基于警告信对美国FDA远程监管评估的探讨分析  

Analysis of FDA's Remote Regulatory Assessments based on Warning Letters

作　　者：陆德 裴宇盛[2] 臧克承 肖妍 Lu De;Pei Yusheng;Zang Kecheng;Xiao Yan(Yangtze River Delta Center for Drug Evaluation and Inspection of NMPA,Shanghai 201210,China;National Institutes for Food and Drug Control,Beijing100050,China;Center for Controlled Drug Inspection of NMPA,Shijiazhuang 050000,China)

机构地区：[1]国家药品监督管理局药品审评检查长三角分中心,上海201210 [2]中国食品药品检定研究院,北京100050 [3]国家药品监督管理局特殊药品检查中心,石家庄050000

出　　处：《中国药事》2024年第8期961-968,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:介绍FDA发布的远程监管评估相关指南,并结合基于远程监管评估发布的警告信进行分析,为行业提供参考。方法:介绍FDA发布的远程监管评估指南及远程交互评估指南,并基于远程监管评估发布的警告信,从缺陷情况以及发布警告信的时间方面进行分析,提出参考建议。结果:FDA基于远程监管评估发布的警告信与现场检查发布的警告信相比,其缺陷条款以及发布时间上均有特点。结论:远程监管评估作为一种新的监管工具,有其独特的优势和不足之处,给监管部门以及药品生产企业均带来新的挑战。Objective:To introduce the relevant guidlines for remote regulatory assessments issued by FDA and analyze the warning letters issued based on remote regulatory assessments to provide references for the industry.Methods:This paper introduced the remote interactive evaluations guidelines and remote regulatory assessments guidclines issucd by FDA,and analyzed the wanning letters issucd based on remote regulatory asscssments from the aspects of defects and the time of issuing warning letters,and put forward reference opinions.Results:Warning letters issued by the FDA based on remote regulatory assessments have unique characteristics in terms of defect terms and timing compared to waring letters issued by inspections.Conclusion:As a new regulatory tool,remote regulatory assessments has its unique advantages and disadvantages,and it also brings new challenges to both regulatory authorities and pharmaceutical manufacturers.

关 键 词：远程监管评估 远程交互评估 警告信 药品生产质量管理规范 质量管理体系 

分 类 号：R95[医药卫生—药学]