生物制品生命周期管理中分析方法变更的审评考虑和案例研究  

Analytical procedure changes in the lifecycle management of biological products:regulatory consideration and case studies

作　　者：李怡君 寇雅真 魏开坤 韦薇 LI Yi-jun;KOU Ya-zhen;WEI Kai-kun;WEI Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2024年第11期1102-1108,共7页Chinese Journal of New Drugs

摘　　要：生物制品的质量控制是其药学研究和评价的关键,贯穿药品的整个生命周期。随着生物制品相关分析技术的发展和上市后产品知识的积累,上市许可持有人(marketing authorization holder,MAH)可持续改进药物分析方法,增强质量风险管理。本文从监管角度出发,探讨关于治疗用生物制品分析方法变更的审评考量,分享分析方法变更的相关案例,为制药企业持续不断提升药物质量控制和完善分析方法变更申报资料提供参考。Quality control of biological products is a keypoint of their pharmaceutical research and evaluation,which runs through the whole life-cycle of the drug management.With the development of analytical technologies related to biological products and the accumulation of post-marketing product knowledge,pharmaceutical companies can continuously improve pharmaceutical analytical procedures and enhance quality risk management.This paper discusses the review considerations for the changes of analytical methods for therapeutic biological products from a regulatory perspective,and shares several typical cases of analytical method changes,so as to provide reference for pharmaceutical companies to continuously improve drug quality control and complete analytical procedure changes submission.

关 键 词：治疗用生物制品 分析方法 全生命周期管理 上市后药学变更 

分 类 号：R95[医药卫生—药学]