目的 分析突发公共卫生事件中药品应急监管面临的态势,为更好开展药品应急监管提供参考。方法 分析突发公共卫生事件中药品质量安全风险及新冠肺炎疫情中采取的措施,参考道斯矩阵(SWOT)分析突发公共卫生事件中药品应急监管的优势、劣势、机会和挑战,介绍美国应急医疗产品监管情况。结果与结论 突发公共卫生事件中,药品质量安全存在诸多风险,加强药品应急监管面临着内部和外部的有利与不利因素,建议借鉴FDA 经验,完善法律法规,科学建立应急预案,充分利用“智慧监管”、快检技术,注重日常监管,确保突发公共卫生事件中药品质量安全。
Abstract
OBJECTIVE To analyze the situation of drug supervision in public health emergencies, and provide a reference for better supervision. METHODS Analyze the risks of drug quality and safety in public health emergencies and the measures taken in the current COVID-19 epidemic. Analyze the strengths, weaknesses, opportunities and threats of drug emergency supervision in public emergencies with SWOT method. Introduce the supervision of medical counter measures in the United States. RESULTS AND CONCLUSION In public health emergencies, there are many risks of the drug quality and safety. The internal and external advantages and disadvantages are faced by drug emergency supervision. It is suggested to learn from FDA experience, improve laws and regulations, scientifically establish emergency plans, and make full use of "smart supervision", fast test technology, strengthen routine supervision to ensure the quality and safety of drugs in public health emergencies.
关键词
突发公共卫生事件 /
新冠肺炎 /
监管
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Key words
public health emergency /
COVID-19 /
supervision
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中图分类号：
R95
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