Human cell-based medicinal products

Current effective version

PDF iconAdopted guideline

Reference number CHMP/410869/06
Published 21/05/2008
Effective from 01/09/2008
Keywords Human cell-based medicinal products, quality, manufacturing aspects, non-clinical development, clinical development
Description 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.


Document history

First version

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

Draft guideline

In operation: 01/09/2008–present

 

Published: 18/04/2008

 

Published: 11/01/2007


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