Europe – European Commission DG Health and Food Safety and European Medicines Agency Action Plan on ATMPs

The term “advanced therapy medicinal products” (“ATMPs”) is used to designate gene therapies, somatic cell therapies and tissue engineered products.

In the EU, these products are governed by Regulation 1394/2007 on advanced therapy medicinal products (“ATMP Regulation”). The cornerstone of the Regulation is that a marketing authorisation must be obtained prior to the marketing of ATMPs. The evaluation of these products is led by a specialised committee within the European Medicines Agency (EMA) i.e. by the Committee for Advanced Therapies (“CAT”) who prepares a draft opinion before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion and the authorisation is granted by the Commission. The ATMP Regulation also empowers Member States to permit the use of advanced therapies that have not been authorised by the Commission under certain conditions (so-called « hospital exemption »)…