EMA releases guidance on the use of pharmacogenomics to improve safety monitoring of medicines

News 30/01/2014

The European Medicines Agency has released a PDF icon draft guideline for public consultation which addresses how pharmacogenomics can support pharmacovigilance activities and in particular how the results of pharmacogenomic studies can help optimise the use of medicines.

Pharmacogenomics is the study of how the genetic makeup of a person affects his or her response to certain medicines, both in terms of efficacy and safety. It is an important new tool that can optimise the use of medicines, by helping to target patients who are likely to respond better to the treatments and helping to mitigate and manage their risks more efficiently.

This draft guideline is directed towards the pharmaceutical industry (marketing authorisation applicants and holders) as well as academia, healthcare professionals and national competent authorities of the European Union. It is intended to provide a framework and recommendations on how to assess pharmacovigilance issues associated with pharmacogenomics, and how to translate the results of these assessments into appropriate recommendations for the labelling of medicines.

The guideline describes how pharmacogenomics can be implemented in risk-management plans, risk-minimisation measures, signal detection and the benefit-risk evaluation of medicines with an established link between genetic features and efficacy and safety.

The guideline also describes different types of genomic biomarkers that can be relevant for pharmacovigilance and provides concrete examples.

Comments on the guideline should be sent to pgwpsecretariat@ema.europa.eu using the template provided by 30 July 2013.

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