The legal framework for market approval in Europe is provided by EU directives and regulations. There are two fundamental pieces of regulation for ATMPs: The European https://samtech.edu/cheap-cialis/ Tissue and Cells Directive (EUTCD) [Directive 2004/23/EC and implementing directives] and the Advance Therapy Medicinal Product (ATMP) Regulations (1394/2007 and 668/2009). European Medicines Agency and its Committee for Advanced Therapies (CAT) are the two most relevant regulatory bodies. A product may be an ATMP scientifically, but legally it may not be so. ATMP classification can be sought from CAT. Market authorisation can be sought nationally, through mutual recognition in a number of states, or centralised in the EU through the European Medicines Agency.