PubMed · 7795141
European regulatory issues.
Abstract
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.
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J Betts. 1994. European regulatory issues.. https://doi.org/10.1097/00001721-199412004-00016
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