CareLit Fachartikel

Legal basis of the Advanced Therapies Regulation

Jekerle, V.; Schröder, C.; Pedone, E. · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · 2009 · Heft 11 · S. 4 bis 8

Dokument
344670
CareLit-ID
Jahr
2009
Publikation
PDF
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Metadaten
DOI
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Bibliografische Angaben

Zeitschrift
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
Autor:innen
Jekerle, V.; Schröder, C.; Pedone, E.
Ausgabe
Heft 11 / 2009
Jahrgang 52
Seiten
4 bis 8
Erschienen: 2009-11-27 14:18:27
ISSN
1437-1588
DOI
10.1007/s00103-009-0990-6

Zusammenfassung

Advanced therapy medicinal products consist of gene therapy, somatic cell therapy and tissue engineered products. Due to their specific manufacturing process and mode of action these products require specially tailored legislation. With Regulation (EC) No. 1394/2007, these needs have been met. Definitions of gene therapy, somatic cell therapy and tissue engineered products were laid down. A new committee, the Committee for Advanced Therapies, was founded, special procedures such as the certification procedure for smalland medium-sized enterprises were established and the technical requirements for Marketing Auth…

Schlagworte

fortgeschrittene Therapien Arzneimittel Gentherapie somatische Zelltherapie Gewebeengineering Gesetzgebung Zulassungsverfahren Ausschuss für fortgeschrittene Therapien Gene Therapy Cell Therapy Tissue Engineering Drug Approval Regulations Advanced Therapy Medicinal Products Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz