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.