新时代我国药品上市后监测评价工作思考

doi:10.19803/j.1672-8629.2020.10.01

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (10): 649-652.
DOI: 10.19803/j.1672-8629.2020.10.01

新时代我国药品上市后监测评价工作思考

沈传勇, 吴婷婷, 刘巍, 郑明节, 樊蓉, 董铎

国家药品监督管理局药品评价中心,北京 100022

收稿日期:2020-10-14 修回日期:2020-10-14 出版日期:2020-10-15 发布日期:2020-10-13
作者简介:沈传勇,男,博士,副教授,药事管理与药物警戒研究。沈传勇 1993年7月毕业于北京医科大学药学院药化专业,获理学博士学位。先后在北京医科大学,北京大学医学部,成都市卫生局,国家食品药品监督管理局药品认证管理中心、机关服务中心、药品评价中心工作。现任国家药品监督管理局药品评价中心党支部书记、中心主任,《中国药物警戒》期刊主编。
基金资助:
国家科技重大专项项目（2017ZX09101001-001-003）

Post-marketing Surveillance and Evaluation of Chinese Drugs in the New Era

SHEN Chuanyong, WU Tingting, LIU Wei, ZHENG Mingjie, FAN Rong, DONG Duo

Center for Drug Reevaluation, NMPA, Beijing 100022, China

Received:2020-10-14 Revised:2020-10-14 Online:2020-10-15 Published:2020-10-13

摘要/Abstract

摘要： 立足我国药品监管新使命、新理念、新制度、新形势,对我国药品上市后监测评价工作面临的机遇和挑战进行分析,并结合国内现状与国际发展,提出了加快完善监测评价制度体系、持续提升监测评价体系能力、着力防控药品安全风险、研究上市后监测评价新方法、努力打造高效能信息化系统等方面的思考。

关键词: 药品上市后监测评价, 药品不良反应, 药物警戒

Abstract: Based on new missions, new ideas, new regulatory systems, and new situation regarding drug supervision, this article analyzes the opportunities and challenges facing post-marketing surveillance and evaluation of drugs in China. In view of the status quo in China and development worldwide, recommendations are offered as to how to improve the regulatory system quickly, continue to enhance the capabilities of monitoring and evaluation, work hard to prevent drug safety risks, research new post-marketing surveillance and evaluation methods, and establish highly efficient information systems.

Key words: post-marketing surveillance and evaluation of drugs, adverse drug reaction, Pharmacovigilance

中图分类号:

R969.3

沈传勇, 吴婷婷, 刘巍, 郑明节, 樊蓉, 董铎. 新时代我国药品上市后监测评价工作思考[J]. 中国药物警戒, 2020, 17(10): 649-652.

SHEN Chuanyong, WU Tingting, LIU Wei, ZHENG Mingjie, FAN Rong, DONG Duo. Post-marketing Surveillance and Evaluation of Chinese Drugs in the New Era[J]. Chinese Journal of Pharmacovigilance, 2020, 17(10): 649-652.

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新时代我国药品上市后监测评价工作思考

Post-marketing Surveillance and Evaluation of Chinese Drugs in the New Era

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