摘要
目的:介绍欧盟疫苗药物警戒制度实施过程中的重要措施,为完善我国疫苗安全监管体系,提升国家公共预防服务中疫苗警戒能力提供借鉴与参考。方法:通过文献分析法,搜集整理欧洲药品管理局官方公布的疫苗药物警戒相关政策文件,以及Web of Science和CNKI数据库中相关中英文文献,梳理欧盟在实施疫苗药物警戒制度中监管部门职责和警戒工作要点,探究可供我国完善落实疫苗药物警戒制度的借鉴经验。结果与结论:相较于普通药品而言,疫苗对人体的不良反应多与疫苗本身以及免疫接种过程相关,其监测更具挑战性。欧盟从顶层设计出发,针对疫苗特性制定了专门的药物警戒规范,在实践中形成了较为完善的疫苗安全监测体系。欧盟在疫苗警戒责任主体风险管控措施、信息收集与安全信号评估、信息公开和国际交流协作等方面进行了比较详尽的规定,对强化我国公共预防接种中疫苗警戒能力具有借鉴意义。
Objective:This paper introduced the important measures in the process of the implementation of the EU vaccine pharmacovigilance system,so as to provide reference for improving the vaccine safety supervision system in China and improving the vaccine vigilance ability in the national public prevention service.Method:Through literature analysis,we collected and sorted out the official vaccine pharmacovigilance policy documents published by the European Medicines Agency,as well as relevant Chinese and English literatures in Web of Science and CNKI databases,and sorted out the responsibilities of regulatory authorities and key points of vigilance in the implementation of the vaccine pharmacovigilance system in the EU,to explores the reference experience for perfect implementation of vaccine pharmacovigilance system in China.Results and Conclusions:Compared with ordinary drugs,the adverse reactions of vaccines to human body are mostly related to the vaccine itself and the immunization process,which is more challenging to monitor.Starting from the top-level design,the EU has formulated special pharmacovigilance specifications for the characteristics of vaccines,and has formed a relatively complete vaccine safety monitoring system in practice.The EU has made detailed regulations on risk control measures,information collection and safety signal assessment,information disclosure,and international exchanges and cooperation for the subject responsible for vaccine vigilance,which can be used as a reference for strengthening vaccine vigilance capacity in public vaccination in China.
作者
张梦瑶
赵晓佩
马美英
胡一琳
Zhang Mengyao;Zhao Xiaopei;Ma Meiying;Hu Yilin(Cancer Hospital Chinese Academy of Medical Sciences,Beijing 100021,China;College of Medical Humanities,Capital Medical University,Beijing 100069,China)
出处
《中国卫生法制》
2023年第6期56-60,65,共6页
China Health Law
基金
北京市社会科学基金规划项目“互联网医疗背景下电子处方法律规制问题研究”(19FXB005)。
关键词
欧盟
疫苗
药物警戒
European Union
Vaccine
Pharmacovigilance
