Today's article will bring about the content of the regulatory system of my country's animal vaccine industry in the knowledge of medical laboratories. Due to the limited space, I will introduce in detail in three articles.

I. National compulsory immunization system

Whether it is poultry and animal husbandry or pet industry, the country has implemented a compulsory immunization system. In addition, the "Animal Epidemic Prevention Law of the People's Republic of China" stipulates: "Practice a prevention-oriented approach to animal diseases, and implement compulsory immunization against animal diseases that seriously endanger livestock production and human health."

At present, in terms of animal vaccines in medical laboratories, the compulsory immunization system implemented by the country includes three types: highly pathogenic avian influenza, foot-and-mouth disease, and petit ruminant disease. In addition, the "Administrative Measures for the Operation and Management of Animal Biological Products" stipulates: "Biological products for national compulsory immunization shall be produced by enterprises designated by the Ministry of Agriculture, and government procurement shall be implemented in accordance with the law, and the relevant administrative departments of the provincial people's government shall organize and distribute them."

II. Standards for quality management of animal vaccine production

Pharmaceutical laboratories must comply with the "Animal Vaccine Production Quality Management Practice", which is also the "Animal Vaccine GMP". This specification is formulated in accordance with the "Regulations on Administration of Animal Vaccines" and is suitable for quality control of the entire process of animal vaccine production. This specification has been implemented since June 19, 2002 as a management system to ensure product quality.
From January 1, 2006, the state has enforced the "Animal Vaccine GMP". If the medical laboratory fails the acceptance, the relevant products will be confiscated. For manufacturing enterprises, they will be sealed up, all production activities will be stopped, all product approval numbers will be cancelled, and production licenses will be revoked.

From July 1, 2006, animal vaccines that have not passed the "Animal Vaccine GMP" cannot be operated or used nationwide. In addition, you must pass the "Animal Vaccine GMP" before you can apply for the "Animal Vaccine Production License" and product approval number.

III, veterinary drug management standards

Pharmaceutical laboratories must comply with the "Animal Vaccine Management Standards", that is, "Animal Vaccine GSP". Its main purpose is to provide relevant enterprises with a scientific quality management ideological system, so as to make fundamental changes in the business ideology and organizational structure of these enterprises. This specification will be enforced on March 1, 2010.

To be continued, please pay attention to the next two articles.