[Regulatory framework of cell therapy products].

Cell therapy can be defined as "the in vivo use of autologous, allogeneic or xenogeneic cells for the prevention, treatment or attenuation of disease". There have been major advances in this field in the last few years, leading to many clinical applications. Because of safety and ethical concerns, the therapeutic use of cells products justified to be regulated. In France, the law number 96-452 and the law number 98-535 defined a specific regulatory framework for these products: previous authorisation is required for the site of preparation of therapeutic cells product, for clinical trial relating to cell therapy products and for their therapeutic use. Some Cell therapy products could be considered as proprietary medicinal product. The authorisation for the site of preparation and for the clinical trial are granted by the French Health Products Agency ("Afssaps"). Depending on the status, the product could be authorised by Afssaps or by the European Agency for the Evaluation of Medicinal Products (EMEA). Whatever the status, the quality and security of these products should be controlled and the therapeutic use validated. In Europe, such products are currently regulated under the varying national laws of each member states. A European regulation must be defined for cell based products.
(John Libbey Eurotext 2003)