Harmonization of bioequivalence standards: A step forward with ICH M13A
On January 25, 2025, the ICH M13A bioequivalence guideline – EMA/CHMP/ICH/953493/2022 "ICH M13A Guideline on bioequivalence for immediate release solid oral dosage forms" – will enter into force
This guideline sets out requirements for the planning, conduct and evaluation of bioequivalence studies of immediate-release systemic dosage forms. ICH M13A aims to harmonize the requirements for conducting bioequivalence studies across different regions of the world, minimizing the need for repeat studies and contributing to a more efficient regulatory assessment.
The ICH M13A guideline will replace the relevant sections of the current CPMP/EWP/QWP/1401/98 Rev. 1 "Guideline on the investigation of bioequivalence". The ICH M13A guideline is the first of three planned (ICH M13A, ICH M13B and ICH M13C). This guideline was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in July 2024. Also in July 2024, the guideline was adopted in Switzerland, and in November 2024, the guideline was adopted in the USA. The implementation process is currently under way in Canada and China.
