From black box to clear box: explainable AI for next-gen pharmacovigilance

The EU AI Act classifies PV algorithms as 'high-risk,' imposing strict requirements for human oversight and transparency, aligning with the FDA's GMLP and India's Responsible AI principles. The review emphasizes traceability and governance, recommending convergence with human oversight into a regulatory-fit XAI framework to maximize safety signal detection and foster international trust in AI-based decision-making.