Follow-up of patients administered with gene therapy medicinal products

Current effective version

PDF iconAdopted guideline

Reference number CHMP/GTWP/60436/07
Published 12/11/2009
Effective from 01/05/2010
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
Description 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.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/05/2010–present


Published: 12/11/2009


Published: 30/05/2008


Published: 26/04/2007

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