The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug-therapy efficacy and safety. The limited scope of clinical trials means that rare but serious adverse drug reactions (ADRs) may not be discovered until after increased population exposure post authorization.

Included in the topics proposed for the guideline are the following:

• Systematic consideration of pharmacogenomic effects and the implications of genomic biomarkers in terms of efficacy, effectiveness, and safety
• Early consideration of when post authorization genomic data should be monitored and collected to confirm appropriate dose or comedication
• Collection of genomic material during clinical trials and in the case of serious ADRs, lack of effectiveness or worsening of the condition
• Methodologies for post authorization safety studies, and post authorization efficacy and effectiveness studies
• Consideration of the level and type of evidence for identification of signals and how to report to the competent authorities
• Risk-minimization measures (depending on the importance of possible clinical implications)
• Labeling issues, including what pharmacogenomic information to include in the product information.

The EMA press release stated, “Identifying individuals at risk of side effects, unexpected complications or lack of efficacy may help the development of strategies to optimize the use of medicines.” The concept paper is open for public consultation until Mar. 15, 2012.