European Medicines Agency, CAT Secretariat & US Food and Drug Administration

Abstract

The European Medicines Agency (EMA) and the Committee for Advanced Therapies (CAT) are responsible for reviewing applications for marketing authorization for Advanced Therapy Medicinal Products (ATMP), which include (stem) cell-based medicines, for the ATMP classification and certification procedure, and to provide scientific advice to developers of ATMPs. The CAT, an expert committee dedicated to ATMPs, was established by the Regulation (EC) No 1394/2007 on Advanced Therapies. The CAT came into operation in January 2009. ATMPs are defined in this Regulation as gene therapy and cell therapy medicinal products, and tissue-engineered products. The US FDA's Center for Biologics Evaluation and Research is responsible for ensuring the safety, purity, potency and effectiveness of many biologically derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products for the prevention, diagnosis and treatment of human diseases, conditions or injury. Human cells or tissue intended for implantation, transplantation, infusion or transfer into a human recipient are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).