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.

This initiative supports the Ethiopian Food and Drug Authority (EFDA) to strengthen national regulatory reliance pathways through enhancements to its electronic Regulatory Information System (eRIS), aligned with Ethiopia’s regulatory reform agenda.  The work enables EFDA to monitor reliance-based decisions in real time and track regulatory performance across product categories.

SHI supports implementation and ensures disciplined execution, while EFDA retains technical direction and ownership.

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 supported implementation of the AU Smart Safety Surveillance (AU-3S) programme, an African Union-led initiative to strengthen medicines safety monitoring across the continent.  Working with AUDA-NEPAD and national regulators, SHI supported early operationalisation, governance arrangements, and delivery coordination across pilot countries including South Africa, Nigeria, Ghana, and Ethiopia.  The work focused on enabling joint signal management mechanisms, harmonised operating procedures, and coordinated data use.

The pilot demonstrated how collaborative, Africa-led pharmacovigilance systems can operate at scale, laying foundations for expansion beyond the initial phase and contributing to more resilient post-market surveillance across the continent.

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.