Eight biological products will be more strictly controlled next year

Published:

2014-10-06


It was learned from the State Food and Drug Administration that from January 1 next year, China will implement the batch issuance system for eight kinds of biological products, including human serum albumin, recombinant hepatitis B vaccine, live attenuated measles vaccine, BCG vaccine, live attenuated oral polio vaccine, adsorbed pertussis, diphtheria and tetanus vaccine. According to relevant sources, this is an important step for China's biological product management standards to be in line with international standards.
Batch issuance of biological products refers to the national system of mandatory inspection and review for vaccine products, blood products, in vitro biological diagnostic reagents for blood source screening and other biological products specified by the state when each batch of products leaves the market or is imported. Those who fail to pass the inspection or are not approved after examination shall not be listed or imported. According to experts, this management method is mainly adopted in the world at present, while the batch inspection system is now used in China.   
It is reported that the four in vitro biological diagnostic reagents used for blood source screening: HBsAg, HIV antibody, HCV antibody and syphilis antibody detection reagents and ABO blood typing reagents are still tested in batches.         
On October 21, 2004, the State Food and Drug Administration issued the Notice on Issues Related to the Issuance of Biological Products (GSYJZ [2004] No. 509), which made the following announcement on issues related to the issuance of biological products: the State Food and Drug Administration authorized the China Institute for the Control of Pharmaceutical and Biological Products and Beijing, Jilin, Shanghai, Hubei, Guangdong, Sichuan, Gansu and other provinces The Municipal Institute for Drug Control shall be responsible for the issuance of biological products. The State Food and Drug Administration authorizes a specially assigned person to be the issuer of the biological product batch issuance certificate of the above drug inspection institution undertaking the biological product batch issuance, and to issue the biological product batch issuance certificate on behalf of the State Food and Drug Administration according to the batch record review, laboratory inspection or review results. The issuance certificate of biological products batch shall be affixed with the special seal for issuance of biological products batch. The varieties of biological products issued in advance include human serum albumin, recombinant hepatitis B vaccine (expressed by yeast and CHO cells), live attenuated measles vaccine, BCG vaccine, live attenuated oral polio vaccine, adsorbed pertussis, diphtheria and tetanus combined vaccine. Four in vitro biological diagnostic reagents (HBsAg, HIV antibody, HCV antibody and syphilis antibody detection reagents) and ABO blood typing reagents used for blood source screening are still tested in the original batch. The batch issuance method of the above six products is the combination of batch record summary review and laboratory inspection. Among them, the China Institute for the Control of Pharmaceutical and Biological Products and the drug inspection institutes authorized to undertake the batch issuance of human serum albumin are respectively responsible for the batch issuance; The batch issuance of vaccine biological products is the responsibility of the China Institute for the Control of Pharmaceutical and Biological Products, and the drug inspection institutes authorized to undertake the batch issuance are responsible for the on-site sampling of vaccine varieties and the inspection of some of the items within their jurisdiction. The China Institute for the Control of Pharmaceutical and Biological Products shall be responsible for organizing the demonstration, determining and notifying the relevant drug inspection institutes authorized to undertake the batch issuance work. If the inspection or review of the varieties of biological products to be issued is added by the drug inspection institutes that are responsible for the issuance of biological products, it must be inspected and accepted by the State Food and Drug Administration. If the products meet the relevant technical conditions and requirements and pass the evaluation, they can be issued only after being authorized. When the import of vaccine products and human serum albumin included in the batch issuance of biological products is filed for customs clearance, the original of the batch issuance certificate issued by the drug administration authority (or authorized batch issuance authority) of the country or region of production shall be provided in accordance with the relevant provisions of the Measures for the Administration of Drug Import. For diagnostic reagent products, it is not required to provide batch issuance certificate temporarily.          
The announcement came into force on January 1, 2005. The former Notice of the State Drug Administration on Issues Related to the Issuance of Biological Products (GYJZ [2003] No. 37) shall be repealed at the same time.

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