Clinical aspects related to tissue engineered products - Scientific guideline
Table of contents
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
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Reflection paper on clinical aspects related to tissue engineered products (PDF/93.23 KB)
Adopted
First published: 11/12/2014
Last updated: 11/12/2014
Legal effective date: 01/12/2014
EMA/CAT/573420/2009 -
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Overview of comments on 'Reflection paper on clinical aspects related to tissue engineered products' (PDF/439.07 KB)
First published: 11/12/2014
Last updated: 11/12/2014
EMA/CAT/20938/2014 -
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Draft reflection paper on clinical aspects related to tissue-engineered products (PDF/77.04 KB)
Draft: consultation closed
First published: 17/04/2012
Last updated: 17/04/2012
Consultation dates: 17/04/2012 to 31/07/2012
EMA/CAT/CPWP/573420/2009
- Multidisciplinary: cell therapy and tissue engineering
- Directive 2001/83/EC
- Directive 2009/120/EC
- Regulation (EC) No 1394/2007
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Safety and efficacy follow-up - risk management of advanced therapy medicinal products
- Human cell-based medicinal products
- Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced therapy medicinal products