国内外药品上市后安全性监管体系及监管要求比较

Comparison on Regulatory System and Requirements for Drug Post-authorization Safety Monitoring among Different Authorities

药品上市后安全性研究是上市后安全性监管的重要关键环节之一。本文由我国及其他发达国家或国际组织在药物警戒相关国际组织参与程度引入,宏观比较各国药品上市后安全性监管体系和监管部门层级关系,微观梳理药品上市后安全性研究的开展流程、申报审批、信息管理等方面监管要求。总结上市后安全性研究的监管要点及具体要求,为我国完善药品上市后安全性监管体系、细化监管要求提供可靠依据。

Post-authorization safety study(PASS)plays a key role in fulfilling drug monitoring process in the according stage.This review firstly introduced participations in international pharmacovigilance organizations by different authorities,then compared their regulatory and hierarchy systems for drug post-authorization safety monitoring.Through clarifying PASS process,fundamental requirements for PASS approval and PASS information,reliable reference would be proposed to modify the regulatory systems and requirements for drug post-authorization monitoring.