兽药产品批准文号管理新要求及常见问题解析  

Analysis of Changes in Regulations and Common Problems in the Management of Veterinary Drug Production Approval

作　　者：安洪泽[1] 冯克清[1] 陈莎莎[1] 吴涛[1] GONG Ai-yan AN Hong-ze;FENG Ke-qing;CHEN Sha-sha;GONG Ai-yan;WU Tao(China Institute of Veterinary Drug Control,Beijing,100081,China)

机构地区：[1]中国兽医药品监察所,北京100000

出　　处：《中国兽药杂志》2023年第10期73-78,共6页Chinese Journal of Veterinary Drug

摘　　要：介绍了近年来文号管理相关制度和技术标准的主要变化,对文号审查中新兽药监测期、比对试验目录产品技术评审标准、特殊产品生产线要求等问题进行了解析。整理汇总了受新制度和技术标准影响的兽药品种,以期为兽药生产企业申请兽药产品批准文号提供参考。This article summarized the main changes of regulations and technical standards related to veterinary drug production approval in recent years.The critical issues have been analyzed in review of veterinary drug production approval,such as monitoring period of new veterinary drugs,evaluation standard for generic drug consistency evaluation and requirement for special production lines.This article summarized the veterinary drug varieties affected by the new regulations and technical standards,aimed to provide references for veterinary pharmaceutical enterprises to apply for veterinary drug.

关 键 词：兽药产品批准文号 监测期 生产线 审查 

分 类 号：S851.66[农业科学—预防兽医学]