Specific requirements for somatic cell therapy medicinal products and tissue engineered products.

Autor: Martín, Rosa M. Hernández, Hernández, Eduardo L. Mariño, Muñoz, José Luis Pedraz, Álvarez, Antonio M. Rabasco
Předmět:
Zdroj: Pharmaceuticals Policy & Law; 2015, Vol. 17 Issue 1/2, p271-277, 7p
Abstrakt: The article focuses on specific requirements for somatic cell therapy medicinal products and tissue engineered products, according to the European Directive. It highlights the importance of advance therapies regulation in translating basic research made in research laboratories and decision making. It offers definitions of cell and tissue engineering as well as explores additional requirements and manufacturing process.
Databáze: Complementary Index