欧盟药物警戒数据库建设对我国的启示

Inspiration from EU Endra Vigilance

目的对欧盟药物警戒数据库(Eudra Vigilance)的法律框架、工作机制以及各利益相关方职责和访问权限进行介绍,为完善我国药物警戒数据库提供借鉴。方法采用文献分析法和比较研究法,在了解欧盟Eudra Vigilance数据库的基础上,审视我国药品不良反应监测系统的不足。结果欧盟药物警戒数据库对各利益相关方的职责和权限有明确的法规要求、数据库功能完善,实现欧盟药品安全信息的收集、管理及分析。结论借鉴欧盟经验,我国不良反应监测系统在立法、访问权限、数据范围以及信息利用等方面进行加强。

Objective To intruduce the legal framework, working mechanism, responsibilities and access rights of various stakeholders of Eudra Vigilance, provide reference for pharmacovigilance database system in China. Methods Using literature analysis and comparative research methods, on the basis of understanding the Eudra Vigilance, examining the inadequacy of China＇s ADR System. Results Eudra Vigilance has clear statutory requirements for the responsibilities and authorities of various stakeholders, the function is perfect to realize the collection, management and analysis of EU drug safety information. Conclusion The adverse reaction monitoring system in China still needs to be strengthened in terms of legislation, access rights, data scope and information utilization.