Human cell-based medicinal products

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Current effective version

Adopted guideline

Reference numberCHMP/410869/06
Effective from01/09/2008
KeywordsHuman cell-based medicinal products, quality, manufacturing aspects, non-clinical development, clinical development
DescriptionThis 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.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/09/2008–present

Published: 18/04/2008

Published: 11/01/2007

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