Abstract
Advanced Therapy Medicinal Products (ATMPs) — gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products — are currently the most innovative drug products and hold promise to offer cure for a variety of diseases for which there are no satisfactory therapies. They have therefore elicited considerable interest and debate. The European Regulation on ATMPs provides a regulatory framework for these innovative medicines, and since 2009 the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) has started its work. The CAT is a multi-disciplinary scientific expert committee, representing all EU member states and EFTA countries, as well as patients’ and physicians’ associations. This book chapter briefly touches upon some of the diffi- culties developers of ATMPs may face, and the opportunities to approach the CAT as a regulatory advisor during development.
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