EMA opens consultation on new guideline for gastrointestinal drug-interaction studies
The European Medicines Agency has opened consultation on a draft guideline addressing the design and interpretation of studies assessing drug absorption interactions within the gastrointestinal tract.
The draft guidance focuses on situations where medicines may alter the absorption of other drugs through mechanisms including changes in gastric pH, gastrointestinal motility, binding or complex formation.
Comments are open until 31 December 2026, after which EMA may revise the guideline before final adoption and implementation across European medicines development.
Field | Content |
Alert Type | Industry Update |
Organisation | European Medicines Agency |
Development Type | Draft regulatory guideline and public consultation |
Topic | Drug absorption interactions in the gastrointestinal tract |
Sector | Pharmaceutical regulation; clinical pharmacology |
Geography | European Union |
What Happened | EMA opened a public consultation on a draft guideline covering the design, conduct and interpretation of studies assessing drug absorption interactions in the gastrointestinal tract. |
Why It Matters | The guideline could influence how pharmaceutical companies design interaction studies and demonstrate the safety and effectiveness of medicines whose absorption may be altered by other drugs. |
Key Areas | Gastric pH changes; gastrointestinal motility; binding and complex formation; study design; data interpretation |
Supporting Context | Gastrointestinal interactions can affect drug exposure without involving conventional metabolic or transporter-mediated drug-drug interaction pathways. |
Potential Impact | Final guidance could standardise European expectations for evaluating these interactions during medicine development and regulatory submissions. |
Key Takeaway | EMA is developing more specific regulatory expectations for assessing drug absorption interactions occurring within the gastrointestinal tract. |
What to Watch | Stakeholder feedback before the 31 December 2026 consultation deadline and subsequent publication of the final guideline. |
Primary Source | European Medicines Agency |
Relevant Date | 11 September 2026 |
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