Human cell-based medicinal products - Scientific guideline
Table of contents
This document addresses development, manufacturing and quality control as well as and non-clinical and clinical development of cell-based medicinal products. It covers somatic cell therapy medicinal products and tissue engineered products.
Keywords: Human cell-based medicinal products, quality, manufacturing aspects, non-clinical development, clinical development
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Guideline on human cell-based medicinal products (PDF/400.09 KB)
Adopted
First published: 21/05/2008
Last updated: 21/05/2008
Legal effective date: 01/09/2008
EMEA/CHMP/410869/2006 -
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Overview of comments received on draft guideline on cell-based medicinal products (PDF/380.95 KB)
First published: 18/04/2008
Last updated: 18/04/2008
EMEA/CHMP/CPWP/182901/2008 -
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Draft guideline on human cell-based medicinal products (PDF/205.15 KB)
Draft: consultation closed
First published: 11/01/2007
Last updated: 11/01/2007
EMEA/CHMP/410869/2006