Regulation

Abstract

The use of in vitro expanded stem cells (cell therapy) is considered an advanced therapy medicinal product (ATMP) that offers new opportunities for the treatment of several human conditions. From a regulatory point of view, it is necessary to address the specific aspects of these medicaments regarding manufacturing, controls, clinical research, assessment, and authorization. All advanced therapy medicines are authorized centrally via the European Medicines Agency, which also monitors the entire process. The legal framework also requires ATMP to be manufactured in a special facility that complains with the good manufacture products (GMP) certification and has been previously authorized by the corresponding regulatory agency.