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The New ICH M12 Guideline – Harmony at Last for DDI Studies!

There is a sigh of relief as the new ICH M12 guideline for drug interaction studies is finally released. The new harmonised guideline, adopted in May 2024, is now likely to be implemented by all the major regulatory agencies who have been actively involved in its creation including the US FDA, the EMA and the Japanese PMDA. Previously, each authority had their individual DDI guidance all with distinct differences in protocols and interpretation, leading to practical challenges in designing and interpreting DDI studies to meet all the recommendations. The new ICH M12 aims to simplify the process by providing a single set of guidelines for the designing, conducting and interpreting metabolic enzyme- or transporter-mediated drug-drug interaction (DDI) studies. The guideline covers both in vitro and clinical DDI studies. It provides a consistent approach to replace existing recommendations from the main regulatory authorities.

The ICH M12 harmonised guideline is concentrated predominantly on small molecules. The DDI of biologics is only briefly covered with a focus on monoclonal antibodies and antibody-drug conjugates. Recommendations on how to address metabolite-mediated interactions and the use of model-based evaluations and DDI predictions are also included.

Watch out for our series of blogs on the key differences between the previous US FDA, EMA and Japanese PMDA guidance and the new ICH M12 and how you might be impacted by the changes. We are also busy updating our popular Everything you need to know about ADME and our DDI guides – we will let you know as soon as these are available!

Read the new ICH M12 guideline on drug interaction studies

We are on hand to assist you with designing, conducting and interpreting your DDI study according to the new ICH M12 guideline:

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