Non-clinical studies required before first clinical use of gene therapy medicinal products

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Current version

Adopted guideline

Reference numberCHMP/GTWP/125459/06
Published30/05/2008
Effective from01/11/2008
KeywordsGene therapy medicinal products, non-clinical, first clinical use
DescriptionThis document defines scientific principles and provides guidance to applicants developing gene therapy medicinal products (GTMPs). It focuses on the non-clinical studies required before the first use of a GTMPs in human subjects.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/11/2008–present


Published: 30/05/2008


Published: 22/03/2007


Published: 17/11/2005


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