中国药物评价2018，Vol.35Issue(6)：475-480,6.
药品上市后主动监测方法探析
Analysis on the Methods of Active Drugs Monitoring
摘要
Abstract
In order to ensure the safety of the public's medication, developed countries such as Europe and the United States have established a relatively complete post-marketing safety monitoring system.In particular, active monitoring after listing not only makes up for the shortcomings of traditional spontaneous reporting, but also provides a basis for subsequent pharmacovigilance activities.Therefore, this paper is concerned with active monitoring in ICH-E2E, EU GVP Guidelines, US Pharmacovigilance Practices and Epidemiological Guidelines, Post-marketing Research and Clinical Trials-<FFDCA>505 (o) (3). The method is combed and analyzed to provide reference for the construction of active drug monitoring methods in China.关键词
被动监测/主动监测/药物警戒Key words
Passive monitoring/Active monitoring/Pharmacovigilance分类
医药卫生引用本文复制引用
平晓秋,吕静,徐威,王琳琳,李晨硕,杨悦..药品上市后主动监测方法探析[J].中国药物评价,2018,35(6):475-480,6.基金项目
丹东市药品不良反应监测中心课题(项目编号:DDCGDY2018001) （项目编号:DDCGDY2018001）
