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.

During the early phase of the COVID-19 pandemic, SHI provided surge coordination support to the African Vaccines Regulatory Forum (AVAREF), hosted by WHO AFRO.  The work enabled expedited and reliance-based regulatory pathways through coordinated joint reviews, familiarisation discussions, and decision-tracking across multiple countries.  Coordination support and disciplined execution ensured continuity under crisis conditions, while regulatory decision-making remained with participating authorities.

This strengthened AVAREF’s operational readiness and enabled Africa-led regulatory collaboration to function at speed during a global health emergency.

During a critical phase of COVID-19 vaccine rollout across sub-Saharan Africa, SHI supported the World Health Organization Regional Office for Africa (WHO AFRO) with targeted programme management support.  The work strengthened coordination, tracking, and decision-support within the IMS Vaccines Pillar, improving visibility of rollout readiness, dependencies, and operational risks across countries.

SHI supported implementation and ensured disciplined execution, while leadership, accountability, and policy direction remained with WHO AFRO and Member States.  This contributed to more coordinated, data-informed regional support to countries during a period of significant system pressure.