ICH M4Q(R2) Step 2 Presentation Now Available on the ICH Website

27 June 2025

In follow up to the publication of the ICH M4Q(R2) draft revised Guideline in May 2025, the EWG has also prepared a Step 2 informational presentation.

In addition to the typical overview of key changes and concepts, this presentation is designed to support public consultation by expanding understanding of the structure, intent, and expected benefits of the revised framework. It also includes additional information to support stakeholders in the comments submission through the provided template.

The M4Q(R2) Step 2 presentation is available for download on the M4Q(R2) page.

The M4Q(R2) EWG is focusing on the revision of CTD Quality sections in Modules 2 and 3 to capture quality information for the registration and lifecycle management of pharmaceuticals for human use. The main issues to be resolved during this revision 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 authorization.

Establishing the role of M4Q(R2) as the main source of the structure and location of regulatory quality information.

Organizing 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 recognized 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.

Pls check the follow

ICH M4Q(R2)_Draft_Guideline_2025_0514.docx