欧盟药物警戒数据库访问政策及启示

Inspiration from EudraVigilance Access Policy for Medicines for Human Use

本文介绍了欧盟药物警戒数据库访问政策主要内容,重点介绍了该数据库不同访问者即各成员国药监局、医务人员、社会公众、上市许可持有者和科研机构的不同权限,分析了欧盟药物警戒数据库访问政策对我国现有工作的启示和借鉴意义。

This article reviews EudraVigilance Access Policy for Medicines for Human Use. The stakeholder groups granted access to EudraVigilance data can be summarized as follows： medicines regulatory authorities, the european Commission and the Agency, healthcare professionals and the general public, marketing authorisation holders and sponsors of clinical trials and research organizations. They have been granted different access authorization. The article analyses inspiration from EudraVigilance Access Policy.