Challenges with advanced therapy medicinal products and how to meet them.
Nat Rev Drug Discov
; 9(3): 195-201, 2010 03.
Article
em En
| MEDLINE
| ID: mdl-20190786
ABSTRACT
Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. They have therefore been subject to considerable interest and debate. Following the European regulation on ATMPs, a consolidated regulatory framework for these innovative medicines has recently been established. Central to this framework is the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA), comprising a multidisciplinary scientific expert committee, representing all EU member states and European Free Trade Association countries, as well as patient and medical associations. In this article, the CAT discusses some of the typical issues raised by developers of ATMPs, and highlights the opportunities for such companies and research groups to approach the EMA and the CAT as a regulatory advisor during development.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Terapia Genética
/
Engenharia Tecidual
/
Transplante de Células-Tronco
/
Regulamentação Governamental
Limite:
Humans
Idioma:
En
Revista:
Nat Rev Drug Discov
Assunto da revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2010
Tipo de documento:
Article