欧盟新的药物警戒法规简介与启示

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (7): 396-399.

欧盟新的药物警戒法规简介与启示

王晓燕,杨悦

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2013-06-24 修回日期:2016-03-09 出版日期:2013-07-08 发布日期:2016-03-09
通讯作者: 杨悦,女,博士,教授,博士生导师,药事法规与药品政策。E-mail：yyue315@126.com
作者简介:王晓燕,女,在读硕士,药事管理。

Brief Introduction and its Implication of New Pharmacovigilance Legislation in EU

WANG Xiao-yan, YANG Yue

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2013-06-24 Revised:2016-03-09 Online:2013-07-08 Published:2016-03-09

摘要/Abstract

摘要： 目的对欧盟新药物警戒法进行介绍,为完善我国药品不良反应报告和监测体系提供参考。方法通过查阅国内外文献,应用文献研究的方法进行分析。结果欧盟药物警戒当前所关注的焦点问题主要集中在收集药品安全性信息,分析和挖掘药品数据信息,开展围绕公众健康监管活动以及与利益相关者进行有效沟通。结论我国应借鉴欧盟新药物警戒法,提高我国药品不良反应报告和监测能力。

关键词: 欧盟, 欧洲药物管理局, 药物警戒法规

Abstract: Objective According to the introduction of new pharmacovigilance legislation in EU, suggestions were put forward to provide the example and reference for perfecting and developing adverse drug reation reporting and monitoring system of China. Methods Literature study was used to analyze the foreign and domestic materials. Results New pharmacovigilance legislation in EU focuses on collection of key information on medicines, better analysis and understanding of data and information, regulatory action to safeguard public health and communication with stakeholders. Conclusion We should learn from the new EU pharmacovigilance law to improve capabilities of adverse drug reaction reporting and monitoring.

Key words: EU, EMA, pharmacovigilance legislation

中图分类号:

R951

王晓燕,杨悦. 欧盟新的药物警戒法规简介与启示[J]. 中国药物警戒, 2013, 10(7): 396-399.

WANG Xiao-yan, YANG Yue. Brief Introduction and its Implication of New Pharmacovigilance Legislation in EU [J]. Chinese Journal of Pharmacovigilance, 2013, 10(7): 396-399.

参考文献

[1] EMA. EMA.New Pharmacovigilance Legislation: Update on implementation[EB/OL].[2013-5-1].http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2012/02/WC500122162.pdf.
[2] MHRA.The New PV Legislation Perspective from a Member State [ EB/OL] .[ 2013-5-1]. http: //www . ema. europa. eu/docs/en_GB/document_library/Presentation/2011/06/WC500107889.pdf.
[3] EMA. 2010 pharmacovigilance legislation [EB/OL]. [2013-5-1]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000492.jsp&mid=WC0b01ac058033e8ad.
[4] EMA. Project 00305: Implementation of the new Pharmacovigilance legislation[EB/OL].[2013-5-1]. http://www.ema.europa.eu/ema/pages/includes/document/open_document .jsp ?webContentId=WC500105351European Medicines Agency and Member States Joint Implementation Check-list.
[5] EMA.Electronic submission of information on medicines [EB/OL]. [2013-5-1].http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000496jsp&mid=WC0b01ac058058f329.
[6] EMA. Countdown to July 2012: the establishment and functioning of the PRAC[EB/OL].[2013-5-1].http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/07/WC500129301.pdf.
[7] EMA.PRAC: Overview [EB/OL].[2013-5-1].http://www.ema.europa. eu/ema/index.jsp?curl=pages/about_us/general/general_content_000538.jsp&mid=WC0b01ac058058cb19.
[8] EMA. Countdown to July 2012: the establishment and functioning of the PRAC[EB/OL].[2013-5-1].http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/07/WC500129301.pdf.
[9] EMA. CO-ORDINATION GROUP FOR MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES-HUMAN(CMDh) WORKPLAN 2012[EB/OL].[2013-5-1]. http://www.hma.eu/cmdh.html.
[10]海颖.欧盟药物警戒信息监管体系的分析与借鉴[J].中国执业药师,2011,8(2):31-33.
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