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

关键词:  欧盟  EMA  兽药  上市许可  集中审评程序

Key words:  EU  EMA  veterinary drug  market approval  centralized procedure  approval

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。

Abstract:

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.