EMA publishes new Guideline

August 07, 2012

The European Medicines Agency (EMA) has published its new Guideline on the Investigation of Drug Interactions, coming into effect January 1, 2013. The new document, replacing the version from 2010, is essential to ensure regulatory compliance in drug development.

As the Guideline’s introduction says: “Drug-drug interactions are a common problem during drug treatment and give rise to a large number of hospital admissions as a result of medically important, sometimes serious or even fatal adverse events. Drug-drug interactions can also cause partial or complete abolishment of treatment efficacy. The ageing European population, where polypharmacy is more frequent, increases the likelihood of such interactions and underlines the importance of a scientifically sound understanding of the potential for drug-drug interactions for all new chemical entities. A number of drugs have been withdrawn from the market as a result of drug-drug interactions that were only discovered post-marketing.”

The new Guideline outlines a comprehensive, systematic and mechanistic approach to the evaluation of the interaction potential of a drug during its development and offers guidance to ensure that the prescriber receives clear information on the interaction potential as well as practical recommendations on how the interactions should be managed during clinical use. It contains recommendations on the pharmacokinetic and pharmacodynamic drug-drug interaction studies as well as food-drug interaction studies to be conducted including advice on study design, presentation of study results and translation of these results to treatment recommendations in the labeling of the drug. General advice is also given for herbal medicinal products.

SOLVO offers further reading about the document and has made it available for download.