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我国兽医诊断制品注册概况

Overview of veterinary diagnostic products registration in China

  • 摘要: 近年来,我国对动物疫病诊断和防治越来越重视,兽医诊断制品在动物疫病诊断和防治中发挥重要作用。我国《兽药管理条例》规定,将兽医诊断制品列入兽用生物制品管理。笔者首先阐述了我国兽医诊断制品管理概况,然后以国家兽药基础数据库为数据来源,从动物疫病病原种类、使用对象、研制单位3个方面分析我国兽医诊断制品类新兽药注册情况,整理了非洲猪瘟病毒诊断制品注册情况及进口兽医诊断制品国内再注册情况;最后预测了我国兽医诊断制品市场发展趋势。结果表明:我国兽医诊断制品新产品注册和生产质量管理体系健全;2010—2020年我国批准的兽医诊断制品类新兽药注册证书数量为70个,涉及36种动物疫病病原,其中猪用产品29项、反刍动物产品19项、宠物产品14项、禽用产品10项、马用产品1项,研制单位(第一单位)共25家;截至2021年7月底,我国有3项非洲猪瘟病毒诊断制品通过新兽药注册评审,获得农业农村部颁发的新兽药注册证书;有9项产品(8项荧光PCR检测法、1项等温扩增法)获得农业农村部颁发的兽药产品批准文号;目前获得兽医诊断制品类进口兽药注册证书的生产企业仅有两家,包括9项检测试剂产品。预测未来几年,我国兽医诊断制品需求量会持续增加,生产将步入生产质量管理规范(GMP)时代,在高通量检测技术领域将有所作为,第三方兽医检测机构将迅速发展。

     

    Abstract: In recent years, more and more attention has been paid to the diagnosis and prevention of animal epidemics in livestock and poultry production. Veterinary diagnostic products play a decisive role in the diagnosis and prevention of animal epidemics. According to the regulations on Administration of Veterinary Drugs in China, veterinary diagnostic products are included in the administration of veterinary biological products. The authors first described the general situation of the management of veterinary diagnostic products in China, and then used the national veterinary drug basic database as the data source to analyze the current status of new veterinary drugs registration of veterinary diagnostic products in China from the three aspects of animal disease pathogen types, users and research institutes. The registration status of diagnostic products related to African swine fever virus and the status of domestic re-registration of imported veterinary diagnostic products were summarized. Finally, the development trend of veterinary diagnostic products market in China was predicted. The results show that the new product registration and production quality management system of veterinary diagnostic products were sound in China. From 2010 to 2020, 70 veterinary diagnostic products for the new veterinary drug registration certificate were approved in China, involving 36 kinds of animal disease pathogens, 29 products for pigs, 19 products for ruminants, and 14 products for pets, 10 products for poultry and one product for horses. There are 25 research institutions(the first organization) in total. As at end of July 2021, three diagnostic products of African swine fever virus in China have passed the review of new veterinary drug registration and obtained the new veterinary drug registration certificate issued by the Ministry of Agriculture and Rural Affairs. Nine products(eight by fluorescence PCR and one by isothermal amplification) have obtained production license issued by the Ministry of Agriculture and Rural Affairs. At present, only two manufacturers have obtained the registration certificate of imported veterinary drugs for veterinary diagnostic products, including nine testing reagent products. It is predicted that in the next few years, the demand for veterinary diagnostic products in China will continue to increase, the production of veterinary diagnostic products will enter the era of good manufacturing practice(GMP), veterinary diagnostic products will make a difference in the field of high-throughput testing technology, and third-party veterinary testing institutions will develop rapidly.

     

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