Artificial Intelligence in Pharmacovigilance: Guiding Principles from the CIOMS Working Group XIV
Year: 2026
Type: article
Abstract: Artificial intelligence (AI) is increasingly being explored to support pharmacovigilance activities including processes involving individual case safety reports. These technologies may improve efficiency and enable new analytical capabilities, but they also raise important questions regarding the responsible use of these systems in contexts that directly support regulatory decision-making and patient safety. In response to these opportunities and challenges, the Council for International Organizations of Medical Sciences (CIOMS) set up Working Group XIV on Artificial Intelligence in Pharmacovigilance to establish and promote principles and guidance for this area. The resulting CIOMS report was published in December 2025 and presents seven guiding principles: risk-based approach, human oversight, validity and robustness, transparency, data privacy, fairness and equity, and governance and accountability. To maximise stakeholder awareness and understanding, this article provides an overview of the CIOMS XIV guidance and illustrates how these principles may be applied in practice through selected use cases. The report aims to support stakeholders in developing and deploying AI systems in a manner that maintains scientific rigor, transparency, and public trust while enabling innovation to support safe use of medicines worldwide.
Source: Drug Safety
Authors: G. Niklas Norén, Julie Durand, Vijay Kara, Elizabeth MacEntee Pileggi, Hua Carroll, Sanna Hill, Manfred Hauben, Taxiarchis Botsis, Lembit Rägo, CIOMS Working Group XIV, Russ Altman, Taxiarchis Botsis, Jean-Michel Dogné, Justyna Amelio, Luisa Barrios, Andrew Bate, Arvind Bellur, Adrian Berridge, Hua Carroll, Yauheniya Cherkas, Selin Cooper, Mariane Diniz, Douglas Domalik, Piero Francesco Franco, Julie Girod, Neal Grabowski, Manfred Hauben, Thomas Henn, Vijay Kara, Dieter Kempf, Kostadinos Kidos, Denny Lorenz, Elizabeth MacEntee Pileggi, Ravi Patel, John Reinhard Pietzsch, Hans-Jörg Römming, Walter Straus, James Whitehead, Brian Buch, Julie Durand, Kirsten Egebjerg Juul, Kendal Harrison, Satoko Hirokawa-Voorburg, Alexander Horst, Morten Jensen, Jesper Kjær, Benny Ling, Monica Da Luz Carvalho Soares, Yusuke Matsunaga, Dirk Mentzer, Manuela Messelhäußer, Flávia Moreira Cruz, Nicolas Perez, Irene Scholz, Thomas Stammschulte, Phil Tregunno, Roli Mathur, Eva-Lisa Meldau, G. Niklas Norén, Stephen Rosenfeld, Brian Yau, Stephen Heaton, Sanna Hill, Hervé Le Louët, Lembit Rägo, Kateriina Rannula, Panos Tsintis
Institutions: Uppsala Monitoring Centre, European Medicines Agency, GlaxoSmithKline (United Kingdom), GlaxoSmithKline Research & Development Limited (United Kingdom), Johnson & Johnson (United States), Biogen (United States), Council for International Organizations of Medical Sciences, Merck Healthcare Germany GmbH (Germany), Merck Healthcare KGaA, Darmstadt (Germany), Johns Hopkins University
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $4,990
OpenAlex ID: W7204275338