中国食品药品监管Issue(11)：74-83,10.DOI:10.3969/j.issn.1673-5390.2023.11.009
省级药监局视角下CAR-T治疗药品生产监管探讨
Discussion on Production Supervision of CAR-T Therapeutic Drugs from the Perspective of Provincial Medical Products Administrations
郭林丰 1魏锡庚 1刘琨 2董雪姣 1张来俊1
作者信息
- 1. 北京市药品监督管理局第三分局
- 2. 北京市药品监督管理局
- 折叠
摘要
Abstract
Objective:Aims to provide references for provincial medical products administration to establish and improve regulatory systems for the production supervision of post-marketing CAR-T therapeutic drugs.Methods:The analysis encompasses the distinctive characteristics of CAR-T therapeutic drugs,including product features,pharmaceutical and clinical research,production,and clinical use.Policies from regulatory agencies such as WHO,PIC/S,FDA,and EMA are introduced,and the existing regulatory system in China is outlined.Results and Conclusion:From the perspective of provincial medical products administration,key areas for attention in the production supervision of post-marketing CAR-T therapeutic drugs are identified.These include a focus on comparability research in change management,six specific points in GMP compliance inspections,extended inspections,post-marketing monitoring in GVP compliance inspections,and daily supervision inspections that focuses on risk signals and enterprise management strategies for medical institutions.关键词
CAR-T/细胞治疗药品/药品监管/生产监管/省级药监局Key words
CAR-T/cell therapy drugs/drug regulation/production supervision/provincial medical products administration分类
医药卫生引用本文复制引用
郭林丰,魏锡庚,刘琨,董雪姣,张来俊..省级药监局视角下CAR-T治疗药品生产监管探讨[J].中国食品药品监管,2023,(11):74-83,10.
