EMA publishes Considerations regarding the Implementation of ICH M13A on Bioequivalence

On 26 February 2025, the European Medicines Agency (EMA) published a new document entitled "Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms".

Background

ICH M13A Guideline on bioequivalence for immediate-release solid oral dosage forms came into effect on 25 January 2025. The guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post-approval phases for orally administered immediate-release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. It aims to ensure consistency and reliability in demonstrating bioequivalence for these products.

ICH M13A is the first part of a planned three-part guideline series (M13A, M13B, M13C).

Implementation of ICH M13A and Transition Period

The purpose of the new 3-page document (Reference number EMA/531548/2024, dated 17 February 2025) is "to address specific considerations to enable the practical application of ICH Guideline M13A in the European Union and the transition from the current EMA Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). This document is intended to provide guidance for Marketing Authorisation Applicants and Marketing Authorisation Holders, Contract Research Organisations, and Regulators."

It is pointed out that "after 25 January 2025, the EMA Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1) pertaining to specific topics not addressed in ICH M13A will continue to apply until such time as they are replaced by new ICH guidance."

EMA will revise existing product-specific bioequivalence guidelines to align with ICH M13A by Q2/2025. Until these updates are complete, both ICH M13A and existing EMA guidelines must be considered together.

For further information and to download the documents, please see the "ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline" section on the EMA's website.