药物警戒的起源与发展  

Development and Origin of Pharmacovigilance

作　　者：彭丽丽[1] 王丹[1] 沈璐[1] 董铎[1] PENG Li-Li;WANG Dang;SHENG Lu;DONG Duo*(Centre for Drug Reevaluation, CFDA, Beijing 100045, China)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2016年第7期410-413,共4页Chinese Journal of Pharmacovigilance

摘　　要：药物警戒贯穿药品整个生命周期,是对于药品相关所有问题的警戒,不仅局限于安全性,更包含有效性等其他与药品相关的所有活动和问题,体现了对药品问题的全方位管理。本文详尽叙述了药物警戒的起源和发展,梳理了不同时期、不同国家对药物警戒定义和对其内涵的理解,全面综述了其工作原则、方法及目的,以期加深读者对药物警戒基本相关概念的认知。Pharmacovigilance is vigilance to all problems of drugs, not only limited to the drug’s safety, but also should containall activities related to drugs, because it is throughout the whole life cycle of the drug. This article discusses the developmentand origin of the pharmacovigilance, summarizes the comprehension of different country during different period, and reviews itsprinciples and methods, so as to strengthen the reader’s understanding about pharmacovigilance.

关 键 词：药物警戒 起源 发展 

分 类 号：R95[医药卫生—药学]