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

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Current effective version

Adopted 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

 

Draft guideline

 

 

Concept 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

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/11/2012–present


Published: 16/07/2012


Published: 18/06/2010


Published: 18/06/2010


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