FDA风险沟通理念在我国药品评价抽验中的应用  

The Application of FDA Risk Communication in China's Drug Evaluation Sampling Work

作　　者：冯磊[1] 王翀[1] 丛佳[1] 朱炯[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2012年第11期1214-1216,1227,共4页Chinese Pharmaceutical Affairs

摘　　要：目的为国家食品药品监督管理局的药品评价抽验工作提供参考。方法通过介绍美国FDA风险沟通的原则和战略要求,讨论这些理念在中国药品评价抽样应用的可能性。结果与结论可以借鉴FDA风险沟通理念,通过制定沟通战略、明确沟通对象、针对性沟通等方式,促进我国药品评价抽验的工作。Objective To provide the reference for drug evaluation sampling work of SFDA.Methods Through the introduction of FDA risk communication principles and strategic requirements,we discussed the application possibility of the ideas in China＇s drug evaluation sampling work.Results and Conclusion We can refer to the ideas of FDA risk communication,working out a plan,establishing communication target,aiming at communication model etc,to promote the work of drug evaluation sampling and make risk minimization in China.

关 键 词：FDA 风险沟通 药品评价抽验 

分 类 号：R95[医药卫生—药学]