Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland.
Adv Exp Med Biol
; 871: 131-45, 2015.
Article
em En
| MEDLINE
| ID: mdl-26374216
ABSTRACT
This chapter aims to describe and summarize the regulation of gene and cell therapy products in Switzerland and its legal basis. Product types are briefly described, as are Swiss-specific terminologies such as the term "transplant product," which means products manufactured from cells, tissues, or even whole organs. Although some parts of this chapter may show a guideline character, they are not legally binding, but represent the current thinking of Swissmedic, the Swiss Agency for Therapeutic Products. As so far the experience with marketing approval of gene therapy and cell therapy products in Switzerland is limited, this chapter focuses on the regulation of clinical trials conducted with these products. Quality, nonclinical, and clinical aspects are summarized separately for gene therapy products and transplant products.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
Base de dados:
MEDLINE
Assunto principal:
Terapia Genética
/
Transplante de Tecidos
/
Marketing
/
Controle de Medicamentos e Entorpecentes
/
Pesquisa Translacional Biomédica
/
Terapia Baseada em Transplante de Células e Tecidos
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Animals
/
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Adv Exp Med Biol
Ano de publicação:
2015
Tipo de documento:
Article