Nouveau paysage réglementaire français dans le domaine des tissus et cellules

Abstract

The new EU directives published in 2004 and 2006 on tissue and cell products, including gametes, have resulted in a change in the French regulations in the frame of their transposition into French law. The French Agency for the Safety of Health Products (AFSSAPS) collaborated with the Directorate General of Health (Direction Générale de la Santé), the Biomedicine Agency (Agence de la BioMédecine), the French Blood Establishment (Établissement Français du Sang), the responsible persons of tissue establishments to produce a new version of best practices applicable to tissue and cell banks. The good tissue and cell practices take into account the requirements of the European directives, the technological changes, the feedback of inspections done by AFSSAPS and the experiences of the responsible persons of the tissue establishment. The new good tissue and cell practices, resulted in the amendment and repeal of other regulations that apply to any such products (such as the Decree relating with the traceability of organs, tissues and cells, the decree setting the conditions for the authorization of tissue establishment). The text contains eleven chapters (Personnel, Facilities, Activities, Quality Control, Third parties, Packaging, Labelling, Transportation, Documentation, Information technologies Systems, Management of non-conformities, complaints and Biovigilance). In its current form, this text provides manufacturers with guidance and clarification on all aspects of their activities. These activities will evolve; this text will evolve as well in the light of experience gained by science, validated practices and lessons learned.