹é£²æ–™ï¼Œå…¶å’–å•¡å› ä¹‹å«é‡ï¼Œé™æ–¼ç™¾åˆ†ä¹‹</span><span style="font-family: calibri;">0.02</span><span style="font-family: 新細明體, serif;">以下，且為防æ¢è£½é€ 時任æ„使用藥å“ã€Œå’–å•¡å› ã€èµ·è¦‹ï¼Œå…¶ä½¿ç”¨ä¸¦ä»¥å«æœ‰å’–å•¡å› ä¹‹å¤©ç„¶ç‰©åŽŸæ–™è€…ç‚ºé™ã€‚åŒæ™‚應在容器上明顯標示，å«æœ‰ã€Œå’–å•¡å› ã€ï¼Œä»¥ä¾¿ä¸å®œé£²ç”¨ã€Œå’–å•¡å› ã€ä¹‹æ¶ˆè²»è€…有所é¸æ“‡ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€é£²æ–™ä¸ä½¿ç”¨åˆæˆæˆ–天然物èƒå–之藥å“ã€Œå’–å•¡å› ã€è€…以藥å“管ç†ã€‚如係使用ä¸è—¥æ或營養劑之飲料而åŒæ™‚使用å«æœ‰å’–å•¡å› ä¹‹å¤©ç„¶ç‰©åŽŸæ–™ï¼Œå…¶å’–å•¡å› å«é‡è¶…éŽé™é‡è€…，ä¾æœ¬ç½²å‰é ’之「使用ä¸è—¥æ或營養劑之食å“</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">飲料</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">管ç†è¦é»žã€æŸ¥é©—時ä¸å¾—予以èªå¯ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€ä½¿ç”¨å«æœ‰å’–å•¡å› ä¹‹å¤©ç„¶ç‰©åŽŸæ–™ä½†æœªå«ä¸è—¥ææˆ–ç‡Ÿé¤ŠåŠ‘è€Œå…¶å’–å•¡å› å«é‡è¶…éŽé™é‡è€…，應é™ç”±å» 商於本</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å…å二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">å¹´ä¹æœˆåº•ä»¥å‰å…¨éƒ¨æ”¶å›žæ”¹å–„。</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ç‚ºé ˆç¶“é†«å¸«è™•æ–¹è—¥å“一案，令復知照<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.07.28.</span><span style="font-family: 新細明體, serif;">北市衛四å—第</span><span style="font-family: calibri;">12614</span><span style="font-family: 新細明體, serif;">號呈悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€é—œæ–¼é ˆç¶“醫師處方之ä¸ã€è¥¿è—¥å“，æ¥æ–¼å„該藥å“許å¯è‰åˆ†åˆ¥æ¨™æ˜Žç•¶å¯æ“šä»¥è™•ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ç‚ºé ˆç¶“é†«å¸«è™•æ–¹è—¥å“管ç†ä¸€æ¡ˆï¼Œä»¤å¸Œéµç…§<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.12.13.</span><span style="font-family: 新細明體, serif;">北市衛四å—第</span><span style="font-family: calibri;">22413</span><span style="font-family: 新細明體, serif;">號函副本悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥æœ¬æ¡ˆé™¤éº»é†‰è—¥å“製劑ã€å®‰çœ 劑ã€éŽ®éœåŠ‘ç‰é¡žè—¥å“應ä¾æ³•åš´å¯†ç®¡ç†å¤–，至其他藥å“凡許å¯è‰åˆ†åˆ¥æ¨™ç¤ºé ˆç¶“醫師處方之ä¸ã€è¥¿è—¥å“，併應ä¾ç…§æœ¬ç½²</span><span style="font-family: calibri;"> 61.09.04.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">08076</span><span style="font-family: 新細明體, serif;">號令示辦ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為增列藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“希知照並轉知由<p><span style="font-family: 新細明體, serif;">一ã€æœ¬ç½²</span><span style="font-family: calibri;">61. 1.25.</span><span style="font-family: 新細明體, serif;">衛署藥å—</span><span style="font-family: calibri;">00286</span><span style="font-family: 新細明體, serif;">號令：為訂定「藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“ç”³è«‹æ ¸ç™¼è‰æ˜Žæ›¸æ³¨æ„è¦é»žã€ä¸€æ¡ˆè¨ˆé”。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ“šå°ç£å€è£½è—¥å…¬æœƒè«‹æ±‚增列藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥æ‰€éœ€ä¹‹åŒ–å¸ç”¢å“ç¨®é¡žä¸€æ‰¹ï¼Œç¶“æ ¸å°šå±¬ç›®å‰åˆæˆåŽŸæ–™è—¥æ‰€éœ€è€…，並經分別徵得財政部åŠç¶“濟部國際貿易局åŒæ„，é™å·¥å» 申請其輸入許å¯è‰è™Ÿç¢¼å—軌為</span><span style="font-family: calibri;">G2</span><span style="font-family: 新細明體, serif;">在案自應准予增列。</span> </p><p><span style="font-family: 新細明體, serif;">三ã€èŒ²æª¢ç™¼å‰é …「增列專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“種類表ã€ä¸€ä»½ï¼Œä»¤å¸ŒçŸ¥ç…§ï¼Œä¸¦è½‰çŸ¥ç…§ç‚ºè¦ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹è—¥å» è£½é€ åŠåŠ å·¥å·¥ä½œå ´æ‰€å››å‘¨èˆ‡å¤–ç•Œæ‡‰ä¿æŒ20公尺以上之è·é›¢ï¼Œå¦‚é‡é¢å‘å±±å¡ï¼Œå…¶è·é›¢æ‡‰å¦‚何計算，åˆè—¥å» å¢žåŠ æ–°åŠ‘åž‹æ™‚ï¼Œæ‡‰å¦æ¯”照辦ç†ç‰æœ‰é—œç–‘義，復請 查照<p><span style="font-family: 新細明體, serif;">一ã€è—¥å» 建於山å¡æˆ–外界有é¢å‘å±±å¡ä¹‹æƒ…形時，å¯å³æŒ‰ç…§å…¶å¡åº¦æ¸¬é‡ï¼Œä¸å¿…å†ä¾å¹³é¢å»¶ä¼¸ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€èˆŠæœ‰è—¥å» ç”³è«‹å¢žåŠ æ–°åŠ‘åž‹æ‡‰ä¸å—è©²é …è¦å®šä¹‹é™åˆ¶ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€å¾©è²´å»³</span><span style="font-family: calibri;">62.11.13.</span><span style="font-family: 新細明體, serif;">建一å—第</span><span style="font-family: calibri;">146941</span><span style="font-family: 新細明體, serif;">號函。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為據請示「高麗人åƒæ±ã€åˆŠè¼‰è—¥å“效能應å¦è¦–為藥å“一案，令復知照<p><span style="font-family: 新細明體, serif;">å—å€ç®¡è¾¦å…¬å®¤</span> <span style="font-family: 新細明體, serif;">å—å€ç®¡ä¸å¿ƒ</span><span style="font-family: calibri;"> 813</span><span style="font-family: 新細明體, serif;">高雄市左營å€è‡ªç”±äºŒè·¯</span><span style="font-family: calibri;">180</span><span style="font-family: 新細明體, serif;">號</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">樓</span> </p><p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">61.10.03.