The “Drug Administration Law of the People′s Republic of China” has undergone two revisions and two amendments since its promulgation in 1984. The process of institutional evolution reflects the continuous deepening of understanding of drug administration courses, the continuous refinement of governance systems, the continuous improvement of governance mechanisms, the continuous enrichment of governance methods, and the continuous improvement of legal liability systems. The revision of the drug administration law in 2019 adheres to political guidance, problem-oriented approach, international perspective, national conditions, reform and innovation, and scientific development. The promulgation and successive revisions of the drug administration law reflect the changes in China′s economic, social, and pharmaceutical industry development, fully reflecting the growing health needs of the people and clearly demonstrating the comprehensive progress of China′s social governance. To advance drug safety on the track of modern rule of law, it is necessary to accurately grasp the historical position, improve the legal system, establish law enforcement authority, enhance legal literacy, and provide more solid legal system underpinnings for accelerating China′s leap towards becoming a pharmaceutical manufacturing powerhouse.

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.

Since the enactment of China′s first “Drug Administration Law of the People′s Republic of China” in 1984, China has entered a phase of legal and standardized drug management. The drug regulatory authorities have continuously strengthened the construction of the legal and regulatory framework for drug supervision and have optimized the drug review and approval system. The accessibility of drugs for rare diseases is a significant challenge worldwide. To meet the medication needs of patients with rare diseases, China has introduced a series of incentive policies to fully support the development of drugs for rare diseases and accelerate their review and approval. This paper systematically reviews the historical evolution, development process, and reform achievements of China′s rare disease drug review and approval system, and looks ahead to the future, aiming to further optimize the system to better meet the medication needs of patients.