Stem cell-based medicinal products - Scientific guideline
HumanAdvanced therapiesScientific guidelines
This document covers specific aspects related to stem cell-based medicinal products for marketing authorisation application. It is relevant to all medicinal products using stem cells as starting material.
Keywords: Advanced therapy medicinal products, embryonic stem cells, induced pluripotent stem cells, adult stem cells, somatic stem cells, marketing authorisation application, quality, non-clinical, clinical considerations