摘要
欧盟的药物警戒信息监管体系对欧洲的药物监管和不良反应监测方面发挥了重要的作用。本文介绍了欧盟药物警戒体系的主要机构,欧盟药物警戒信息体系的组成,包括不良反应报告体系、上市后研究、风险管理策略等。目的是为我国的不良反应监测体系和药物警戒的发展提供借鉴和启示。
EU pharmacovigilance information monitoring system plays an important role in drug supervision and adverse reaction monitoring in Europe. This paper presented the major agencies and the components of EU pharmacovigilance system, including adverse reaction reporting system, post-marketing study, risk management strategy etc. The objective is for reference and inspiration for the adverse reaction monitoring system and the development of pharmacovigilance in our country.
出处
《中国执业药师》
CAS
2011年第2期30-33,共4页
China Licensed Pharmacist
关键词
药物警戒信息
欧盟
不良反应监测
Pharmacovigilance Information
EU
Adverse Reaction Monitoring
