Stem cell-based medicinal products

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Reflection 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.


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First version

Current version

Reflection paper


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Draft reflection paper

Published: 03/02/2011


Published: 03/02/2011


Published: 30/03/2010


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