EMA Releases Pharmacogenomics Guidance

Jan 30, 2014
By BioPharm International Editors

The European Medicines Agency has released a draft guideline that addresses how pharmacogenomics can support pharmacovigilance activities. The guideline document also details how the results of pharmacogenomics, the study of how the genetic makeup of a person affects his or her response to certain medicines, can help optimize the use of drugs. Pharmacogenomics can help 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 marketing authorization applicants and holders as well as academia, healthcare professionals, and national competent authorities of the European Union. The guidance provides 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 labeling of drugs.

The guideline describes the use of pharmacogenomics in risk-management plans, risk-minimization measures, signal detection and the benefit-risk evaluation of drugs 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.

Source: European Medicines Agency