AVAREF Partners
AVAREF is based on the Pan-African Clinical Trials Partnership (PACTA) principle, which brings together Ethics Committees (ECs), National Regulatory Authorities (NRAs), the Pan-African Clinical Trials Registry(PACTR) and other partners involved in product development and clinical trials. The key partners of AVAREF provide financial and technical support to AVAREF. Partners participate in all Steering Committee and Technical Coordinating Committee meetings to plan and implement activities with the AVAREF Secretariat, providing expert advice and support. Partners fall into three broad categories:
Funding Partners
The Bill & Melinda Gates Foundation currently funds AVAREF. Previous funding partners include the European Union, through the European and Developing Countries Clinical Trials Partnership (EDCCTP) and the Government of Canada, through the Canadian HIV Vaccine Initiative.
Technical Partners
Technical partners include NRAs from other countries, including the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), Swissmedic, and Health Canada, as well as the Paul Ehrlich Institute, the Wellcome Trust and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University.
Collaboration Partners
Collaboration partners include the Coalition for Epidemic Preparedness Innovations (CEPI), the United States Agency for International Development (USAID), the International AIDS Vaccine Initiative (IAVI), the Africa Centres for Disease Control and Prevention (Africa CDC), and the African Academy of Sciences (AAS). Collaboration partners support AVAREF initiatives through providing technical support and/or collaboration to strengthen regulatory system strengthening and improve access to quality medicines and vaccines in the region.
Funding Partners
1) The Economic Community of West African States (ECOWAS)
The Bill & Melinda Gates Foundation is a key longstanding partner of AVAREF, providing financial, technical, and other support as needed. The foundation’s work with AVAREF is in synergy with the support they provide to the AMRH and aims to ensure predictable timelines for clinical trials and accelerated product development in Africa.
2) The European and Developing Countries Clinical Trials Partnership (EDCTP)
The EDCTP provided funding to AVAREF until 2009. The EDCTP supports capacity building for clinical trials and product development in Africa. As a major product development partner, EDCTP supports ECs and NRAs in different African countries, and provided critical support for AVAREF to ensure accelerated product development to address public health priorities.
Technical Partners
1) U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has provided technical support in collaboration with the AVAREF Secretariat. Technical staff of the FDA share expertise and updated regulatory developments through presentations in AVAREF webinars and related capacity building events.
2) European Medicines Agency
The European Medicines Agency (EMA) is an important partner of AVAREF, providing regulatory collaboration and information-sharing. Regulators of the EMA participate in AVAREF Joint Reviews for clinical trial applications and share dossiers for product development as well as information on products which have been tested in clinical trials in Europe.
3) Swissmedic
Swissmedic is the Swiss authority responsible for the authorization and supervision of therapeutic products. It serves as a technical partner to the AVAREF.
4) Health Canada
Health Canada is the government agency responsible for Canada’s federal health policy. It provides technical support to the AVAREF Secretariat.
5) Paul Ehrlich Institute (PEI), Germany
The Paul Ehrlich Institute (PEI) is a German research institution and medical regulatory body, and is the German federal institute for vaccines and biomedicines. PEI provides technical support to some AVAREF Member States and works with the AVAREF Secretariat to undertake assessments and provide training to ECs and NRAs.
6) The Wellcome Trust
The Wellcome Trust is an independent global charitable foundation based in the UK. Wellcome is a technical partner of AVAREF.
7) Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center)
The MRCT Center is a research and policy center at Brigham and Women’s Hospital and Harvard University. The Center works to identify challenges and deliver solutions for global clinical trials, with a focus on emerging economies. The Center provides technical support to AVAREF.
8) Medicines and Healthcare Products Regulatory Authority (MHRA), UK
The MHRA – the UK’s regulatory authority – plays a key role in research, clinical trials and product development globally. It provides expert advice to the NRAs of AVAREF Member States and shares information on clinical trials of products.
Collaboration Partners
1) The African Medicines Regulatory Harmonisation (AMRH)
The African Medicines Regulatory Harmonisation (AMRH) Initiative, led by the AUDA-NEPAD, has been a longstanding collaborator with AVAREF. In 2019, it was agreed that AVAREF would become one of AMRH’s Continental Technical Working Groups. Once this change in governing structure is officially implemented, AVAREF will report to the AMRH Steering Committee and its activities will be coordinated by the AMRH Joint Secretariat (comprising AUDA-NEPAD and WHO representatives) with the AMRH Partnership Platform (AMRH PP).
2) The Coalition for Epidemic Preparedness Innovations (CEPI)
CEPI is a global partnership launched in 2017 to develop vaccines to stop future epidemics. CEPI is an innovative global partnership between public, private, philanthropic, and civil society organizations. CEPI and AVAREF work together to accelerate the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines during outbreaks.
3) The Africa Centres for Disease Control and Prevention (Africa CDC)
The Africa CDC is the disease control arm of the African Union. It provides advocacy and policy support to AVAREF.
4) African Academy of Sciences (AAS)
The African Academy of Sciences (AAS) is a not-for-profit pan-African organization that works to see transformed lives on the African continent through science. AAS is a collaboration partner of AVAREF.
5) Africa Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD)
AUDA-NEPAD is the development agency of the African Union. AUDA-NEPAD is a key partner of AVAREF, working with WHO to ensure that AVAREF is aligned with the AMRH. AUDA-NEPAD and AVAREF constitute the joint secretariat of the AMRH.