Across the globe, regulatory authorities are embracing artificial intelligence (AI) to enhance their scientific assessments and decision-making processes. Two major agencies, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are setting important examples of how AI can be responsibly integrated into regulatory frameworks.
The FDA recently announced the successful completion of its first AI-assisted scientific review pilot. This initiative demonstrated that AI can support the review of complex data by improving the speed, consistency, and scalability of analyses. Importantly, while AI enhances the technical review, final decisions remain firmly in the hands of human experts. The FDA is now actively advancing a broader, agency-wide AI strategy to further embed these technologies into its operations, aiming for greater efficiency, transparency, and innovation across all regulatory activities.
Meanwhile, the EMA has been emphasizing the power of data and advanced analytics in improving public and animal health outcomes. In its latest communications, EMA outlines how it is strengthening its capabilities to harness data science and AI. By making better use of large datasets and sophisticated analytical tools, EMA is enhancing the quality of its scientific evaluations, enabling faster, evidence-based responses to emerging health threats, and reinforcing public trust.
Both agencies show that AI is no longer a future ambition, it is becoming an integral part of regulatory science today. Their initiatives underline a crucial message: AI should serve to support, not replace, expert judgment, ensuring that technological innovation goes hand-in-hand with safeguarding public health.
As regulatory bodies around the world follow suit, the integration of AI promises a new era of more data-driven, efficient, and transparent regulation while keeping human oversight at its core.
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