The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings regulatory authorities and the pharmaceutical industry together with a mission to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines.
The ICH Expert Working Group (EWG) for M13B intends to publish 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.
The 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.
We invite UK stakeholders and other ICH members to complete the consultation. Following the consultation, the feedback will be reviewed and discussed by the ICH M13B EWG.
We do not intend to publish a full response to this consultation, as comments and suggestions will be reviewed by ICH directly.
The consultation closes at 11:59pm on Thursday, 31 July, 2025.