European union and Spanish regulations on quality and safety of tissues and cells: overview and biovigilance.

BACKGROUND The increasing therapeutic possibilities offered by tissues and cells during the last years, the existing discrepancies in regulation between Member States (MS), and the associated risks have led legislators in the European Union (EU) and its MS to establish a set of supranational standards that ensure quality and safety of human tissues/cells as well as processes related to donation, procurement, processing, and utilization. MS are under the obligation to incorporate the requirements of the European rules in their internal regulations. REGULATION The regulations in the European Directives on tissues and cells range from the broad principles stated in Directive 2004/23/EC, to the detailed requirements described in Directives 2006/17/EC and 2006/86/EC. The aspects related to biovigilance were described in the latter. Spain has already complied with the obligation to transpose these Directives through the Royal Decree 1301/2006. BIOVIGILANCE Surveillance is a methodology often used in public health. The design of a surveillance system implies a decision-making process on the elements, procedures, and principles of the system. Regarding Spain, some of the elements have already been defined in the European or Spanish rules; however, other components of the biovigilance system have been discussed and developed in working documents outside of regulation.