摘要
药物警戒对于确保兽药在临床应用中持久的安全性和有效性具有十分重要的意义.虽然我国有兽药不良反应监测法规层面的条款,但没有制定具体的实施细则和分析、评价、指南报告等具体操作层面的指导文件.本文通过解读VICH药物警戒指导原则:GL24不良反应报告的管理、GL29定期汇总更新报告的管理、GL42提交不良反应报告的数据元素(AERS),以期为我国兽药产品不良反应报告提供借鉴,并为加强我国兽药产品警戒法规和监测体系建设提供参考.
Abstract
Pharmacovigilance plays a crucial role in ensuring the long-term safety and efficacy of veterinary drugs in clinical settings.Although China has regulatory provisions for monitoring veterinary adverse drug reactions,there is a lack of specific operational-level implementation rules and guidance documents for activities such as analysis,evaluation,and guidance reports.In this paper,by interpreting the VICH guiding principles of pharmacovigilance:GL24 adverse reaction report management,GL29 regular summary update report management,GL42 to submit adverse reaction report data elements(AERS),in order to provide reference for the adverse reaction report of veterinary drug products,and to strengthen China's veterinary drug product vigilance regulations and monitoring system construction to provide reference.
维普
万方数据