目的：通过对欧美药物警戒和风险管理体系的研究分析，结合目前我国新药临床试验药物警戒发展现状，为临床试验期间药物警戒科学监管及申办者药物警戒体系建设提供参考，以切实保护临床试验受试者的安全和权益。方法：对欧美及我国临床试验期间药物警戒监管进行了研究，为提高我国临床试验期间药物警戒的监管要求和申办者建立药物警戒体系提供参考建议。结果与结论：欧美药物警戒起步较早，发展已相对成熟。我国近两年通过逐步完善法规，不断推动我国临床试验期间药物警戒科学监管发展及申办者药物警戒体系的建立健全，以保护临床试验受试者的安全和权益。
Based on the research and analysis of pharmacovigilance and risk management systems in Europe and America, references for scientifi c supervision of pharmacovigilance and the construction of sponsors' pharmacovigilance system during clinical trial were provided by combining with the current development of pharmacovigilance in clinical trials of new drugs in China, so as to effectively protect the safety and rights of trial subjects. Methods: The pharmacovigilance supervision during clinical trials in Europe, America andChina was studied, and the study provides references and suggestions for improving regulatory requirements of pharmacovigilance and establishing pharmacovigilance system for sponsors during clinical trial in China. Results and Conclusion: Pharmacovigilance in EU and US started early and is relatively mature. In order to protect the safety, rights and interests of clinical trial subjects, China has continuously promoted the development of scientifi c supervision of pharmacovigilance during clinical trials and the establishment and improvement of sponsors' pharmacovigilance system through the gradual improvement of regulations in recent two years.
[1] 中共中央办公厅,国务院办公厅.关于深化审评审批制度改革鼓励药品医疗器械创新的意见[EB/OL].(2017-10-08)[2021-10-20].http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm.
[2] 国家药品监督管理局.国家药品监督管理局关于调整药物临床试验审评审批程序的公告(2018 年第50号)[EB/OL].(2018-07-24)[2021-10-20].https://www.cfdi.org.cn/resource/news/10628.html.
[3] 全国人民代表大会常务委员会.中华人民共和国药品管理法[EB/OL].(2019-08-26)[2021-10-20].http://www.gov.cn/xinwen/2019-08/26/content_5424780.htm.
[4] Congress of the United States.The Food,Drug,and Cosmetic Act(FD&C Act)[EB/OL].(2018-03-29)[2021-10-20].https://www.fda.gov/regulatory-information/lawsenforced-fda/federal-food-drug-and-cosmetic-act-fdcact.
[5] U.S.Food & Drug Administration.Code of Federal Regulations 21[EB/OL].(2021-04-07)[2021-10-20].https://www.ecfr.gov/cgi-bin/text-idx?gp=&SID=0478e bf4 c00b3db656724600c353952d&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl.
[6] European Medicines Agency.How the Committees Work [EB/OL].[2021-10-20].https://www.ema.europa.eu/en/committees/how-committees-work.
[7] EMA.Regulation(EU)No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use,and Repealing Directive 2001/20/EC Text with EEA Elevance[EB/OL].[2021-11-10].https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536.
[8] EMA.Regulation(EC)No 726/2004 of the European Parliament and of the Council of 31 March 2004,Laying down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency-Chapter 3 Pharmacovigilance[EB/OL].[2021-11-10].https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf.
