欧盟药品上市许可持有人的药物警戒责任研究

Research on Pharmacovigilance Responsibility of the Marketing Authorization Holder in EU

目的:简要介绍欧盟对药品上市许可持有人的药物警戒责任,为建立和完善我国药品上市许可持有人直接报告不良反应制度提供借鉴与参考。方法:通过查阅国内文献,欧盟药品管理局官方网站,欧盟药物警戒体系及药品上市许可持有人承担的药物警戒责任,并进行分析。结果:欧盟针对药品上市许可持有人的药物警戒责任做出了详细规定,包括药品不良反应报告责任、对药物警戒合格人员管理责任、负责实施质量体系、对分包的药物警戒任务的质量体系管理责任。结论:应进一步建立与完善我国药品上市许可持有人直接报告不良反应制度,提高药品不良反应监测水平。

Objective:This research will have a brief introduction on the pharmacovigilance responsibility of Marketing Authorization Holder(MAH)in EU and then provide references for the establishment and improvement of MAH′s direct reporting of adverse drug reactions in China.Methods:Through consulting domestic literature,EU official website,EU drug alert system to analyze the EU drug pharmacovigilance system and the pharmacovigilance responsibility of MAH.Results:EU has some very detailed regulations on the pharmacovigilance responsibilities of MAH,including the responsibility of reporting the adverse drug reaction,the responsibility of managing qualified pharmacovigilance personnel,the responsibility of implementing the quality system,and the responsibility of managing the subcontracted pharmacovigilance quality system.Conclusion:It is necessary that we should take further actions to establish and improve the system that allows the MAH in our country to report the ADR directly,and then hopefully these cations will improve the ability to monitor the ADR in our country.