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Swissmedic: Launch of public consultation on ICH Guideline M4Q(R2) “Guideline on the Common Technical Document for the registration of pharmaceuticals for human use – Quality”

8 July 2025

Swissmedic: Launch of public consultation on ICH Guideline M4Q(R2) “Guideline on the Common Technical Document for the registration of pharmaceuticals for human use – Quality”

Swissmedic has launched the public consultation on Guideline M4Q(R2) “Guideline on the Common Technical Document for the registration of pharmaceuticals for human use – Quality” of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for stakeholders in Switzerland. The consultation process will end on 24 October 2025.

The guideline provides guidance on the structure and format for presenting information on quality aspects in the Common Technical Document (CTD) and applies to all medicinal products for human use requiring a marketing authorisation. The revision focuses on CTD Quality sections in order to capture quality information for the registration and lifecycle management of pharmaceuticals for human use. Furthermore, it shall improve the efficiency in registration and lifecycle management, leverage digital technologies as well as accelerate patient and consumer access to pharmaceuticals.

For more information, see here.

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