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.

drug safety  /  drug administration law  /  drug governance  /  institutional evolution  /  administration rationale