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">33676</span><span style="font-family: 新細明體, serif;">號呈悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è©²æ¼¢åŸŽé«˜éº—åƒä¼æ¥ç¤¾å‡ºå“「高麗人åƒæ±ã€åŒ…è£ç´™ç›’上刊載該æ±ã€Œä¿‚以傳統秘方é…åˆç§‘å¸æŠ€è¡“精製而æˆï¼Œæ—¥å¸¸é£²ç”¨ï¼Œå¯èª¿ç¯€èº«é«”生ç†ï¼Œå¢žå¼·é«”力，防æ¢è¡°è€</span> <span style="font-family: 新細明體, serif;">ã€ç‰è©žï¼Œä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•ç¬¬äº”æ¢ç¬¬äºŒã€ä¸‰æ¬¾è¦å®šæ„旨，å‡å±¬è—¥å“之效能，其å為飲料，實則應視為藥å“。</span> </p>2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹ç‚ºè—¥ç”¨è† å›Šä¹‹å°å—å·¥ä½œå ´æ‰€æ‡‰å¦ç¶“檢查åˆæ ¼å§‹å¾—准予營æ¥ä¸€æ¡ˆä»¤å¾©çŸ¥ç…§ç”±<p><span style="font-family: 新細明體, serif;">一ã€</span><span style="font-family: calibri;">60.12.29.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">40986</span><span style="font-family: 新細明體, serif;">號呈悉。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è—¥ç”¨è† 囊屬藥å“ä¸ä¹‹è£½åŠ‘，為é¿å…污染，其å°å—工作乃製劑程åºä¸ŠéŽç¨‹ä¹‹ä¸€ï¼Œæ‡‰é™ç”±åŽŸè—¥å“è£½é€ å·¥å» æˆ–åˆæ ¼ä¹‹è—¥ç”¨ç©ºå¿ƒè† å›Šè£½é€ å·¥å» è£½é€ ï¼Œå…¶å·¥å» ä»é ˆéµç…§è¨å» 標準第å二æ¢è¦å®šè¾¦ç†ã€‚</span> </p>2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1170&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1171&type=0
藥政管ç†é¡ž,藥事法行政解釋為藥å“包è£å…§ä¸å¾—é™„åŠ è´ˆå“券ç‰ï¼Œä»¤å¸ŒçŸ¥ç…§è½‰çŸ¥ç”±<p><span style="font-family: 新細明體, serif;">一ã€å‡†é™½æ˜Žå±±ç®¡ç†å±€</span><span style="font-family: calibri;">61.11.06.</span><span style="font-family: 新細明體, serif;">陽明衛å—第</span><span style="font-family: calibri;">36252</span><span style="font-family: 新細明體, serif;">號函略以：邇來市é¢å‡ºå”®è—¥å“，部份於包è£å…§é™„有贈å“券或優待券ç‰ï¼Œæ˜¯å¦é•å藥物藥商管ç†æ³•è¦å®šï¼Ÿæ•¬è«‹ç¤ºå¾©ï¼Œä»¥ä¾¿éµå¾ªç‰ç”±ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è—¥å“ä¹‹è¼¸å…¥æˆ–è£½é€ ï¼Œæ‡‰åˆ†åˆ¥ä¾ç…§è—¥ç‰©è—¥å•†ç®¡ç†æ³•ç¬¬ä¸‰å五æ¢æˆ–第四å三æ¢è¦å®šç”³è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŸ¥é©—登記；åˆåŒæ³•ç¬¬ä¸‰åå…«æ¢åŠç¬¬å››åä¹æ¢è¦å®šï¼Œç¶“æ ¸å‡†è¼¸å…¥æˆ–è£½é€ ä¹‹è—¥ç‰©ï¼Œéžç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¹‹æ ¸å‡†ï¼Œä¸å¾—è®Šæ›´åŽŸç™»è¨˜äº‹é …ã€‚å¦‚æœ‰é•å，應ä¾åŒæ³•ä¸ƒåä¹æ¢è¦å®šè™•ç½°ã€‚至藥å“以治療疾病為目的，與一般商å“ä¸åŒï¼Œç‚ºç¶è·åœ‹æ°‘å¥åº·ï¼ŒåŠ 強藥政管ç†ï¼Œä¸å¾—以çŽå‹µæœè—¥æ–¹å¼æ–¼è—¥å“廣告內併刊或附載贈çŽäº‹é …，å‰ç¶“內政部五åå…«å¹´å…月二å一日臺內衛å—第</span><span style="font-family: calibri;">320418</span><span style="font-family: 新細明體, serif;">號令知有案，則藥å“包è£å…§è‡ªä¸å¾—é™„åŠ è´ˆå“券或優待券。</span> </p>2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1175&type=0;;https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1176&type=0
藥政管ç†é¡ž,藥事法行政解釋為藥å“舊包è£ä¸å¾—繼續使用一案，令希éµç…§ä¸¦è½‰çŸ¥ç”±<span style="font-family: 新細明體, serif;">一ã€æŸ¥å…§æ”¿éƒ¨æ›ç™¼è—¥å“許å¯è‰é ˆçŸ¥ç¬¬å…æ¢è¦å®šï¼šã€Œæ›è‰å¾Œä¹‹èˆŠåŒ…è£è—¥å“，自新許å¯è‰ç”Ÿæ•ˆä¹‹æ—¥èµ·åœ¨ä¸€å¹´å…§æœªå”®å®Œè€…，應自第二年起æ›æ–°åŒ…è£æˆ–åŠ è²¼æ–°æ ¸å‡†å—號後方得銷售。ã€æŒ‰æ¤é …è—¥å“許å¯è‰æ›ç™¼å·¥ä½œï¼Œæ¥æ–¼å…å年七月底辦ç†å®Œç«£ï¼Œé—œæ–¼è—¥å“舊包è£ï¼Œä¾ç…§è¦å®šåŽŸæ—©å·²ä¸å¾—使用，惟查目å‰å¸‚售藥å“，ä»æœ‰éƒ¨ä»½ç¹¼çºŒä½¿ç”¨èˆŠåŒ…è£ï¼Œæ®Šæœ‰ä¸åˆã€‚本應å³äºˆä¾æ³•æŸ¥è™•ï¼ŒæƒŸç‚ºé¡§å¿µå» 商倉å’改æ›åŒ…è£ï¼Œå®¹æˆ–ä¸åŠï¼Œç‰¹äºˆå¯¬é™è‡³æ°‘國å…å二年三月底以å‰ï¼Œå„å» å•†å°æ–¼åº«å˜åŠæµå…¥å¸‚é¢ç‰èˆŠåŒ…è£è—¥å“，應予全部清點收回，ä¾ç…§æ ¸å‡†å®Œå…¨æ”¹æ›æ–°åŒ…è£ï¼Œåš´é™å¦‚期完æˆï¼Œä¸å¾—å†æœ‰èˆŠåŒ…è£ç™¼ç¾ï¼Œé€¾æœŸæŸ¥ç²ï¼Œä¸€æ¦‚視其實際情狀，分別以å½åŠ£è—¥æˆ–é•å藥物藥商管ç†æ³•ç¬¬å…å五æ¢ç‰è¦å®šè™•è¾¦ã€‚</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為藥å“舊包è£ä½¿ç”¨ä¸€æ¡ˆï¼Œå¾©å¸ŒçŸ¥ç…§<p><span style="font-family: 新細明體, serif;">一ã€å…åå¹´ä¹æœˆäºŒå二日</span><span style="font-family: calibri;">(60)</span><span style="font-family: 新細明體, serif;">çœè—¥èª¿ç¸½å—第</span><span style="font-family: calibri;"> 103</span><span style="font-family: 新細明體, serif;">號呈為建è°æ›è‰è—¥å“舊包è£å‡†äºˆç¹¼çºŒä½¿ç”¨ä¸€æ¡ˆæ‚‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å·æŸ¥å…§æ”¿éƒ¨æ›ç™¼è—¥å“許å¯è‰é ˆçŸ¥ç¬¬å…æ¢è¦å®šï¼šã€Œæ›è‰å¾Œä¹‹èˆŠåŒ…è£è—¥å“，自新許å¯è‰ç”Ÿæ•ˆä¹‹æ—¥èµ·åœ¨ä¸€å¹´å…§æœªå”®å®Œè€…，應自第二年起æ›æ–°åŒ…è£æˆ–åŠ è²¼æ–°æ ¸å‡†å—號後方准銷售。ã€é—œæ–¼è—¥å“使用舊包è£ä¸€ç¯€ï¼Œæ‡‰ä¾ä¸Šé …è¦å®šè¾¦ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋為續增列藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥å“之化å¸ç”¢å“希知照，並轉知由<p><span style="font-family: 新細明體, serif;">一ã€æœ¬ç½²</span><span style="font-family: calibri;">61.06.14.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">05560</span><span style="font-family: 新細明體, serif;">號令為增列藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“一案計é”。