Follow-up of patients administered with gene therapy medicinal products - Scientific guideline

This document addresses specific aspects of the active clinical follow-up of patients administered with gene therapy medicinal products in order to detect signals of early or delayed adverse reactions, to prevent clinical consequences of such reactions, to ensure timely treatment and to gain information on the long-term safety and efficacy of the intervention.

Keywords: Gene therapy medicinal product, follow-up, risk, adverse events, viral vectors, non-viral vectors, plasmid, genetically modified cell, long-term safety, long-term efficacy

Current effective version

Guideline on follow-up of patients administered with gene therapy medicinal products

Adopted Reference Number: EMEA/CHMP/GTWP/60436/2007 Legal effective date: 01/05/2010

Document history - First version (current)

Guideline on follow-up of patients administered with gene therapy medicinal products

Adopted Reference Number: EMEA/CHMP/GTWP/60436/2007 Legal effective date: 01/05/2010

Overview of comments received on draft guideline on follow-up of patients administered with gene therapy medicinal products (EMEA/CHMP/GTWP/60436/2007)

Reference Number: EMEA/570240/2009

Draft guideline on follow-up of patients administered with gene therapy Medicinal products

Draft: consultation closed Reference Number: EMEA/CHMP/GTWP/60436/2007

Concept paper on the development of a Guideline on clinical monitoring and follow-up of patients exposed to gene therapy/gene transfer medicinal products

Draft: consultation closed Reference Number: EMEA/CHMP/GTWP/367513/2006