1月14日，EMA发布了EMA/419571/2021《药品上市许可持有人与GMP反思文件
文件内容包括如下：
1.Introduction and Purpose
介绍和目的
2.Scope
范围
3.How this Reflection Paper setsout the various MAH Responsibilities
本反思文件如何阐述MAH的各种责任
4. The role of the MAH inFacilitating Compliance with GMP and theMarketing Authorisation (MA)
MAH在促进符合GMP和上市许可（MA）方面的作用
5. Areas of the EC Guide to GMP thatrelate to MAHs
欧盟GMP指南中与MAHs相关的领域
5.1. Outsourcing and TechnicalAgreements
外包和技术协议
5.3. Communication withManufacturing Sites and Competent Authorities (e.g. MA Dossier Information,Variations, Regulatory Commitments, etc.) 12
与生产场地和主管当局的沟通（例如 MA 档案信息、变更、监管承诺等）
5.4.Product Quality Reviews (PQRs)
产品质量回顾
5.5.Quality Defects, Complaints andProduct Recalls
质量缺陷，投诉和产品召回
5.6.Maintenance of Supply ofMedicinal Products
维持药品供应
5.7.Continual Improvement Activities
持续改善活动
6.Falsified Medicines Directive(FMD)-related Responsibilities
药品防伪指令相关的责任
7.Conclusion
结论
8.References
参考文献
9.List of Abbreviations
缩略语列表