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€èŒ²å†æ“šè‡ºç£å€è£½è—¥å…¬æœƒè«‹æ±‚增列藥å“è£½é€ æ¥è€…輸入專供åˆæˆåŽŸæ–™è—¥æ‰€éœ€ä¹‹åŒ–å¸ç”¢å“ç¨®é¡žä¸€æ‰¹ï¼Œç¶“æ ¸å°šå±¬ç›®å‰åˆæˆåŽŸæ–™è—¥æ‰€éœ€è€…，並經分別徵得財政部åŠç¶“濟部國際貿易局åŒæ„，自應准予增列。</span> </p><p><span style="font-family: 新細明體, serif;">三ã€èŒ²æª¢ç™¼å‰é …「續增列專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“種類表ã€ä¸€ä»½ï¼Œä»¤å¸ŒçŸ¥ç…§ï¼Œä¸¦è½‰çŸ¥ç…§ç‚ºè¦ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€å‰¯æœ¬æŠ„é€è¡Œæ”¿é™¢ç§˜æ›¸è™•ï¼Œè²¡æ”¿éƒ¨ï¼Œè²¡æ”¿éƒ¨æ©Ÿé—œå‹™ç½²ï¼Œè²¡æ”¿éƒ¨åŸºéš†é—œã€è‡ºåŒ—é—œã€é«˜é›„關，經濟部國際貿易局，臺ç£å€è£½è—¥å·¥æ¥åŒæ¥å…¬æœƒï¼Œè‡ºç£çœè—¥å“調製商æ¥å…¬æœƒï¼Œè‡ºåŒ—市藥å“調製商æ¥åŒæ¥å…¬æœƒï¼ŒæŠ„發本署藥政處</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å‡é€£åŒé™„件一份</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">附</span> <span style="font-family: 新細明體, serif;">ä»¶ï¼šè©³è¦‹è¡›ç”Ÿç½²å…¬å ±</span> <span style="font-family: 新細明體, serif;">總號</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 33 </span><span style="font-family: 新細明體, serif;">號</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體, serif;">é </span> <span style="font-family: 新細明體, serif;">續增列專供åˆæˆåŽŸæ–™è—¥ç”¨ä¹‹åŒ–å¸ç”¢å“種類表</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋藥å“è£½é€ æ¥è€…ï¼Œå…¼è¼¸å…¥åœ‹å¤–å» å•†è—¥å“(製劑)æ¥å‹™æ‡‰å¦ç”³è«‹è—¥å“販賣æ¥è—¥å•†è¨±å¯åŸ·ç…§åŠå¯å¦ç”±åŽŸè—¥å“管ç†äººå“¡ç™»è¨˜ç®¡ç†ä¸€æ¡ˆï¼Œä»è«‹ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•æ–½è¡Œç´°å‰‡ç¬¬åå…æ¢ä¹‹è¦å®šè¾¦ç†<span style="font-family: 新細明體, serif; font-size: 12pt;">復貴處</span><span style="font-family: calibri, sans-serif; font-size: 12pt;">63.3.21.</span><span style="font-family: 新細明體, serif; font-size: 12pt;">衛四å—第</span><span style="font-family: calibri, sans-serif; font-size: 12pt;">12833</span><span style="font-family: 新細明體, serif; font-size: 12pt;">號函</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋訂定「生物製劑管ç†è¾¦æ³•ã€å…¬ä½ˆæ–½è¡Œå‰è¡›ç”Ÿå±¬æ–¼æ°‘國26å¹´ 2月27日公佈åŠå‰è¡›ç”Ÿéƒ¨æ–¼æ°‘國37å¹´ 3月29日修æ£å…¬ä½ˆä¹‹ã€Œç´°èŒå¸å…ç–«å¸è£½å“管ç†è¦å‰‡ã€åŒæ™‚廢æ¢ã€‚<p><span style="font-family: 新細明體, serif;">生物製劑管ç†è¾¦æ³•</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">一</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">本辦法ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•ç¬¬å››åå››æ¢ä¹‹è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">二</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">凡ä¾æ“šå¾®ç”Ÿç‰©å¸ã€å…ç–«å¸å¸ç†è£½é€ 之血清ã€æŠ—æ¯’ç´ ã€ç–«è‹—ã€é¡žæ¯’ç´ ã€èŒæ¶²ç‰ç”Ÿç‰©è£½åŠ‘，或販賣生物製劑æ¥è€…，除ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•æœ‰é—œè—¥å•†ç®¡ç†ä¹‹è¦å®šå¤–，ä¾æœ¬è¾¦æ³•ä¹‹è¦å®šç®¡ç†ä¹‹ï¼Œæœ¬è¾¦æ³•æœªè¦å®šè€…，ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•æ–½è¡Œç´°å‰‡åŠå…¶ä»–有關法令之è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">三</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">ç”Ÿç‰©è£½åŠ‘è£½é€ æ¥è€…ä¾æ³•æ‡‰è˜ç”¨ä¹‹å°ˆé–€æŠ€è¡“äººå“¡ï¼Œé ˆä¿‚åœ‹å…§å¤–å¤§å¸æˆ–專科å¸æ ¡ä»¥ä¸Šé†«è—¥æˆ–生物å¸ç‰æœ‰é—œç§‘系畢æ¥ä¸¦æ›¾ä¿®ç¿’微生物å¸ã€å…ç–«å¸å°ˆé–€èª²ç¨‹åŠæ ¼ä¸¦æœ‰å…©å¹´ä»¥ä¸Šç”Ÿç‰©è£½åŠ‘è£½é€ ä¹‹ç¶“é©—ï¼Œç¶“ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œä¹‹å¯©æŸ¥èªå¯ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">å››</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">ç”Ÿç‰©è£½åŠ‘ä¹‹è£½é€ æˆ–è¼¸å…¥ï¼Œç¶“æŸ¥é©—æ ¸å‡†é ˜å¾—è¨±å¯è‰å¾Œï¼Œå…¶æ‰€è£½æˆã€åŠ å·¥ã€åˆ†è£ã€è¼¸å…¥ä¹‹è£½åŠ‘，應按批檢åŒæª¢å®šç´€éŒ„，é€è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŒ‡å®šä¹‹æ©Ÿæ§‹æŠ½æ¨£æª¢é©—åˆæ ¼åŠ è²¼å°ç·˜ï¼Œå§‹å‡†éŠ·å”®ä½¿ç”¨ã€‚</span> <span style="font-family: 新細明體, serif;">ç”Ÿç‰©è£½åŠ‘åŽŸæ¶²ä¹‹è¼¸å…¥ï¼Œä»¥ç”Ÿç‰©è£½åŠ‘è£½é€ æ¥è€…為é™ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">五</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">ç”Ÿç‰©è£½åŠ‘ä¹‹è£½é€ æˆ–è¼¸å…¥åŽŸæ¶²ä¹‹åŠ å·¥ã€åˆ†è£ï¼Œå…¶æ¯æ‰¹è£½é€ åŠæª¢å®šç´€éŒ„å‡æ‡‰ä¿å˜äº”年。</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">å…</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">生物製劑檢定費，ä¸è«–è£½é€ æˆ–è¼¸å…¥ï¼Œå‡æ‡‰æŒ‰æ‰¹å‘ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŒ‡å®šä¹‹æª¢é©—機構繳ç´ä¹‹ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">七</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">生物製劑之容器ã€æ¨™ç±¤ã€ä»¿å–®åŠåŒ…è£ï¼Œé™¤ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•åŠå…¶æ–½è¡Œç´°å‰‡æœ‰é—œè¦å®šå¤–，並應以ä¸è‹±æ–‡æ¨™æ˜Žå«é‡</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">有單ä½è€…標明單ä½æ•¸</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">åŠæœ‰æ•ˆæ—¥æœŸï¼Œå«æœ‰é˜²è…劑者，應註明防è…劑é‡ã€è²¯è—方法ç‰ï¼›å¦‚ä¿‚è¼¸å…¥åŽŸæ¶²åŠ å·¥ã€åˆ†è£è€…ï¼Œä¸¦æ‡‰åŠ è¨»åŽŸæ¶²ä¾†æºã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">å…«</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">生物製劑應按其貯è—方法貯è—，å¦å‰‡ä¸å¾—銷售或使用。</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">ä¹</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">生物製劑之銷售紀錄應ä¿å˜äº”年。</span> <span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">å</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">本辦法自公佈日施行。</span> </p>2013-12-16
