Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

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Download document Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products
Reference number EMA/281371/2013
Status draft: consultation open
First published 30/01/2014
Last updated 30/01/2014
Consultation start date 30/01/2014
Consultation end date 30/07/2014
Email address for submissions PGWPSecretariat@ema.europa.eu

Summary

This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products with pharmacogenomic associations, and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.