《兽药比对试验要求》修订变化与意义  

Revision Purpose and Key Changes of the Requirement of Veterinary Drug Comparison Test

作　　者：陆连寿[1] 冯华兵 杨大伟[1] 梁先明[1] 苏富琴[1] 冯克清[1] 安洪泽[1] 杜雨 汪霞[1] 卢旺 LU Lian-shou;FENG Hua-bing;YANG Da-wei;LIANG Xian-ming;SU Fu-qin;FENG Ke-qing;AN Hong-ze;DU Yu;WANG Xia;LU Wang(China Institute of Veterinary Drug Control,Beijing 100081,China;Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs of the People's Republic of China,Beijing 100125,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 [2]中华人民共和国农业农村部畜牧兽医局,北京100125

出　　处：《中国兽药杂志》2024年第8期47-51,共5页Chinese Journal of Veterinary Drug

摘　　要：开展兽药比对试验是兽药产品批准文号管理的重要政策之一。为科学规范兽药比对试验目录产品的批准文号申请,农业农村部畜牧兽医局在2016年发布实施的《兽药比对试验要求》基础上,结合国内兽药比对研究现状,2024年修订发布了《兽药比对试验要求》。本文详细阐述了兽药比对试验要求的修订背景、主要变化和修订意义,旨在加强研发单位或相关临床试验机构对该项政策的理解,并对开展兽药比对试验提供指导和帮助。Veterinary Drug Comparison Test is one of the key policies for the management of the approval document number of veterinary drug products.In order to scientifically standardize the application for the approval document number of veterinary drug products,Animal Husbandry and Veterinary Bureau of the Ministry of Agriculture and Rural Affairs combined with the comparative research status of veterinary drugs in China on the basis of the pubilshed and implemented on the Requirement of Veterinary Drug Comparison Test in 2016,the Requirement of Veterinary Drug Comparison Test were revised and published in 2024.In this paper,the background,key changes and purpose for the revsion of Veterinary Drug Comparison Test were described,aiming to enhance the understanding of the policy by enterprises or relevant clinical trial institutions,and to provide guidance and help for the development of veterinary drug comparison test.

关 键 词：兽药 比对试验要求 主要变化 修订意义 

分 类 号：S859.79[农业科学—临床兽医学]