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Keywords:

  • biomedicine;
  • cellular therapy;
  • good manufacturing practices;
  • stem cells

Cell-based medicine is regulated in Europe by Regulation no. 1394/2007 of the European Parliament and of the Council. This regulation defines a new category of products named ‘advanced therapy medicinal products’ and provides rules for their marketing authorization, instructions for the definition of product characteristics, specifications on product labelling and product package leaflet. Moreover, it defines the types of cell or tissue manipulations that are not associated to the category of ‘engineered’ cells or tissues. Finally, it describes the composition and function of the Committee for Advanced Therapies, which can be consulted for the categorization of novel biomedicine products.