欧盟兽药上市许可途径介绍及EMA集中审评程序批准兽药情况分析  

Overview of EU Market Approval Channels for Veterinary Drugs and Analysis of the Approved Veterinary Drugs by Centralized Procedure Since the Establishment of EMA

作　　者：孙雷[1] 李丹[1] 徐倩[1] 王亦琳[1] 叶妮[1] 孙红洋 汪霞[1] SUN Lei;LI Dan;XU Qian;WANG Yi-lin;YE Ni;SUN Hong-yang;WANG Xia(China Institute of Veterinary Drug Control,Beijing 100081,China)

机构地区：[1]中国兽医药品监察所(农业农村部兽药评审中心),北京100081

出　　处：《中国兽药杂志》2024年第8期36-46,共11页Chinese Journal of Veterinary Drug

摘　　要：本文介绍了欧盟兽药上市许可途径,汇总了EMA(含EMEA)成立以来由集中审评程序(CP)批准的兽药情况,并从批准动物和批准用途等方面进行统计分析,希望能对我国的兽药研发和审评工作有一定指导意义。This article overviews the veterinary drug marketing approval channels of EU.It has summarized the approved veterinary drugs by centralized procedure(CP)since the establishment of EMA(EMEA).Analysis is conducted from the aspects of approved animal species and approved indication types,hoping to provide some guidance for the research and approval of the veterinary drugs in China.

关 键 词：欧盟 EMA 兽药 上市许可 集中审评程序 批准 

分 类 号：S859.79[农业科学—临床兽医学]