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.

This grant focused on strengthening regulatory systems and advancing medicines regulation across multiple African countries through targeted technical support, regional collaboration, and capacity building. The work was delivered in partnership with national regulatory authorities and regional bodies, with SHI playing an enabling and coordination role to support implementation, fiduciary oversight, and programme execution.

The initiative contributed to improved regulatory performance, supported progress toward WHO maturity levels, and facilitated more efficient and harmonised regulatory processes across participating countries. Key areas of achievement included strengthening institutional systems, supporting digital and data-driven regulatory tools, enabling regional work-sharing mechanisms, and building sustainable capacity within national authorities.

SHI supported the Africa Centre for Disease Control and Prevention (Africa CDC) to address regulatory and policy bottlenecks affecting access to COVID-19 vaccines and therapeutics across Africa.  The work identified priority constraints in clinical trial authorisation and marketing approval processes, and clarified Africa CDC’s convening role alongside continental mechanisms such as AVAREF and AMRH.  The initiative resulted in an evidence-based position paper and implementation roadmap, enabling engagement with Ministers of Health and Heads of State on actionable, Africa-led reforms during a critical phase of the pandemic.

A landmark multi-country investment advancing digital and AI-ready regulatory systems across National Regulatory Authorities and the African Medicines Agency.  The work advances digital systems, AI and Software-as-a-Medical-Device regulatory readiness, and the development of a 5–10-year continental digital and AI roadmap.

SHI supports implementation and ensures disciplined execution across national and continental workstreams, while governance, adoption, and long-term ownership remain with African institutions.

 

 

SHI supports the Rwanda Food and Drugs Authority (Rwanda FDA) to consolidate progress toward WHO Maturity Level 4. The work focuses on strengthening regulatory throughput, consistency, and assessor capacity through coordinated delivery, mentoring, quality assurance, and performance tracking.  Implementation is supported with disciplined execution, while regulatory decision-making and institutional leadership remain with Rwanda FDA.

The initiative strengthens long-term regulatory self-reliance by embedding systems, skills, and accountability mechanisms aligned with international benchmarks.