As artificial intelligence becomes more embedded in drug development, regulatory expectations for AI are rapidly evolving.
In January 2026, the FDA and EMA released Guiding Principles of Good AI Practice in Drug Development, establishing a shared framework for responsible AI use across the therapeutic and regulatory lifecycle Good AI Practice and the Regula….
This commentary examines what Good AI Practice (GxP for AI) means for regulatory teams managing submission strategy, documentation workflows, and health authority interactions.
Inside the piece, we explore:
- FDA and EMA expectations for AI governance in drug development
- Human oversight and risk-based application in regulatory environments
- AI alignment with eCTD structure and submission lifecycle management
- Governance, traceability, and transparency across IND, NDA, and BLA milestones
- For regulatory leaders, AI is not simply about efficiency. It must operate within the same rigor, structure, and lifecycle continuity as the submissions it supports.
Download the full commentary to understand how Good AI Practice applies to regulatory operations and submission lifecycle management.
