国内外药品智慧监管的发展及对我国的启示

中国医药导刊 ›› 2021, Vol. 23 ›› Issue (8): 626-629.

国内外药品智慧监管的发展及对我国的启示

苏小洁，张磊，苗会青，林凯*

海南省药品不良反应监测中心，海南海口 570216

收稿日期:2021-09-26 修回日期:2021-06-24 出版日期:2021-08-28 发布日期:2021-08-28

Development of Drug Smart Regulation at Homeland and Abroad and the Enlightenment to China

SU Xiaojie， ZHANG Lei， MIAO Huiqing， LIN Kai*

Center for ADR Monitoring of Hainan Province，Hainan Haikou 570216， China

Received:2021-09-26 Revised:2021-06-24 Online:2021-08-28 Published:2021-08-28

摘要/Abstract

摘要： 近年来，在党中央、国务院关于“网络强国”战略决策的部署下，强化药品监管信息化建设，推进药品智慧监管的发展及完善，成为当前药品监管和研究的重点。药品智慧监管取得长足的发展，但也面临许多问题。本研究通过梳理智慧监管概念，细数国内药品智慧监管的发展历程，解析国外药品智慧监管优秀案例发展现状，经过综合考量，提出促进我国药品智慧监管发展的建议。

关键词: 智慧监管, 医药, 监管信息化, 监管科学

Abstract: In recent years， under the development of “Network Power” strategic decision in the CPC Central Committee the State Council's in China, it has become the focus of the current drug supervision and research to the strengthen the informatization construction of drug regulation, promoting the development and improvement of drug Smart regulation. Smart regulation of drugs has made great progress， but it also faces many problems. By sorting out the concept of smart regulation， enumerating the development process of smart regulation of drugs in China， analyzing the development status of excellent cases of smart drug supervision abroad， this paper puts forward suggestions on promoting the development of smart regulation of drugs in China after comprehensive consideration.

Key words: Smart regulation； , Medical； , Informatization of supervision； , Regulatory science

中图分类号:

苏小洁, 张磊, 苗会青, 林凯. 国内外药品智慧监管的发展及对我国的启示[J]. 中国医药导刊, 2021, 23(8): 626-629.

SU Xiaojie, ZHANG Lei, MIAO Huiqing, LIN Kai. Development of Drug Smart Regulation at Homeland and Abroad and the Enlightenment to China[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2021, 23(8): 626-629.

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