AI-ENABLED HORIZON SCANNING FOR GLOBAL HEALTH POLICY AND DRUG REGULATION: A FRAMEWORK FOR CROSS-JURISDICTIONAL HARMONIZATION

*Chinenye Blessing Onyekaonwu

ABSTRACT

The growing complexity of pharmaceutical innovation and the fragmentation of regulatory frameworks across jurisdictions continue to constrain timely access to safe and effective medicines. This study investigates how artificial intelligence (AI) can be systematically integrated into global health policy and drug regulation through an AI-enabled horizon scanning framework designed to support cross-jurisdictional harmonization. Using a mixed-methods approach that combines qualitative case analysis of existing AI deployments with quantitative assessment of stakeholder perceptions, the research evaluates how automated data ingestion, semantic normalization, and predictive analytics can transform regulatory workflows. The proposed framework operationalizes horizon scanning by continuously monitoring regulatory texts, clinical evidence, and safety signals, enabling early detection of emerging risks, prioritization of high-impact submissions, and automated comparison of jurisdictional requirements against harmonized reference standards. Findings indicate that AI reduces regulatory cycle times, improves consistency in safety evaluations, and minimizes duplication across agencies while preserving national regulatory autonomy through interoperable architectures and federated data governance. The study further demonstrates that AI-driven decision support enhances policy agility, strengthens international coordination, and provides auditable, reproducible analytics that reinforce accountability. Policy recommendations emphasize common technical standards, legal clarity for automated decision support, and institutional mechanisms for human oversight. By extending regulatory practice from retrospective compliance toward predictive, adaptive governance, this research establishes AI as a structural enabler of coordinated global drug regulation. The framework offers a scalable pathway for aligning regulatory processes, improving public health responsiveness, and fostering equitable access to therapeutics in an increasingly interconnected healthcare ecosystem.

Keywords: Artificial Intelligence; Horizon Scanning; Drug Regulation; Global Health Policy; Regulatory Harmonization.