从我国获批兽医诊断制品谈兽医诊断制剂发展现状  

Development Status of Veterinary Diagnostic Preparations from Approved Veterinary Diagnostic Products in China

作　　者：王建中 颜航 张兆欣 严英夫 李晓光 李宏全[1] WANG Jianzhong;YAN Hang;ZHANG Zhaoxin;YAN Yingfu;LI Xiaoguang;LI Hongquan(Shanxi Key Laboratory for Modernization of TCVM,College of Veterinary Medicine,Shanxi Agricultural University,Taigu 030801,China;Sichuan Provincial Department of Agriculture and Rural Affairs,Chengdu 610041,China;Hangzhou Aijin Biotechnology Co.,Ltd.,Hangzhou 310018,China)

机构地区：[1]山西农业大学动物医学学院中兽医药现代化山西省重点实验室,山西太谷030801 [2]四川省农业农村厅,四川成都610041 [3]杭州爱谨生物科技有限公司,浙江杭州310018

出　　处：《中国兽医杂志》2024年第11期147-156,共10页Chinese Journal of Veterinary Medicine

基　　金：山西省中央引导地方科技发展资金项目(YDZJSX2021A034);山西省优秀博士来晋工作奖励(SXBYKY2021047);山西农业大学博士科研启动项目(2021BQ06)。

摘　　要：兽医诊断制品是兽用生物制品的组成部分,是科学开展动物疫病监测和诊断及动物免疫状态监测的重要保证,是依法防疫的物质基础,在动物疫病防控中发挥重要作用。近年来,我国出台一系列有利于兽医诊断制品行业健康发展的法律法规,农业农村部已经批准多项兽医诊断制品类新兽药注册证书。本文从国家兽药基础数据库中归纳并整理国内获批兽医诊断制品类新兽药注册证书相关数据,并对获新兽药注册证书的兽医诊断制品研发和应用特点以及我国兽医诊断制品发展中存在的问题进行探讨,旨在为主管部门、科研人员、临床兽医从事者和兽医诊断制品研发企业提供参考依据。Veterinary diagnostic products are essential components of veterinary biological products,serving as crucial guarantees for the scientific monitoring and diagnosis of animal diseases,as well as the surveillance of animal immune status.They form the material foundation for legally mandated epidemic prevention and play a significant role in the prevention and control of animal diseases.In recent years,China has enacted a series of laws and regulations conducive to the healthy development of the veterinary diagnostic product industry,with the Ministry of Agriculture and Rural Affairs approving many new veterinary diagnostic product registrations.This paper summarizes and collates relevant data on domestically approved veterinary diagnostic product registrations from the National Veterinary Drug Database,and discusses the characteristics of research,development,and application of veterinary diagnostic products that have obtained new veterinary drug registrations,as well as the existing issues in the development of veterinary diagnostic products in China.The aim is to provide reference for regulatory authorities,researchers,clinical veterinarians,and veterinary diagnostic product development enterprises.

关 键 词：兽医诊断制品 发展现状 注册数据 药品生产质量管理规范 

分 类 号：S854[农业科学—临床兽医学]