基于风险管理的FDA药品安全监管发展历程及启示

doi:10.5246/jcps.2015.06.052

中国药学(英文版) ›› 2015, Vol. 24 ›› Issue (6): 405-411.DOI: 10.5246/jcps.2015.06.052

基于风险管理的FDA药品安全监管发展历程及启示

王宝敏¹, 周林光², 李斌³, 杨松¹, 江滨^1,4*

1. 北京大学药学院药事管理与临床药学系, 北京 100191
2. 北京大学国际医院药剂科, 北京 102206
3. 中国人民解放军军事科学院门诊部, 北京 100091
4. 北京大学医药管理国际研究中心, 北京 100191

收稿日期:2015-01-10 修回日期:2015-03-07 出版日期:2015-06-26 发布日期:2015-03-09
通讯作者: Tel.: 86-10-82801701-233
基金资助:
National Social Science Fund (Grant No. 13BGL141).

Risk management of drug products in FDA: the development and implication

Baomin Wang¹, Linguang Zhou², Bin Li³, Song Yang¹, Bin Jiang^1,4*

1. Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191
2. Department of Pharmacy, Peking University International Hospital, Beijing 102206
3. Outpatient Department, Academy of Military Sciences of PLA, Beijing 100091
4. International Research Center for Medicinal Administration, Peking University, Beijing 100191

Received:2015-01-10 Revised:2015-03-07 Online:2015-06-26 Published:2015-03-09
Contact: Tel.: 86-10-82801701-233
Supported by:
National Social Science Fund (Grant No. 13BGL141).

摘要/Abstract

摘要：

本文以时间为主线, 全面介绍了FDA药品风险管理概念的形成、建设、逐步完善的历程和经验。以三个阶段为节点, 探究了FDA在上市前审批和上市后安全监管、不良反应以及风险沟通等方面药品风险管理法规制度的建设情况。最后, 结合我国药品风险管理的现状, 提出了发展和完善我国药品风险管理的建议。

关键词: 药品风险管理, 药品安全, 药品监管, 美国食品药品监督管理局

Abstract:

This paper presented detailed information about the timeline of development of drug risk management in FDA. The time process was divided into three stages: the launch of laws and regulations of drug risk management, pre-market approval and post-market safety supervision, adverse drug reaction and risk communication. To address the problems existing in drug risk management in China, suggestions to further and improve the development of drug risk management are proposed.

Key words: Drug risk management, Drug safety, Drug supervision, FDA

中图分类号:

R951

Supporting:

王宝敏, 周林光, 李斌, 杨松, 江滨. 基于风险管理的FDA药品安全监管发展历程及启示[J]. 中国药学(英文版), 2015, 24(6): 405-411.

Baomin Wang, Linguang Zhou, Bin Li, Song Yang, Bin Jiang. Risk management of drug products in FDA: the development and implication[J]. Journal of Chinese Pharmaceutical Sciences, 2015, 24(6): 405-411.

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基于风险管理的FDA药品安全监管发展历程及启示

Risk management of drug products in FDA: the development and implication

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