Clinical aspects related to tissue engineered products

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Current version

Reflection paper

Reference numberEMA/CAT/573420/2009
Published11/12/2014
KeywordsAdvanced Therapy medicinal products, tissue engineered products, clinical, dossier requirements, safety, efficacy
DescriptionThis 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.


Document history

First version

Current version

Reflection paper


Overview of comments


Draft reflection paper

Published: 11/12/2014


Published: 11/12/2014


Published: 29/05/2009


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