EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation

Posted 24 January 2012 | By Alexander Gaffney

The European Medicines Agency (EMA) issued a concept paper on 23 January that calls for a new guideline to be issued on the use of pharmacogenomics in the conduct of pharmacovigilance.

The concept paper notes that the response most individuals have to drug therapy is highly variable, and a prominent component of this variability is related to genetic variations. This can relate to drug disposition (pharmacokinetics) or drug action (pharmacodynamics).

Accurate knowledge of a patient's susceptibility to adverse drug reactions (ADRs) is currently done through the use of clinical trials, but there trials have a number of limitations including small subject size relative to the total population, underrepresentation of important subpopulations, restrictions to trial participation and restrictions related to drug treatment.

Shifting to an approach that relies on pharmacogenomic information determined through the use of biomarkers may aid in the development and marketing of safer medicinal products.

The Concept paper on key aspects for the use of pharmacogenomics methodologies in the pharmacovigilance evaluation of medicinal products specifically calls for a guideline to address seven main areas:

  • Systematic consideration of pharmacogenomic effects and its implications on efficacy, effectiveness and safety
  • Determining when postmarketing genomic data needs to be monitored and/or collected
  • How genomic material should be collected and stored
  • How to conduct postmarketing safety, efficacy and effectiveness studies involving pharmacogenomics
  • How to report ADR signals to the competent authorities
  • How to mitigate risk when pharmacogenomics data determines likely risk factors
  • How to determine what information needs to be present on the product information (labeling)


The concept paper anticipates that the draft guideline will be available sometime in 2013, with a 3 months of consultation occurring before finalization is sought. Development of the guideline will be done by the Pharmacogenomics Works Party (PGWP) and the Pharmavigilance Working Party (PhVWP). Comments are due by 15 March.


Tags: EU

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