White Paper: The Global AI Regulation Shift in Pharma Biotech

Artificial intelligence is no longer a future consideration in life sciences regulation. Regulators are already using AI to review submissions, target inspections, and assess compliance, fundamentally changing expectations for data integrity, documentation quality, and governance.

In this NSF Life Sciences white paper, our experts examine how global regulators are embedding AI into oversight between 2025 and 2028, and what this means for pharmaceutical, biotech, and medical device organizations. From the EU AI Act and GMP Annex 22 to the FDA’s deployment of agentic AI, the regulatory environment is shifting rapidly from guidance to enforcement.

This resource provides practical insight into how AI is reshaping regulatory scrutiny and outlines the actions life science leaders must take now to remain compliant, inspection-ready, and competitive.

What you’ll learn

• How regulators in the EU, UK and US are using AI to accelerate reviews and inspections.
• Why AI governance, validation and lifecycle oversight are becoming non-negotiable.
• The implications of the EU AI Act, Annex 22 and FDA agentic AI for regulated workflows.
• What “good” AI governance looks like in GxP and regulatory environments.
• How to assess your organization’s readiness for AI-driven oversight.