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.

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.

SHI supported the ZAZIBONA collaborative medicines regulatory initiative, a SADC-based work-sharing mechanism led by participating national regulatory authorities.  The work strengthened coordination, continuity, and delivery of joint regulatory activities across countries, while national authorities retained full regulatory decision-making authority.

Coordination support, fiduciary oversight, and disciplined execution enabled the mechanism to function effectively across multiple jurisdictions.  This contributed to sustained joint assessments, improved operational processes, and strengthened performance tracking, supporting more efficient progression from joint review to national authorisation.

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.

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.