AI-Enabled Global Collaboration

Artificial intelligence has become a core enabler of global pharmacovigilance collaboration — not merely an efficiency tool for individual organisations, but shared infrastructure through which the global safety system is evolving.

VigiAI is the WHO-UMC’s suite of AI tools for VigiBase analysis: NLP models for multilingual ICSR entity extraction, ML-augmented disproportionality analysis, and case similarity detection for duplicate identification — made available to national PV centres through the UMC AI Hub, giving smaller programmes access to AI-assisted signal detection they couldn’t build independently.

DARWIN EU is EMA’s federated real-world evidence network, connecting EHR data sources across EU member states using the OMOP Common Data Model for regulatory RWE studies without patient-level data leaving national custodians. Sentinel NextGen is the current generation of FDA’s active surveillance infrastructure, integrating AI-based signal analytics across more than 100 million covered lives, with near-real-time signal detection for selected product classes expanded in 2024–2025.

What ties VigiAI, DARWIN EU, and Sentinel NextGen together is that each was built by an organisation with resources most national PV programmes don’t have — and each is deliberately designed to be shared rather than kept proprietary. That’s a meaningful shift from how PV technology historically diffused: a smaller country’s regulator no longer needs to build its own AI signal-detection capability from scratch, it can plug into the UMC AI Hub and inherit years of shared development. This is quietly one of the more consequential trends in global PV — capability is becoming decoupled from any single country’s budget.