美国药品质量抽查检验管理分析与启示

Analysis and Enlightenment of the American Drug Quality Sampling and Testing Management

目的分析美国药品质量抽查检验管理要点,为中国药品监督管理提供参考。方法采用文献研究法和数据分析法,通过相关文献和FDA官方网站等查找药品质量抽查检验相关文件,汇总2013—2017年抽查检验年报数据,研究美国药品质量抽查检验管理策略。结果美国药品质量抽查检验制定了抽查检验程序文件,建立了基于药品风险的品种遴选标准,注重质量监督检验和药品审评、监督检查的工作衔接与数据共享。结论美国药品质量抽查检验管理经验为中国推动监管科学研究、进一步提高药品抽检的科学性和靶向性提供参考。

OBJECTIVE To analyze the key points of American management of drug quality sampling and testing,and provide reference for the drug administration of China.METHODS Literature research and data analysis were conducted,relevant literatures were consulted,and the official website of FDA was retrieved to find documents related to drug quality sampling and testing,the data disclosed in the annual report of the drug sampling and testing between 2013 and 2017 were summarized,and the regulatory strategies revealed in American drug quality sampling and testing were researched.RESULTS The Compliance Program Guidance Manual for drug quality sampling and testing was established,the risk-based selection criteria was constructed,work cohesion seamless integration of surveillance,review,inspection and data sharing was emphasized in American.CONCLUSION The regulatory experiences of American drug quality sampling and testing,are still useful for the advancement of regulatory science,and further improvement of scientific and targeted nature of drug sampling and testing in China.