2025年版《中国药典》三部关于异常毒性检查修订内容的解读  

Introduction on the revised content on abnormal toxicity test in the Chinese Pharmacopoeia 2025 Edition(VolumeⅢ)

作　　者：王晓娟[1] 王立萍 曹琰[1] 刘英 李慧义[1] WANG Xiaojuan;WANG Liping;LIU Ying;LI Huiyi(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China;Henan Provincial Institute For Drug and Medical Device Control,Zhengzhou 450018,China)

机构地区：[1]国家药典委员会,药品监管科学全国重点实验室,北京100061 [2]河南省药品医疗器械检验院,郑州450018

出　　处：《中国药品标准》2025年第1期105-109,共5页Drug Standards of China

摘　　要：基于GMP的实施、质量控制措施的全面提升以及实验动物3Rs原则的考虑,WHO、欧洲药典委员会和FDA数年前相继逐步取消了生物制品的异常毒性检查,2025年版《中国药典》三部对生物制品异常毒性检查也进行了修订。为使广大《中国药典》(三部)的使用者更好地理解和执行本部药典,本文详细梳理了各国关于异常毒性检查监管理念的转变与逐步取消异常毒性检查的过程、我国制药行业实际情况,解读2025年版《中国药典》三部关于生物制品异常毒性检查修订的思路与考虑。Based on the implementation of GMP,comprehensive improvement of quality control measures,and consideration of the 3Rs principle for experimental animals,Several years ago,WHO,the European Pharmacopoeia and the FDA gradually abolished the testing for abnormal toxicity of biological products,and the Chinese Pharmacopoeia 2025 Edition(VolumeⅢ)also revised the testing for abnormal toxicity of biological products.In order to help users of the Chinese Pharmacopoeia(VolumeⅢ)better understand and implement this pharmacopoeia,this article provides a detailed review of the changes in regulatory concepts for abnormal toxicity test in various countries and the process of gradually phasing out abnormal toxicity test,as well as the actual situation of China′s pharmaceutical industry.It also interprets the ideas and considerations for revising the Chinese Pharmacopoeia 2025 Edition(VolumeⅢ)on abnormal toxicity test for biological products.

关 键 词：异常毒性 《中国药典》 生物制品 解读 

分 类 号：R921.2[医药卫生—药学]