[Safety monitoring of cell-based medicinal products (CBMPs)]. / Überwachung der Sicherheit von Zelltherapeutika (CBMPs).
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
; 58(11-12): 1239-46, 2015 Nov.
Article
em De
| MEDLINE
| ID: mdl-26391098
ABSTRACT
Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Controle de Qualidade
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Produtos Biológicos
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Aprovação de Drogas
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Terapia Baseada em Transplante de Células e Tecidos
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Legislação de Medicamentos
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Programas Nacionais de Saúde
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Humans
País como assunto:
Europa
Idioma:
De
Ano de publicação:
2015
Tipo de documento:
Article