Supporting Health Initiatives (SHI) supports the Rwanda Food and Drugs Authority (Rwanda FDA) to sustain WHO Maturity Level 3 (ML3) and strengthen regulatory capacity for medicines and vaccines. Through targeted technical and operational support, SHI enables structured dossier assessment, performance monitoring, and quality assurance processes to manage increasing application volumes, reduce backlogs, and improve review timelines. This work contributes to strengthened regulatory efficiency and supports Rwanda’s ambition to become a regional hub for vaccine manufacturing.

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 grant supports the Moroccan Agency for Medicines and Health Products (AMMPS) as it transitions into an autonomous national regulatory authority and advances toward higher WHO maturity levels, in line with national reforms and public health priorities.  SHI supports implementation, manages fiduciary processes, and ensures disciplined execution, while AMMPS leadership drives technical direction and ownership.

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.

SHI supported the establishment and early operationalisation of the African Medicines Agency (AMA) and its emerging continental laboratory network, in partnership with AUDA-NEPAD, the African Union Commission, and national regulators. The work focused on translating political mandate into functional readiness, including Governing Board operations, secretariat systems, and the development of a reliance-based continental laboratory network.

This contributed to the progression of harmonised regulatory mechanisms from pilot platforms to operational systems, including the first continental listing of medical products following joint evaluation. SHI supported coordination and ensured disciplined execution, while leadership, decision-making, and ownership remained with AMA and African regulators.

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 supports the Rwanda Food and Drugs Authority (Rwanda FDA) to consolidate progress toward WHO Maturity Level 4. The work focuses on strengthening regulatory throughput, consistency, and assessor capacity through coordinated delivery, mentoring, quality assurance, and performance tracking.  Implementation is supported with disciplined execution, while regulatory decision-making and institutional leadership remain with Rwanda FDA.

The initiative strengthens long-term regulatory self-reliance by embedding systems, skills, and accountability mechanisms aligned with international benchmarks.

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.

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.