Clinical aspects related to tissue engineered products - Scientific guideline

This document provides specific guidance on clinical testing for tissue engineered products (TEPs). It is intended as a supplement to the guideline on human cell-based medicinal products and gives current thinking regarding clinical aspects on TEPs.

Keywords: Advanced Therapy medicinal products, tissue engineered products, clinical, dossier requirements, safety, efficacy

Current version

Reflection paper on clinical aspects related to tissue engineered products

Adopted Reference Number: EMA/CAT/573420/2009 Legal effective date: 01/12/2014 Summary:

This reflection paper is intended as a supplement to the guideline on human cell-based medicinal products (EMEA/CHMP/410869/2006) and gives current thinking regarding clinical aspects on tissue engineered products (TEPs). It is intended to update the guideline on human cell-based medicinal products with the information in this reflection paper at the next revision.

Document history - First version (current)

Reflection paper on clinical aspects related to tissue engineered products

Adopted Reference Number: EMA/CAT/573420/2009 Legal effective date: 01/12/2014 Summary:

This reflection paper is intended as a supplement to the guideline on human cell-based medicinal products (EMEA/CHMP/410869/2006) and gives current thinking regarding clinical aspects on tissue engineered products (TEPs). It is intended to update the guideline on human cell-based medicinal products with the information in this reflection paper at the next revision.

Overview of comments on 'Reflection paper on clinical aspects related to tissue engineered products'

Reference Number: EMA/CAT/20938/2014

Draft reflection paper on clinical aspects related to tissue-engineered products

Draft: consultation closed Consultation dates: 17/04/2012 to 31/07/2012 Reference Number: EMA/CAT/CPWP/573420/2009 Summary:

This reflection paper is intended as a supplement to the guideline on human cell-based medicinal products (EMEA/CHMP/410869/2006) and gives current thinking regarding clinical aspects on tissue-engineered products. It is intended to update the guideline on human cell-based medicinal products with the information in this reflection paper at the next revision.