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 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.

SHI supported the development of an evidence-based strategy to strengthen pharmaceutical manufacturing and regulatory skills in Africa, with focused analyses in Ghana and South Africa. The work assessed regulatory and manufacturing skills gaps, reviewed existing training provision, and analysed alignment with regulatory maturity and industry demand.   SHI supported structured analysis and ensured disciplined execution, while findings and strategic direction were shaped through engagement with regional stakeholders.

The initiative identified scalable, high-impact intervention options, contributing to a shared understanding of where targeted skills development could strengthen local manufacturing, regulatory resilience, and health security.

SHI supported the South African Health Products Regulatory Authority (SAHPRA) to address a historically entrenched medicines registration backlog of more than 16,000 applications inherited at the Authority’s establishment. The work translated strategic intent into sustained operational execution at scale, including coordinated delivery, mobilisation of regulatory assessor capacity, and strengthening of workflows, quality assurance, and performance tracking.  SHI supported implementation and ensured disciplined execution, while regulatory decision-making and institutional leadership remained with SAHPRA.

The programme contributed to complete backlog clearance, restoring regulatory throughput and confidence, and strengthening internal systems to sustain performance beyond the life of the programme.

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.

SHI supported the African Union Development Agency–NEPAD (AUDA-NEPAD) to prepare for the transition of the African Medicines Regulatory Harmonization (AMRH) initiative into the African Medicines Agency (AMA) following adoption of the AMA Treaty. The work focused on developing a continent-wide Country Engagement and Implementation Plan to align national regulators, policymakers, and regional bodies around a shared approach to AMA operationalisation.  SHI supported coordination and ensured disciplined execution, while leadership and decision-making remained with AUDA-NEPAD and African institutions.

The initiative strengthened readiness for treaty ratification and early AMA operationalisation, while maintaining continuity of existing AMRH programmes during a critical institutional transition.