臨床試驗類,è—¥å“生體å¯ç”¨çŽ‡åŠç”Ÿé«”相ç‰æ€§è©¦é©—準則行政解釋訂定「生體相ç‰æ€§è©¦é©—之å—è¨—ç ”ç©¶æ©Ÿæ§‹ç®¡ç†è¦ç¯„ã€ï¼Œä¸¦è‡ªå³æ—¥èµ·ç”Ÿæ•ˆè©³å¦‚附件2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=4662&type=0
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記,指示藥å“審查基準,胃腸製劑,眼用製劑,解熱鎮痛劑,綜åˆæ„Ÿå†’è—¥,瀉藥,鎮咳祛痰劑,驅蟲劑,鎮暈劑,抗éŽæ•åŠ‘,指示藥å“審查基準-一般皮膚外用劑,西藥åŠé†«ç™‚器æ查驗登記審查費收費標準,藥物資料公開辦法,æ–°åž‹æµæ„Ÿç–«è‹—查驗登記指引,æ ¸é†«æ”¾å°„æ€§è—¥å“審查基準,生物相似性藥å“查驗登記技術性資料審查é‡é»žè¡¨,æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記療效åŠå®‰å…¨æ€§ä¹‹è€ƒé‡é‡é»ž,原料藥主檔案(DMF)æ ¸å‚™åŠåœ‹ç”¢åŽŸæ–™è—¥æŸ¥é©—登記精實é€å¯©æ–‡ä»¶è³‡æ–™,新藥查驗登記精簡審查程åº,新藥查驗登記優先審查機制,國產創新藥å“查驗登記專案試辦計畫行政解釋訂定「原料藥分è£è¾¦æ³•ã€å…¬ä½ˆæ–½è¡Œ<p><span style="font-family: 新細明體, serif;">原料藥分è£è¾¦æ³•</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">一</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">本辦法ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•ç¬¬ä¸‰åå››æ¢ä¹‹è¦å®šè¨‚定之。</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">二</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">本辦法所稱原料藥，係指經ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæŸ¥é©—ç™»è¨˜ï¼Œæ ¸å‡†è¼¸å…¥æˆ–è£½é€ ï¼Œä¸¦å¾—åˆ†è£å‡ºå”®ä¹‹éžè£½åŠ‘è—¥å“。</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">三</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">原料藥之分è£ï¼Œæ‡‰ç”±å„該藥å“代ç†æˆ–輸入之藥商，檢具左列å„件申請ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†å¾Œï¼Œç”±æ”¿åºœæŒ‡å®šä¹‹æ©Ÿæ§‹æˆ–具有分è£å ´æ‰€èˆ‡è¨å‚™ä¸¦è˜æœ‰è—¥åŠ‘師</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">è² è²¬ç›£ç£åˆ†è£</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">之藥商分è£ï¼š</span> </p><p><span style="font-family: 新細明體, serif;">一ã€ç”³è«‹æ›¸ä¸€ä»½è¼‰æ˜Žè©²æ‰¹åŽŸæ–™è—¥ä¹‹å“åã€è¨±å¯è‰å—號ã€æ‰¹è™Ÿã€åŠæœ‰æ•ˆæœŸé™ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€è—¥å“許å¯è‰å½±æœ¬ä¸€å¼µã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€æµ·é—œé€²å£å–®æˆ–統一發票影本一張。</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€åŽŸå» 檢驗æˆç¸¾æ›¸ä¸€ä»½ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">五ã€æª¢é©—方法åŠæœ‰é—œæ–‡ç»</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">藥典藥å“å…附</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">å…ã€åˆ†è£ç”¨å®¹å™¨åŠæ¨™ç±¤ä¹‹å¯¦æ¨£å„四份。</span> </p><p><span style="font-family: 新細明體, serif;">å‰é …第å…款之標籤應載明ä¸è‹±æ–‡å“åã€è¨±å¯å—號ã€ä¸»è¦æˆåˆ†ã€å«é‡</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">藥典藥å“應刊載藥典ååŠç‰ˆæ¬¡ï¼Œå¾—å…載æˆåˆ†åŠå«é‡</span><span style="font-family: calibri;"> )</span><span style="font-family: 新細明體, serif;">ã€åŽŸè£½é€ å» å•†åŠåˆ†è£å‡ºå”®è—¥å•†å稱ã€åœ°å€ã€æ ¸å‡†åˆ†è£æ–‡è™Ÿã€åŠåˆ†è£æ—¥æœŸã€‚è—¥å“具有有效期é™è€…，並應載明其期é™ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">å››</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">藥商申請為分è£åŽŸæ–™è—¥è€…，應檢具分è£å ´æ‰€å¹³é¢åœ–åŠè¨å‚™æ¦‚æ³è¡¨ç”³è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">å‰é …分è£å ´æ‰€åŠè¨å‚™ï¼Œå¾—視實際情形，åƒç…§è£½è—¥å·¥å» è¨å‚™æ¨™æº–辦ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">五</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‡†åˆ†è£åŽŸæ–™è—¥æ¡ˆä»¶ï¼Œé™¤é€šçŸ¥åŽŸç”³è«‹è—¥å•†å¤–，並應以副本抄發çœ</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">市</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">衛生主管機關。</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">å…</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">ä¾æœ¬è¾¦æ³•åˆ†è£ä¹‹åŽŸæ–™è—¥ï¼Œå…¶æ¯ä¸€åŒ…è£æ‡‰åˆ†åˆ¥åŠ 貼本辦法第三æ¢ç¬¬ä¸€é …第å…æ¬¾æ‰€ç¨±ä¹‹æ¨™ç±¤ï¼Œä¸¦åŠ å°ç·˜æ¢å¾Œæ–¹å‡†å‡ºå”®ã€‚</span> <span style="font-family: 新細明體, serif;">政府指定機構所用å‰é …å°ç·˜æ¢ä¹‹ç¤ºæ¨£ï¼Œé™¤å…¬å‘Šé€šçŸ¥å¤–ï¼Œä¸¦æ‡‰å‘ˆå ±ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œå‚™æ¡ˆã€‚</span> <span style="font-family: 新細明體, serif;">藥商分è£æ‰€ç”¨å°ç·˜æ¢æ‡‰ä¾çµ±ä¸€è¦å®šæ ¼å¼</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">如附件</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">å°è£½ï¼Œä¸¦æª¢æ¨£å ±è«‹ä¸å¤®è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œæ ¸å‚™å¾Œå…¬å‘Šä¹‹ã€‚</span> <span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">七</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">ä¾æœ¬è¾¦æ³•è¾¦ç†åŽŸæ–™è—¥ä¹‹åˆ†è£è€…å‡æ‡‰ä½œæˆç´€éŒ„，ä¿å˜äº”年以備查考。