药品检查视角下上市后变更管理研究与常见问题分析  

Research on Post-Marketing Change Management and Analysis of Common Issues from the Perspective of Drug Inspection

作　　者：吴凡 梅蕾蕾 付文艳 杜传龙 孙西军 胡媛 Wu Fan;Mei Leilei;Fu Wenyan;Du Chuanlong;Sun Xijun;Hu Yuan(Jiangxi Drug Inspection Center,Nanchang 330001,China;Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China;The Second Affiliated Hospital of Nanchang University,Nanchang 330001,China)

机构地区：[1]江西省药品检查员中心,南昌330001 [2]上海药品审评核查中心,上海201203 [3]南昌大学第二附属医院,南昌330001

出　　处：《中国药事》2025年第2期123-131,共9页Chinese Pharmaceutical Affairs

基　　金：江西省药品监督管理局科研项目(编号2022GL09)。

摘　　要：目的:基于我国药品上市后变更管理框架,对变更典型问题类型和问题实例进行提炼与阐述,为药品上市许可持有人建立良好的药品上市后变更控制体系提供借鉴,也为药品上市后变更监督检查提供参考。方法:通过文献研究法,以药品管理、药品变更、药品上市后变更等为关键词,检索国家药品监督管理局、国家药品监督管理局药品审评中心及各省级药品监督管理局官方网站,对我国近年来出台的系列药品变更法规进行梳理,总结我国药品变更管理框架,对2021年至2023年美国食品药品管理局警告信提出的药品变更控制缺陷进行统计与分析;通过调查研究法,基于笔者近年实际检查情况,梳理我国药品上市后变更管理的典型问题类型和问题实例。结果:我国药品变更管理框架基本完善,在国内外药品检查中发现药品上市许可持有人在药品上市后变更管理方面仍有不足,例如变更控制管理体系建立不完善,变更管理类别不恰当,未按要求进行补充申请、备案或者报告,变更未纳入变更控制管理体系,变更研究缺乏或不充分等。结论:药品上市许可持有人应建立科学合理的内部变更控制体系,开展必要的变更研究工作,并运用监管部门的沟通交流机制,就尚不确定的变更类别充分沟通;药品检查员应注重知识管理和检查经验总结,形成系统全面的变更理念,对检查过程中涉及的药品上市后变更问题进行针对性分析。Objective:To refine and elaborate on typical types of change-related issues and specific cases,based on China’s post-marketing change management framework for drugs,providing a reference for marketing authorization holders to establish a robust post-marketing change control system and offering guidance for postmarketing management,drug change,and post-marketing changes in pharmaceuticals were used to search on the official websites of the National Medical Products Administration(NMPA),the Center for Drug Evaluation(CDE)of NMPA,and provincial medical products administrations.A series of drug change regulations issued in China in recent years were sorted out,and the framework for drug change management in China was summarized.Statistical analysis was conducted on the drug change control deficiencies raised in FDA warning letters from 2021 to 2023.Additionally,based on the author’s recent inspection experiences,typical types of issues and specific cases related to post-marketing change management in China were identified through a survey research method.Results:China’s framework for drug change management is basically well-established.However,inspections of drugs conducted both domestically and internationally have uncovered deficiencies in the post-marketing change management by drug marketing authorization holders.These deficiencies include imperfections in the establishment of a change control management system,inappropriate categorization of change management,failure to submit supplementary applications,filings,or reports as required,exclusion of changes from the change control management system,and inadequate or insufficient research on changes.Conclusion:Marketing authorization holders should establish a scientific and reasonable internal change control system,conduct necessary research on changes,and utilize the communication mechanisms of regulatory authorities to fully discuss uncertain change categories.Drug inspectors should focus on knowledge management and summarizing inspection experience to form

关 键 词：药品检查 药品变更 检查缺陷 变更管理 警告信 

分 类 号：R95[医药卫生—药学]