Artificial Intelligence in Pharmacovigilance: Guiding Principles from the CIOMS Working Group XIV.
TL;DR
An overview of the CIOMS XIV guidance on Artificial Intelligence in Pharmacovigilance presents seven guiding principles and illustrates how these principles may be applied in practice through selected use cases.
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.