《药品管理法》颁布四十年来药品生产监管制度的变迁  

Changes in the Drug Manufacturing Supervision System Since the Promulgation of the Drug Administration Law 40 Years

作　　者：杨悦 YANG Yue(School of Pharmaceutical Sciences,Tsinghua University,Beijing 100084,China)

机构地区：[1]清华大学药学院,北京100084

出　　处：《中国药学杂志》2024年第18期1674-1678,共5页Chinese Pharmaceutical Journal

基　　金：国家自然科学基金面上项目资助(72374115)。

摘　　要：本文旨在回顾《中华人民共和国药品管理法》(以下简称《药品管理法》)颁布四十年来的药品生产监管制度的演进与变化。采用文献研究方法,检索1985年以后的法律、法规和配套文件,对药品监管体系、药品生产许可、GMP认证与检查、检查人员管理、委托生产等关键性制度要素进行回顾。生产监管制度的改革包括药品生产许可简化优化,由药品监督员、GMP检查员制度升级为职业化专业化检查员,由GMP认证转变为动态GMP检查,药品委托生产管理逐渐扩大范围。四十年来,药品生产管理制度适应并引领了我国医药产业发展,实现了制度的更新迭代,促进了产业高质量发展。To review the evolution and changes of the drug manufacturing supervision system since the promulgation of the“Drug Administration Law of the People′s Republic of China”40 years ago.The literature research method was used to retrieve laws,regulations,and supporting documents after 1985,and to review key institutional elements such as drug regulatory system,drug manufacturer license,GMP certification and inspection,inspector management,and commissioned production.The reform includes the drug production license simplified and optimized,and the system of drug supervisors and GMP inspectors has been upgraded to professional and specialized inspectors.GMP certification has been transformed into dynamic GMP inspection,and the scope of drug commissioned production management has gradually expanded.Over the past forty years,the drug manufacturing management system has adapted to and led the development of China′s pharmaceutical industry,achieved institutional updates and iterations,and promoted high-quality development of the industry.

关 键 词：药品管理法 生产监管 检查员 委托生产 药品上市许可持有人 

分 类 号：R951[医药卫生—药学]