已上市治疗用重组蛋白药物生产场地变更药学研究审评思考  

CMC considerations of manufacturing site changes for marketed therapeutic recombinant protein drugs from regulatory review

作　　者：赛文博 马晓娟 邱晓 韦薇 SAI Wenbo;MA Xiaojuan;QIU Xiao;WEI Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China;不详)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076 [2]国家药品监督管理局审评检查长三角分中心,上海201210

出　　处：《中国生物制品学杂志》2025年第2期252-256,共5页Chinese Journal of Biologicals

摘　　要：随着我国药品监管法律法规的持续完善,全生命周期药品监管已成为保障公众用药安全的关键手段与必然发展趋势。已上市生物制品的药学变更管理模式已由按事项转变为基于风险的变更管理模式。近年来,已上市治疗用重组蛋白药物在生产场地变更方面的补充申请数量大幅增长,但不同情形下生产场地变更风险各异,所需开展的研究也不尽相同。本文从风险评估和分级、药学研究的一般要求与特殊情形以及申报常见问题三方面进行探讨,提出生产场地变更研究的一般要求,以期为业界提供有益参考。通过监管部门与业界的共同努力,切实保障患者权益,持续为公众提供高质量的药品。With the continuous improvement of China's drug regulatory laws and regulations,Life-cycle regulatory management has become a key means and an inevitable development trend to ensure the safety of public drug use.The management of post-approval changes to biological products is gradually shifting towards the risk-based model from the item-based model.In recent years,there has been a significant increase in supplementary applications for manufacturing site changes of marketed therapeutic recombinant protein drugs.However,the risks associated with manufacturing site changes vary under different circumstances.Therefore,the research that needs to be carried out is also different.This paper provides an in-depth discussion on three key aspects:risk assessment and grading,general requirements and special considerations for pharmaceutical research,and common application issues.It outlines general requirements for manufacturing site change,aiming to offer valuable insights for industry needs.Through the collaborative efforts between regulatory authorities and the industry,patient rights and interests can be effectively protected,and high-quality drugs can be made available to the public.

关 键 词：全生命周期监管 已上市治疗用重组蛋白药物 生产场地变更 风险评估 技术要求 可比性研究 

分 类 号：R95[医药卫生—药学]