新兽药监测期规定引起我国兽药产品批准文号申报审查的新变化

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

介绍了农业部1899号公告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给兽药产品批准文号申报、审查带来的新变化,以期为兽药生产企业兽药的注册和申报产品批准文号提供参考。

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.