22 April 2025 – Swissmedic has launched the public consultation on Guideline M13B of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines). Stakeholders in Switzerland can comment on the draft of the Guideline “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” until 9 July 2025.

Current regional or multi-regional guidelines have different views and criteria regarding the design of bioequivalence (BE) studies and the subsequent data analysis. This lack of harmonisation could hamper streamlined global drug development, with product developers having to follow different approaches in different regions.

For more information, see here.