Lot Release Annual Report of Biological Products in 2016: Albumin and Coagulation Factor VIII were Still in Short Supply

Lot Release Annual Report of Biological Products in 2016: Albumin and Coagulation Factor VIII were Still in Short Supply
In July 4th , 2017, official website of CFDA issued the Lot Release Annual Report of Biological Products in 2016, which was compiled by National Institutes for Food and Drug Control. This report was the most authoritative source of data to comprehend the market demand and supply of domestic vaccines and plasma products.
Hualan Biological Human Albumin

In 2016, release 3949 batches of vaccines and approximately 646 million doses; 4025 batches of plasma products and approximately 59.278 million vials; 836 batches of blood screening reagent and about 878 million doses. At present, the lot released vaccines and blood screening reagents are mainly made in China, while the imported products are less than 5 %. As for the plasma products, due to the lack of raw plasma, clinical supply of human albumin has more than 50 % insufficiency, relying on the supplementation of imported human albumin. The production standardization of lot released products is great, and the quality is stable and controllable. There are few unqualified products in recent years, and only 1 batch of domestic vaccines and 2 batches of imported human albumin fail to meet the requirements in 2016.
Hualan Biological Human Coagulation Factor VIII

Human coagulation factor VIII is used for the treatment of hemophilia. The CFDA pays high attention to this product due to the shortage in domestic market. At present, domestic human coagulation factor VIII is managed according to lot release system, while imported human coagulation factor VIII is not included in the lot release system, and is inspected as normal import products. 5 enterprises produce human coagulation factor VIII in China. It released 988.6 thousand vials of domestic products in 2016, which increased 196 thousand vials and 19.8% compared with 2015 (792.6 thousand vials). 685.9 thousand vials were imported in 2016, showing an increasing trend year by year. The imported human coagulation factor VIII accounted for 41 %, which effectively complemented the supply of market.

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