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 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.