Draft of ICH M13B Guideline on Bioequivalence : EMA

The European Medicines Agency (EMA) published the ICH Guideline M13B on bioequivalence (BE) for immediate-release solid oral dosage forms on April 9, 2025, for public consultation. This document builds on the previously released ICH M13A and is part of a planned three-part series (M13A, M13B, M13C).

The guideline provides recommendations on obtaining biowaivers for additional strengths of drug products once in vivo BE has been established for at least one strength. It applies to oral tablets, capsules, and granules/powders.

Key content includes:

• Criteria for biowaiver eligibility (e.g., pharmacokinetic dose proportionality, composition, in vitro dissolution similarity).
• Specific topics for Fixed Dose Combinations (FDCs) and deviation from direct compositional proportionality.
• A decision tree to determine biowaiver eligibility for non-high-risk drugs.

The draft is available for download, with a public consultation period until July 9, 2025. Comments should be submitted using the provided template.

24-04-2025