Public consultation on ICH Guideline M13 “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” launched in Switzerland


Swissmedic launches the public consultation on Guideline M13 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 26 May 2023 for comments.

Stakeholders in Switzerland have until 26 May 2023 to comment on the draft of Guideline M13 “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 M13A Guideline is intended to provide recommendations on conducting BE studies during both the development and post-approval phases for orally administered immediate-release (IR) solid dosage forms. This Guideline is the first in the planned series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid dosage forms. Comments can be provided using the feedback form specified by ICH to 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: