对实施药品风险管理的思考

目的:探讨以药品生产企业为实施主体的风险管理具体策略。方法:从药品风险管理理论的内涵、制度概念剖析入手,结合药品风险评价的核心原则,重点采用系统分析方法进行论述性阐述。结果与结论:药品风险管理看似缘起于风险,但对具体品种进行评价时,脱离不开其疗效和效益。它是一个系统工程,涉及药品监管的各个方面。它作为一种制度形式,虽然已有国外趋于成型的经验,但在我国尚需进一步完善。

Views on Implementation of Drug Risk Management

OBJECTIVE: To probe into the strategies of drug risk management with drug manufacturers as subject. METHODS: Combining with the core principle of drug risk assessment, the connotation and system conception of the theory of drug risk management were interpreted by systematic analytical method. RESULTS&CONCLUSIONS: Drug risk management seems to be caused by the risk. However, when the specific product is evaluated, its curative effect and benefit are still involved. Risk management that refers to respects of ...