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| column | value |
|---|---|
| 類別 | 查驗登記類,藥品查驗登記審查準則,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,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 |
| 法規性質 | 法規命令 |
| 法規名稱 | 「藥品查驗登記審查準則」附件十核醫放射性藥品查驗登記應檢附資料表 |
| 條文內容 | <p style="layout-grid-mode: char; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: #000000;">附件十</span> </p><p style="layout-grid-mode: char; text-align: center; margin: 0cm 0cm 9pt;"><span style="font-family: 標楷體; color: #000000;">核醫放射性藥品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;">應檢送資料 </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: 4.12%; 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;">規費 </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;">藥品查驗登記申請書正 </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;">切結書甲 </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;">乙 </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;">標籤仿單黏貼表二份 </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;">證照黏貼表 </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;">出產國許可製售證明</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;">處方依據</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;">符合藥品優良製造規範之證明文件影本</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: 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;">有效成分檢驗規格 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、方法及檢驗成績書 </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: 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;">賦形劑檢驗規格、 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">方法及檢驗成績書 </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: 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;">成品檢驗規格 </span></p> <p style="text-align: center; line-height: 12pt;"><span style="font-size: 10pt; font-family: 標楷體; color: #000000;">、方法及檢驗成績書 </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: 3.74%; 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;">製造管制標準書或批次製造紀錄 </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;">分析方法確效資料 </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;">關鍵性製程確效資料</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;">採用證明</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;">送驗</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;">術 </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;">料 </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;">新藥</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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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;">依 </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;">十 </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;">規 </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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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;">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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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;">新劑量</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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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;">學名藥</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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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;">○</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 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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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;">○</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 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：○ 表示須檢附該項目之資料。 ╳ 表示不須檢附該項目之資料。 </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;">如出產國許可製售證明中未刊載完整之製造廠址者，應另附最近一次GMP查廠報告憑核</span><span style="font-size: 10pt;">。（如僅未刊載郵遞區號或區者，得以原廠函說明） </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;">由國內自行研發之核醫放射性藥品新藥、新劑型、新劑量，免附處方依據。但應另附處方設計研究及該藥品之技術性資料。 </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;">申請輸入藥品查驗登記，如係無菌製劑產品者，其關鍵性製程確效應含滅菌確效資料。 </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;">*4 </span><span style="font-size: 10pt;">國產之核醫放射性藥品新藥、新劑型、新使用劑量、新單位含量製劑，均應檢附處方設計研究。 </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;">依第二十四條第二項規定，除經中央衛生主管機關認有必要送驗者外，得以書面審核而免送驗樣品。 </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;">監視藥品之學名藥，監視期間內應檢附與以新藥提出查驗登記申請且取得許可證之廠商相同標準之國內臨床試驗報告（含銜接性試驗）；如前述新藥於查驗登記核准時未檢送國內臨床試驗報告（含銜接性試驗）者，則其學名藥應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。監視期滿藥品，應檢送（1）生體相等性試驗報告，或（2）生體可用率及臨床試驗報告。 </span></span></p> |
| 發佈日期 | 2013-12-03 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6091&type=0 |