我国药品安全风险管理现状与思考

Status quo and reflections of drug safety risk management in china

目的分析我国药品安全风险的研究现状,为进一步的研究指明方向。方法对我国药品监督管理体制中已存在的涉及安全风险管理的方面进行客观的分析,系统总结了我国药品监督管理体系在药品安全风险管理政策方面所做的工作,分析了国内药品安全风险管理面临的问题。结果与结论提出了我国药品安全风险管理的改进措施,为我国今后实施药品风险管理战略或计划提供重要参考。

Objective To analyze the status quo of drug safety risk management policy of our current drug surveillance and management departments and point out the direction for the futural research.Methods The status quo of drug safety risk management of the system organization in our country were discussed.The work of drug safety risk research policy of the supervise system in our country was summarized and the problems were analyzed.Results Conclusions The improving measures of drug safety risk management were listed in order to provide references for future drug risk management strategy or plan of our country.