CareLit Fachartikel
CAT – The new committee for advanced therapies at the European Medicines Agency
Celis, P. · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · 2010 · Heft 1 · S. 9 bis 13
Dokument
344639
CareLit-ID
Jahr
2010
Publikation
PDF
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Metadaten
DOI
ja
zitierfähig
Bibliografische Angaben
Zusammenfassung
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…
Schlagworte
CAT
fortgeschrittene Therapien
europäische Arzneimittelbehörde
Gene
Zelltherapie
Gewebeengineering
Zulassungsverfahren
wissenschaftliche Beratung
Gene Therapy
Cell Therapy
Tissue Engineering
Advanced Therapy Medicinal Products
Regulatory Approval
Scientific Advisory Committees
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
