重大公共卫生事件相关药品及检验试剂研发审批和上市国内外比较

Research/development, approval and marketing of medicine and test reagents for major public health events: a comparison between China and foreign countries

摘要: 2019年的新型冠状病毒肺炎疫情对中国应对重大突发公共卫生事件的应急反应是一个严峻的考验。本文通过收集国际上重大公共卫生事件背景下药品及检验试剂审批制度，归纳各国重大公共卫生事件下的药品及检验试剂的研发审批流程，比较分析国内外药品试剂的研发及审批体系，为我国突发公共卫生事件的药品审批和上市提供制度借鉴。

Abstract: The epidemic of coronavirus disease 2019 is a severe test for China′s response to major public health emergencies. Through literature reviews, we summarized approval system and process for research/development and marketing of medicine and test reagents related to responses to major public health emergencies in many foreign countries and conducted comparative studies on the system and process at home and abroad for providing references to relevant system construction and administrative management China.