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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (3): 157-161.

所属专题: "新冠肺炎防控"专栏

• 新冠肺炎防治专栏 • 上一篇    下一篇

突发公共卫生事件下的药械紧急使用授权政策思考

王颖,张小平,杨依晗,胡骏*   

  1. 上海市食品药品安全研究中心, 上海 200233
  • 收稿日期:2020-03-23 修回日期:2020-04-01 出版日期:2020-03-31 发布日期:2020-05-14

Considerations on Emergency Use Authorization Policies of Drugs and Medical Device During Emergent Event of Public Health

WANG Ying, ZHANG Xiaoping, YANG Yihan, HU Jun*   

  1. Shanghai Institute for Food and Drug Safety, Shanghai 200233, China
  • Received:2020-03-23 Revised:2020-04-01 Online:2020-03-31 Published:2020-05-14

摘要: 新冠肺炎(COVID-19)是一种新型冠状病毒感染引起的急性呼吸道传染病。由于缺乏特效药物,国家和地方科研攻关组在多轮筛选基础上,聚焦到少数几个具有潜在临床疗效的新冠肺炎治疗药物,但距离药物上市,尚需进行严谨的临床试验和审批。探索突发公共卫生事件条件下的用药制度,对于潜在有效药品的应急储备和供应、有效控制疫情具有重要意义。本文拟通过分析和借鉴美国FDA医药产品紧急使用授权制度(EUA),在我国在突发公共卫生事件中,为进一步加大临床救治效果较好的药物向临床一线投放使用,加强国家和省级药品监管部门的药品审批提出政策建议。

关键词: FDA, 医药产品, 紧急使用授权, 公共卫生事件

Abstract: Corona virus disease is an acute respiratory infectious disease caused by COVID-19. Due to lack of specific drugs, national and local research teams find some drugs with potential clinical efficacy on the basis of multiple rounds of drug screening. However, rigorous clinical trials and approval are still needed before the drugs come into the market. It is of great significance to explore the medication system under the condition of public health event .By analyzing and learning lessons from FDA's emergency use authorization of medical products , this paper proposes drug approval policy suggestions for national and provincial medical products administration when China face the challenge of public health events.

Key words: US FDA, Medical Products, Emergency Use Authorization, Public Health Event

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