Digital Transformation of Medicines Regulation in Africa-Perspectives from a Stakeholder Convening.

Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision-making, and protecting public health, their approaches differ according to institutional structures, capacity, maturity, and regional priorities. In the United States, the FDA adopts a model-focused approach, treating AI primarily as a regulatory science tool to strengthen analytical components of decisions such as patient selection, biomarker substitution, and predictive modeling. The agency emphasizes credibility and validation through a risk-based framework that evaluates AI models according to their influence on regulatory decisions and potential consequences of error. In Europe, the EMA pursues system-level digital transformation, embedding AI within a broader data and analytics strategy emphasizing interoperability, data structuring, automation, and governance supported by legislation. African national regulatory authorities are advancing AI through pragmatic pilot initiatives. The South African Health Products Regulatory Authority (SAHPRA) is implementing AI within a structured digitization strategy, including AI-assisted dossier screening and automated GMP review to address backlogs and workflow inefficiencies. The Medicines Control Authority of Zimbabwe (MCAZ) deploys AI-driven dossier screening through its in-house digital systems, while Kenya's Pharmacy and Poisons Board has proposed a risk-based framework for regulating AI-enabled medical devices. At the continental level, the African Medicines Agency and AUDA-NEPAD aim to harmonize digital transformation and responsible AI adoption through reliance and cross-border data sharing. This paper summarizes discussions from a convening to identify priorities for digitization and digital transformation of African medicines regulation.