Betts J
Alpha Therapeutic UK Ltd, Thetford, Norfolk.
Blood Coagul Fibrinolysis. 1994 Dec;5 Suppl 4:S57-61. doi: 10.1097/00001721-199412004-00016.
Current EU regulations do not cover all aspects of the manufacture and control of blood products. Recent legislation coming into force on 1 January 1995 has established the European Medicines Evaluation Agency and introduced revised systems for approving pharmaceutical products, including blood products. There remains a need for comprehensive harmonized legislation covering plasma collection and screening, virus validation studies, and batch release.
现行欧盟法规并未涵盖血液制品生产与控制的所有方面。1995年1月1日生效的最新立法设立了欧洲药品评估局，并引入了包括血液制品在内的药品审批修订系统。仍然需要有涵盖血浆采集与筛查、病毒验证研究以及批签发的全面统一立法。
