ICH M13A 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.
This guideline came into effect in the EU on 25 January 2025, six months after its adoption by CHMP, formally superseding applicable parts of the previously enforced EMA Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). This EMA Guideline had been in effect since 1 August 2010. From this date, stakeholders are required to follow ICH M13A recommendations. Specific topics not addressed in ICH M13A will continue to apply until such time as they are replaced by new ICH guidance.
On 17 February 2025, EMA published a three-page implementation document (EMA/531548/2024) to address specific considerations to enable the practical application of the guideline in the EU. With this document EMA wishes to provide guidance for Marketing Authorisation Applicants, Marketing Authorisation Holders, Contract Research Organisations, and Regulators.
BE studies included in a regulatory submission submitted after 25 January 2025 should follow the requirements of ICH M13A. Any deviation from the requirements (e.g. studies conducted in compliance with EMA guideline and finalised before ICH M13A became effective) should be discussed in the respective application and will be assessed on a case-by-case basis.
EMA is currently reviewing all its existing product-specific bioequivalence guidance to determine whether they are compatible with the requirements of ICH M13A, and to revise as needed. After 25 January 2025 and pending finalisation of this revision of existing product-specific bioequivalence guidelines (anticipated Q2 2025), EMA product-specific bioequivalence guidelines will also need to be read in conjunction with the requirements of ICH M13 and any deviations from the ICH or EMA Guidelines will need to be appropriately scientifically justified.
If you would like to know more about bioequivalence studies for your product, or how Starodub can assist your projects, please reach out to us via our Contact form.
