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

作　　者：高艳春[1] 宫爱艳[1] 秦玉明[1] 康孟佼[1] 冯克清[1] 

机构地区：[1]中国兽医药品监察所,北京100081

出　　处：《中国兽药杂志》2013年第10期50-52,共3页Chinese Journal of Veterinary Drug

摘　　要：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.

关 键 词：新兽药 监测期 兽药产品批准文号 

分 类 号：S851.66[农业科学—预防兽医学]