药物警戒的起源与发展

中国药物警戒 ›› 2016, Vol. 13 ›› Issue (7): 410-413.

药物警戒的起源与发展

彭丽丽, 王丹, 沈璐, 董铎

国家食品药品监督管理总局药品评价中心，北京 100045

收稿日期:2016-06-17 修回日期:2018-07-17 出版日期:2016-07-20 发布日期:2018-07-17
通讯作者: 董铎，女，主任药师，上市后药械安全监测。E-mail：dongduo@cdr-adr.org.cn
作者简介:彭丽丽，女，硕士，工程师，中药学。

Development and Origin of Pharmacovigilance

PENG Li-Li, WANG Dang, SHENG Lu, DONG Duo

Centre for Drug Reevaluation, CFDA, Beijing 100045, China

Received:2016-06-17 Revised:2018-07-17 Online:2016-07-20 Published:2018-07-17

摘要/Abstract

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。

关键词: 药物警戒, 起源, 发展

Abstract: Pharmacovigilance is vigilance to all problems of drugs, not only limited to the drug’s safety, but also should contain all activities related to drugs, because it is throughout the whole life cycle of the drug. This article discusses the development and origin of the pharmacovigilance, summarizes the comprehension of different country during different period, and reviews its principles and methods, so as to strengthen the reader’s understanding about pharmacovigilance.

Key words: pharmacovigilance, origin, development

中图分类号:

彭丽丽, 王丹, 沈璐, 董铎. 药物警戒的起源与发展[J]. 中国药物警戒, 2016, 13(7): 410-413.

PENG Li-Li, WANG Dang, SHENG Lu, DONG Duo. Development and Origin of Pharmacovigilance [J]. Chinese Journal of Pharmacovigilance, 2016, 13(7): 410-413.

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