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Erschienen in: Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz 1/2010

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

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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.
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Metadaten
Titel
CAT – Der neue Ausschuss für Neuartige Therapien bei der Europäischen Agentur für Arzneimittel
verfasst von
P. Celis
Publikationsdatum
01.01.2010
Verlag
Springer-Verlag
Erschienen in
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz / Ausgabe 1/2010
Print ISSN: 1436-9990
Elektronische ISSN: 1437-1588
DOI
https://doi.org/10.1007/s00103-009-0998-y

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