首页|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

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

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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.
Overview of FDA's Legal Marketing Channels for Veterinary Drugs and Analysis of Newly Approved Veterinary Drugs in the Recent Years
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.

US FDAveterinary drugslegal marketing channelsnewly approved veterinary drugsanalysis

孙雷、李丹、徐倩、王亦琳、叶妮、孙红洋、汪霞

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中国兽医药品监察所(农业农村部兽药评审中心),北京 100081

美国FDA 兽药 上市许可 新批准兽药 分析

2024

中国兽药杂志
中国兽医药品监察所

中国兽药杂志

CSTPCD
影响因子:0.49
ISSN:1002-1280
年,卷(期):2024.58(7)