[关键词]
[摘要]
2019年的新型冠状病毒肺炎疫情对中国应对突发公共卫生事件的应急反应是一个严峻的考验。研究了美国食品药品监督管理局(FDA)医疗对策、紧急使用授权,以及药品审评审批加急程序的相关政策,为重大威胁相关的药品审评审批政策的制定提供参考,并为应对突发公共卫生事件的药品的战略性研制和储备提供思路。
[Key word]
[Abstract]
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.
[中图分类号]
R951
[基金项目]