Human cell-based medicinal products - Scientific guideline

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

Adopted Reference Number: EMEA/CHMP/410869/2006 Legal effective date: 01/09/2008

Document history

Guideline on human cell-based medicinal products

Adopted Reference Number: EMEA/CHMP/410869/2006 Legal effective date: 01/09/2008

Overview of comments received on draft guideline on cell-based medicinal products

Reference Number: EMEA/CHMP/CPWP/182901/2008

Draft guideline on human cell-based medicinal products

Draft: consultation closed Reference Number: EMEA/CHMP/410869/2006