Open consultation

Consultation on the International Council for Harmonisation (ICH) M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms

From:: Medicines and Healthcare products Regulatory Agency
Published: 9 May 2025

Summary

The ICH Expert Working Group (EWG) for ICH M13B has been drafting the second guideline in the series which describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for orally administered immediate-release solid oral dosage forms.

This consultation closes at
11:59pm on 31 July 2025

Consultation description

The Medicines and Healthcare products Regulatory Agency (MHRA) became a full member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2022.

Documents