The future update of ICH M4Q is expected to bring relevant changes to the way quality information is structured and presented, with anticipated impact on Module 2.3 and Module 3 of the dossier.
Beyond the formal change itself, this type of regulatory evolution raises a broader question: is your current CMC maintenance model prepared to absorb that adaptation in an efficient and structured way?
In broad portfolios—especially those including mature products, generics, or products managed across multiple markets—the challenge is not only to adapt a dossier, but to do so consistently, with full traceability, and without creating additional pressure that internal teams may struggle to absorb.
For that reason, preparation for this type of change should not start when the update becomes imminent. In many cases, the real preparatory work involves:
- identifying the most complex or critical dossiers;
- reviewing the level of order and consistency of CMC information;
- assessing the traceability of historical changes and regulatory rationale;
- and evaluating whether the current operating model will be able to support future adaptations in a sustainable way.
The evolution of ICH M4Q will likely be much more than a structural adjustment to the dossier. For many organizations, it will also be a test of how robustly they are managing the CMC lifecycle of their portfolio.
Anticipation does not remove complexity, but it does make it easier to manage with greater control.
Contact us to learn how we can help you strengthen your CMC lifecycle management: [email protected]
