《已上市生物制品药学变更研究技术指导原则(试行)》解读  

Interpretation of Technical Guideline for Post-approval Pharmaceutical Changes of Biological Products(Trial)

作　　者：邱晓 项金忠[1] 赵靖 何伍[1] QIU Xiao;XIANG Jin-zhong;ZHAO Jing;HE Wu(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2023年第2期28-35,共8页China Food & Drug Administration Magazine

摘　　要：为了给药品上市后监管提供技术支撑,按照国家药监局统一部署,国家药监局药品审评中心制定了《已上市生物制品药学变更研究技术指导原则(试行)》,并于2021年6月发布,受到了广泛关注。本文详细论述了在基于风险进行分类管理的上市后监管制度下,药品质量体系在变更中的重要作用,明确了基于变更进行分类管理及开展相关研究的基本原则,并对几个具有代表性的变更事项的分级及需要开展的技术研究进行了说明,以期加强指导原则的指导作用。In order to provide technical support for regulation of post-approval pharmaceutical changes of biological products,the Center for Drug Evaluation drafted the Technical Guideline for Post-approval Pharmaceutical Changes of Biological Products(Trial),which has received extensive attention since its official release in June 2021.This paper discusses in detail the important role of pharmaceutical quality system in change management under post-marketing regulatory system and the basic principles of classification management and related research based on the change classification.In addition,this paper explains the classification of several representative change items and the technical research needed to be carried out,so as to strengthen the guiding role of the guiding principle.

关 键 词：全生命周期管理 基于风险的变更分类 药品质量体系 变更研究 可比性 

分 类 号：R95[医药卫生—药学]