药品监管法治体系建设中风险管理理念的演进与深化

Evolution and deepening of the concept of risk management in the construction of the rule of law system for drug regulation

关键词:  风险管理  药品管理法  药品全生命周期管理

Key words:  Risk Management  Drug Administration Law  Drug Life Cycle Management

摘要:

目的 以《药品管理法》制定修订为主线，分析药品风险管理理念的演进与深化过程，为进一步在药品监管法治体系建设中贯彻风险管理理念提供思路。方法 系统检索药品管理政策文件和相关文献，梳理《药品管理法》颁布以来风险管理理念在药品监管法治建设中的演进历程，探究风险管理理念在药品研制与注册管理、药品生产与经营管理、上市后管理三个方面的应用和体现。结果和结论 从以质量风险防控、药品不良反应监察为主初步构建风险管理体系，过渡至接轨国际形成药品风险管理理念，再发展到于《药品管理法》总则中确立风险管理基本原则，我国不断将风险管理理念贯彻落实到药品全生命周期监管法治体系中，在药品监管全生命周期法治体系建设中兼顾风险监测、识别、评估、控制要素，对标国际药品风险管理思路和模式，逐步深化药品风险管理理念，更好实现风险管理资源配置，平衡获益风险。

Abstract:

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 We 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 based on the monitoring of adverse drug reactions 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 whole life cycle regulation of drugs, and taken into account the monitoring, identification and control elements of risk in the construction of the rule of law system of the whole life cycle regulation of drugs, In the construction of the rule of law system for the whole life cycle 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.