Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

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Download document Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
Reference number EMA/CAT/GTWP/671639/2008 Rev. 1
Status draft: consultation open
First published 2018-07-31
Last updated 2018-07-31
Consultation start date 2018-07-31
Consultation end date 2019-07-31
Email address for submissions CATsecretariat@ema.europa.eu

Summary

This guideline 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. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.