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

Current version

PDF iconAdopted 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

PDF iconAdopted guideline


PDF iconOverview of comments


Draft guideline


PDF iconConcept paper

In operation: 01/11/2008–present


Published: 30/05/2008


Published: 22/03/2007


Published: 17/11/2005


Related content


How useful was this page?

Add your rating