欧美药物警戒政策研究及对我国的启示

doi:10.19803/j.1672-8629.2020.12.06

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (12): 877-882.
DOI: 10.19803/j.1672-8629.2020.12.06

欧美药物警戒政策研究及对我国的启示

柳鹏程¹, 王佳域², 陈锦敏¹, 王敏娇¹, 沈梦秋², 李明^2*

1中国药科大学,江苏南京 211198;
²江苏省药品不良反应监测中心,江苏南京 210002

收稿日期:2020-03-30 修回日期:2020-12-07 出版日期:2020-12-15 发布日期:2020-12-07
通讯作者: ^*李明,男,硕士,药品安全性监测。
作者简介:柳鹏程,男,讲师,药物警戒,医疗保险,药品价格。

Pharmacovigilance Laws in Europe and America and Their Implications for China

LIU Pengcheng¹, WANG Jiayu², CHEN Jinmin¹, WANG Minjiao¹, SHEN Mengqiu², LI Ming^2*

¹China Pharmaceutical University,Nanjing Jiangsu 211198,China;
²Jiangsu Province Drug Adverse Reaction Monitoring Center,Nanjing Jiangsu 210002,China

Received:2020-03-30 Revised:2020-12-07 Online:2020-12-15 Published:2020-12-07

摘要/Abstract

摘要： 目的比较欧盟、美国和中国的药物警戒法规体系,分析其中对药品上市许可持有人药物警戒工作的相关要求,为完善我国药物警戒制度体系提供建议与参考。方法采用理论研究与比较分析法,分析欧盟、美国与中国的上市后药物警戒相关法律法规。结果与结论 美国和欧盟法律法规中对药品上市许可持有人如何开展药品不良反应监测与报告、上市后安全性研究、风险管理等方面的规定相对完善。我国可借鉴国外先进经验,进一步完善药物警戒法规体系,推进主动监测与上市后安全性研究工作,制定风险管理相关指导性文件,多措举并推动我国药物警戒制度得以实施。

关键词: 药物警戒, 药品上市许可持有人, 欧盟, 美国

Abstract: Objective To compare the pharmacovigilance regulations in the European Union, the United States and China, analyze the relevant requirements for holders of drug marketing authorization, and offer recommendations on how to improve the pharmacovigilance system in China.Methods Theoretical analysis and comparative analysis were used to compare and analyze the laws and regulations concerning pharmacovigilance in the European Union, the United States and China.Results and Conclusion The laws and regulations of the United States and the European Union have relatively perfect provisions on how to carry out adverse reaction monitoring and reporting, post-market safety research, and risk management. It is suggested that China learn from foreign experience, further improve the pharmacovigilance regulatory system, promote active monitoring and post-marketing safety research, formulate related guidelines for risk management, and take multiple measures to promote the implementation of pharmacovigilance systems.

Key words: pharmacovigilance, holder of drug marketing authorization, the European Union, the United States

中图分类号:

R951

柳鹏程, 王佳域, 陈锦敏, 王敏娇, 沈梦秋, 李明. 欧美药物警戒政策研究及对我国的启示[J]. 中国药物警戒, 2020, 17(12): 877-882.

LIU Pengcheng, WANG Jiayu, CHEN Jinmin, WANG Minjiao, SHEN Mengqiu, LI Ming. Pharmacovigilance Laws in Europe and America and Their Implications for China[J]. Chinese Journal of Pharmacovigilance, 2020, 17(12): 877-882.

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参考文献

[1] WHO.The Importance of Pharmacovigilance:safety monitoring of medicinal products[J/OL].(2002-01-01) [2019-04-05].http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf.
[2] Yang RY,Jia GS,Liang Y.Research on the implementation difficulties of China's MAH system under the background of the Chinese Drug Administration Law (2019)[J].China Food &Drug Administration Magazine(中国食品药品监管),2019,10(189):20-21.
[3] XU PH,LIU TY,GAN RF.New Ideas for the Development of Chinese Pharmaceutical Industry under the New Policy of Medicine[J].Chinese Journal of Pharmaceuticals(中国医药工业杂志),2018,49(11):1624-1628,1634.
[4] Bian BY,Chang F,Shao R.The EnlIghtment of FDA’s Drug Safety Risk Management Final Guidelines to Drug Safety Risk Management in China[J].Chinese Pharmaceutical Affairs(中国药事),2007(12):956-959,985.
[5] Dong D,Liu CL.The Revelation of Study on Drug Manufacture Post Marketing Surveillance System in the United States[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2013,10(8):456-459,463.
[6] ZHOU YA,HU XM.Comparative analysis of ADR reporting and monitoring systems between China and EU[J].China Pharmacist(中国药师),2012,15(12):1784-1787.
[7] Zhao JZ,Xie SM,Yang JB,et al.Comparison of drug post-marketing studies among the different agencies[J].Chinese Journal of New Drugs(中国新药杂志),2014,23(22):2589-2592.
[8] European Medicines Agency.Guidelines on good pharmacovigilance practices[J/OL].(2012-06-25)[2020-07-21].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32010R1235.
[9] European Medicines Agency.Guidelines on good pharmacovigilance practices[EB/OL].(2012-06-25) [2020-07-21].http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_ listing/documentlisting_ 000345.jsp.
[10] National Medical Products Administration.Drug Administration Law of the People's Republic of China[EB/OL].(2019-08-27)[2020-03-25].http://www.nmpa.gov.cn/WS04/CL2076/357712.html.
[11] National Medical Products Administration.Announcement of National Medical Products Administration on the direct reporting of adverse reactions by Marketing Authorization Holder (No.66 of2018)[EB/OL].(2018-09-30) [2020-03-25].http://www.nmpa.gov.cn/WS04/CL2093/331214.html.
[12] Cong LL,Bai YX,Li HY,et al.Comparison of pharmacovigilance information utilization in WHO,Europe,USA and China[J].Chinese Journal of New Drugs(中国新药杂志),2015,24(8):844-848,874.
[13] Hou YF,Song HB,Liu HL,et al.Practice and Discussion on Active Surveillance by China Hospital Pharmacovigilance System[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2019,16(4):212-214.
[14] FDA.Postmarketing Requirements and Commitments:Intro-duction [EB/OL].(2016-01-12) [2020-07-21].https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments.
[15] FDA.Guidance for industry good pharmacovigilance practices and pharmacoepidemiologic assessment [EB/OL].(2005-03-01) [2019-
04-22].https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm118777.html.
[16] FDA.Risk Evaluation and Mitigation Strategies [EB/OL].(2019-08-08) [2020-07-21].https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
[17] FDA.Risk Minimization Action Plans (RiskMAPs) for Approved Products [EB/OL].(2020-05-12)[2020-07-21].https://www.fda.gov/animal-veterinary/product-safety-information/risk-minimization-action-plans-riskmaps-approved-products.

欧美药物警戒政策研究及对我国的启示

Pharmacovigilance Laws in Europe and America and Their Implications for China

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