title: 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.
authors.affiliation: Alpha Therapeutic UK Ltd, Thetford, Norfolk.
authors.forename: J
authors.initials: J
authors.lastname: Betts
mesh_terms: D001685:Biological Factors / Q000191:economics / Q000592:standards* / Q000600:supply & distribution; D001769:Blood / Q000821:virology; D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D001798:Blood Proteins / Q000191:economics / Q000592:standards* / Q000600:supply & distribution; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D012449:Safety; D012926:Social Control, Formal; D014777:Virus Diseases / Q000517:prevention & control / Q000635:transmission
chemical_list: D001685:Biological Factors; D001798:Blood Proteins