Consultation on the International Council for Harmonisation (ICH) M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Published 9 May 2025
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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.
The MHRA is consulting with UK stakeholders on the M13B guideline will focus on providing recommendations on obtaining waivers of 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 (‘in vivo’ refers to a medical test, experiment, or procedure that is done on (or in) a living organism, such as a laboratory animal or human). See the draft M13B guideline.
Following the consultation, feedback from the UK and other ICH members will be reviewed and discussed by the ICH M13 EWG.
We do not intend to publish a full response to this consultation, as we are not required to for this type of consultation. Comments and suggestions will be reviewed by ICH directly.