ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline

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. For more information on harmonisation of BE, please refer to the dedicated ICH M13 page.

Currently, the anticipated finalisation date of ICH M13A is May 2024. Once finalised, the CHMP will implement it as a European guideline superseding the EMA Guideline on the investigation of bioequivalence for these oral dosage forms. Note Appendix III of the EMA guideline is already superseded by the ICH M9 Guideline on biopharmaceutics classification system-based biowaivers.

Keywords:
bioequivalence, clinical trials, immediate release, oral dosage forms, pharmacokinetics

Current effective version

ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b

Consultation dates: 26/01/2023 to 26/05/2023Draft: consultation closedReference Number: EMA/CHMP/ICH953493/2022

Overview of comments received on ICH M13A Guideline on bioequivalence for immediate-release solid oral dosage forms

Reference Number: EMA/CHMP/ICH/953493/2022