Stem cell-based medicinal products

Current version

PDF iconReflection paper

Reference numberEMA/CAT/571134/2009
Published03/02/2011
KeywordsAdvanced therapy medicinal products, embryonic stem cells, induced pluripotent stem cells, adult stem cells, somatic stem cells, marketing authorisation application, quality, non-clinical, clinical considerations
DescriptionThis 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.


Document history

First version

Current version

PDF iconReflection paper


PDF iconOverview of comments


PDF iconDraft reflection paper

Published: 03/02/2011


Published: 03/02/2011


Published: 30/03/2010


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