新兽药监测期规定对我国兽药产品批准文号申报审查的新变化

本文介绍了农业部关于新兽药监测期的新规定,从新兽药监测期计算方法、监测期内生产企业数量、监测期内不良反应报告和监测期新规定的适用范围等四方面阐述了新兽药监测期规定对兽药产品批准文号申报、审查带来的新变化,希望能为兽药产品批准文号申报、审查工作提供参考。

Effects of New Regulation Related to Veterinary Drug Monitoring Period in the Application and Administration of Veterinary Drug Products License

This paper introduces the updates of the regulations for new veterinary drug monitoring period announced by Ministry of Agriculture. And interprets the new situation of application and administration of veterinary drug products license(VDPL) in terms of following 4 aspects- calculation method of new veterinary drug monitoring period, applicant qualification for VDPL according to new veterinary drug, adverse reaction report during monitoring period, and application range of the new regulations. Herein, we hope this will bring some useful reference on the application and administration of VDPL.