我国建立药物警戒制度的初步思考

doi:10.19803/j.1672-8629.2020.11.01

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (11): 749-752.
DOI: 10.19803/j.1672-8629.2020.11.01

我国建立药物警戒制度的初步思考

袁林, 高燕, 路长飞

国家药品监督管理局,北京 100037

收稿日期:2020-11-10 修回日期:2020-11-10 出版日期:2020-11-15 发布日期:2020-11-10
作者简介:袁林,男,国家药品监督管理局药品监管司,博士,药品监管。华西医科大学药物化学专业本科;美国蒙特雷国际研究院国际工商管理专业硕士;沈阳药科大学药事管理专业博士。曾先后就职于北京市药品检验所、北京市卫生局、北京市劳动保障局、北京市药品监督管理局。曾担任原国家食品药品监督管理局政策法规司司长、原国家食品药品监督管理总局国际合作司司长。现任国家药品监督管理局药品监督管理司司长。

Preliminary Thinking on the Establishment of Pharmacovigilance System in China

YUAN Lin, GAOYan, LU Changfei

National Medical Products Administration, Beijing 100037, China

Received:2020-11-10 Revised:2020-11-10 Online:2020-11-15 Published:2020-11-10

摘要/Abstract

摘要： 2019年8月26日颁布的《中华人民共和国药品管理法》提出建立药物警戒制度。本文对药物警戒概念的起源与发展进行回顾,从药品监管理念变革角度对药物警戒制度进行思考,对药物警戒在我国的适用性进行剖析,提出了当前建立药物警戒制度需要关注的问题。

关键词: 药品管理法, 药物警戒, 药品不良反应监测, 药品监管

Abstract: The new Drug Administration Law required the establishment of pharmacovigilance system in China. In this paper, the origin and development of pharmacovigilance concept were reviewed, the pharmacovigilance system and its applicability were discussed from the perspective of drug regulatory concept reform, and the concerned problems in the establishment of pharmacovigilance system were put forward.

Key words: drug administration law, pharmacovigilance, adverse drug reaction monitoring, drug supervision

中图分类号:

R951

袁林, 高燕, 路长飞. 我国建立药物警戒制度的初步思考[J]. 中国药物警戒, 2020, 17(11): 749-752.

YUAN Lin, GAOYan, LU Changfei. Preliminary Thinking on the Establishment of Pharmacovigilance System in China[J]. Chinese Journal of Pharmacovigilance, 2020, 17(11): 749-752.

参考文献

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我国建立药物警戒制度的初步思考

Preliminary Thinking on the Establishment of Pharmacovigilance System in China

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