EMA Publishes ICH M13B Guideline on Bioequivalence for Additional Strengths

In April 2025, the European Medicines Agency (EMA) released the draft ICH Guideline M13B on Bioequivalence for Immediate Release Solid Oral Dosage Forms – Additional Strengths for public consultation, with comments due by 9 July 2025. The guideline advises on obtaining waivers for bioequivalence (BE) studies when in vivo BE is established for at least one strength. It applies to development and post-approval phases of orally administered immediate-release products, including tablets, capsules, and powders for suspension.

Feedback published on 25 July 2025 came from industry, academia, and professional bodies such as Medicines for Europe, EUFEPS, and the German Pharmaceutical Society. Key topics included dissolution profile similarity (f2 factors), batch selection flexibility, analytical validation in non-QC media, variability considerations, bootstrap methodology, and refined definitions. The ICH M13B Expert Working Group is now reviewing these inputs as part of Step 3 of the ICH process.

10-08-2025