Two decades of AVAREF: successes, lessons, and the path forward in the African Medicines Agency Era
Benido Impouma, David Mukanga, Mohamed Yakub Janabi
Corresponding author: Benido Impouma, Gates Foundation, Nairobi, Kenya 
Received: 08 Dec 2025 - Accepted: 14 Dec 2025 - Published: 28 Dec 2025
Domain: Global health,Public health
Keywords: African Vaccine Regulatory Forum, African Medicines Agency, National Regulatory Authorities
Funding: This work received no specific grant from any funding agency in the public, commercial, or non-profit sectors.
This article is published as part of the supplement The African Vaccine Regulatory Forum (AVAREF): a model for advancing innovation and achieving continent-wide regulatory harmonization through partnerships and collaboration, commissioned by World Health Organization Regional Office for Africa.
©Benido Impouma et al. Pan African Medical Journal (ISSN: 1937-8688). This is an Open Access article distributed under the terms of the Creative Commons Attribution International 4.0 License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Cite this article: Benido Impouma et al. Two decades of AVAREF: successes, lessons, and the path forward in the African Medicines Agency Era. Pan African Medical Journal. 2025;52(2):1. [doi: 10.11604/pamj.supp.2025.52.2.50546]
Available online at: https://www.panafrican-med-journal.com//content/series/52/2/1/full
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Two decades of AVAREF: successes, lessons, and the path forward in the African Medicines Agency Era
Two decades of AVAREF: successes, lessons, and the path forward in the African Medicines Agency Era
Benido Impouma1,&, David Mukanga2, Mohamed Yakub Janabi1
&Corresponding author
This supplement reflects on nearly two decades of experience of the African Vaccine Regulatory Forum (AVAREF) and examines its contributions to strengthening ethics and regulatory oversight of clinical trials in Africa. Established by the World Health Organization in 2006, AVAREF has played a central role in promoting regulatory collaboration, harmonization, and reliance approaches that support timely and high-quality clinical development of priority health products on the continent. The articles in this supplement explore how AVAREF’s joint review mechanisms, scientific advice processes, and capacity-strengthening initiatives have contributed to improved regulatory efficiency, particularly during public health emergencies and in the development of novel vaccines for diseases of regional importance. They also highlight the enabling factors behind these achievements, including sustained leadership, strong partnerships, and active engagement of national ethics committees and regulatory authorities. As Africa enters a new regulatory era with the operationalization of the African Medicines Agency, this supplement situates AVAREF’s experience as a foundation for future regional regulatory coordination. The lessons presented provide practical insights for advancing clinical trial oversight, supporting local innovation, and strengthening regulatory systems to meet emerging public health and manufacturing priorities.
This supplement highlights the successes, lessons learned, and enabling factors of the African Vaccine Regulatory Forum (AVAREF) over its nearly two decades of existence since its establishment by the WHO in 2006. AVAREF's mandate to strengthen the ethics and regulatory capacities of National Ethics Committees and National Regulatory Authorities has produced tangible results in clinical trial oversight and vaccine development across Africa [1,2]. The forum's involvement has facilitated the development, licensing, prequalification, and introduction of vaccines against meningococcal meningitis, pneumococcal pneumonia, malaria, rotavirus diarrhoea, Ebola, and COVID-19, demonstrating significant impact on disease prevention and control.
The articles in this supplement examine key areas of AVAREF's contribution: regulatory and ethics harmonization initiatives, contributions to research and development of novel vaccines against priority diseases, joint review processes and scientific advice mechanisms for improved clinical trial outcomes, the AVAREF toolkit for efficient oversight and enhanced harmonization, regulatory procedures and timelines during public health emergencies, and AVAREF's evolving role in the African Medicines Agency era. The successes documented reflect the zeal and commitment of ethics committees and National Regulatory Authorities, productive technical and strategic committees, excellent collaboration with the Gates Foundation and other partners, active stakeholder engagement in research and development, and strong WHO secretariat leadership. AVAREF has successfully minimized regulatory inefficiencies, fostered harmonization, and strengthened partnerships, establishing foundations for transformative growth in clinical development. The operationalization of the African Medicines Agency presents unprecedented opportunities to enhance regulatory systems, increase clinical trial activity, and support pharmaceutical manufacturing across the continent.
The African Vaccine Regulatory Forum was established by the WHO in 2006 to strengthen the ethics and regulatory capacities of National Ethics Committees and National Regulatory Authorities for oversight of clinical trials in Africa [3,4]. AVAREF´s contribution to ethics and regulatory systems strengthening and harmonization over nearly two decades has produced tangible results and made an impact on disease prevention and control. Vaccines against meningococcal meningitis, pneumococcal pneumonia, malaria, rotavirus diarrhoea, Ebola, and COVID-19 were all developed, licensed, prequalified, and introduced with the involvement of AVAREF [5-7].
The purpose of this supplement in PAMJ is therefore to highlight successes and lessons of AVAREF and the enabling factors in its two decades of existence. The articles focus on steps taken towards regulatory and ethics harmonization, contributions to R&D of novel vaccines against priority diseases, joint reviews and scientific advice for better outcomes of clinical trials and product approvals, the AVAREF toolkit for efficient oversight and better harmonization, regulatory procedures and timelines for product development in public health emergencies, and AVAREF´s contributions and future role in the African Medicines Agency era. The zeal, commitment, and hard work of ethics committees (EC) and National Regulatory Authorities (NRAs), the productivity of their technical and strategic committees, excellent collaboration and sincere partnerships with the Gates Foundation (GF) and other partners, contribution of stakeholders in R&D, as well as a strong WHO secretariat, led to the successes.
The partnership with the GF ensures an accelerated product development while maintaining the highest international standards of ethics and regulation. The role of the GF and other partners is to support African partners whose bold ideas and creative approaches have the potential to save lives, improve health, and help families across the continent. AVAREF has minimized regulatory inefficiencies, fostered harmonization, and strengthened partnerships, paving the way for transformative growth in clinical development [8]. The Clinical Trial Pilot Project and the operationalization of AMA offer unprecedented opportunities to enhance regulatory systems, increase clinical trial activity, and support pharmaceutical manufacturing and the life science economy on the continent [9]. WHO is committed to further strengthening the capacities of ethics committees and NRAs through AVAREF/AMA and continuing the partnership with partners.
The authors declare no competing interests.
All the authors have read and approved the final version of this manuscript.
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