欧盟药物警戒数据库功能升级与思考  

Upgrade of Eudra Vigilance in the EU and Its Considerations

作　　者：王涛[1] 王丹[1] 范燕[1] 董铎[1] WANG Tao;WANG Dan;FAN Yan;DONG Duo(Center For Drug Reevaluation,CFDA,Beijing 100022,China)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100022

出　　处：《中国药物警戒》2018年第7期411-413,418,共4页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项项目(2017ZX09101001-001-003):药品再评价政策法规及实施策略研究

摘　　要：目的对欧盟药物警戒数据库主要功能及其升级情况进行介绍,为促进我国现有不良反应监测工作发展提供思考和借鉴。方法采用文献分析法,围绕欧盟药物警戒数据库(Eudra Vigilance)的2017年年度报告内容,介绍了目前该数据库的主要功能及其升级情况。结果欧盟药物警戒数据库对通过审查的新功能、内置的药品信息词典及医学文献监测等内容进行了升级和强化。结论借鉴欧盟药物警戒数据库功能升级经验,我国药品不良反应监测系统在数据格式的国际化、扩大数据共享范围及完善药品信息数据库等方面可进一步加强。Objective To introduce the main and upgraded features of EudraVigilance,so as to provide consideration and reference for the development of our national ADR monitoring in China.Methods Based on 2017 Annual Report on EudraVigilance for the European Parliament,the council and the commission,the new and enhanced functionalities of this database were analyzed.Results The enhanced functionalities of this database were mainly focused on functionalities subject to audit,the dictionary for medicinal product information and medical literature monitoring,etc.Conclusion The adverse reaction monitoring system in China still needs to be strengthened in internationalization of data formats,expansion of data sharing and improvement of drug information database.

关 键 词：人用药品 数据库 功能 药物警戒 

分 类 号：R95[医药卫生—药学]