美国突发公共卫生事件医疗对策对我国药品审评审批和监管的启示

Enlightenment of American medical countermeasures policies on the drug evaluation, approval and management in response to public health emergencies in China

面对新型冠状病毒肺炎疫情,药监部门对临床急需药品的快速审评审批和应急监管是一项重要课题,关系公众生命健康和安全。本文借鉴美国食品药品监督管理局(FDA)面对突发公共卫生事件的医疗对策相关的紧急使用授权、拓展性使用、紧急用新药研究申请及医疗对策的监测和评价,为应对突发公共卫生事件的药品审评审批和监管提供参考依据。

It is crucial for China’s medical products administration to response to the epidemic of coronavirus disease 2019, which relates the health and safety of public.This article investigated the Food and Drug Administration(FDA) medical countermeasures, emergency use authorization, expanded access, emergency use investigational new drug, and related policies for expedited drug approval and emergency management.It provides references for the development of policies on the drug evaluation, approval and management in response to public health emergencies in China.