Human cell-based medicinal products - Scientific guideline
HumanScientific guidelines
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
Current effective version
Guideline on human cell-based medicinal products
AdoptedLegal effective date: Reference Number: EMEA/CHMP/410869/2006
English (EN) (400.09 KB - PDF)
First published: Last updated:
Document history
Guideline on human cell-based medicinal products
AdoptedLegal effective date: Reference Number: EMEA/CHMP/410869/2006
English (EN) (400.09 KB - PDF)
First published: Last updated:
Overview of comments received on draft guideline on cell-based medicinal products
Reference Number: EMEA/CHMP/CPWP/182901/2008
English (EN) (380.95 KB - PDF)
First published: Last updated:
Draft guideline on human cell-based medicinal products
Draft: consultation closedReference Number: EMEA/CHMP/410869/2006
English (EN) (205.15 KB - PDF)
First published: Last updated:
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