I believe that through the first two issues, everyone has a preliminary understanding of the content of the regulatory system of my country's animal vaccine industry in the medical laboratory. In this issue, I will continue to introduce you to this aspect.

1. Administrative Measures for Animal Vaccine Product Approval Numbers

According to the regulations in the Regulations on Administration of Animal Vaccines, companies or medical laboratories must obtain a product approval number to produce animal vaccines, otherwise they will not be recognized by laws and regulations and are considered prohibited products. Note that the validity period of this document number is 5 years.

The approval document number mentioned above mainly refers to the animal vaccine approval document number, which is the animal vaccine production approval certificate issued by the Ministry of Agriculture according to relevant national standards, production technology and production conditions to enterprises or medical laboratories that meet these requirements file. At present, the Ministry of Agriculture is responsible for the issuance, supervision and management of the national animal vaccine product approval number.

2. Inspection and acceptance system of animal vaccine production quality management standards

The production of animal vaccines must comply with this inspection and acceptance system, otherwise the production is not allowed. The core of the system is the "Measures for Inspection and Acceptance of Animal Vaccine Production Quality Management Practices", which came into effect on May 25, 2015.

This system has two provisions for the Ministry of Agriculture. The first is to formulate animal vaccine GMP and its inspection and acceptance evaluation standards, and the second is responsible for the guidance and supervision of the national animal vaccine GMP inspection and acceptance work. The specific work is handled by the relevant departments of the Ministry of Agriculture. They assign the work to the relevant departments of the provincial people's governments, and these departments are responsible for the work within their jurisdiction.

3. New animal vaccine development and management measures

The New Animal Vaccine Development and Management Measures came into effect on November 1, 2005, and their role is to standardize the development of animal vaccines and ensure the safety and quality of products. Enterprises or medical laboratories conducting research on new animal vaccines must comply with this management method.

The Ministry of Agriculture is responsible for this work. The relevant departments of the provincial people’s governments are responsible for the approval of other new animal vaccine clinical trials, and the relevant departments of the local people’s governments at or above the county level are responsible for the supervision and management of the development of new animal vaccines in their jurisdictions. .

4. Animal vaccine management and supervision system

For relevant enterprises or medical laboratories, the management of animal vaccines must have the corresponding technical personnel, business premises, storage equipment and quality management agencies, and obtain the business license issued by the people's government at or above the county level. The development of animal vaccines requires business licenses issued by the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.

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