美国FDA兽药上市许可途径介绍及近年来新批准兽药情况分析
Overview of FDA's Legal Marketing Channels for Veterinary Drugs and Analysis of Newly Approved Veterinary Drugs in the Recent Years
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
介绍了美国FDA兽药上市许可途径,汇总了2018 年1 月至2024 年3 月美国FDA原始批准的新兽药申请(NADA)、简化新兽药申请(ANADA)和附条件批准(CA)三种类型的兽药品种,并从批准动物和批准用途等方面进行统计分析,希望能对我国新兽药研发和审评工作有一定的指导意义.
Abstract
This article overviews the veterinary drug marketing approval channels of US FDA.It summarizes the three types of veterinary drug varieties that were originally approved by the US FDA from January 2018 to March 2024,including NADA,ANADA and CA.Statistical 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 new veterinary drugs in China.
关键词
美国FDA/兽药/上市许可/新批准兽药/分析Key words
US FDA/veterinary drugs/legal marketing channels/newly approved veterinary drugs/analysis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