GMP合规性对我国仿制药参比制剂可及性的影响示例  

The Examples for the Influence of GMP Compliance to the Availability of Reference Listed Drug for Generic Drug Product in China

作　　者：杨东升 牛剑钊[1] 冯玉飞[1] 綦梦洁 翟晨斐 马玲云[1] Yang Dongsheng;Niu Jianzhao;Feng Yufei;Qi Mengjie;Zhai Chenfei;Ma Lingyun(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2025年第2期132-138,共7页Chinese Pharmaceutical Affairs

基　　金：中国食品药品检定研究院化学药品检定所学科建设资助项目(编号2024HYZX42)。

摘　　要：目的:研究参比制剂生产企业的GMP合规状态对其产品质量和可及性的影响。方法:在概述我国和世界其他国家GMP的法律法规基础上,通过注射用紫杉醇(白蛋白结合型)和度他雄胺软胶囊两个示例,系统地介绍生产企业GMP合规性对参比制剂质量和可及性的影响。结果与结论:参比制剂生产企业的GMP合规状态是其产品质量和可及性的重要依据和保证,不合格的参比制剂会对仿制药的研发带来一定的风险,制药企业和国家药监机构应该加强对参比制剂生产企业的GMP合规信息的收集和整合。Objective:To investigate the influence of the GMP compliance status of a reference listed drug manufacturer on the quality and availability of its products.Methods:In this article,it outlines the laws and regulations basis of GMP in China and the other countries;and also,by taking the reference listed drugs of Paclitaxel For Injection(Albumin Bound)and Dutasteride Soft Capsules,which are adopted in the Chinese reference listed drug directory for generic drug products,as examples,the influence of GMP compliance status of the corresponding production enterprises on the quality and availability of the reference listed drugs was introduced systematically.Results and Conclusion:The GMP compliance status of a reference listed drug manufacturer is an important basis and guarantee for the quality and availability of its products,and the unqualified reference listed drugs can introduce risks to the research and development of corresponding generic drug products.Thus,the pharmaceutical enterprises and national drug regulatory agencies should strengthen the collection and integration of GMP compliance information for reference listed drug manufacturers.

关 键 词：参比制剂 生产质量管理规范 仿制药 合规性 可及性 

分 类 号：R95[医药卫生—药学]