Practical implication
PV teams should update SOPs related to DDI study design and regulatory compliance to align with the ICH M12 guidelines. Additionally, workflows regarding gastrointestinal interactions will need revision following forthcoming guidelines addressing these gaps.
The ICH M12 guideline, effective from 30 November 2024, establishes best practices for designing, conducting, and interpreting drug-drug interaction (DDI) studies. This guideline supersedes the previous EMA guideline and specifically focuses on pharmacokinetic interactions mediated by metabolic enzymes and transporters, with limited coverage of gastrointestinal interactions.
What changed: The introduction of the ICH M12 guideline standardizes DDI study methodologies, phasing out the EMA Guideline on Drug Interactions Revision 1 from 1 January 2013. It also outlines gaps in gastrointestinal interaction assessments, prompting further guidelines to address these gaps.
Why it matters: This regulatory update is critical as it impacts all marketing authorization holders (MAHs) and sponsors by enforcing a more consistent standard for DDI evaluations, which is essential for patient safety and effective treatment outcomes. Effective implementation will help prevent adverse events linked to drug interactions, particularly in polypharmacy scenarios.
Practical implication: PV teams should update SOPs related to DDI study design and regulatory compliance to align with the ICH M12 guidelines. Additionally, workflows regarding gastrointestinal interactions will need revision following forthcoming guidelines addressing these gaps.
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- Source: EMA - What's new RSS
- Published at source: 2026-09-11T00:00:00.000Z
- Discovered by monitor: 2026-09-11T21:31:04.783Z
Published from the regulator source ingestion pipeline after PV impact triage.
