ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline

ICH M13B Guideline is intended to provide recommendations (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of 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.

The ICH M13B Guideline is the second 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 international harmonisation of BE, please refer to the dedicated ICH M13 page.

Specific considerations to enable the practical application of ICH M13 Guidelines in the European Union and the transition from the current EMA Guideline on the investigation of bioequivalence have been published here: ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms.

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

Current version

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

Draft: consultation closed Consultation dates: 09/04/2025 to 09/07/2025 Reference Number: EMA/CHMP/ICH/85092/2025 Summary:

This guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of 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.

Comments should be provided using this template. The completed comments form should be sent to [e-mail] 

Overview of comments received on ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver (EMA/CHMP/ICH/85092/2025)

Reference Number: EMA/237572/2025