摘要
药品定期安全性更新报告(PSUR)作为药物警戒的重要工具,是完善我国药品不良反应报告制度和加强药品上市后安全监管的有效手段,药品生产企业负责撰写PSUR。通过对我国药品生产企业在执行《药品定期安全性更新报告》中的责任和现状分析,探讨生产企业在执行PSUR面临的问题和挑战,对药品生产企业上报PSUR提出了建议。
The periodic safety update report （PSUR） as an important tool for pharmacovigilance is to improve our adverse drug reaction reporting system, meanwhile it is an important method for drug safety administration of post-marketing drugs. PSUR should be submitted by pharmaceutical enterprises at defined time point. This paper analyzed and evaluated the present situation of PSUR in our country together with responsibility and challenge of pharmaceutical enterprises to bring up corresponding suggestion.
出处
《中国药物警戒》
2014年第9期547-549,共3页
Chinese Journal of Pharmacovigilance
关键词
药品定期安全性更新报告
药物警戒
生产企业
建议
periodic safety update report
pharmacovigilance
pharmaceutical enterprise
suggestion
