Quality, preclinical and clinical aspects of gene therapy medicinal products

  • Email
  • Help
Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCHMP/GTWP/234523/09
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 progress

Draft guideline

Concept paper

Published: 20/05/2015

Published: 12/01/2010

First version

Current version

Adopted guidelineIn operation: 01/10/2001–present

Related content

How helpful is this page?

Average rating:

 Based on 30 ratings

Add your rating:

See all ratings
5 ratings
5 ratings
5 ratings
5 ratings
10 ratings

Tell us more