关于药品定期安全性更新报告审核的一点思考  

Thoughts on the Assessment of Drug Periodic Safety Update Report

作　　者：刘肃 刘颍 朱飞跃 LIU Su;LIU Ying;ZHU Feiyue(Guangzhou Center for ADR Monitoring,Guangzhou Guangdong 510160,China;Center for ADR Monitoring of Guangdong,Guangzhou Guangdong 510080,China)

机构地区：[1]广州市药品不良反应监测中心,广东广州510160 [2]广东省药品不良反应监测中心,广东广州510080

出　　处：《药品评价》2024年第10期1174-1177,共4页Drug Evaluation

基　　金：广东省药品监督管理局科技创新团队项目(2023TDB17)。

摘　　要：药品定期安全性更新报告(PSUR)制度是药品许可报告单位定期向药品监管部门汇总生产品种在报告期内安全性信息的情况,是开展药品上市后安全性监测和再评价的重要制度。通过对广州市近年来在平台系统中收到的PSUR进行汇总和分析,结合当前辖区内报告的实际情况,探讨更加完善的审核机制,尤其是针对不同风险品种的技术审核举措,督促报告单位完善PSUR的撰写和提交,提升监管效能,同时也促进我市药品许可持有人(MAH)获得更大的获益-风险比。The Drug Periodic Safety Update Report(PSUR)is a summary of the safety information of the produced varieties regularly to the drug regulatory authorities during the reporting period,and is an important system for the post-marketing safety monitoring and re-evaluation of drugs.Through statistics and analysis of PSUR received in the platform system in Guangzhou in recent years,combined with the actual situation of reports in the current jurisdiction,a more perfect audit mechanism was discussed,especially the technical assessment measures for different risk varieties,urging holders to complete the writing and submission of PSUR,improving drug administration effectiveness while also promoting a greater benefit-risk ratio for MAH in our city.

关 键 词：药品定期安全性更新报告 技术审核 药品监管 药品许可持有人 获益-风险比 

分 类 号：F83[经济管理—金融学]