美国医药产品紧急使用授权风险管理研究

Research on Risk Management of Emergency Use Authorization of Pharmaceutical Products in the United States

目的:研究美国医药产品紧急使用授权法规及指南,梳理对紧急使用授权产品监管措施,探讨建立适合我国国情的医药产品紧急使用授权制度。方法:查阅美国食品药品管理局官方网站及国内外文献数据库,分析美国医药产品紧急使用授权制度及实践经验。结果:美国医药产品紧急使用授权需要进行申请、审评、授权、定期收集安全性信息、持续风险效益评价等风险管理措施。结论:紧急使用授权制度对于加强公共卫生事件应对能力至关重要,我国应建立医药产品紧急使用授权制度,全面提升药械审评与评价能力及时发现授权产品风险,同时重视紧急使用授权产品的信息公开。

Objective: To study the regulations and guidelines for emergency use authorization of pharmaceutical products in the United States, sort out the regulatory measures for emergency use authorization products, and explore the establishment of an emergency use authorization system for pharmaceutical products suitable for China national conditions. Methods: by consulting the official website of the US Food and Drug Administration and literature databases at home and abroad, the emergency use authorization system and practical experience of pharmaceutical products in the United States were analyzed.Results: Risk management measures such as application, review, authorization, regular collection of safety information and continuous risk benefit evaluation are needed for emergency use authorization of pharmaceutical products in the United States. Conclusion: The emergency use authorization system is very important to strengthen the ability to respond to public health events. China should establish the emergency use authorization system of pharmaceutical products, comprehensively improve the evaluation and evaluation ability of medical devices, timely discover the risks of authorized products and pay attention to the information disclosure of emergency use of authorized products.