Nov–Dec2025Virtual
AVAREF Pilot Network – Expert support review
AVAREF supported Review for Investigational Vaccine under the AVAREF Pilot Network
WHAT'S AVAREF
Our Vision
A continent where every African has timely access to innovative, safe, effective, and affordable medicines, vaccines, and other health products of assured quality.
Our Mission
Supporting African countries to strengthen clinical trial ecosystem through regulatory and ethical oversight, harmonization, timely decisions, and promotion of excellence along the innovation life cycle.
Engage With Us
Stay informed about AVAREF’s latest work, publications, and upcoming events, and join the community advancing clinical trial excellence in Africa.
AVAREF Ecosystem Survey 2025 – Initiative
×The AVAREF Ecosystem Survey 2025 is a regional evidence-building initiative designed to map the current state of clinical trial oversight across Africa. It provides a standardized baseline of how National Regulatory Authorities (NRAs) and Ethics Committees (ECs) operate, including their review timelines, staffing, resources, digital systems, and emergency preparedness.
By collecting accurate, nationally validated information, the initiative supports AVAREF’s mandate to strengthen regulatory systems, improve harmonization, and accelerate access to high-quality clinical trials. The data will help identify bottlenecks, highlight priority gaps, and guide targeted capacity-building efforts such as training, policy development, digital transformation, and regional collaboration.
Insights from the survey will also inform the long-term AVAREF Strategic Roadmap (2025–2035), including development of harmonized pathways, strengthening of joint review mechanisms, and investment planning. The results will be used to track progress over time and support transparent, evidence-based regulatory strengthening across the continent.
Featured & Upcoming Events
Shows 6 most recent by default. Use filters (status, type, year, category) or click Next to browse older activities.
Nov–Dec2025Virtual
Multi-country scientific advice
This scientific advice supported the preparation of the Phase II Larissa II clinical trial protocol for the Rift Valley Fever vaccine candidate
Apr–Nov2025Virtual
Reliance-based facilitated registration
This facilitated registration process supported rapid, aligned evaluation of the Men5V conjugate vaccine in high-risk meningitis belt countries.
It applied AVAREF’s reliance model to accelerate access while ensuring rigorous review.
Apr–Sep2025Virtual
Ebola post-exposure prophylaxis CTA
This joint review evaluated the EBO-PEP clinical trial application for Ebola post-exposure prophylaxis across four primary countries, with four additional observer countries. It enabled harmonized assessment of scientific, ethical, and safety considerations for outbreak-relevant research.
Mar–Aug2025Virtual
Preparedness master protocols (platform trials)
This joint review assessed multicountry Clinical trial Master protocols for Filovirus Solidarity and Partners trials, supporting Africa’s preparedness for future filovirus outbreaks.
28–29MAY2025
TCC – Mid-year technical review
This meeting reviewed progress of AVAREF’s technical workstreams for 2025 and validated priorities for the second half of the year.
It focused on guideline development, pilot implementation, and strengthening regulatory preparedness.
02–03OCT2025
AVAREF Digital Platform workshop
This workshop provided hands-on training on the use of the AVAREF digital platform to facilitate joint reviews and reliance workflows.
It aimed to improve reviewer coordination, data sharing, and tracking of multi-country review processes.
24–26SEP2025
ATMP regulatory frameworks (TRS 1048)
This workshop supported African countries in adapting WHO regulatory guidance on human cells, tissues, and advanced therapies.
It focused on TRS 1048 Annex 3 and the development of national frameworks for ATMP regulation
22–23SEP2025
Pilot countries harmonization kickoff
This workshop launched the Harmonization Working Group, establishing a collaborative structure to advance regulatory convergence across 16 pilot countries.
It initiated a comparative analysis of regulations and processes to support the development of a long-term harmonization roadmap
Aug–Oct2024Virtual
Emergency facilitated review (EUA)
This facilitated review supported rapid evaluation of the MVA-BN Mpox vaccine dossier for emergency use across 13 African countries.
It aimed to ensure harmonized scientific and regulatory conclusions to guide national emergency decisions.
Jun–Sep2024Hybrid
R21/Matrix-M facilitated review (reliance)
This facilitated review supported synchronized assessment of the R21 malaria vaccine across 22 African countries.
It applied reliance principles to accelerate national implementation while maintaining rigorous scientific review.
Apr–Jun2024Virtual
Severe Malaria CTA – SMAART-MAP
This joint review evaluated the SMAART-MAP clinical trial application through a harmonized, multi-country process.
It enabled coordinated scientific and ethical assessment across six African regulators.
Jan–Feb2024Hybrid
TB vaccine candidate CTA joint review
This joint review examined the clinical trial application for a new TB vaccine candidate across four African countries.
It aimed to harmonize key scientific, safety, and ethical considerations for trial initiation.
19–20SEP2024
Advisory Committee – Strategic guidance
This AC meeting provided strategic guidance on AVAREF’s role in the clinical trial ecosystem in the era of AMA.
It reviewed TCC recommendations, endorsed key initiatives, and agreed on priorities for the AVAREF Clinical Trial Pilot Project
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15–16SEP2024
TCC – Technical agenda & AC recommendations
This TCC meeting advanced AVAREF’s technical agenda and prepared recommendations for the Advisory Committee.
It focused on the clinical trial pilot project, guideline and tool development, performance metrics, and support to AMA operationalization.
MAR2024Virtual
TCC – Annual technical review
This meeting reviewed progress on AVAREF’s technical programmes for 2023–2024 and validated priorities for the year ahead.
It focused on guideline development, joint review processes, and strengthening the reliance mechanisms.
23–27SEP2024
CTA assessment training (Francophone)
This workshop strengthened the capacity of francophone African regulators to assess clinical trial applications using AVAREF tools and international standards.
It focused on non-clinical, clinical, statistical, and quality assessment, as well as GCP, pharmacovigilance, and inspection.
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18–20SEP2024
Ethics oversight & WHO benchmarking tool
This workshop strengthened national ethics committees’ capacity to review clinical trials and to use the WHO Benchmarking Tool for Research Ethics Oversight.
It combined technical lectures, case studies, and group work to identify gaps, best practices, and priority actions for ethics system strengthening
15–19JUL2024
CTA training (Southern & Eastern Africa)
This regional workshop built the capacity of Southern and Eastern African regulatory reviewers using AVAREF’s harmonized CTA evaluation tools.
It combined in-person and virtual sessions with practical dossier-based exercises.
15–19APR2024
CTA assessment training (West Africa)
This workshop strengthened the capacity of 3 West African regulators to assess clinical trial applications using AVAREF tools.
It provided hands-on training with real dossiers and harmonized evaluation grids
22–26JUL2024
Clinical trial ecosystem optimization mission
This AVAREF assessment examined Zambia’s clinical trial review and approval system to identify bottlenecks, overlaps, and root causes of long timelines.
It aimed to develop concrete actions and a strategic roadmap to optimize regulatory and ethics processes and move toward AVAREF and WHO maturity targets.
23–26JAN2024
Clinical trial ecosystem optimization mission
This mission assessed Ethiopia’s clinical trial ecosystem to identify strengths, bottlenecks, and opportunities for optimization.
It aimed to support the country in improving oversight systems, timelines, and site readiness.
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