DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

Published by European Commission (EC)

Quality and SafetyDonationProcessingPreservationDistributionHuman Tissues and Cells

This Directive sets the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

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The ITF is a multidisciplinary EMA group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development. Area of interest: innovative therapeutics and techniques, innovative development methods, borderline products.
From the first request by the applicant, the procedure lasts approximately 8-10 weeks (ITF Secretariats confirms eligibility criteria approx. within 2 weeks; when confirmed, then approx. 2 weeks about experts’ involvement + meeting date after 4-6 weeks).

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