其由藥商分è£è€…，並應於æ¯æ¡ˆåˆ†è£å®Œç«£å¾Œï¼Œå…©æ˜ŸæœŸå…§å°‡è©²é …ç´€éŒ„å ±ç”±è©²ç®¡ç¸£</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">市</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">或直轄市衛生主管機關備案。</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">å…«</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">é•å本辦法之è¦å®šè€…，ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•æœ‰é—œè¦å®šè™•ç†ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">第</span> <span style="font-family: 新細明體, serif;">ä¹</span> <span style="font-family: 新細明體, serif;">æ¢</span> <span style="font-family: 新細明體, serif;">本辦法自公布日施行。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋食用紫色一號åŠå…¶é‹éº—基著色劑 (ACID VIOLET 6B & ITS ALUMINUM LAKE) æ¥ç¶“本署公告ç¦ç”¨ï¼Œå‡¡æ ¸å‡†è£½é€ 或輸入之藥å“，其處方內å«æœ‰ä¸Šè¿°ç¦ç”¨è‰²ç´ 者，é™æœŸè¾¦ç†è™•æ–¹è®Šæ›´ç™»è¨˜<p><span style="font-family: 新細明體, serif;">一ã€é£Ÿç”¨ç´«è‰²ä¸€è™ŸåŠå…¶é‹éº—åŸºè‘—è‰²åŠ‘ï¼Œå› é•·æœŸä½¿ç”¨å¯èƒ½å°Žè‡´å±å®³äººé«”å¥åº·ï¼Œæœ¬ç½²ç‚ºç¶è·åœ‹æ°‘å¥åº·æ›¾ä»¥</span><span style="font-family: calibri;">(62)6.22.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">27894</span><span style="font-family: 新細明體, serif;">號公告ç¦ç”¨ï¼Œä¸¦è¦å®šè‡ªå…¬å‘Šæ—¥èµ·å…個月後ç¦æ¢éŠ·å”®ä½¿ç”¨æœ¬è‘—色劑之藥å“在案。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å„è—¥å•†æ ¸å‡†è£½é€ æˆ–è¼¸å…¥ä¹‹è—¥å“，其å«æœ‰ä¸Šè¿°ç¦ç”¨è‰²ç´ ï¼Œè€Œéœ€è®Šæ›´è©²é …è™•æ–¹å…§å®¹</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">è‰²ç´ </span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">é™æ–¼æœ¬</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å…å二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">å¹´ä¹æœˆä¸‰åæ—¥å‰å¡«å…·è—¥å“è®Šæ›´ç™»è¨˜äº‹é …ç”³è«‹æ›¸ï¼Œæª¢åŒè—¥</span> <span style="font-family: 新細明體, serif;">å“許å¯è‰ï¼Œé€•å‘本署藥政處申請辦ç†è®Šæ›´ç™»è¨˜ï¼Œé€¾æœŸå‰‡ä¾è—¥ç‰©è—¥å•†ç®¡ç†æ³•ç¬¬å››åæ¢åŠç¬¬äº”å三æ¢ç¬¬äºŒé …之è¦å®šï¼Œäºˆä»¥æ’¤éŠ·è—¥å“許å¯è‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€å¸Œå³è½‰é”å„藥商查照辦ç†ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,生物藥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•è¡Œæ”¿è§£é‡‹ä¿®æ£ç”Ÿç‰©è—¥å“檢驗å°ç·˜ä½œæ¥è¾¦æ³•è©³å¦‚附件2013-12-16
臨床試驗類,è—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„行政解釋修訂公告_è—¥å“éžè‡¨åºŠè©¦é©—安全性è¦ç¯„_第四版_詳如附件2013-12-16
查驗登記類,è—¥å“查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,ç–«è‹—é¡žè—¥å“之查驗登記,åŸºå› å·¥ç¨‹è—¥å“之查驗登記,生物相似性藥å“之查驗登記,éŽæ•åŽŸç”Ÿç‰©è—¥å“之查驗登記,指示藥å“審查基準,胃腸製劑,眼用製劑,解熱鎮痛劑,綜åˆæ„Ÿå†’è—¥,瀉藥,鎮咳祛痰劑,驅蟲劑,鎮暈劑,抗éŽæ•åŠ‘,指示藥å“審查基準-一般皮膚外用劑,西藥åŠé†«ç™‚器æ查驗登記審查費收費標準,藥物資料公開辦法,æ–°åž‹æµæ„Ÿç–«è‹—查驗登記指引,æ ¸é†«æ”¾å°„æ€§è—¥å“審查基準,生物相似性藥å“查驗登記技術性資料審查é‡é»žè¡¨,æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記療效åŠå®‰å…¨æ€§ä¹‹è€ƒé‡é‡é»ž,原料藥主檔案(DMF)æ ¸å‚™åŠåœ‹ç”¢åŽŸæ–™è—¥æŸ¥é©—登記精實é€å¯©æ–‡ä»¶è³‡æ–™,新藥查驗登記精簡審查程åº,新藥查驗登記優先審查機制,國產創新藥å“查驗登記專案試辦計畫行政解釋「原料藥分è£è¾¦æ³•ã€ç¬¬å››æ¢ç¬¬äºŒé …末å¥æ‡‰ä¿®æ£ç‚ºã€Œåƒç…§è—¥ç‰©è£½é€ å·¥å» è¨å» 標準辦ç†ã€ï¼Œè«‹ 查照。<span style="font-family: 新細明體, serif;">一ã€æœ¬ç½²</span><span style="font-family: calibri;">62.3.30</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">20770</span><span style="font-family: 新細明體, serif;">號令計é”。</span> <span style="font-family: 新細明體, serif;">二ã€å¥‰</span> <span style="font-family: 新細明體, serif;">行政院</span><span style="font-family: calibri;">62</span><span style="font-family: 新細明體, serif;">å¹´</span><span style="font-family: calibri;"> 5</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">28</span><span style="font-family: 新細明體, serif;">æ—¥</span> <span style="font-family: 新細明體, serif;">臺</span><span style="font-family: calibri;">62</span><span style="font-family: 新細明體, serif;">å…§å—第</span><span style="font-family: calibri;">4592</span><span style="font-family: 新細明體, serif;">號函辦ç†</span>2013-12-16
查驗登記類,國產創新藥å“查驗登記專案試辦計畫行政解釋國產創新藥å“查驗登記專案試辦計畫詳如附件2013-12-16
