英国药物警戒检查简介及启示

Overview of Pharmacovigilance Inspection in UK

为促进药品安全第一责任人即药品生产企业上市后监测责任的落实,英国于2003年启动了药物警戒检查项目,目前已经形成了一套完整的检查体系。通过对英国药物警戒检查类型、检查流程、检查结果等内容介绍,提出了对我国生产企业药品不良反应报告和监测的检查分工、检查指南、自我检查指标体系以及信息沟通方面的思考和建议。

To promote pharmaceutical manufacturer, the first person for products safety to undertake post-marketing surveillance responsibility,UK initiated pharmacovigilance inspection programme in 2003, and now it formed a set of complete inspection system.This article introduced pharmacovigilance inspection type, process, findings and so on in UK, and proposed recommendation on adverse drug reaction report and monitoring inspection responsiblity division, guideline, self-checking indicatior system and information communication.