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

Document history

Guideline on human cell-based medicinal products

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

Draft guideline on human cell-based medicinal products

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