风险评估在国家药品评价抽验工作中的应用  

Application of Risk Assessing in State Drug Sampling Analysis for Quality Evaluation

作　　者：郭志鑫[1] 黄志禄[1] 张弛[1] 朱嘉亮[1] 姜雄平[2] 徐万魁[3] 杨悦[4] 李延敏[4] 杨玉奎 

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]总后卫生部药品仪器检验所 [3]辽宁省食品药品检验所 [4]沈阳药科大学工商管理学院 [5]河南省食品药品监督管理局

出　　处：《中国药事》2011年第8期764-767,775,共5页Chinese Pharmaceutical Affairs

摘　　要：目的探讨在国家药品评价抽验工作中如何进行风险评估。方法介绍国内外药品风险评估概况及在国家药品评价抽验工作中引入风险评估理念的背景和风险指数的计算原理,对国家评价抽验品种进行风险指数的计算。结果通过在国家药品评价抽验工作中尝试性地进行风险指数的计算,了解了同一品种不同企业的产品质量等级。结论风险评估结果为监管决策提供了一定的技术依据,但仍需要进一步完善。Objective Explore the use of risk assessing method in the state drug sampling analysis for quality evaluation.Methods By introducing the general situation of drug risk assessing in domestic and foreign,the background of inducting the risk assessing idea in the area of drug,and the calculation principle of the risk index,calculate the risk index of the sampling and testing products.Results By calculate the risk index in the state drug sampling analysis for quality evaluation,find out the quality level of the same product in different industry.Conclusion The use of risk assessing method in the state drug sampling analysis for quality evaluation can provide some technical supports for regulatory decision,but still need further improvement.

关 键 词：风险评估 药品评价抽验 风险指数 

分 类 号：R954[医药卫生—药学]