Europe Advances AI Testing to Reshape Drug Safety Oversight

The EU is pushing AI beyond pilots in drug safety, signaling new expectations for data quality, oversight, and regulatory readiness

6 Feb 2026

Europe is quietly reshaping how drug safety is watched. Artificial intelligence, once confined to research papers and pilot projects, is edging closer to real regulatory use in pharmacovigilance.

The shift is being driven by Horizon Europe’s Innovative Health Initiative, which is steering regulators and industry away from experimentation and toward practical testing. The goal is not hype, but learning what actually works when AI meets the daily demands of medicine safety.

That pressure is real. Safety teams now face a flood of information from patients, clinicians, clinical trials, and routine healthcare. Millions of safety reports arrive each year. Human review alone struggles to keep pace, raising the risk of delays in spotting potential harm. EU funding calls are meant to support AI tools that can sift through this volume, flag unusual patterns, and help experts focus their attention where it matters most.

This does not mean AI is about to run Europe’s drug safety systems. For now, the emphasis is collaboration. Regulators, pharmaceutical companies, and researchers are working together to test how these tools perform in realistic settings. Evidence from these efforts will shape what comes next, rather than sweeping mandates.

European regulators are also careful about the rules of the road. The European Medicines Agency has laid out principles that stress human oversight, transparency, and systems that can explain their reasoning. AI is framed as a support for expert judgment, not a substitute for it.

For drug companies, the message is already clear. Clean data, interoperable systems, and strong digital foundations are becoming essential to credible engagement with regulators. Even if AI is not yet required everywhere, being unprepared is starting to look like a risk in itself. Earlier insight into safety signals could mean fewer surprises later and steadier risk management.

There are still hurdles. Data fragmentation, internal change, and fears of over automation remain unresolved. But the direction is unmistakable. Europe is building a cautious, shared framework to see how AI can strengthen drug safety without eroding trust.

Pharmacovigilance is not transformed yet. But the testing phase is ending, and real oversight is coming into view.