Erschienen in:
01.01.2010 | Leitthema
CAT – Der neue Ausschuss für Neuartige Therapien bei der Europäischen Agentur für Arzneimittel
verfasst von:
P. Celis
Erschienen in:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
|
Ausgabe 1/2010
Einloggen, um Zugang zu erhalten
Abstract
The Regulation on Advanced Therapies (Regulation (EC) 1394/2007) establishes a new scientific committee, the Committee for Advanced Therapies (CAT), at the European Medicines Agency. The CAT is composed of experts in the field of Advanced Therapy Medicinal Products (ATMPs) – gene and cell therapy and tissue engineered products – and is responsible for the evaluation of the marketing authorisation applications for this novel class of products. The CAT is also involved in all scientific advice on ATMPs and in two new regulatory procedures for ATMPs, the classification and the certification procedures. The CAT will also play a key role in early contacts with developers of ATMPs.