ICH M12 Guideline on Drug Interaction Studies

The draft ICH M12 Guideline on drug interaction studies was published for comment on the EMA website in July 2022. Now, the final ICH M12 guideline has been published by the EMA and will apply from 30 November 2024. The guideline will replace the EMA Guideline on the investigation of drug interactions when it comes into effect. In comparison to the existing EMA guideline, ICH M12 does not address drug interactions in the gastro-intestinal tract to the same extent. This will be addressed by the development of accompanying EMA guidance, expected to take the form of a Questions and Answers document.

The Final ICH M12 Guideline and the supporting M12 Questions and Answers (Q&As) were adopted just prior to the Fukuoka meeting in May 2024. The guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. The supporting Q&As are intended to provide additional clarification and improve harmonization of drug interaction assessment.

In addition, the harmonized approach is intended to clarify the requirements of various regulatory authorities for the pharmaceutical industry and thus enable resources to be used more efficiently.

More information is available on the ICH Multidisciplinary Guidelines website.