M4Q(R2) is the upcoming second revision of the ICH M4 Quality CTD guideline. It establishes a new and modernised structure for the quality information required in marketing authorisation applications for medicinal products for human use, fundamentally updating how applicants organise and submit CMC data. The revision aims to enhance clarity, consistency, and lifecycle alignment within Modules 2.3 and 3.2 of the CTD.
Building on this framework, the ICH M4Q(R2) Expert Working Group has released “Sakura Bloom R2,” a draft mock example designed to illustrate the proposed structure and presentation of information in the revised Quality modules.
This small-molecule example demonstrates how the concepts outlined in the draft guideline may be applied in practice, supporting clearer understanding of dossier organisation, content expectations, and the future format of quality submissions.
One of the main differences compared to the current structure lies in the respective roles and interaction of Modules 2 and 3. Currently, Module 2.3 primarily serves as a high-level summary of the detailed information presented in Module 3.2, which contains the full CMC data and supporting documentation. Under the new draft guidance, the data provided in Module 3 should be in support of the information in Module 2.
Other noteworthy changes are the enhanced focus on quality by design principles and product lifecycle management. However, the mock example is particularly valuable in illustrating the proposed granularity expected in both Modules, highlighting a significantly more structured approach.
We look forward to seeing how the adoption of M4Q(R2) will streamline regulatory interactions and enhance the clarity and consistency of quality data across product lifecycles. If you want to discuss this topic with our experts, reach out via [email protected]. For more information about our company and areas of interest, visit starodub.nl.
