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