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

This 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.

Keywords: Gene therapy medicinal products, non-clinical, first clinical use

Current effective version

Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products

Adopted Reference Number: EMEA/CHMP/GTWP/125459/2006 Legal effective date: 01/11/2008

Overview of comments received on guideline on non-clinical studies required before first clinical use of gene therapy medicinal products

Reference Number: EMEA/CHMP/GTWP/65260/2008

Draft guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products

Draft: consultation closed Consultation dates: 01/03/2007 to 01/11/2007 Reference Number: EMEA/CHMP/GTWP/125459/2006

Draft concept paper on the development of a guideline on the non-clinical Studies prior to clinical use of gene therapy medicinal products

Draft: consultation closed Reference Number: EMEA/CHMP/GTWP/203821/2005