Author(s): Migliaccio G, Pintus C
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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 particular, by Regulation 1394/2007/EC.
This article was published in Adv Biochem Eng Biotechnol
and referenced in Journal of Stem Cell Research & Therapy