The first category: products created by China; Products only reported in foreign literature but not approved for production.
The second category: products that have been approved for production abroad but not yet produced in China.
The third category: products that have fundamentally improved the strains (viruses, insects) and production processes used in approved biological products in China. Article 5 The naming of new products shall conform to the Naming Principles for Biological Products (see Annex I). Chapter III Requirements for New Product Development Article 6 A new product shall go through laboratory test, field test, intermediate test, regional test and other research processes to obtain complete data and put forward the draft manufacturing and inspection regulations (see Annex 5 for test data requirements). Article 7 Laboratory tests shall include the reproduction and identification of bacteria (viruses and insects), toxicity, antigenicity, immunogenicity, stability, specificity, production technology, safety, effectiveness (experimental animals and animals to be used), immunization period and shelf life of products, etc. Article 8 In the field test, animals are tested with 3-5 batches of new products produced in the laboratory under production conditions to observe their safety and effectiveness. Article 9 The intermediate trial production shall be based on the laboratory production process, and the trial production of 5- 10 batches (not less than 3 batches of diagnostic preparations) shall be carried out in a biopharmaceutical factory with certain conditions or a pilot workshop recognized by the Ministry of Agriculture, and the production process shall be finally determined.
Diagnostic preparations with small batch and complicated process can be trial-produced in qualified laboratories, and the batch number is the same as above. Tenth regional trials should use more than three batches of intermediate trial-produced products for large-scale animal experiments of different varieties to further observe the safety and effectiveness of products. Eleventh field experiments must be approved by the county animal husbandry (agriculture and animal husbandry) bureau where the experiment is located; The regional test must be approved by the animal husbandry (agriculture and animal husbandry) department (bureau) of the province, autonomous region and municipality directly under the central government where the test is located. The research unit shall be responsible for the adverse consequences caused by the product quality in the test. Chapter IV Procedures for the Examination and Approval of New Products Article 12 After the intermediate trial production and regional tests of new products prove that the production process is perfect, the safety and effectiveness are good, the research and development unit may propose a draft regulation for the production and inspection of new products (see Annex III or Annex IV for the format) and submit it to the Ministry of Agriculture together with relevant technical data (see Annex II). Article 13 The Ministry of Agriculture shall pre-examine the application materials. In line with the requirements of pre-trial, notify the applicant.
The Ministry of Agriculture shall make a decision on whether to accept the application within one month after receiving the application materials. Article 14 The Ministry of Agriculture shall organize relevant experts to conduct a preliminary examination of the application materials that have passed the preliminary examination. The Ministry of Agriculture shall put forward preliminary examination opinions within three months after receiving all the application materials. Fifteenth Veterinary Drug Review Committee shall review the application materials that have passed the preliminary examination, and if they meet the requirements, put forward technical review opinions and draft regulations and send them to the Ministry of Agriculture. When necessary, the reporting unit will send the samples to China Veterinary Drug Control Institute for quality review and inspection.
The Ministry of Agriculture shall make a decision on whether to approve or not within three months after receiving the technical review opinions of the Veterinary Drug Review Committee. Article 16 The Ministry of Agriculture examines and approves new products, issues product quality standards, and issues new veterinary drug certificates to research units. Only holders of new veterinary drug certificates can declare official scientific research results or transfer technology. Article 17 After the new product quality standard is approved and issued by the Ministry of Agriculture, the original R&D unit shall be responsible for the identification, storage and supply of strains (viruses and insects) for production inspection during the production protection period, and the identification results shall be reported to the China Veterinary Drug Monitoring Institute for the record; After the expiration of the production protection period, the original research unit shall be handed over to the China Veterinary Drug Monitoring Institute or the relevant units entrusted by the Ministry of Agriculture for identification, storage and supply. Eighteenth more than two research units to declare the same product with similar production technology and quality standards, three months before the review meeting of the Veterinary Drug Review Committee, but only one product quality standard is formulated. Chapter V Production of New Products Article 19 After the promulgation of quality standards for new products, a production entity applying for the production of new products must submit a document approved by the Ministry of Agriculture for the production of biological products, a copy of a veterinary drug production license, a copy of a new veterinary drug certificate, a contract for technology transfer or a document approved by the original R&D unit, and issue a trial production approval number after approval by the Ministry of Agriculture. Article 20 The trial production period of new products is five years for Category I, three years for Category II and two years for Category III. Article 21 During the trial production, the production unit shall, together with the original research and development unit, continue to evaluate the product quality and improve the quality standard. China Veterinary Drug Control Institute shall conduct sampling inspection, and if it finds serious reactions or inaccurate results, it shall report to the Ministry of Agriculture and may order it to stop production and use. Twenty-second six months before the expiration of the trial production of new products, the production unit and the original research and development unit will report the production and use of summary materials and their conversion to formal production to the Ministry of Agriculture. If it is re-evaluated by the Veterinary Drug Review Committee and recommended to be included in the regulations, it will be issued a formal production approval number after approval by the Ministry of Agriculture. If it is not reported within the time limit, the original approval number shall be cancelled.