Quality, preclinical and clinical aspects of gene therapy medicinal products

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCHMP/GTWP/234523/09
Published24/04/2001
Effective from01/10/2001
KeywordsGene therapy medicinal products, advanced therapy medicinal products (ATMPs), quality, non-clinical, clinical
DescriptionThis document provides recommendations with respect to the quality, preclinical and clinical aspects of gene transfer medicinal products. It assists with generating data supporting marketing authorisation applications. Read together with the annex on non-clinical testing for inadvertent germline transmission of gene transfer vectors.


Document history

Superseding document

In progess

Draft guideline


Concept paper

Published: 20/05/2015


Published: 12/01/2010

First version

Current version

Adopted guidelineIn operation: 01/10/2001–present


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