Pharmacovigilance Laws in Europe and America and Their Implications for China

doi:10.19803/j.1672-8629.2020.12.06

Abstract

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

CLC Number:

R951

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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References

[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.