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.

drug administration law  /  production supervision  /  inspector  /  commissioned production  /  drug marketing authorization holder