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| 基于警告信对FDA远程监管评估的探讨分析 |
| Analysis of FDA's remote regulatory assessment based on warning letters |
| 投稿时间：2024-04-18 修订日期：2024-07-17 |
| DOI： |
| 中文关键词: 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 |
| 英文关键词: Remote Regulatory Assessments,Remote Interactive Evaluations,Warning Letter,Good Manufacturing Practice for Drugs,Quality Management System |
| 基金项目: |
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| 中文摘要: |
| 目的 通过对FDA发布的远程监管评估指南及远程交互评估指南介绍,结合FDA基于远程监管发布的警告信,为行业提供参考。方法 针对相关指南进行介绍,并梳理汇总FDA基于远程监管评估发布警告信，对比分析远程监管评估警告信内容,提出参考意见。结果与结论 2019年国际突发公共卫生事件期间,FDA使用了包括远程记录审核、视频连线直播等替代工具代替现场检查,并于2023年及2024年发布并更新相关指南,确定在国际突发公共卫生事件后继续使用替代工具协助监管。本文通过对指南及警告信等进行介绍,提高行业对于远程监管的认识。 |
| 英文摘要: |
| Objective To provide reference for the industry through the introduction of the remote regulatory evaluation guidelines and remote interactive evaluation guidelines issued by FDA, combined with the warning letters issued by FDA based on remote supervision. Methods Introduce relevant guidelines, sort out and summarize warning letters issued by FDA based on remote regulatory assessment, compare and analyze the contents of remote regulatory assessment warning letters, and put forward reference opinions. Results and Conclusion During the 2019 International Public Health Emergency, the FDA used alternative tools, including remote record review and live video connection, instead of on-site inspection, and issued and updated relevant guidance in 2023 and 2024 to determine the continued use of alternative tools to assist supervision after international public health emergencies. This paper introduces the guidelines and warning letters to improve the industry"s understanding of remote supervision. |
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