The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built.
Adv Exp Med Biol
; 871: 213-9, 2015.
Article
em En
| MEDLINE
| ID: mdl-26374221
The regulation of cell therapy and gene therapy products is a major challenge for the Brazilian state. From a legal point of view, the legislative apparatus, including constitutional, prohibits the marketing and patent of human substances. From the point of view of the organization of the state bureaucracy, the responsibilities for the regulation of research and application of these technologies in humans may involve up to four different institutions. The National Agency for Health Surveillance (ANVISA) has been the protagonist in structuring the regulation of cell therapy and gene therapy in Brazil, and steps have been taken to ensure quality of these products. However, obstacles such as the commercialization of these therapies and the need to determine whether these products will be regulated following the assumptions adopted in Brazil for drugs and biological products or for human blood and tissues still remain.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Terapia Genética
/
Controle de Medicamentos e Entorpecentes
/
Terapia Baseada em Transplante de Células e Tecidos
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Animals
/
Humans
País/Região como assunto:
America do sul
/
Brasil
Idioma:
En
Revista:
Adv Exp Med Biol
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Estados Unidos