SHI is supporting this grant to strengthen selected African National Regulatory Authorities (NRAs) to attain and sustain higher levels of regulatory maturity, particularly WHO Maturity Level 3 (ML3) and above, through targeted technical assistance, capacity building, and institutional strengthening. This includes addressing gaps identified in WHO Institutional Development Plans, building assessor and inspector capability, developing policies and standard operating procedures, and enabling peer-to-peer support between more mature and less mature agencies. The ultimate aim is to establish a core group of “anchor NRAs” capable of contributing to regional regulatory systems and supporting the operationalisation of the African Medicines Agency (AMA), while improving oversight of medicines and vaccines to ensure their safety, quality, and timely availability across the continent.

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.

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.