国内外血液制品药物警戒体系的比较与分析  

Comparison and Analysis of Domestic and Foreign Pharmacovigilance Systems of Blood Products

作　　者：林兆媛 旺茂才吉 宋英杰 李霞[4] 许莉莉 宋申猛[1,2] 李连 王凤山[1,2] 臧恒昌 Lin Zhaoyuan;Wangmao Caiji;Song Yingjie;Li Xia;Xu Lili;Song Shenmeng;Li Lian;Wang Fengshan;Zang Hengchang(School of Pharmacy Sciences,Shandong University,Jinan 250012,China;Institute of Regulatory Science for Medical Products,Shandong University,Jinan 250012,China;NMPA Key Laboratory for Technology Research and Evaluation of Drug Products,Jinan 250012,China;Shandong Provincial Center for ADR Monitoring,Jinan 250012,China)

机构地区：[1]山东大学药学院,济南250012 [2]山东大学药品监管科学研究院,济南250012 [3]国家药品监督管理局药物制剂技术研究与评价重点实验室,济南250012 [4]山东省药品不良反应监测中心,济南250012

出　　处：《中国药事》2025年第2期139-148,共10页Chinese Pharmaceutical Affairs

基　　金：中国药品监督管理研究会研究课题项目(编号2024-Y-Y-020)。

摘　　要：目的:分析国内外血液制品药物警戒体系,为完善我国血液制品药物警戒体系提供参考。方法:查阅有关国外血液制品药物警戒体系的文献和其他公开资料,梳理其组织构架、法规指南、自发报告与主动监测系统等方面的现状,并与我国血液制品药物警戒体系进行比较分析。结果与结论:当前,我国相继出台一系列法律法规对血液制品实行严格监管,已经建成国家、省、市、县四级不良反应监测体系和“一体两翼”的监测格局。但与美国、欧盟、加拿大和WHO的药物警戒体系相比,我国在血液制品药物警戒法规体系、组织体系和技术体系方面仍有较大进步空间,例如国家层面还未针对血液制品或生物制品出台专门的药物警戒规范指南,药物警戒涉及的药品上市前审批、审核查验等职能部门、卫生健康主管部门相互之间尚未建立有效的沟通协调机制,尚未开展血液制品相关的主动监测、真实世界研究等工作。我国应进一步建立健全血液制品药物警戒法规体系,完善血液制品药物警戒体系顶层设计;加强血液制品主动监测,建设血液制品不良反应监测平台;营造良好的药物警戒社会氛围,指导血液制品上市许可持有人承担药物警戒主体责任。Objective:To analyze the domestic and foreign pharmacovigilance systems of blood products and provide a reference for the construction of the pharmacovigilance systems of blood products in China.Methods:Literatures and other publicly available information on the pharmacovigilance systems of blood products were reviewed,the current status of the organization framework,regulatory guidelines,voluntary reporting systems and active monitoring systems was straightened out,and the comparison and analysis with those in our country were conducted.Results and Conclusion:Currently,a series of laws and regulations have been successively promulgated in China to impose strict supervision on blood products,and a fourlevel adverse reaction monitoring system at the national,provincial,municipal and county levels,as well as a monitoring pattern of“one body with two wings”,has been established.Compared with the pharmacovigilance systems for blood products in the United States,the European Union,Canada and WHO,there is still much room for improvement in the regulatory system,organizational system and technical system for the pharmacovigilance of blood products in China.For example,there are no specific pharmacovigilance guidelines for blood products or biologics at the national level.An effective communication and coordination mechanism have not been established between functional departments such as pre-market approval,review and inspection of drugs involved in drug surveillance,as well as health regulatory authorities.Active monitoring and realworld research related to blood products have not been performed.China should establish and improve the regulatory systems for the pharmacovigilance system of blood products,and improve the top-level design of the pharmacovigilance system;strengthen the active monitoring of blood products and build the monitoring platform for adverse reactions of blood products;create a good social environment for pharmacovigilance,and guide the Marketing Authorization Holder of blood products to assume

关 键 词：血液制品 药物警戒 比较 国内国外 

分 类 号：R95[医药卫生—药学]