Institutional History Evolution of Drug Management Legislation in China
Since the reform and opening up,the Drug Administration Law,as the foundational legal framework for pharmaceutical administration in China,has evolved from the primitive to the modern era.Initially,during the early reform period,the Regulations on Drug Administration(Trial)were introduced,which laid the groundwork for China's drug management legislation.The Drug Administration Law was enacted and implemented in 1984,along with subsequent regulations and rules on special drug management,drug review,and Good Manufacturing Practice,laying the foundation for China's pharmaceutical legal system.To adapt to the changes since the reform,the Drug Administration Law underwent a revision in 2001,reflecting the core legal values of ensuring drug safety and efficacy,as well as incorporating the principles of modern administrative law.This revision also enhanced legislative techniques.The 2018 Changchun Changsheng vaccine incident heightened public concerns over drug safety,underscoring the need to consolidate the legal framework to support drug approval reforms.The 2019 revision,the second major comprehensive overhaul of the law,introduced elements of risk management,encouraged pharmaceutical innovation,reformed regulatory systems and mechanisms,and established stricter legal liabilities,marking the modernization of China's pharmaceutical management.This paper summarizes the development of Drug Administration Law and the institutional evolution of drug management in China,aiming to provide a reference for further improving drug management and ensuring public drug safety.
drug managementDrug Administration Lawrisk managementsocial co-governancehistory of drug law
万方数据
维普