藥政管ç†é¡ž,藥事法行政解釋通知外銷藥å“包è£ä¸Šé ˆåˆŠå°æ‰¿è£½é€ å» å稱以åŠè²¬ä»»æ¡ˆ<p><span style="font-family: 新細明體, serif;">一ã€è²´å…¬å¸</span><span style="font-family: calibri;">60.9.29.(60)</span><span style="font-family: 新細明體, serif;">ä¸è—¥å¤–å—第</span><span style="font-family: calibri;">0768</span><span style="font-family: 新細明體, serif;">號申請書暨附件å‡æ‚‰ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æ‰€è«‹ã€Œ</span><span style="font-family: calibri;">VITAMIN B</span><span style="font-family: 新細明體, serif;">，</span><span style="font-family: calibri;">INJECTION 1,000MG. 10ML. VIAL</span><span style="font-family: 新細明體, serif;">ã€ç‰å››ç¨®è—¥å“ä»¥å¤–éŠ·é¦™æ¸¯ï¼Œåƒ…ä½¿ç”¨é¦™æ¸¯ç™¾å¾—å˜‰è£½è—¥å·¥å» å稱與商標，而ä¸ä½¿ç”¨æœ¬å…¬å¸å稱åŠå•†æ¨™ä¸€ç¯€æ‚‰ã€‚ç¶“æ ¸ä¾ç…§è¦å®šå¤–銷藥å“å‡é ˆç¶“æ”¿åºœæ ¸å‡†æœ‰æ¡ˆè€…å§‹å¯è¼¸å‡ºï¼ŒèŒ²ç‚ºé©æ‡‰å¤–國藥商</span> <span style="font-family: 新細明體, serif;">之è¦æ±‚，本案å¯å°ˆæ¡ˆç”³è«‹æŸ¥é©—登記，經許å¯å¾Œå§‹å‡†å¤–銷，但製å“包è£ä¸Šå¿…é ˆåˆŠå°æ‰¿è£½é€ å» å稱以明責任，如為供外銷而åŒæ™‚åŠ åˆŠä»£éŠ·å•†å稱則無ä¸å¯ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋原料藥之分è£å°ç·˜æ¥å‹™ï¼Œåœ¨æœªè®Šæ›´å‰ï¼Œå¯æš«ç”±è‡ºç£çœè¡›ç”Ÿè©¦é©—所繼續辦ç†<span style="font-family: 新細明體, serif; font-size: 12pt;">復</span><span style="font-family: calibri, sans-serif; font-size: 12pt;">62.5.24.</span><span style="font-family: 新細明體, serif; font-size: 12pt;">衛四å—第</span><span style="font-family: calibri, sans-serif; font-size: 12pt;">19262</span><span style="font-family: 新細明體, serif; font-size: 12pt;">號函</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋氯乙烯 (VINYL CHLORIDE) ç¦æ¢ä½¿ç”¨æ–¼ç’°å¢ƒè¡›ç”Ÿç”¨æ®ºèŸ²åŠ‘ã€è—¥å“ã€é£Ÿå“ã€åŒ–粧å“噴霧劑ä¸<p><span style="font-family: 新細明體, serif;">環境衛生用殺蟲劑ã€è—¥å“ã€é£Ÿå“ã€åŒ–粧å“噴霧劑ä¸æ·»åŠ 氯乙烯</span><span style="font-family: calibri;">(VINYL CHLORIDE)</span><span style="font-family: 新細明體, serif;">長期使用å¯èƒ½å°Žè‡´å±å®³äººé«”å¥åº·ï¼Œç‚ºç¶è·åœ‹æ°‘å¥åº·èµ·è¦‹ï¼Œç‰¹è¦å®šå¦‚左：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€è‡ªå…¬å‘Šæ—¥èµ·ç¦æ¢è¼¸å…¥æˆ–è£½é€ å«æœ‰æ°¯ä¹™çƒ¯</span><span style="font-family: calibri;">(VINYL CHLORIDE)</span><span style="font-family: 新細明體, serif;">之環境衛生用殺蟲劑ã€è—¥å“ã€é£Ÿå“ã€åŒ–粧å“噴霧劑。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å¾©æŸ¥æ›¾ç¶“æ ¸å‡†è¼¸å…¥æœ‰æ¡ˆè€Œå«æœ‰æ°¯ä¹™çƒ¯</span><span style="font-family: calibri;">(VINYL CHLORIDE)</span><span style="font-family: 新細明體, serif;">之下列環境衛生用殺蟲劑ã€è—¥å“åŠåŒ–粧å“噴霧劑產å“亦應自å³æ—¥èµ·ä¸€å¾‹ç¦æ¢ä¾›å”®ä½¿ç”¨ï¼Œé•è€…應ä¾æ³•è™•ç½°ã€‚</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">內衛環輸å—第</span><span style="font-family: calibri;">0011</span><span style="font-family: 新細明體, serif;">號安ä½æ®ºèŸ²åŠ‘</span><span style="font-family: calibri;">( AEROSOL </span><span style="font-family: 新細明體, serif;">“</span><span style="font-family: calibri;">KATOL</span><span style="font-family: 新細明體, serif;">”</span><span style="font-family: calibri;">)( </span><span style="font-family: 新細明體, serif;">日製安ä½åŒ–å¸</span><span style="font-family: calibri;"> )</span><span style="font-family: 新細明體, serif;">。</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">內衛環輸å—第</span><span style="font-family: calibri;">0032</span><span style="font-family: 新細明體, serif;">號自動噴霧å¼è …æ»äº†æ–¯å·´</span><span style="font-family: calibri;">(INSURA SUPER AEROSOL)(</span><span style="font-family: 新細明體, serif;">日製</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">善利亞製藥</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">內衛藥輸å—第</span><span style="font-family: calibri;">08104</span><span style="font-family: 新細明體, serif;">號å¥èº«å™´å°„液</span><span style="font-family: calibri;">(KEIN SPERTS MAN AEROSOL)( </span><span style="font-family: 新細明體, serif;">日製界化å¸</span><span style="font-family: calibri;"> )</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å››</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">美國克來樂</span><span style="font-family: calibri;">(CLAIROL)</span><span style="font-family: 新細明體, serif;">å…¬å¸åŠä¿è€</span><span style="font-family: calibri;">(BONAT)</span><span style="font-family: 新細明體, serif;">å…¬å¸å‡ºå“之噴髮劑。</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋發布「å«Bufexamacæˆä»½è—¥å“å†è©•ä¼°æœªç²é€šéŽç›¸é—œäº‹å®œã€è©³å¦‚附件2013-12-16
查驗登記類,æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記療效åŠå®‰å…¨æ€§ä¹‹è€ƒé‡é‡é»žè¡Œæ”¿è§£é‡‹æ–°æˆåˆ†æ–°è—¥æŸ¥é©—登記éžè‡¨åºŠè—¥æ¯’之審查é‡é»žèˆ‡è€ƒé‡è©³å¦‚附件2013-12-16
藥政管ç†é¡ž,藥事法行政解釋ç¦ç”¨é£Ÿç”¨ç´«è‰²ä¸€è™ŸåŠå…¶é‹éº—基著色劑 (ACID VIOLET 6B and ITS ALUMINUM LAKE)<p><span style="font-family: 新細明體, serif;">å…¬å‘Šäº‹é …ï¼š</span> <span style="font-family: 新細明體, serif;">食用紫色一號åŠå…¶é‹éº—基著色劑</span><span style="font-family: calibri;">(ACID VIOLET 6B and ITS ALUMINUM LAKE)</span><span style="font-family: 新細明體, serif;">長期使用å¯èƒ½å°Žè‡´å±å®³äººé«”å¥åº·ï¼Œç‚ºç¶è·åœ‹æ°‘å¥åº·èµ·è¦‹ï¼Œç‰¹è¦å®šå¦‚左：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€è‡ªå…¬å‘Šæ—¥èµ·ç¦æ¢è¼¸å…¥æˆ–è£½é€ æœ¬è‘—è‰²åŠ‘ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€è‡ªå…¬å‘Šæ—¥èµ·å…個月後</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">å³æ»¿å…個月之次日起</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">ç¦æ¢éŠ·å”®æœ¬è‘—色劑åŠä½¿ç”¨æœ¬è‘—色劑所著色之藥å“ã€åŒ–粧å“åŠé£Ÿå“。</span> </p>2013-12-16https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1887&type=0
