Brasília – The Council for International Organizations of Medical Sciences (CIOMS) published a new guideline on the responsible use of artificial intelligence (AI) in pharmacovigilance, offering global recommendations for the safe, ethical and transparent deployment of AI systems in drug safety monitoring. According to Anvisa, which participated in the development process, the document provides direction on risk management, model validation, data governance, human oversight and accountability frameworks to ensure that AI-enabled tools enhance, rather than compromise, patient safety.

The guideline also addresses emerging challenges related to algorithmic bias, system explainability and integration with existing regulatory processes. Anvisa highlighted that the publication represents a significant step toward harmonizing international approaches to AI in pharmacovigilance and will support both regulators and industry in adopting advanced technologies aligned with global best practices.

Source: Anvisa