African Vaccine Regulatory Forum (AVAREF)
in the African Region have quality control laboratories in place.
have developed legislation for medical products, only.
have full-time regulatory personnel conducting assessment of quality and preclinical data.
About the African Vaccine Regulatory Forum (AVAREF)
What is AVAREF?
AVAREF is the African Vaccine Regulatory Forum, a network of ethics committees and national medicines regulatory authorities of African countries.
Why was AVAREF created?
African Vaccine Regulatory Forum (AVAREF) was established by WHO as a platform for strengthening regulatory capacity for clinical trials and harmonization of regulatory practices through joint activities.
The development of vaccines and medicines against diseases that affect millions of Africans such as malaria, HIV/AIDS, and tuberculosis is carried out outside the region. But these products require testing in humans in Africa which is endemic for these diseases. The capacity of the National Regulatory Authorities (NRAs) in African countries, that are eventual users of these vaccines or become centers for clinical trials to regulate clinical trials, was weak. The need therefore arose to create a forum for discussion and exchange of information, build capacity, and facilitate collaboration for the evaluation of vaccines, during clinical development and later registration.
What is a clinical trial or clinical evaluation of a vaccine?
Vaccines are made and tested systematically in carefully designed experiments, first in animals and then in humans. These human studies of new products are called clinical trials.
What does AVAREF do?
AVAREF exists to strengthen ethics and regulatory capacity for clinical trials ensuring oversight of product development in African countries. AVAREF’s vision is “An African population that has timely access to safe and efficacious medical products of assured quality”. New terms of reference endorsed in June 2016, have expanded AVAREF scope beyond clinical trials for vaccines to all medical products, and embraced a product life cycle approach.
Do vaccines and medicines need to be regulated?
Yes. Because these products are first tested in animals and then in humans starting with small number of adults and then to more people and younger people until we are certain they are safe and can protect or cure illnesses. Regulators ensure that the testing in humans meets international standards of safety for the human subjects.
Governance of the African Vaccine Regulatory Forum (AVAREF)
How is AVAREF managed?
AVAREF has four bodies that manage its strategic and operational functions viz - the Assembly; Steering Committee; Technical Coordination Committee; and, Secretariat. The Assembly is the overarching body of AVAREF. A special session is convened at the African Medicines Regulators Conference that is attended by all heads of agencies, that forms the Assembly.
The Steering Committee defines policies, strategies, and plans for AVAREF, and oversees implementation by AVAREF members. The Steering Committee is comprised of 16 representatives drawn from the eight RECs in the AU.
The Technical Coordination Committee serves as a standing committee of the SC, providing advice and guidance on all matters related to scientific and technical issues, and working closely with Secretariat and the Steering Committee. The Secretariat functions will be performed by the WHO.
Who funds AVAREF?
AVAREF is currently funded by the Bill and Melinda Gates Foundation. Previous funding has come from the EU (through the European and Developing Countries Clinical Trials Partnership - EDCTP), and Canada (through the Canadian HIV Vaccine Initiative (CHIV).
Who are AVAREF members?
All 54 African countries are eligible to become members of AVAREF provided they commit to subscribe to the principles and goals of AVAREF. Regional Economic Communities (RECs) are associate members of AVAREF, while regulatory agencies (from outside Africa), industry associations, PDPs, NGOs, donors, researchers, and any other relevant stakeholders can be admitted as observers.
How does one become a member?
Send an email to the Secretariat based at WHO AFRO in Brazzaville Congo (avarefsec [at] who.int) and request for a membership application and guidelines. They will also soon become available on the AVAREF webpage on the WHO AFRO website.
How does a country benefit by being part of AVAREF?
Through information, scientific knowledge, and best practices that are shared among members enabling countries to make informed decisions regarding the authorization and inspection of clinical trials for all medical products, as well as for the evaluation of registration of dossiers for vaccines in the region. AVAREF provides opportunities for training, mentorship and provides external expertise as needed to countries for review, and authorization of clinical trial applications.
Steering Committee Members (AVAREF)
|Ms Portia Nkambule, South Africa||Mr Hiiti Sillo, Tanzania|
|Ms Portia Nkambule is Director for Clinical Evaluations and Trials at the Medicines Control Council of South Africa where she oversees the work of the Clinical Trials, Clinical Evaluations – Pre and Post Registration Unit, Pharmacovigilance, and Section 21 units and is responsible for authorization of the use of unregistered medicines.||Mr Hiiti Sillo is currently the Director General of the Tanzania Food and Drugs Authority (TFDA) since June 2011 after acting in the same capacity since May 2010. Prior to this, he served the Authority on several managerial positions that included the Director of Medicines and Cosmetics between 2008 and 2010.|
|Dr Paul Ndebele, Zimbabwe||Dr Samba Cor Sarr, Senegal|
|Dr Paul Ndebele is the Director General of the Medical Research Council of Zimbabwe (MRCZ). He joined the MRCZ from the Division of AIDS (DAIDS), at the National Institutes of Health (NIH) in USA, where he was serving as a Contractor Bioethicist at the Henry Jackson Foundation for the Advancement of Military Medicine.||Dr Samba Cor Sarr is the Chief of the Health Research Department within the Ministry of Health, Senegal. He has served as coordinator of the National Health Research Review Committee since 2004. He has served as principal investigator of the EDCTP project “Strengthening of National Ethical Committee Capacity in Africa”, and coordinated research and related ethical aspects during the West Africa Ebola Virus Disease epidemic, and as a member of the Steering Committee for the global summit of bioethical committees held in Mexico June 2014.|
|Dr Simon K. Langat, Kenya||Mr Yehulu Denekew, Ethiopia|
|Dr Simon K. Langat is Chief Science Secretary and Head of Health Science for the National Commission for Science, Technology and Innovation (NACOSTI) of Kenya. He is also Secretary, National Bioethics Committee, and Vice-Chairperson of the Bioethics Society of Kenya.||Mr Yehulu Denekew is the Director General of the Food, Medicine and Health Care Administration and Control Authority of Ethiopia (FMHACA), an institution he has been leading since 2007.|
|Dr Rassul Nalá, Mozambique||Mr Hudu Mogtari, Ghana|
|Dr Rassul Nalá works for the National Institute of Health within the Ministry of Health of Mozambique. She has been a member of the National Bioethics Committee since its inception in 2002, and serves as Executive Secretary to the Committee. She also chairs the National Task Force for Eradication of Polio in Mozambique.||Mr Hudu Mogtari is the Chief Executive Officer for the Ghana Food and Drugs Authority (FDA) since 2013.Mr Mogtari received his Bachelor of Science in Pharmacy at the Hacetepe Üniversitesi, Master of Business Administration from the Ghana Institute of Management and Public Administration, attended a course in Strategic Management for Regulatory and Enforcement Agencies at the John F Kennedy School of Government at Harvard.|
|Ms Kasanga Sakha, Zambia|
|Ms Kasanga Sakha is a Senior Registration Officer with the Zambia Medicines Regulatory Authority where she is responsible for management and assessment of new applications for human medicines and biotech products as well as management of activities involved in clinical trial authorization and monitoring.|