CAJ | 학술논문

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。
약품정기안전성경신보고（Periodic Safety Update Report，PSUR）시제약기업정기향약품감관부문회총모일약품상시후모일시간단내전구안전성신식적일충보고형식。통과해독《약품불량반응보고화감측관리판법》중관우PSUR 적상관법규，개소아성현계단개전약품정기안전성경신보고적공작현상，병분석소면림적문제，동시관규전국약품정기안전성경신보고공작적현상화존재적문제，병침대문제제출료추진약품정기안전성경신보고공작적건의，위약품정기안전성경신보고공작적제승제공삼고。
Periodic safety update report(PSUR) is a kind of report that pharmaceutical manufacturers regularly compile security informations about a drug to the drug regulatorg departments.This paper explained the relative articles of PSUR based on the regulation. The status of the implement ation on PSUR was introduced, and the problems were analysized 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.