ICH M4Q(R2), “The Common Technical Document for the Registration of Pharmaceuticals for Human Use” is a revised draft version of the guidance that outlines how the quality sections of your medicinal product dossier are presented.

ICH M4Q(R2) was signed off as a Step 2 document in May 2025. Public consultation closed in October 2025. In February 2026 an overview of the comments were published. It was 145 pages long! These comments will be taken into consideration by ICH M4Q (R2) Expert Working Group in the context of Step 3 of the ICH process. Step 4 is aimed to be adopted by June 2027.

The ICH M4Q(R2) revision marks an exciting evolution for eCTD Modules 2.3 and 3.2, modernising the Quality section to fully support emerging therapies and structured digital data.

Its objectives are to improve submission and assessment efficiency, resulting in accelerated access to pharmaceuticals by way of the six ‘E’s:

1. Encouraging global convergence of science- and risk-based regulatory approaches in the preparation of dossiers.
2. Explaining and defining the organisation and positioning of information for Modules 2 and 3.
3. Enriching communication between regulators and applicants and enhancing lifecycle and knowledge management.
4. Embracing product and process innovation.
5. Enabling efficient use of digital tools for submission and assessment and preparing for the closely linked, upcoming ICH guideline on structured pharmaceutical quality submission.
6. Elucidating regulatory expectations and supporting efficient assessments, decision making, and actions.

For industry, it hopes to

• clarify regulatory expectations
• facilitate the application of the enhanced ICH quality strategy/vision
• streamline regulatory application preparation
• improve the quality of submissions
• facilitate data and information management
• promote communication with regulators
• and foster harmonisation and standardisation of data/information requirements for regulatory submissions, while increasing regulatory convergence

But what does this ICH update mean for you?

Module 2.3 will no longer just be a retrospective summary of Module 3. It will serve as the basis of regulatory assessment and will facilitate lifecycle management.

It will be a comprehensive overview of the product and core quality information. Its components will apply science- and risk-based principles.

Module 3 will serve as a repository for the detailed descriptions of methods, data, and other relevant quality information that supports Module 2.3

Most subsections will follow a ‘DMCS’ model:

• Description: Identifies the material and its key characteristics;
• Manufacture: Outlines the production process and process controls;
• Control: Describes quality control measures such as specifications;
• Storage: Provides container closure system, stability, storage condition, and retest period/shelf life.

 Implementation

As you will see R2 is simply not just a reorganisation of information, it will require careful and detailed planning and efforts to implement. HOWEVER, clarification on transition and implementation timelines are awaited.

Future

Here at ERA, we will keep up to date on this topic, as it evolves, by attending workshops and webinars when they become available.

We hope to see the publication of clear guidance from the regulators and a pragmatic approach adopted (especially for legacy products). We wouldn’t say no to a nice little Q&A document either…

If you would like to discuss any of the above and if you need support with any of your future applications, we are ready to assist you and your team. Feel free to contact us and we will be happy to help.

Written by

Fiona Downey