Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

Current effective version

PDF iconAdopted guideline

Currently under revision - see below

Reference numberCHMP/GTWP/671639/2008
Published03/05/2012
Effective from01/11/2012
KeywordsGenetically modified cell, advanced therapy, gene therapy, cell therapy, somatic cell, quality, non-clinical, clinical
DescriptionThis document defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation.


Document history

Revision 1

In progress

PDF iconDraft guideline

PDF iconConcept paper

Published: 31/07/2018

Deadline for comments: 31/07/2019

Published: 24/07/2017

Deadline for comments: 31/10/2017

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/11/2012–present


Published: 16/07/2012


Published: 18/06/2010


Published: 18/06/2010


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