Follow-up of patients administered with gene therapy medicinal products

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Current effective version

Adopted guideline

Reference numberCHMP/GTWP/60436/07
Published12/11/2009
Effective from01/05/2010
KeywordsGene therapy medicinal product, follow-up, risk, adverse events, viral vectors, non-viral vectors, plasmid, genetically modified cell, long-term safety, long-term efficacy
DescriptionThis 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

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/05/2010–present


Published: 12/11/2009


Published: 30/05/2008


Published: 26/04/2007


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