2019年的新型冠狀病毒肺炎疫情對中國應(yīng)對突發(fā)公共衛(wèi)生事件的應(yīng)急反應(yīng)是一個嚴峻的考驗。研究了美國食品藥品監(jiān)督管理局（FDA）醫(yī)療對策、緊急使用授權(quán)，以及藥品審評審批加急程序的相關(guān)政策，為重大威脅相關(guān)的藥品審評審批政策的制定提供參考，并為應(yīng)對突發(fā)公共衛(wèi)生事件的藥品的戰(zhàn)略性研制和儲備提供思路。

The epidemic of new coronavirus pneumonia in 2019 is a severe test for China's emergency response to public health emergencies. This article studies the FDA's medical countermeasures (MCM), emergency use authorization (EUA), and related policies for drug review and approval expedited programs, provides a reference for the development of material threat-related drug review and approval policies, and provides ideas for strategic development and stockpile of medicines in response to public health emergencies.

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