中美应对突发公共卫生事件医药产品应急政策分析与思考

The Analysis and Consideration for Emergency Policies of Medical Products Used for Dealing with Public Health Emergency in China and US

目的结合新冠肺炎疫情的发展,对照美国紧急使用授权制度,收集和分析我国在应对突发公共卫生事件中与医药产品应急审批使用有关政策,探讨适合中国国情的药品紧急使用相关管理建议,以期为将来制修订相关法律法规提供参考。方法查阅有关政策法规文献,并对应急态势下中美两国的相关政策法规进行分析研究。结果与结论美国紧急使用授权法律几经修订,相对比较完善。中国更侧重于应急审批,紧急使用授权相对缺失,需加以完善并制度化。

OBJECTIVE To collect and analyze some policies used for expedited review of medical products in dealing with public health emergencies in China and discuss administrative proposals for medical products emergency use, which are suitable in China, for offering a reference for amending related laws and regulations in the future. METHODS Relative policies and regulation and literatures are consulted, relative policies in China and U.S were analyzed. RESULTS AND CONCLUSION In U.S. The Emergency Use Authorization had been amended time after time, which is comparatively completed. In China expedited review of medical products were valued, other than emergency use authorization, which needed to be institutionalized.