ICH - M12 Guideline reaches Step 4 of the ICH Process

6th June 2024

ICH - M12 Guideline reaches Step 4 of the ICH Process

The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.

This 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 Questions and Answers is intended to provide additional clarification and improve harmonisation of drug interaction assessment.

A Step 4 Introductory Training Presentation has been developed by the M12 EWG to summarise the content of the Guideline.

Further information can be found on the M12 page, including the Guideline and the Step 4 Introductory Training Presentation available for download.

Back to Recent News