Sanofi’s regulatory CMC head, Manda Pasarkar, outlined how ICH’s first major revision to the M4Q quality module in more than 20 years could reshape marketing applications. The shift to M4Q(R2) is designed to move module 2.3 away from static PDFs toward a more knowledge-centric submission model centered on product quality information. The interview also flags operational challenges for legacy portfolios and implementation friction for smaller biotechs, while arguing that the new structure aligns better with advances in manufacturing complexity and information technology. For biopharma teams preparing submissions, the update raises planning questions around data governance, knowledge representation, and transition timelines for existing CMC document workflows.