WHAT IS AVAREF?

A vision of an African population with timely access to safe and efficacious medical products of assured quality.

ABOUT US

The AdVAncIng Clinical TRials Excellence in Africa (AVAREF) is the regional platform advancing clinical trial regulation, ethics oversight, and collaborative capacity building across Africa. 

MANDATE

Established by WHO in 2006, AVAREF brings together all 55 African National Regulatory Authorities (NRAs) and National Ethics Committees (NECs) to build shared regulatory capacity, harmonize processes, and accelerate access to safe, effective, and quality-assured medical products.

Objectives

Patient Safety

Promoting patient safety by strengthening regulatory practices and ensuring reliable oversight in healthcare systems.

Trial Transparency

Enhancing the timeliness and transparency of clinical trials conducted across Africa for better outcomes.

Innovation & Research

Stimulating innovation and advancing scientific research across Africa to support health and development.

Review & Inspection Quality

Improving efficiency and quality of regulatory reviews and inspections to build trust and accountability.

Regulatory Harmonization

Accelerating the African Medicines Regulatory Harmonization (AMRH) process to align all Regional Economic Communities.(RECs)​

Emergency Preparedness

Strengthening preparedness across the continent, in RECs, and in individual countries to respond to emergencies.

Governance Structure

Click each box for more information

  • AMRH Steering Committee
    Strategic Director & Oversight

    AMRH Steering Committee

    Strategic Director and Oversight

    Strategic direction & oversight. Responsible for setting AVAREF’s strategic direction, workplans, and priorities. It includes representatives from all 8 African Union Regional Economic Communities (RECs) to ensure continental inclusivity and alignment.

    • AVAREF Assembly
      Highest decision-making body

      AVAREF Assembly

      Highest decision-making body

      The highest decision-making body, composed of all Heads of National Regulatory Authorities (NRAs) and National Ethics Committees (NECs). It provides continental-level leadership and endorses strategic directions.

      • Technical Coordinating Committee
        Coordination and Oversight

        Technical Coordinating Committee

        Coordination and Oversight

        Coordination & Acts as the main scientific and technical advisory body. It ensures coherence across AVAREF’s workstreams, guides technical initiatives, and reviews deliverables from the working groups.

        • Antimicrobial Resistance (AMR)

          Antimicrobial Resistance (AMR)

          Focuses on regulatory preparedness for clinical trials addressing AMR, including antibiotics, diagnostics, and stewardship interventions. It contributes to WHO’s One Health approach and AMR strategic objectives.

        • Vaccine R&D

          Vaccine R&D

          Supports regulatory readiness for early-stage vaccine development and clinical trial design. The group collaborates with product developers, research centres, and WHO partners to ensure ethical and scientifically rigorous vaccine R&D in Africa. It plays a critical role in pandemic preparedness, equitable innovation, and the adoption of novel platforms and technologies.

        • Controlled Human Infection Models (CHIM)

          Controlled Human Infection Models (CHIM)

          Develops frameworks for the ethical and regulatory oversight of CHIM studies across African countries, ensuring safety and compliance with international standards.

        • Snakebite Treatment (SBT)

          Snakebite Treatment (SBT)

          Works on protocols and regulatory guidance for clinical trials evaluating antivenoms and other snakebite interventions, contributing to WHO’s NTD roadmap.

      • AVAREF Secretariat
        Coordination and Support

        AVAREF Secretariat

        Coordination and Support

        Located at the WHO Regional Office for Africa, the Secretariat is responsible for day-to-day coordination, partner engagement, documentation, knowledge-sharing, capacity-building activities, and resource mobilization.

The AVAREF Secretariat and Key Functions

Housed within the WHO Regional Office for Africa in Brazzaville, the Secretariat coordinates AVAREF’s operations, partnerships, and strategic implementation.

Clinical Trial Reviews

Organizing joint and assisted clinical trial reviews, both virtually and in person

Training & Education

Coordinating training workshops, continuing education, and specialized webinars

Communication & Engagement

Managing communication, outreach, and partner engagement

Guidelines & Tools

Drafting and publishing guidelines, emergency frameworks, and technical tools

AMA & System Strengthening

Supporting the African Medicines Agency (AMA) and strengthening national systems

Expert Roster & Specialists

Maintaining the Roster of Experts, mobilizing technical specialists across clinical trial domains