Quality, preclinical and clinical aspects of gene therapy medicinal products

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CAT/80183/2014
Published13/07/2018
Effective from01/03/2018
KeywordsGene therapy medicinal products, advanced therapy medicinal products (ATMPs), quality, non-clinical, clinical
DescriptionThis guideline is a revision of the Note for Guidance on the Quality, Preclinical and Clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99), which was published in 2001. It defines scientific principles and provides guidance for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, safety and efficacy requirements of GTMPs.


Document history

Revision 1
Current version

PDF iconAdopted guideline

PDF iconOverview of comments

Draft guideline

PDF iconConcept paper

Published: 13/07/2018


Published: 13/07/2018

Published: 20/05/2015


Published: 12/01/2010

First version PDF iconAdopted guideline In operation: 01/10/2001–present


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