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

Abstract

Advanced-therapymedicinal products (ATMPs) are medicines for human use that are based on genes (gene therapy), cells (somatic-cell therapy) or tissues (tissue engineering) and include autologous, allogeneic, or xenogenic origin products. They are new therapeutic strategies and their development will contribute to providing opportunities for some diseases that so far lack effective treatments. The main objective of the pharmaceutical industry is to introduce on the market effective medications that increase hope and quality of life of the population, not to mention the safety criteria. To do this, it is important to know well the existing advanced therapies regulation allowing you to more easily perform the translation of basic research carried out in research laboratories and that decision making is quality. Definitions from a point of view regulatory of these medications are in the Regulation (EC) N◦ 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy (Chapter 1, article 2) drugs and the Directive 2001/83/CE of the European Parliament and of the Council of 6 November 2001 by establishing a community relating to medicinal products for human use code (annex I part IV, according to its last modification).