EMA Updates Information Page on Bioequivalence Guidelines

On 14 October 2026, the European Medicines Agency (EMA) updated its information page "Investigation of bioequivalence - Scientific guideline". The update explains how new ICH guidelines affect the European regulatory framework. The guideline itself has not been changed.

The guideline sets out requirements for the design, conduct, and evaluation of bioequivalence studies for immediate-release dosage forms with systemic action. The page highlights the following:

• ICH M13A: Since 25 January 2025, this guideline has replaced the corresponding sections of the European guideline on study design, conduct, and data analysis for bioequivalence studies of immediate-release oral dosage forms.
• ICH M13B: This guideline takes effect on 17 March 2027. It will replace the existing EMA requirements for biowaivers for additional strengths, provided in vivo bioequivalence has already been demonstrated for at least one strength.
• ICH M9: Appendix III of the European guideline has already been replaced by the ICH M9 guideline on biopharmaceutics classification system (BCS)-based biowaivers.

For further information, please see the EMA website. You can also find articles on the ICH M13A and M13B guidelines in our news archive.