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| column | value |
|---|---|
| 類別 | 其他類,衛生福利部食品藥物管理署專案諮詢輔導要點 |
| 法規性質 | 行政解釋 |
| 法規名稱 | 衛生福利部食品藥物管理署專案諮詢輔導要點 |
| 條文內容 | <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;">衛生福利部食品藥物管理署</span><b><span style="font-size: 20pt;">藥品專案諮詢輔導要點 </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;">年</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;">年</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;">日修正 </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、</span><span style="color: windowtext; font-size: 14pt;">衛</span><span style="color: windowtext; font-size: 14pt;">生福利部食品藥物管理署</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;">為協助我國製藥產業 </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，針對國內準備上市或研發中之新</span><span style="font-size: 14pt;">藥</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">含生物藥品</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，特訂定本要點。 </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、</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協助專案達到下列研發里程碑：臨床前進 </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;">、進入下一期臨床試驗、進入 </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;">樞紐性試驗、申請藥品查驗登記、取得藥品許可證， </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、獲得國外藥品許可證、獲國外法規單位核准執行 </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、獲得生技獎章等。</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、</span><span style="font-size: 14pt;">申請資格：</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;">署得依廠</span><span style="font-size: 14pt;">商之申請或就國內準備上市或研發中之新藥</span></span><span style="font-family: arial,sans-serif; font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">含生 </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;">物藥品</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;">四、申請文件： </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;">廠商提出前項申請，應填妥如附件之申請表，並檢附不超過</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;">十</span><span style="font-size: 14pt;">頁之資料，說明以下事項：</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）藥品敘述，說明其中的新科技或新臨床議題，並請提供充足之背景說明、研發現況、國內外相關文獻或資料。 </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）概述藥品預期的臨床應用。 </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、評選程序： </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;">本署就產品之「創新程度」、「貢獻程度」、「早收程度」與「滿足法規程度」等四項評估指標，初步評選申請案。</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）經本署初</span><span style="font-size: 14pt;">步評選符合評估指標者，且廠商同意列為財團法人醫藥品查驗中心（以下簡稱醫藥品查驗中心）之「藥物法規科學諮詢輔導指標案件</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;">」</span><span style="font-size: 14pt;">，正式成<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;">六、</span><span style="font-size: 14pt;">輔導</span><span style="font-size: 14pt;">方式：</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;">署得組成專案諮詢輔導團隊，成員包含本署指定人員、醫藥品查驗中心審查人員，必要時邀請本署藥品諮議小組委員及專家學者加入。</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）專案輔導團隊將每季與專案廠商聯繋，詢問目前之研發進度、預定工作項目、待解決事項、預估問題解決時間、是否有議題需徵詢法規單位，必要時召開廠商會議。 </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）專案輔導中所召開之廠商會議決議，原則上將可作為日後案件審查之參考。 </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、本署每年得重新檢討評估專案諮詢輔導案件，如產品未達預估成效、或因廠商研發暫停或終止，得停止專案諮詢輔導</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;">八、案件管理：</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;">專案諮詢輔導案件依產品研發進度，分為下列二類： </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;">產品尚在</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、準備或執行</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;">由廠商依需求主動向本署請求召開</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;">廠商會議。 </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;">積極輔導案件： </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; color: windowtext; font-size: 14pt;"> 1. </span><span style="font-family: 標楷體; color: windowtext; font-size: 14pt;">產品進入</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;">本署將主動召開</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;">，以協助廠商於申請</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;">前了解相關缺失。 </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;">廠商申請</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，本署將依據實際審查狀況，主動召開廠商會議，溝通應補件與修正處。 </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;">藥品專案諮詢輔導要點</span> <span style="font-family: 標楷體; color: black; font-size: 14pt;">流程圖</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;">署得組成專案諮詢輔導團隊，成員包含本署指定人員、醫藥品查驗中心審查人員，必要時邀請本署藥品諮議小組委員及專家學者加入。</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;">依廠商之申請或就國內準備上市或研發中之新藥</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;">含生物藥品</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;">評選。</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;">廠商是否同意加入查驗中心「藥物法規科學諮詢輔導指標案件</span><span style="font-family: arial,sans-serif; font-size: 9pt;">(IDX)</span><span style="font-family: 標楷體; font-size: 9pt;">」，正式成為專案諮詢輔導案件。</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;">不列入諮詢輔導案件 </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;">不符合 </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;">符合 </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;">就產品之「創新程度」、「貢獻程度」、「早收程度」、「滿足法規程度」等4項評估指標，初步評選申請案。 </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>每季</b>與專案廠商聯繋，詢問目前之研發進度、預定工作項目、待解決事項、預估問題解決時間、是否有議題需徵詢法規單位，必要時召開廠商會議。專案輔導中所召開之廠商會議決議，原則上將可作為日後案件審查之參考。 </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;">否 </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;">未達成效 </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;">不列入諮詢輔導案件 </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>每年</b>得重新檢討評估專案諮詢輔導案件，如產品未達預估成效、或因廠商研發暫停或終止，得停止專案諮詢輔導。</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;">停止專案諮詢輔導 </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;">依產品研發進度分類 </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;">積極輔導案件</span></b><b> </b></p> <p style="text-align: center;"><span style="font-family: 標楷體; font-size: 9pt;">【產品進入</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;">署</span>主動召開</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;">依審查狀況，本署主動召開</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;">廠商會議</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;">正式送件</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 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;">【產品尚在</span><span style="font-size: 9pt;">R&D</span><span style="font-family: 標楷體; font-size: 9pt;">階段、準備或執行</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;">廠商依需求，自行提出</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;">廠商依需求，自行提出</span> </p> <p style="text-align: center;"><span style="font-size: 9pt;">IND</span><span style="font-family: 標楷體; font-size: 9pt;">廠商會議</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;">正式送件</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;">藥品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、</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;">申請單位</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;">負責人</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;">地址</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、</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;">聯絡人</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;">職稱</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: 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、</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;">案件名稱</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;">新藥成分</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;">稱適應症</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;">藥品研發階段 </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;">□<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; color: black; font-size: 14pt;">設計開發 □ 原型試製 □ 實驗室產品驗證 </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<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;">臨床前資料準備</span><span style="font-family: 標楷體; color: black; font-size: 14pt;"> □ </span><span style="color: black; font-size: 14pt;">Phase I</span><span style="font-family: 標楷體; color: black; font-size: 14pt;">產品驗證 </span></p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<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;">試量產 □ </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;">□<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 (請依已完成試驗進行複選)</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;">案名 </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;">重要性 </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;">□<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;">□ </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">具貢獻性</span> </p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□<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;">□ </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">符合政策鼓勵方向 </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;">申請者可自行評估，可重複勾選)</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;">是否有政府計畫補助 </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;">□</span><span style="color: black; font-size: 14pt;"> </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">無</span> </p> <p><span style="font-family: 新細明體,serif; color: black; font-size: 14pt;">□</span><span style="color: black; font-size: 14pt;"> </span><span style="font-family: 標楷體; color: black; font-size: 14pt;">有，補助來源或所屬計畫為_____________________</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;">廠商開發利基產品說明 </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;">對申請案件之期許或預期達成效益 </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> |
| 發佈日期 | 2013-12-05 |
| 附件檔案 |