Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/281371/2013
Published20/11/2015
Effective from01/04/2016
KeywordsPharmacogenomics, pharmacovigilance, biomarkers, genomic variations
DescriptionThis document addresses the influence of pharmacogenomics on pharmacovigilance activities. It includes 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..


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/04/2016–present


Published: 20/11/2015


Published: 30/01/2014


Published: 15/02/2012


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