从罗格列酮案例看FDA药品风险管理的实施与应用

Implementation and application of FDA′s drug risk management:by analyzing the case of rosiglitazone

目的通过罗格列酮案例分析FDA药品风险管理的实施与应用。方法于2012年12月查阅FDA网站关于罗格列酮风险管理相关信息,运用文献分析的方法进行研究。结果 FDA在药品风险管理的过程中重视药品风险沟通,基于实证理念及REMS的应用。结论学习和运用风险管理和循证理念是我国药品监管的当务之急。

Objective To analyze the implementation and application of drug risk management of FDA through the rosiglitazone case. Methods Information of rosiglitazone risk management on website of FDA on December 2012 was searched and analyzed by literature research methods. Results FDA paid much attention to the application of risk communication and evidence-based concept and the REMS during drug risk management process. Conclusion Learning and using risk management and evidence-based concept is the top priority of drug regulatory in our country.