French and European regulations for tissue and cell therapy.
Fiche publication
Date publication
janvier 2012
Auteurs
Membres identifiés du Cancéropôle Est :
Pr BENSOUSSAN Danièle
Tous les auteurs :
Caunday O, Bultel S, Decot V, Bensoussan D, Stoltz JF
Lien Pubmed
Résumé
This article is focused on the current European and French regulations from a tissue and cell therapy perspective. The first part covers the different Directives of the European Parliament such as the 2004/23/CE and the 2006/17/CE that are applied in France through different Laws (2011-814 Bioethics), Decrees and Orders. The French 2007-1220 Decree sets a framework for science-oriented research as opposed to the 2008-968 Decree that applies to therapy-oriented organizations. The French good manufacturing practices that apply to tissue and cells were published in October 2010, they have been applicable for all tissue and cellular therapy product processing facilities. The sole purpose of all these regulations is to promote good clinical care by increasing safety and control at every single stage of the tissue and cell therapy lifecycle.
Référence
Biomed Mater Eng. 2012;22(4):255-9