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
孙雷 1李丹 1徐倩 1王亦琳 1叶妮 1孙红洋 1汪霞1
作者信息
- 1. 中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
- 折叠
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.
关键词
欧盟/EMA/兽药/上市许可/集中审评程序/批准Key words
EU/EMA/veterinary drug/market approval/centralized procedure/approval引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据