Evolution and Deepening of the Concept of Risk Management in the Construction of the Rule of Law System for Drug Regulation

OBJECTIVE  To analyze the evolution and deepening process of the concept of risk management of pharmaceuticals in the context of the enactment and revision of the Drug Administration Law of the People's Republic of China(hereinafter referred to as the Drug Administration Law), and to provide ideas for the further implementation of the concept of risk management in the construction of the rule of law system of drug regulation.

METHODS  This study systematically searched drug management policy documents and relevant literature, analyzed the evolution of the risk management concept in the construction of the rule of law for drug regulation since the promulgation of the Drug Administration Law, and explored the application and embodiment of the risk management concept in the three aspects of drug development and registration management, drug production and operation management, and post-market management.

RESULTS ＆ CONCLUSION  From the initial construction of risk management system focused on quality risk prevention and control, adverse drug reaction monitoring, to the formation of the concept of drug risk management in line with international standards, and then to the establishment of the basic principles of risk management in the general principles of the Drug Administration Law, China has continuously implemented the concept of risk management into the rule of law system of the lifecycle regulation of drugs. In the construction of the rule of law system for the lifecycle of drug supervision, it takes into account the elements of risk monitoring, identification, assessment and control, and benchmarks the ideas and models of international drug risk management, so as to gradually deepen the concept of drug risk management, better realize the allocation of risk management resources, and balance the risks of benefits.