title: [Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products].
abstract: Regulation (EC) n° 1394/2007 from the European Parliament and the Council describes a new category of health products termed « Advanced Therapy Medicinal Products » (ATMPs). ATMPs derive from cell engineering, tissue engineering or genetic manipulations, and can in some instances be combined with medical devices. ATMPs are distributed and administered to patients, after biotechnology or pharmaceutical companies have obtained a marketing authorization that is granted by the European Commission on the basis of the European Medicines Agency (EMA) assessment. Seven years after the publication of the regulation, few of these therapies have received a marketing authorization, and even fewer have met commercial success, suggesting that a number of medical and economic issues still need to be sorted out in order to achieve sustainability in this field. The coexistence of three sets of rules for three categories of health products that are biologically and medically related - ATMPs, ATMPs produced under the hospital exemption rule, and cell therapy products (CTPs) (a specific legal category in France) that have long been used in hematopoietic cell transplantation - constitutes a complex regulatory framework. This situation raises significant issues for historical as well as emerging operators in this moving field that are discussed thereafter.
authors.affiliation: Centre de thérapie cellulaire, département de biologie du cancer, institut Paoli-Calmettes, 232 boulevard Sainte-Marguerite, 13273 Marseille Cedex, France - Aix-Marseille université (AMU), Marseille, France - Inserm-centre d'investigations cliniques en biothérapie (CBT)-510, Marseille, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Chabannon
authors.affiliation: Aix-Marseille université (AMU), Marseille, France - Inserm-centre d'investigations cliniques en biothérapie (CBT)-510, Marseille, France - laboratoire de culture et de thérapie cellulaire, hôpital de la Conception, Assistance publique-hôpitaux de Marseille, Marseille, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Sabatier
authors.affiliation: Inserm UMR 1027, épidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps, équipe génomique, biothérapies et santé publique-approche interdisciplinaire, Toulouse, France - université Paul Sabatier-Toulouse 3, Toulouse, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Rial-Sebbag
authors.affiliation: Centre de thérapie cellulaire, département de biologie du cancer, institut Paoli-Calmettes, 232 boulevard Sainte-Marguerite, 13273 Marseille Cedex, France - Inserm-centre d'investigations cliniques en biothérapie (CBT)-510, Marseille, France.
authors.forename: Boris
authors.initials: B
authors.lastname: Calmels
authors.affiliation: Inserm-centre d'investigations cliniques en biothérapie (CBT)-510, Marseille, France - laboratoire de culture et de thérapie cellulaire, hôpital de la Conception, Assistance publique-hôpitaux de Marseille, Marseille, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Veran
authors.affiliation: Aix-Marseille université (AMU), Marseille, France - Inserm-centre d'investigations cliniques en biothérapie (CBT)-510, Marseille, France - laboratoire de culture et de thérapie cellulaire, hôpital de la Conception, Assistance publique-hôpitaux de Marseille, Marseille, France.
authors.forename: Guy
authors.initials: G
authors.lastname: Magalon
authors.affiliation: Centre de thérapie cellulaire, département de biologie du cancer, institut Paoli-Calmettes, 232 boulevard Sainte-Marguerite, 13273 Marseille Cedex, France - Inserm-centre d'investigations cliniques en biothérapie (CBT)-510, Marseille, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Lemarie
authors.affiliation: Inserm UMR 1027, épidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps, équipe génomique, biothérapies et santé publique-approche interdisciplinaire, Toulouse, France - université Paul Sabatier-Toulouse 3, Toulouse, France - Institut de recherche en droit européen, international et comparé (IRDEIC), université Toulouse 1-Capitole, Toulouse, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Mahalatchimy
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D015507:Drugs, Investigational / Q000627:therapeutic use*; D005062:European Union; D006801:Humans; D007883:Legislation, Medical / Q000639:trends*; D007885:Legislation, Pharmacy; D017410:Practice Guidelines as Topic; D035703:Therapies, Investigational / Q000592:standards*
chemical_list: D015507:Drugs, Investigational