Stem cell-based medicinal products - Scientific guideline
Table of contents
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
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Reflection paper on stem cell-based medicinal products (PDF/113.08 KB)
Adopted
First published: 03/02/2011
Last updated: 03/02/2011
EMA/CAT/571134/2009 -
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Overview of comments received on reflection paper on stem cell-based medicinal products (PDF/841.13 KB)
First published: 03/02/2011
Last updated: 03/02/2011
EMA/CAT/55107/2011 -
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Draft reflection paper on stem cell-based medicinal products (PDF/119.97 KB)
Draft: consultation closed
First published: 30/03/2010
Last updated: 30/03/2010
EMA/CAT/571134/2009