Progress on regulations for human-derived therapeutic products.
Several European work programmes are building a unified regulatory framework for therapeutic products that utilise material of human origin, that is, substances, derivatives or tissues of human origin or viable cells of human origin. This is a report on progress to date.
Cox
Michael
M
Danish Medicines Agency, Inspection & Enforcement Division, Copenhagen, Denmark. mic@dkma.dk
D001187:Artificial Organs / Q000592:standards* / Q000639:trends; D021522:Bioartificial Organs / Q000592:standards / Q000639:trends; D004869:Equipment Safety / Q000379:methods / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D006801:Humans; D023822:Tissue Engineering / Q000331:legislation & jurisprudence* / Q000592:standards* / Q000639:trends