A revised draft of the ICH M4Q guideline has recently been released for public consultation. This important guideline defines how quality information should be structured and located within applications for all human medicinal products, including both initial and post-approval submissions.
We have read this announcement with great interest, as the restructuring of this section of the CTD is expected to have a significant impact on the regulatory affairs field.
Currently, under version R1 of the M4Q guideline, Module 3 serves as the primary basis for regulatory review, while Module 2 is largely a summarised “copy and paste” of its contents. The proposed revision, M4Q(R2), introduces a significant reorganisation of both Modules 2 and 3.
Module 2.3 will become the central document for regulatory assessment, offering a concise, high-level overview and lifecycle management framework. It will include:
- General Information (2.3.1)
- Development and Control Strategy (2.3.2)
- Core Quality Information (2.3.3)
- Development Summary and Justification (2.3.4)
- Product Lifecycle Management (2.3.5)
- Product Quality Benefit-Risk Considerations (2.3.6)
Module 3 will contain the detailed data and supporting methodologies referenced in Module 2.3. Content will be organised by component (e.g., drug substance, substance intermediate, excipient, drug product) using standard subsections:
- Description
- Manufacture
- Control
- Storage
This new structure is expected to come into effect in two years time. In short, M4Q(R2) aims to deliver a more flexible and detailed framework to enhance the preparation, review, and lifecycle management of quality dossiers across global regulatory landscapes. We are interested to follow these changes in the future and how these will be implemented. If you have any thoughts on this, it will be interesting to exchange ideas here.
When you are planning to submit a new MAA or post-approval update in the near future and could benefit from regulatory support, our team is ready to assist with in-depth expertise in the current CTD quality structure. Feel free to contact us at [email protected].
