Bioequivalence and Bioavailability Forum

Dear all,

see the EMA’s announcement of 02 August 2024.

ICH M13A 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 oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
The ICH M13A Guideline is the first guideline in a foreseen ICH series describing the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms.
On 25 January 2025, the date of coming into effect, ICH M13A will supersede applicable parts of the EMA Guideline on the investigation of bioequivalence related to bioequivalence study considerations and data analysis for a non-replicate study design.
Note: Appendix III of the EMA guideline is already superseded by the ICH M9 Guideline on biopharmaceutics classification system-based biowaivers.
Further EMA guidance on how the ICH M13 series will replace the EMA guideline will be published in due course.

CHMP adopted ICH M13A Guideline on bioequivalence for immediate release solid oral dosage forms – Step 5 on 25 July 2024.
See also the Q&A document.

Not sure what is meant by »in due course«. While M13B (strength biowaivers) will be doable, M13C (dealing with HVDs, NTIDs, and advanced BE study design and data analysis) will be a nightmare to develop. The current approaches of the FDA and all others (‼) are controversial to such an extent that a compromise will be impossible. Who will prevail?