藥政管ç†é¡ž,藥事法行政解釋經濟部85å¹´9月16日商85217699號<span style="font-family: 新細明體, serif;">樟腦油ã€æ¨Ÿè…¦ç²¾ç”¢å“是å¦ç‚ºè—¥å“疑義乙案案經洽准行政院衛生署八å五年ä¹æœˆä¸ƒæ—¥è¡›ç½²è—¥å—第八五○四八八四三號函以</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">å«æ¨Ÿè…¦ä¹‹ç”¢å“用於人體，宣稱醫療用途者，以人用藥å“管ç†ï¼Œé©ç”¨è—¥äº‹æ³•ï¼›</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">è‹¥éžç”¨æ–¼äººé«”，ä¸ä»¥äººç”¨è—¥å“管ç†ï¼Œä¸å¾—宣稱醫療效能。是以，用於人體之å«æ¨Ÿè…¦ç”¢å“，其標示應ä¾è—¥äº‹æ³•è¦å®šï¼Œéžç”¨æ–¼äººé«”者，其標示則ä¾å•†å“標示法è¦å®šè¾¦ç†ã€‚</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋電å仿單公告詳如附件2013-12-16
藥政管ç†é¡ž,藥事法行政解釋å°æ–¼å«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“藥類之å£æœæ¶²åŠ‘è—¥å“自7月1日起ä¸å¾—è£½é€ æˆ–è²©è³£ï¼Œå…¶è—¥å“許å¯è‰æ‡‰äºˆæ’¤éŠ·<p><span style="font-family: 新細明體, serif;">è«‹åƒé–±æœ¬ç½²</span><span style="font-family: calibri;">61.5.24</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號åŠ</span><span style="font-family: calibri;">61.7.11.</span><span style="font-family: 新細明體, serif;">衛署藥å—第</span><span style="font-family: calibri;">06241</span><span style="font-family: 新細明體, serif;">號令。</span> <span style="font-family: 新細明體, serif;">辦</span> <span style="font-family: 新細明體, serif;">法：</span> </p><p><span style="font-family: 新細明體, serif;">一ã€å«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“藥類之å£æœæ¶²è¨ˆæ’¤éŠ·å二件。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€ä½¿ç”¨ã€Œå…§æœæ¶²ã€æˆ–「液ã€å稱，其å«æœ‰å½±éŸ¿ä¸æ¨žç¥žç¶“藥類之藥å“雖未使用å£æœæ¶²ç‚ºå，而其包è£åƒ…有一次用é‡è€…，亦應撤銷計一件。</span> </p><p><span style="font-family: 新細明體, serif;">三ã€æ„Ÿå†’糖漿所å«ç³–é‡æ¿ƒåº¦ä¸è¶³äº”五﹪者計撤銷三å一件。</span> </p><p><span style="font-family: 新細明體, serif;">å››ã€ç¶ä»–命åŠå¼·è‚é¡žå£æœæ¶²å«æœ‰å’–å•¡å› åœ¨é™é‡ä»¥ä¸Šè€…計撤銷五件。</span> </p><p><span style="font-family: 新細明體, serif;">五ã€ä»¥ä¸Šæ’¤éŠ·è¨±å¯è‰è¨ˆå››åä¹ä»¶</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">如附表</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">附</span> <span style="font-family: 新細明體, serif;">è¡¨ï¸°è©³è¦‹è¡›ç”Ÿç½²å…¬å ±</span> <span style="font-family: 新細明體, serif;">總號</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 46 </span><span style="font-family: 新細明體, serif;">號</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體, serif;">é </span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋臺北市政府89å¹´9月14日府訴å—第8908510300號訴願決定書節錄<span style="font-family: 新細明體, serif;">å››ã€æŒ‰è—¥äº‹æ³•ä¿®æ£æ¢æ–‡æ¥æ–¼å…«åä¹å¹´å››æœˆäºŒåå…日公布施行，ä¾ä¸å¤®æ³•è¦æ¨™æº–法第å三æ¢è¦å®šè‡ªå…«åä¹å¹´å››æœˆäºŒå八日起生效。ä¾ä¿®æ£å¾Œè—¥äº‹æ³•ç¬¬äºŒæ¢è¦å®šï¼šã€Œæœ¬æ³•æ‰€ç¨±è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¸°åœ¨ä¸å¤®ç‚ºè¡Œæ”¿é™¢è¡›ç”Ÿç½²ï¼›åœ¨ç›´è½„巿為直轄巿政府；在縣（巿）為縣（巿）政府。ã€æŸ¥æœ¬ä»¶åŽŸè™•åˆ†æ©Ÿé—œæ–¼å…«åä¹å¹´å…月二日é‡ç‚ºå¾©æ ¸è™•åˆ†æ™‚，該法修æ£æ¢æ–‡æ¥å·²å…¬å¸ƒæ–½è¡Œï¼Œè‡ªæ‡‰ä¾ä¿®æ£å¾Œè—¥äº‹æ³•è¦å®šç‚ºè™•æ–·ã€‚ä¾å‰æè¦å®šï¼ŒåŽŸè™•åˆ†æ©Ÿé—œè¾¦ç†é•å藥事法案件所為處罰，應以本府å義行之，惟本件原處分機關逕以其åç¾©ç‚ºå¾©æ ¸è™•åˆ†ï¼Œæ˜¯è©²è™•åˆ†åœ¨å¯¦è³ªä¸Šç„¡è«–å¦¥é©èˆ‡å¦ï¼Œå…¶è¡Œæ”¿ç®¡è½„終究難謂é©æ³•ã€‚從而原處分應予撤銷，由原處分機關於收å—決定書之日起三å日內å¦ç‚ºè™•ç†ã€‚</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋臺北高ç‰è¡Œæ”¿æ³•é™¢ä¹å二年度簡å—第四八å…號判決è¦æ—¨<span style="font-family: 新細明體, serif;">至於原告訴稱：○○藥房僅售æˆè—¥ï¼Œä¸¦ç„¡è²©å”®è™•æ–¹è—¥ã€æŒ‡ç¤ºè—¥å“，更無藥師法第å五æ¢ä¹‹æ¥å‹™ï¼Œä¾è—¥äº‹æ³•ç¬¬äºŒåå…«æ¢è¦å®šè‡ªç„¡å³å¦è˜è—¥äº‹äººå“¡ä¹‹å¿…è¦ç‰èªžã€‚惟查原告雖訴稱僅販賣æˆè—¥ï¼Œä½†ä¾è—¥äº‹æ³•ç¬¬å…«æ¢è¦å®šï¼šã€Œæœ¬æ³•æ‰€ç¨±ä¹‹è£½åŠ‘ï¼Œä¿‚æŒ‡ä»¥åŽŸæ–™è—¥ç¶“åŠ å·¥èª¿è£½ï¼Œè£½æˆä¸€å®šåŠ‘åž‹åŠåŠ‘é‡ä¹‹è—¥å“。製劑分為醫師處方藥å“ã€é†«å¸«è—¥å¸«è—¥åŠ‘生指示藥å“ã€æˆè—¥åŠå›ºæœ‰æˆæ–¹è£½åŠ‘。……ã€åŒæ³•ç¬¬ä¹æ¢è¦å®šï¼šã€Œæœ¬æ³•æ‰€ç¨±æˆè—¥ï¼Œä¿‚æŒ‡åŽŸæ–™è—¥ç¶“åŠ å·¥èª¿è£½ï¼Œä¸ç”¨å…¶åŽŸå稱，……並明示其效能ã€ç”¨é‡ã€ç”¨æ³•ï¼Œæ¨™æ˜Žæˆè—¥è¨±å¯è‰å—號，其使用ä¸å¾…醫師指示，å³ä¾›æ²»ç™‚疾病之用者。ã€æ•…æˆè—¥ä»å±¬è—¥å“，凡ä¾è—¥äº‹æ³•æˆç«‹è¨ç½®ä¹‹è¥¿è—¥è²©è³£æ¥è€…或西藥種商，å‡æ‡‰ä¾è¦å®šè˜è«‹è—¥å¸«æˆ–藥劑生，而ä¸è«–其是å¦è²©è³£ã€Œæˆè—¥ã€ï¼Œè‡ªä»æ‡‰å—藥事法第二åå…«æ¢ä¹‹è¦ç¯„，並ä¾åŒæ³•ç¬¬ä¸‰åæ¢è¦å®šæ–¼è—¥å¸«è¾è˜å¾Œæ‡‰å³å¦è˜ã€‚故原告顯已é•å藥事法第三åæ¢ä¹‹è¦å®šï¼Œè¢«å‘Šå‰è¿°æ‰€è¨´ï¼Œé¡¯ä¿‚其主觀å°æ³•ä»¤æœ‰æ‰€èª¤è§£ï¼Œè‡ªä¸è¶³æŽ¡ã€‚</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋衛署藥å—第0970307154號公告詳如附件2013-12-16
