摘要
药品定期安全性更新报告(Periodic Safety Update Report,PSUR)是药品上市许可持有人落实药品安全主体责任和开展药物警戒的重要内容。近年来,国家对药物警戒工作重视程度不断提高,药品上市许可持有人对PSUR工作认知和落实显著增强。本文就我省药品上市许可持有人PSUR撰写常见问题进行分析,旨在提高药品上市许可持有人PSUR撰写能力。
The periodic safety update report( PSUR) is an important content for MAH( Marketing Authorization Holder) to implement the responsibility of drug safety subjects and to carry out pharmacovigilance. In recent years,the state has paid more attention to pharmacovigilance work,and the recognition and implementation of PSUR work have been significantly enhanced by MAH. This paper analyzes the common problems of PSUR writing for MAH in our province,aiming to improve the writing ability of PSUR.
作者
赵世丹
徐霜
刘悦
刘翠丽
Zhao Shidan(Heilongjiang drug evaluation and risk monitoring center,Harbin Heilongjiang 150076)
出处
《黑龙江医药》
CAS
2021年第4期818-820,共3页
Heilongjiang Medicine journal
