The Chemistry, Manufacturing, and Controls (CMC) regulatory landscape is rapidly evolving to streamline product registration and lifecycle management through digital and science risk-based approaches. A key driver of this transformation is the revision of ICH M4Q (R2), modernizing the Quality Common Technical Document. Complementing this, the forthcoming ICH Structured Product Quality Submissions (SPQS) guideline introduces harmonized, structured data formats for product quality, catalyzing the shift from document-centric files to standardized, data-driven electronic submissions and enabling more automated exchange between industry and regulators. In parallel, the emerging ICH Pharmaceutical Quality Knowledge Management (PQKM) concept promotes data-centric knowledge capture and reuse across the lifecycle, improving consistency, transparency, and the quality of CMC information.

Collectively, these initiatives advance global harmonization by aligning data structures and definitions across regions; strengthen benefit–risk evaluation through more complete, comparable datasets; and accelerate patient access by reducing redundancies and enabling parallel, reliance-based reviews. They also lay the foundation for cloud-based submissions, AI-assisted analytics, and collaborative reviews by standardizing digital CMC submissions and supporting real-time data sharing with version control. Ongoing multi-agency programs, including Project Orbis, ACCESS, and ICMRA’s PAC reliance pilots, stand to benefit from digital CMC data submissions, as structured, reusable data improves cross-agency comparability, enables shared analytics, and streamlines both marketing authorization and post-approval change assessments.

This session will present current initiatives, practical examples, and actionable recommendations to help organizations prepare their data, systems, and teams for digital CMC and collaborative review at a global scale.

Session Speakers:

Connecting Industry and Regulators in the QbD Landscape
Sarah Pope Miksinski, Gilead Sciences, Inc.

ICH M16 - Transitioning to Structured Product Quality Submissions
Rodrigo Palacios, F. Hoffmann-La Roche Ltd.

Collaborative CMC Assessment of Post-Approval Change Management Protocols: A Regulatory Health Authority-Perspective
Willie Wilson III, CDER, FDA

No AI Without Architecture: FHIR as the Data Foundation
Kåre Hyttel, NNIT A/S

Fadi Hakki

Appearances