Eight types of biological products will be more strictly regulated next year

　　According to the National Medical Products Administration, starting from January 1 next year, China will implement a batch release system for eight types of biological products including human albumin, recombinant hepatitis B vaccine, measles live attenuated vaccine, BCG vaccine, oral poliovirus live attenuated vaccine, and adsorbed combined vaccines for pertussis, diphtheria, and tetanus. According to relevant personnel, this is an important step for China's biological product management standards to align with international standards.

　　Batch release of biological products refers to the mandatory inspection and review system conducted by the state for each batch of vaccine products, blood products, in vitro biological diagnostic reagents used for blood source screening, and other specified biological products before they are marketed or imported. Products that fail inspection or are not approved in the review are not allowed to be marketed or imported. Experts indicate that this management method is currently the main approach used worldwide, whereas China currently uses a batch-by-batch inspection system. 　

　　It is reported that the four types of in vitro biological diagnostic reagents used for blood source screening—hepatitis B surface antigen, HIV antibody, HCV antibody, and syphilis antibody test reagents—as well as ABO blood typing reagents, will continue to be tested using the batch-by-batch verification method.        

　　On October 21, 2004, the National Medical Products Administration issued the "Notice on Matters Related to the Implementation of Batch Release of Biological Products" (Document No. Guo Shi Yao Jian Zhu [2004] 509), announcing the following regarding the implementation of batch release for biological products: The National Medical Products Administration authorizes the National Institute for the Control of Pharmaceutical and Biological Products and the drug testing institutes in Beijing, Jilin, Shanghai, Hubei, Guangdong, Sichuan, Gansu, and other provinces and cities to undertake the batch release work for biological products. The National Medical Products Administration authorizes designated personnel as signatories for the batch release certificates issued by these authorized drug testing institutions. Based on batch record review, laboratory testing, or re-examination results, these signatories represent the National Medical Products Administration in issuing batch release certificates for biological products. The batch release certificates are also stamped with a special seal for biological product batch release. Initially, the batch release will cover six products: human albumin, recombinant hepatitis B vaccine (expressed in yeast and CHO cells), measles live attenuated vaccine, BCG vaccine, oral poliovirus live attenuated vaccine, and adsorbed combined vaccines for pertussis, diphtheria, and tetanus. The four in vitro biological diagnostic reagents used for blood source screening (hepatitis B surface antigen, HIV antibody, HCV antibody, and syphilis antibody test reagents) and ABO blood typing reagents will continue to be tested using the original batch-by-batch verification method. The batch release method for the six products combines batch record summary review and laboratory testing. Among them, the batch release work for human albumin is undertaken separately by the National Institute for the Control of Pharmaceutical and Biological Products and the authorized drug testing institutes. The batch release work for vaccine biological products is undertaken by the National Institute for the Control of Pharmaceutical and Biological Products, while the authorized drug testing institutes are responsible for on-site sampling and testing of certain items for the specified batch release vaccine varieties within their jurisdictions. Specific matters will be determined and notified by the National Institute for the Control of Pharmaceutical and Biological Products after organizing demonstrations. If any authorized drug testing institute undertaking batch release work adds testing or re-examination for additional batch release varieties, it must undergo inspection and acceptance organized by the National Medical Products Administration, meet relevant technical conditions and requirements, and pass evaluation before being authorized to carry out batch release work. When vaccine biological products and human albumin included in the batch release system are imported and cleared through customs, the original batch release certificate issued by the drug regulatory authority (or authorized batch release institution) of the producing country or region must be provided in accordance with the relevant provisions of the "Drug Import Management Measures." Diagnostic reagent products are temporarily not required to provide batch release certificates.         

　　This announcement will take effect from January 1, 2005. The original notice from the former State Drug Administration on matters related to the implementation of batch release of biological products (Document No. Guo Yao Jian Zhu [2003] 37) is hereby repealed.