Eight kinds of biological products will be stricter next year

　　It was learned from the State Food and Drug Administration that from January 1 next year, China will have human albumin, recombinant hepatitis B vaccine, live attenuated measles vaccine, BCG, oral polio attenuated vaccine, and pertussis. Eight kinds of biological products such as diphtheria and tetanus combined vaccines began to implement the batch issuance system. According to relevant sources, this is an important step for China's biological product management standards to be integrated into the international arena.

The batching of biological products refers to the state's system for compulsory inspection and audit of vaccine products, blood products, in vitro biodiagnostic reagents for blood source screening, and other biological products as specified, each batch of products being listed or imported. If the inspection fails or the approval is not approved, it may not be listed or imported. According to experts, the current management method is mainly used in the world, and China is now using a batch inspection system.

　　It is reported that four in vitro biodiagnostic reagents for blood source screening: hepatitis B surface antigen, HIV antibody, HCV antibody and syphilis antibody detection reagent, and ABO blood type styling reagent are still in batch approval mode.

On October 21, 2004, the State Food and Drug Administration issued the “Notice on Issues Related to the Issuance of Biological Products” (Guo Food and Drug Administration [2004] No. 509), on issues related to the issuance of biological products. The following notice was issued: The State Food and Drug Administration authorized the China National Institute for the Control of Pharmaceutical and Biological Products and the provincial and municipal drug testing institutes in Beijing, Jilin, Shanghai, Hubei, Guangdong, Sichuan, Gansu and other provinces to undertake the issuance of biological products. The State Food and Drug Administration authorizes the person to issue the certificate for the issuance of the biological product batch approval certificate for the above-mentioned drug inspection agency that is responsible for the issuance of biological products. According to the batch record review, laboratory test or review result, the State Food and Drug Administration signs the batch of the product. Issue a supporting document. The certificate of issuance of the batch of biological products is also stamped with a special seal for the issuance of biological products. The batches of biological products issued in advance are human albumin, recombinant hepatitis B vaccine (yeast and CHO cell expression), live attenuated measles vaccine, BCG, oral polio attenuated live vaccine, adsorption of pertussis, diphtheria, tetanus 6 kinds of products such as combined vaccine. The four in vitro biodiagnostic reagents (hepatitis B surface antigen, HIV antibody, HCV antibody and syphilis antibody detection reagent) for blood source screening and ABO blood type styling reagents are still performed in the original batch calibration method. The batch issuance method for the above six products is carried out by a combination of batch record summary review and laboratory test. Among them, the batching of human albumin is handled by the China National Institute for the Control of Pharmaceutical and Biological Products and the drug testing institutes authorized to issue batches of labor; the batching of vaccine biological products is handled by the China National Institute for the Control of Pharmaceutical and Biological Products. The drug testing institutes that have issued batches of work are responsible for managing the on-site sampling of the batches of vaccines issued in the jurisdiction and the inspection of some of them. The specific matters shall be determined by the China National Institute for the Control of Pharmaceutical and Biological Products after the organization is responsible for the identification and notification of the relevant drug inspection agency authorized to undertake the issuance work. If the drug inspection institutes that undertake the batching of biological products are inspected or reviewed, they must be inspected and accepted by the State Food and Drug Administration. If they meet the relevant technical conditions and requirements and pass the assessment, they may be authorized. Carry out batch issuance work. In the case of the registration of the vaccine products and the human blood albumin import clearance issued by the batch of biological products, it is necessary to provide the batch issued by the drug regulatory agency (or authorized batch issuing institution) of the producing country or region in accordance with the relevant provisions of the Measures for the Administration of Pharmaceutical Imports. Issue the original certificate. Diagnostic reagent products are not required to provide a batch issuance certificate.

　　The announcement was implemented on January 1, 2005. The Notice of the State Drug Administration on the Relevant Matters Concerning the Issuance of Biological Product Approvals (Guo Yao Jian Jian [2003] No. 37) was also abolished at the same time.