美国药品安全风险管理最终指南对我国药品安全风险管理的启示

从"万络事件"和"欣弗事件"中,探寻中美两国对药品风险管理手段的差异,从中为我国药品安全管理提出可行性建议。通过例证法分析两国在药品风险管理手段中的不同。我国在药品风险管理中主要采取行政手段进行管理.而在新的形势下,一方面在重视行政监管的同时加强对企业的技术性支持;另一方面在保证原有审查方式的同时,应当重视药物流行病学研究结果。

The Enl Ightment of FDA' s Drug Safety Risk Management Final Guidelines to Drug Safety Risk Management in China

From "VIOXX accedent"and "Xinfu accedent", we want to find the differecence of tool for the drug risk management and make some feasible suggestions for drug safety management in China. We use the case study on two drug safety accedents on China and USA to analysis the difference of drug safety managements between two countries. In china, SFDA used administrative means in drug safety managements. In future, SFDA should emphaise in two aspects: First, give technical guideline for enterprises while still pay attention to administrative management. Second, SFDA should emphaise on the research results of pharmacoepidemiology.