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

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

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药物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。

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 drug species, hoping to provide some guidance for the research and approval of the new veterinary drugs in China.