欧盟EMEA以风险为基础的抽验品种选择方法探析  

Discussion on the EMEA Risk-based Selection Approach for Testing Samples

作　　者：张弛[1] 郭志鑫[1] 朱嘉亮[1] 姜典财[1] 黄志禄[1] 杨悦[2] 

机构地区：[1]国家食品药品监督管理局药品市场监督办公室,北京100050 [2]沈阳药科大学工商管理学院

出　　处：《中国药事》2010年第6期617-618,共2页Chinese Pharmaceutical Affairs

摘　　要：目的了解欧盟药品抽验的模式和经验,对我国的评价抽验提供参考和借鉴。方法介绍了针对欧盟集中审评程序批准上市药品的抽验中,以风险为基础的抽验品种选择方法 ,对其中的风险水平量化模型以及专家意见法给予分析。结果与结论对我国的药品评价抽验具有一定的参考价值。Objective To understand the models and experience of drug sampling and testing in the EU,to provide some references for our country.Methods This article elaborated on the risk-based selection approach for testing samples of EMEA centrally authorised products,with which quantitative model of risk levels was provided and expert opinions were analyzed.Results and Conclusion Providing some references to drug sampling and testing in China.

关 键 词：欧盟药品管理局 抽验 品种 风险 

分 类 号：R951.5[医药卫生—药学]