我国药品定期安全性更新报告的实施现状与展望

The Status and Prospective of PSUR in China

药品定期安全性更新报告(Periodic Safety Update Report,PSUR)是制药企业定期向药品监管部门汇总某一药品上市后某一时间段内全球安全性信息的一种报告形式。通过解读《药品不良反应报告和监测管理办法》中关于PSUR的相关法规,介绍我省现阶段开展药品定期安全性更新报告的工作现状,并分析所面临的问题,同时管窥全国药品定期安全性更新报告工作的现状和存在的问题,并针对问题提出了推进药品定期安全性更新报告工作的建议,为药品定期安全性更新报告工作的提升提供参考。

Periodic safety update report（PSUR） is a kind of report that pharmaceutical manufacturers regularly compilesecurity informations about a drug to the drug regulatorg departments.This paper explained the relative articles ofPSUR based on the regulation. The status of the implement ation on PSUR was introduced, and the problems wereanalysized in our province. These data are used to infer the situation throughout the country. Related recommenda-tions were proposed to promote the work on PSUR.