假冒伪劣药品的界定与防控  

Definition and prevention of substandard/spurious/falsely labelled/falsified and counterfeit medicines

作　　者：王蒙[1] 叶小飞[1] 冯红云[2] 侯永芳[2] 郭晓晶[1] 贺佳[1] WANG Meng;YE XiaoFei;FENG HongYun;HOU YongFang;GUO XiaoJing;HE Jia(Teaching Office of Health Statistics,Faculty of Health Service,Second Military Medical University,Shanghai 200433,China;Center of Drug Evaluation,China Food and Drug Administration,Beijing 100045,China)

机构地区：[1]第二军医大学卫生勤务系卫生统计学教研室,上海200433 [2]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《药学服务与研究》2018年第2期120-122,共3页Pharmaceutical Care and Research

基　　金：国家自然科学基金面上项目(81373105);上海市第四轮公共卫生三年行动计划重点学科建设项目(15GWZK0901)

摘　　要：世界各国政府都面临假冒伪劣药品监管的难题,但目前对此尚无统一概念,可能不利于在全球范围内对假冒伪劣药品进行监管。本文使用了世界卫生组织推荐使用的一组术语"劣质、假造、标签不当、伪造、假冒"对假冒伪劣药品的概念进行界定,介绍了其危害及防控措施,以期为药品监管工作提供参考。Governments around the globe are faced with the hard problem in the control of substandard/spurious/falsely labeled/falsified and counterfeit(SSFFC)medicines.However,at present,there is no unified definition on the matter,which is unfavorable to the control of SSFFC medicines globally.In this paper,we use such technical terms as SSFFC medical prod-ucts to define what used to be widely known as“counterfeit medicine”.At the same time,we also introduce the harms and con-trol measures for SSFFC drugs,so as to provide reference for drug supervision and surveillance.

关 键 词：假冒伪劣药品 药事管理 药物警戒 综述 

分 类 号：R954[医药卫生—药学]