Role of the EU Framework in Regulation of Stem Cell-Based Products

Abstract

The use of stem cells for therapeutic purposes is regulated by two overlapping sets of rules. If used for transplantation, stem cells are covered by the collection, traceability and technical aspects of three European directives. When the stem cells are used as part of a medicinal product, they are covered by the legislation on pharmaceutical production and marketing authorization—in par-ticular, by Regulation 1394/2007/EC.