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
陆德 1裴宇盛 2臧克承 3肖妍2
作者信息
- 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
- 折叠
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.
Abstract
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 guidelines issued by FDA,and analyzed the warning letters issued based on remote regulatory assessments 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 warning 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Key words
remote regulatory assessments/remote interactive evaluations/warning letters/good manufacturing practice for drugs/quality management system引用本文复制引用
出版年
2024
NETL
NSTL
万方数据