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 closed
First published 2014-01-30
Last updated 2014-01-30

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.