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• W2054928657 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." @default.
• W2054928657 created "2016-06-24" @default.
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• W2054928657 date "2013-11-01" @default.
• W2054928657 modified "2023-09-28" @default.
• W2054928657 title "Chinese plasma-derived products supply under the lot release management system in 2007–2011" @default.
• W2054928657 cites W2024630021 @default.
• W2054928657 cites W2083017360 @default.
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• W2054928657 doi "https://doi.org/10.1016/j.biologicals.2013.06.009" @default.
• W2054928657 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/23856276" @default.
• W2054928657 hasPublicationYear "2013" @default.
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