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

"新冠肺炎（COVID-19）疫情蔓延全球，為防止疫情擴散，各國陸續採用各種藥物緊急核准上市制度，讓相關藥物與疫苗得以盡快上市供公眾利用，我國亦依據《藥事法》第48-2條及《特定藥物專案核准製造及輸入辦法》規定，讓COVID-19疫苗得以盡快上市提供大眾施打。惟由於我國《特定藥物專案核准製造及輸入辦法》目前規範較為概括，於專案核准疫苗上市之過程中亦引發諸多爭議。本文比較先進國家藥物緊急核准上市制度，包括美國緊急使用授權（Emergency Use Authorization, EUA）、歐盟有條件上市許可（Conditional Marketing Authorisation, CMA）、日本特例許可、加拿大臨時命令、英國臨時授權之相關規範，為我國《特定藥物專案核准製造及輸入辦法》提出明確前端程序開啟、加強後端藥物上市後持續監控機制、提供使用者資訊獲取機制等方面之修法建議，期能完善我國緊急情況下之特定藥物專案核准制度。"

"In Taiwan, Covid-19 vaccines have been approved for public use in accordance with Article 48-2 of Pharmaceutical Affairs Act and Regulations for Approval of Specific Medical Products' Manufacturing or Importing as a Special Case (hereinafter referred to as 'Regulations for Approval of Specific Medical Products'). However, since the 'Regulations for Approval of Specific Medical Products' are stipulated with many indefinite concepts, some controversies have also arisen during approval procedures. In order to find the solution for the controversies, this article compares various emergency approval systems for medical product in advanced countries, including the Emergency Use Authorization (EUA) in the United States, Conditional Marketing Authorisation (CMA) in the European Union, Special Approval for Emergency (SAFE) in Japan, Interim Order in Canada, and Temporary Authorisation in the United Kingdom. Based on the comparison of these emergency approval systems, we proposed that the 'Regulations for Approval of Specific Medical Products' could be further amended to achieve a complete approval system for specific medical products in emergency situations."