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,regula-tions,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 produc-tion 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 pro-duction 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 devel-opment 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
Key words
drug administration law/production supervision/inspector/commissioned production/drug marketing authorization holder
维普
万方数据