Supporting Health Initiatives (SHI) supports the Rwanda Food and Drugs Authority (Rwanda FDA) to sustain WHO Maturity Level 3 (ML3) and strengthen regulatory capacity for medicines and vaccines. Through targeted technical and operational support, SHI enables structured dossier assessment, performance monitoring, and quality assurance processes to manage increasing application volumes, reduce backlogs, and improve review timelines. This work contributes to strengthened regulatory efficiency and supports Rwanda’s ambition to become a regional hub for vaccine manufacturing.