EMA Releases Pharmacogenomics Guidance - - BioPharm International

ADVERTISEMENT

EMA Releases Pharmacogenomics Guidance


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

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Launches Human Safety Study of Ebola Vaccine Candidate
August 29, 2014
Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
USP Awards Analytical Research
August 15, 2014
Author Guidelines

Click here