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題 名 | COVID-19疫情下我國藥事法專案核准制度議題--以國際藥物緊急核准上市機制為借鏡=Issues Concerning Taiwan Pharmaceutical Affairs Act and Regulations for Approval of Specific Medical Products under COVID-19 Pandemic |
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作 者 | 周晨蕙; 施雅薰; | 書刊名 | 科技法律透析 |
卷 期 | 33:10 2021.10[民110.10] |
頁 次 | 頁49-72 |
分類號 | 412.24 |
關鍵詞 | 緊急使用授權; 藥事法第48-2條; 特定藥物專案核准製造及輸入辦法; 有條件許可; 特例許可; Emergency use authorization; EUA; Article 48-2 of Pharmaceutical Affairs Act; Regulations for Approval of Specific Medical Product's Manufacturing or Importing as a Special Case; Conditional marketing authorisation; CMA; Special approval for emergency; SAFE; |
語 文 | 中文(Chinese) |