Today’s article will then introduce you to the medical laboratory knowledge about my country’s animal vaccine industry regulatory system, including new animal vaccine registration methods and animal vaccine production license system.

I. New animal vaccine registration method

The so-called new animal vaccines mainly refer to animal vaccines that are not on the market, including animal vaccines in medical laboratories. According to the regulations in the "Registration Classification and Registration Information Requirements for Animal Biological Products" (Announcement No. 442 of the Ministry of Agriculture), preventive animal biological products are divided into the following three categories:

Category 1: Products that are not on the market at home and abroad.

Category 2: Products that have been marketed abroad but have not been marketed in China.

Category 3: Products that have fundamentally changed the bacteria (virus, insect) strains, antigens, main raw materials or production processes used in products that have been marketed in China.

Article 9 of the "Regulations on the Administration of Animal Biological Products" also contains the content of the registration of new animal vaccines. In order to protect the legitimate rights and interests of enterprises, after the medical laboratory has completed the animal vaccine clinical trials, it can submit the product to the administrative department of biological products under the State Council. Samples and relevant materials for registration application.

After receiving the application for product registration from the pharmaceutical laboratory, the biological product administrative department of the State Council must send the acceptance materials to the review agency for review within 10 working days, and send the product samples to the designated inspection agency for review and inspection. It will be completed within 60 working days after receiving the application, and the registration certificate and quality standard will be issued to the qualified ones.

Regarding the registration of new animal vaccines, the Ministry of Agriculture Announcement No. 1899 of the People’s Republic of China stipulates that the monitoring period of new animal vaccines shall be calculated from the date of approval of production. The products during the monitoring period must be produced by registered companies. If the registered companies do not have relevant production conditions, The production of 1 other enterprise can be transferred.

II. Animal vaccine production license system

The animal vaccine production license must have 4 clear information, namely: production scope, production location, validity period, and the name and address of the legal representative of the enterprise. The validity period of this license is 5 years, and the enterprise can apply for renewal to the original issuing authority 6 months before the expiration of the validity period.

The next article will bring about animal vaccines (3) of medical laboratory knowledge. Please pay attention to it.