国产及进口药品质量差异分析与风险控制的研究  

Research on Analysis of Quality Difference and Risk Control between Domestic and Imported Drugs

作　　者：王林波[1] 林梅[1] 杨美成[1] 张予敏[2] 李彬[2] 

机构地区：[1]上海市食品药品检验所,上海201203 [2]上海市食品药品监督管理局

出　　处：《中国药事》2012年第3期224-228,共5页Chinese Pharmaceutical Affairs

基　　金：上海市食品药品监督管理局资助研究课题:国产及进口药品质量差异分析与风险控制的研究(编号B2009J2-018)

摘　　要：目的分析国产和进口药品质量存在差异的原因,探索进行药品生产企业风险控制和提高国产药品质量的方法。方法以2007～2009年上海市食品药品检验所及7家区域药品检验所的进口和国产药品的检验数据为基础,进行比较和分析。结果与结论国产药品和进口药品的质量存在着比较显著的差异。应从完善药品质量标准,强化企业管理,增加抽验针对性等多方面入手,提高国产药品质量。Objective To analyze the reasons that lead to the difference between domestic and imported drugs and to research the method to control the risk and improve the domestic drugs＇ quality.Methods To compare and analyze the inspection datas of imported and domestic drugs from the shanghai and it＇s 7 regional institute for food and drug control in 2007~2009.Results and Conclusion There are significant difference between domestic and imported drugs.We should perfect the drug quality standard,strengthen the management of enterprises and increase the pertinence of sampling,in order to improve the domestic drugs＇ quality.

关 键 词：国产药品 进口药品 质量差异 风险控制 

分 类 号：R954.6[医药卫生—药学]