title: Chinese plasma-derived products supply under the lot release management system in 2007-2011.
abstract: In 2007, the Chinese State Food and Drug Administration (SFDA) implemented a management system for lot release of all plasma-derived products. Since then, there have been only a few systematic studies of the blood supply, which is a concern when considering the small amount of plasma collected per capita (approximately 3 L/1000 people). As a result, there may be a threat to the safety of the available blood supply. In this study, we examined the characteristics of the supply of Chinese plasma-derived products. We investigated the reports of lot-released biological products derived from all 8 national or regional regulatory authorities in China from 2007 to 2011. The market supply characteristics of Chinese plasma-derived products were analyzed by reviewing the changes in supply varieties, the batches of lot-released plasma-derived products and the actual supply. As a result, the national regulatory authorities can more accurately develop a specific understanding of the production and quality management information provided by Chinese plasma product manufacturers. The implementation of the lot release system further ensures the clinical validity of the plasma-derived products in China and improves the safety of using plasma-derived products. This work provides an assessment of the future Chinese market supply of plasma-derived products and can function as a theoretical basis for the establishment of hemovigilance.
authors.affiliation: Institute of Blood Transfusion, Chinese Academy of Medical Sciences＆Peking Union Medical College, Chengdu, Sichuan, China.
authors.forename: Xuejun
authors.initials: X
authors.lastname: Zhang
authors.forename: Shengliang
authors.initials: S
authors.lastname: Ye
authors.forename: Xi
authors.initials: X
authors.lastname: Du
authors.forename: Jing
authors.initials: J
authors.lastname: Yuan
authors.forename: Chaoming
authors.initials: C
authors.lastname: Zhao
authors.forename: Changqing
authors.initials: C
authors.lastname: Li
mesh_terms: D001688:Biological Products / Q000097:blood* / Q000600:supply & distribution*; D002681:China; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011786:Quality Control
chemical_list: D001688:Biological Products
keywords: Albumin; BIFDC; Beijing institute for drug control; Blood supply; Chinese national institute for food and drug control; Clotting factors; FB; FVIII; GDIFDC; GSIFDC; Gansu province for food and drug control; Guangdong province for food and drug control; HBIFDC; Hubei province for food and drug control; IMIG; IVIG; Immunoglobulin; JLIFDC; Jilin province for food and drug control; Lot release; NIFDC; PCC; Plasma-derived products; SCIFDC; SFDA; SIFDC; Shanghai institute for drug control; Sichuan province for food and drug control; coagulation factor VIII; fibrinogen; intramuscular immunoglobulin; intravenous immunoglobulin; prothrombin complex; state food and drug administration