藥政管ç†é¡ž,è—¥äº‹æ³•è¡Œæ”¿è§£é‡‹æ“šè«‹æ ¸ç¤ºè—¥å» è®Šæ›´å» åæˆ–è² è²¬äººæ™‚å¾—è¦–ç‚ºè®Šæ›´ç™»è¨˜äº‹é …è¾¦ç†ä¸€æ¡ˆä»¤å¸Œéµç…§ç”±<p><span style="font-family: 新細明體, serif;">一ã€æ“šè‡ºç£çœè—¥å“調製商æ¥å…¬æœƒè¯åˆæœƒ</span><span style="font-family: calibri;">60. 9.23.(60)</span><span style="font-family: 新細明體, serif;">çœè—¥èª¿ç¸½å—第</span><span style="font-family: calibri;">105</span><span style="font-family: 新細明體, serif;">號文建è°ï¼š</span> <span style="font-family: 新細明體, serif;">「</span><span style="font-family: calibri;">1.</span><span style="font-family: 新細明體, serif;">æŸ¥è—¥å» å‡ç¶“政府檢查è¨å‚™åˆæ ¼é ˜è‰è¨ç«‹ï¼Œä¸”ç¶“å¸¸èˆ‰è¡Œæ™®æŸ¥ï¼Œè‹¥åƒ…è®Šæ›´å» åæˆ–è² è²¬äººå³èˆ‡è¨å‚™æ¯«ç„¡é—œä¿‚ï¼Œä¼¼ç„¡é ˆç”±çœæ–¹æ´¾å“¡æª¢æŸ¥ã€‚</span><span style="font-family: calibri;"> 2.</span><span style="font-family: 新細明體, serif;">本會第五屆第一次ç†ç›£äº‹æœƒé€šéŽæ案；建è°æ”¿åºœï¼šå°æ–¼è£½è—¥å» å•†ç”³è«‹è®Šæ›´å» åæˆ–è² è²¬äººå‡†å…å†æ´¾å“¡æª¢æŸ¥è¨å‚™ï¼Œå¯æŽˆæ¬Šç¸£å¸‚è¡›ç”Ÿå±€ç…§æœƒå±¬å¯¦å¾Œæ ¸å‡†ï¼Œç„¶å¾Œå ±çœå‚™æŸ¥ã€‚ã€ç‰æƒ…到署。</span> </p><p><span style="font-family: 新細明體, serif;">二ã€æŸ¥è®Šæ›´è—¥å» åç¨±æˆ–è² è²¬äººæ‡‰å±¬æ–¼è—¥å•†ç™»è¨˜äº‹é …ï¼Œä½†éŽåŽ»ç‚ºé˜²æ¢è—¥å» ç§è‡ªè½‰è®“或改變è¨å‚™èµ·è¦‹ï¼Œæ¤ç‰è®Šæ›´ç™»è¨˜äº‹é …，å‡åˆ—ç‚ºä¾‹è¡Œæª¢æŸ¥é …ç›®äºˆä»¥è©•å¯©ã€‚èŒ²ç‚ºç°¡åŒ–ä½œæ¥åŠä¾¿æ°‘èµ·è¦‹ï¼Œè—¥å» ä¹‹è®Šæ›´äº‹é …å¦‚ä¿‚ä¸‹åˆ—æƒ…å½¢è€…ï¼Œæ‡‰å…ˆä»¥è—¥å•†è®Šæ›´ç™»è¨˜äº‹é …ç¨‹åºè¾¦ç†ã€‚</span><span style="font-family: calibri;"> 1.</span><span style="font-family: 新細明體, serif;">å› æ”¿ä»¤è€Œè®Šæ›´é–€ç‰Œè™Ÿç¢¼è€…ã€‚</span><span style="font-family: calibri;"> 2.</span><span style="font-family: 新細明體, serif;">è®Šæ›´è—¥å•†è² è²¬äººå¦‚ä¿‚å…¶é…å¶æˆ–ç›´ç³»è¦ªå±¬æˆ–å› å…¬å¸ä¾ç« 改é¸è€…。</span><span style="font-family: calibri;"> 3.</span><span style="font-family: 新細明體, serif;">åƒ…ç‚ºè®Šæ›´å» å。</span><span style="font-family: calibri;"> 4.</span><span style="font-family: 新細明體, serif;">å› è®Šæ›´é§å» 監製人後雖經åœæ¥ï¼Œä½†åœ¨çŸæœŸå…§</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">得以三å天內為度</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">辦ç†çºŒè˜æ‰‹çºŒå®Œæˆè€Œç”³è«‹å¾©æ¥è€…。</span> <span style="font-family: 新細明體, serif;">å°æ–¼ç”³è«‹è®Šæ›´å€˜è©²è™•èªç‚ºå¿…è¦èª¿æŸ¥å…¶å·¥å» è¨å‚™è€…，自å¯å¦è¡Œæ´¾å“¡æˆ–é£çŸ¥ç¸£å¸‚æŸ¥å ±ã€‚</span> </p>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋醫療器財販賣æ¥è€…ä¾æ³•è¾¦ç†è—¥å•†ç™»è¨˜ï¼Œé ˜å¾—藥商許å¯åŸ·ç…§å¾Œï¼Œå¦‚é ˆè²©è³£è—¥å“，ä»æ‡‰å¦ç‚ºè—¥å“營æ¥é …目之登記，ä¸ä¾è¦å®šè¾¦ç†å…¶ç™»è¨˜è€…以é•å藥物藥商管ç†æ³•ç¬¬äºŒå三æ¢è¦å®šè«–處。藥å“販賣æ¥è€…éŽåŽ»å·²æœ‰å…¼ç‡Ÿé†«ç™‚器æ之販賣時，亦應é™æœŸè£œè¾¦é†«ç™‚器æ營æ¥é …目之登記，請查照辦ç†<span style="font-family: 新細明體, serif; font-size: 12pt;">醫療器財販賣æ¥è€…ä¾æ³•è¾¦ç†è—¥å•†ç™»è¨˜ï¼Œé ˜å¾—藥商許å¯åŸ·ç…§å¾Œï¼Œå¦‚é ˆè²©è³£è—¥å“，ä»æ‡‰å¦ç‚ºè—¥å“營æ¥é …目之登記，ä¸ä¾è¦å®šè¾¦ç†å…¶ç™»è¨˜è€…以é•å藥物藥商管ç†æ³•ç¬¬äºŒå三æ¢è¦å®šè«–處。藥å“販賣æ¥è€…éŽåŽ»å·²æœ‰å…¼ç‡Ÿé†«ç™‚器æ之販賣時，亦應é™æœŸè£œè¾¦é†«ç™‚器æ營æ¥é …目之登記，請查照辦ç†</span>2013-12-16
藥政管ç†é¡ž,藥事法行政解釋藥商為推銷藥物，所作之廣告屬營æ¥ä¸æŽ¨éŠ·ç¯„åœï¼Œå¦‚è©²å•†æ—¢ç¶“æ ¸å‡†åœæ¥ï¼Œç‡Ÿæ¥å³å‘Šåœæ¢ï¼Œè‡ªä¸å¾—å†çºŒç‚ºå»£å‘Šä¹‹å®£å‚³ï¼Œå…¶åº«å˜è—¥ç‰©åŠè—¥å•†è¨±å¯åŸ·ç…§ã€è—¥ç‰©è¨±å¯è‰ç‰ï¼Œå‡æ‡‰ä¾ç…§è—¥ç‰©è—¥å•†ç®¡ç†æ³•æ–½è¡Œç´°å‰‡æœ‰é—œè¦å®šè™•ç†<p><span style="font-family: 新細明體, serif;">醫療器財販賣æ¥è€…ä¾æ³•è¾¦ç†è—¥å•†ç™»è¨˜ï¼Œé ˜å¾—藥商許å¯åŸ·ç…§å¾Œï¼Œå¦‚é ˆè²©è³£è—¥å“，ä»æ‡‰</span> </p><p><span style="font-family: 新細明體, serif;">一ã€è—¥å•†ç”³è«‹åœæ¥ï¼Œæ‡‰å°‡è—¥å•†è¨±å¯åŸ·ç…§åŠè—¥ç‰©è¨±å¯è‰éš¨ç¹³ç•¶åœ°è¡›ç”Ÿä¸»ç®¡æ©Ÿé—œï¼Œæ–¼åŸ·ç…§ä¸Šè¨˜æ˜Žåœæ¥ç†ç”±èˆ‡æœŸé™å¾Œï¼Œä¿Ÿæ ¸å‡†å¾©æ¥æ™‚發還之，施行細則第二åæ¢å·²æœ‰æ˜Žæ–‡è¦å®šã€‚</span> </p><p><span style="font-family: 新細明體, serif;">二ã€å› åœæ¥åŽŸå› 繳銷藥物許å¯è‰å¾Œä¹‹åº«å˜è—¥ç‰©ï¼Œå…¶è™•ç†æ–¹å¼å·²è©³ç´°è¦å®šæ–¼æ–½è¡Œç´°å‰‡ç¬¬äºŒå一æ¢é™„件八「藥物許å¯è‰æ’¤éŠ·å¾Œä¹‹è—¥ç‰©è™•ç†äº‹é …表ã€ã€‚</span> </p><p><span style="font-family: 新細明體, serif;">三ã€ä¾ç…§å³é–‹èªªæ˜Žè—¥å•†æ–¼åœæ¥ä¸¦ç¹³å˜å…¶è—¥å•†è¨±å¯åŸ·ç…§èˆ‡è—¥ç‰©è¨±å¯è‰å¾Œï¼Œåœ¨è¡Œæ”¿ä½œæ¥ä¸Šå·²ç„¡å¾žæ ¸å‡†å…¶è—¥ç‰©å»£å‘Šï¼Œè«‹æŸ¥ç…§è¾¦ç†</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">本案係據臺ç£çœæ”¿åºœè¡›ç”Ÿè™•</span><span style="font-family: calibri;">62.11.6.</span><span style="font-family: 新細明體, serif;">衛四å—第</span><span style="font-family: calibri;">35625</span><span style="font-family: 新細明體, serif;">è™Ÿå‡½å ±è«‹é‡‹ç¤º</span><span style="font-family: calibri;"> )</span><span style="font-family: 新細明體, serif;">。販賣時，亦應é™æœŸè£œè¾¦é†«ç™‚器æ營æ¥é …目之登記，請查照辦ç†ã€‚</span> </p>2013-12-16
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