Stakeholders in Switzerland have until 09 July 2025 to comment on the draft of Guideline M13B “Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. Current regional or multi-regional guidelines have different views and criteria regarding design of bioequivalence (BE) studies and data analysis. This lack of harmonisation can result in product developers having to follow different approaches in different regions and conducting additional BE studies, hampering streamlined global drug development. Part of the planned ICH M13 Guideline series (M13A-C), the ICH M13B 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 M13B Guideline is the first Guideline in the foreseen series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms. Comments can be provided using the feedback form specified by ICH to networking@swissmedic.ch. Stakeholders will receive confirmation of receipt of their comments but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working groups and taken into account where appropriate.
Links to the guideline and feedback form can be found on the following page: