The Gates Foundation engaged the START Center to support the development of AI-driven regulatory processes in Africa by identifying essential medicines with strong data availability across four key therapeutic areas: malaria, tuberculosis (TB), HIV, and women’s health. The team conducted a structured review to select a gold standard drug and backup compound for each area based on clinical efficacy, pharmacokinetics (PK/PD), safety, regulatory approvals, and real-world use throughout Africa.
To assess AI readiness, the team quantified data availability for each gold standard drug, extracting key metrics such as the number of randomized clinical trials, regulatory approvals, post-market safety reports, and inclusion in global and national guidelines. Additionally, a high-quality sources guide was developed, prioritizing publicly available structured datasets with the identified metrics to support AI-based dossier review. Findings from this review highlight substantial gaps in structured, publicly available data, particularly for essential medicines widely used in Africa. The report provides insights into existing data landscapes and emphasizes the need for standardized, AI-compatible datasets to improve regulatory efficiency and increase access to essential medicines across the continent.
