Public consultation on ICH Guideline M4Q(R2) “Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality” launched in Switzerland

Swissmedic launches the public consultation on Guideline M4Q(R2) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 24 October 2025 for comments.

Stakeholders in Switzerland have until 24 October 2025 to comment on the draft of Guideline M4Q(R2) “Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality”.

The M4Q(R2) revision focuses on CTD Quality sections in Modules 2 and 3 to capture quality information for the registration and lifecycle management of pharmaceuticals for human use. The Revision will further improve registration and lifecycle management efficiency, leverage digital technologies, and accelerate patient and consumer access to pharmaceuticals.

This revised ICH guideline will include:

• Expanding the scope of M4Q(R1) guideline. This M4Q(R2) guideline applies to all pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorisation.
• Establishing the role of M4Q(R2) as the main source of the structure and location of regulatory quality information.
• Organising product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.
• Incorporating concepts and data expectations presented in ICH Quality guidelines and aligning with currently recognised international standards and guidelines.
• Better capturing the pharmaceutical development and the proposed overall control strategy, which should be the backbone of the revised M4Q structure. This should address key elements of the proposed pharmaceutical product, including the Quality Target Product Profile (QTPP), manufacturing process, and overall control strategy.
• Enhancing the Quality Module 2 to facilitate the efficiency and effectiveness of regulatory submissions and assessments.

Comments can be provided to networking@swissmedic.ch using the feedback form specified by ICH. 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: