緊急使用授權──世界衛生組織、歐盟、美國及台灣之比較【月旦時論】 試閱
Emergency Use Authorization -- Comparison between WHO, EU, US and Taiwan
發生公共衛生緊急事件時，有時候並沒有現成已核准的醫藥品可供使用，必須緊急使用尚處於研發階段的產品來救急。為了因應這種緊急情況，許多國家及國際組織會建立規範機制，確保緊急使用研發中產品的合理性，以維護民眾健康。本文將簡介及比較世界衛生組織、歐盟、美國及台灣的規範機制，並反思台灣機制的若干問題。
In the event of a public health emergency, sometimes there are no approved medical products available for use, and products that are still in the research and development stage must be used urgently for emergency relief. In order to respond to such emergencies, many countries and international organizations will establish a regulatory mechanism to ensure the rationality of the emergency use of products under research and development to protect the health of the people. This article will introduce and compare the regulatory mechanisms of the World Health Organization, the European Union, the United States, and Taiwan, and reflect on some issues with the Taiwan mechanism.
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