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

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7期66-74,共9页Chinese Journal of Veterinary Drug

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)和有条件批准(CA)三种类型的兽药品种,并从批准动物种类和批准用途种类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。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 

分 类 号：S859.79[农业科学—临床兽医学]