Affiliations: CHU Nancy, Vandoeuvre-lès-Nancy, France | Université de Nancy and CNRS UMR 7561, Faculté de médecine, Vandoeuvre-lès-Nancy, France
Note: [] Address for correspondence: Olivia Caunday, Unité de thérapie cellulaire et tissulaire, CHU Nancy Brabois and UMR CNRS 7561, Faculté de médecine de Nancy, 54500 Vandoeuvre-lès-Nancy, France. E-mail: [email protected].
Abstract: 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.
Keywords: Tissue and cell, regulation, good manufacturing practices, science-oriented, therapy-oriented
