Public Consultation on ICH M13B Guideline on Bioequivalence launched in Switzerland

As recently reported, the European Medicines Agency (EMA) published the "ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b" on its website for public consultation.

The M13B Guideline is part of the planned ICH M13 Guideline series (comprising M13A–C) and provides recommendations for conducting bioequivalence studies during the development and post approval phases for orally administered immediate-release solid dosage forms, such as tablets, capsules, as well as granules or powders for suspension. The aim is to harmonize the currently differing regional requirements for the design and analysis of bioequivalence studies in order to avoid redundant studies and to make global drug development more efficient.

In a presss release dated 22 April 2025, Swissmedic announced that stakeholders in Switzerland have the opportunity to comment on the draft guideline until 9 July 2025. Comments can be sent to the Swiss authority by email using the feedback form provided by the ICH.

Regarding the further procedure, Swissmedic states: "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."