Back to: ICH M12 Drug-Drug Interaction Studies Final Guidance
🔔 Note: Stop playback at 8:56 to complete this lesson.
Presenter
Helen Heymann, MMSc, PMP, CPH
Regulatory Health Project Manager
Executive Program and Project Management Staff
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This webinar introduces the ICH M12 Drug-Drug Interaction Studies Final Guidance, presented by Helen Heymann, who outlines its framework, rationale, goal, scope, process, timeline, and the implications of its adoption by the FDA. The presentation highlights the critical need to assess drug-drug interactions (DDIs), which can occur when patients, particularly fragile or those with multiple health issues, take more than one drug, posing risks of adverse events or loss of efficacy. Since comprehensively evaluating all DDIs in clinical trials is impractical, the guidance advocates for systematic, risk-based approaches. A key objective of this global harmonization effort is to resolve inconsistencies among previous regional guidelines, which led to differing interpretations across regulatory agencies. Approved in May 2024, the ICH M12 guideline marks the first globally harmonized regulatory guidance for pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters, applicable to small molecules and biologics. This landmark guideline was the result of a six-year collaborative effort involving numerous regulatory agencies and industry organizations and was adopted by the FDA in August 2024, replacing their earlier 2020 guidances on drug interaction studies.