Investigation of Pharmaceutical Manufacturers' Establishments on Management System for Monitoring and Reporting Adverse Drug Reactions

Abstract

Abstract: Rules on adverse drug reaction reporting and monitoring in China require that pharmaceutical manufacturers should establish a management system for monitoring and reporting adverse drug reactions(ADR). Through observing the present situation of companies'establishment and implementation of their standard operation procedures and ADR reporting structures, as well as analyzing relevant EU laws, this article discussed ways to improve our country enterprise to implement the reporting system and the mode of government supervision.

Key words: pharmaceutical manufacturers, adverse drug reaction reporting and monitoring, management system

CLC Number:

SUN Jun, WEI Zhen, LI Ming. Investigation of Pharmaceutical Manufacturers' Establishments on Management System for Monitoring and Reporting Adverse Drug Reactions[J]. Chinese Journal of Pharmacovigilance, 2014, 11(1): 8-11.

References

[1] CFDA.药品不良反应报告和监测管理办法[EB/OL].(2011-05-04)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0053/62621.html.
[2] CFDA.中华人民共和国药品管理法[EB/OL].(2001-02-28)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0064/23396.html.
[3] CFDA. 药品生产质量管理规范（2010年修订）[EB/OL].(2011-01-17)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0053/58500.html.
[4] 王丹,杜晓曦.药品不良反应报告和监测管理办法解读及对中药不良反应监测的意义[J].中国中药杂志,2012,37(18)：2686-2688.
[5] CFDA. 药品召回管理办法[EB/OL].(2007-12-10)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0053/26913.html.
[6] CFDA. 药品注册管理办法[EB/OL].(2007-07-10)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0053/24529.html.
[7] CFDA. 药品说明书和标签管理规定[EB/OL].(2006-03-15)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0053/24522.html.
[8] CFDA. 国家食品药品监督管理局发布2010年药品不良反应报告[EB/OL].(2011-04-25)[2013-5-15].http://www.sda.gov.cn/WS01/CL0051/60952.html.
[9] CFDA. 2011年国家药品不良反应监测年度报告[EB/OL].(2012-05-31)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0078/72193.html.
[10] CFDA.国家食品药品监督管理局发布2012年药品不良反应监测年度报告[EB/OL].(2013-03-14)[2013-5-15]. http://www.sda.gov.cn/WS01/CL0051/79058.html.
[11] 陈易新.对实施药品风险管理的思考[J].上海食品药品监管情报研究,2010,(103)：38-42.
[12] 陈易新,李少丽,曹立亚,等.现代药品不良反应报告制度的建立与其医药背景[J].中国心血管病研究杂志,2004,2(3)：233-235.
[13] 刘巍,陈易新.药品不良反应监测与药物警戒[J].中国执业药师,2008,5(8) ：18-20.
[14] European Commission.The EU pharmacovigilance system[EB/OL].[2013-5-17].http://ec.europa.eu/health/human-use/pharmacovig-
ilance/index_en.htm.
[15] 周三多,陈传明,鲁明泓.管理学-原理与方法[M].5版,上海：复旦大学出版社,2009：11.
[16] 陈氚.制度概念的歧义与后果[J].湖南师范大学社会科学学报,2013,(2) ：91-97.
[17] 董铎,吴桂枝,程刚.欧盟新法规下的药物警戒制度简介[J].中国药物警戒,2012,9(11)：662-665.
[18] European Medicines Agency. Good Pharmacovigilance Practices[EB/OL].(2012-01-03)[2013-5-15]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c.
[19] European Medicines Agency. Guideline on good pharmacovigilance pracices(GVP） Module III-pharmacovigilance inspections[EB/OL].（2012-12-12）[2013-5-17]. http: //www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/12/WC500136230.pdf.
[20] 梅旭辉.药品一味降价的危害值得重视[J].医药导报,2012,31(2) ：270-271.