F74European Parliament and Council of the European Union. REGULATION (EC)No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

Published by European Commission (EC)

Medicinal ProductsAdvanced Therapy Regulation

This regulation addresses issues related to the definition and  the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering

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