AVAREF Overview

The African Vaccine Regulatory Forum (AVAREF) is a network of African national regulatory authorities and ethics committees that uses harmonization and reliance as pillars for capacity building.

AVAREF works to ensure collaboration between key stakeholders across the continent—including donors, health professionals, and regional economic blocs—by promoting joint reviews and the sharing of work and expertise.

As a result of AVAREF’s efforts, vaccines against meningitis, malaria, rotavirus, pneumococcal pneumonia, and Ebola have been developed, and medicines against neglected diseases such as human African trypanosomiasis and leishmaniasis are currently being developed.

 

Misson

The African Vaccine Regulatory Forum (AVAREF) is a network of African national regulatory authorities and ethics committees that uses harmonization and reliance as pillars for capacity building.

AVAREF works to ensure collaboration between key stakeholders across the continent—including donors, health professionals, and regional economic blocs—by promoting joint reviews and the sharing of work and expertise.

As a result of AVAREF’s efforts, vaccines against meningitis, malaria, rotavirus, pneumococcal pneumonia, and Ebola have been developed, and medicines against neglected diseases such as human African trypanosomiasis and leishmaniasis are currently being developed.

 

History

AVAREF was established by the World Health Organization (WHO) in 2006 as a platform for building ethics and regulatory capacity for clinical trials in Africa and promoting the harmonization of ethics and regulatory processes on the continent. AVAREF emerged as the natural outgrowth of a 2006 joint review of a clinical trial application for a new group A meningococcal conjugate vaccine and the subsequent joint good clinical practice (GCP) inspection of the vaccine’s phase II trial. Since 2006, AVAREF has convened annual meetings to review clinical trial applications for vaccines against meningitis, malaria, tuberculosis, and other diseases.

Recognizing the pressing health needs on the continent, the AVAREF Assembly extended AVAREF’s governance and scope during its 2016 meeting in Addis Ababa, Ethiopia. While AVAREF’s initial focus was on vaccine clinical trials, its new mandate includes improving and harmonizing ethics and regulatory processes for clinical trials of vaccines as well as medical products and devices, in line with its 2018-2020 strategic plan. In addition, in 2019, AVAREF became one of the Continental Technical Committees of the African Medicines Regulatory Harmonisation (AMRH) Initiative. Once the new governance structure is implemented, AVAREF will play a significant role in supporting the African Medicine Agency to become better established.

Among many other activities, AVAREF has been working collaboratively with Member States and sponsors to expedite emergency joint reviews of clinical trial applications for products that target COVID-19.

 

AVAREF’s History at a Glance

2006	AVAREF is founded by WHO to ensure timely regulatory evaluations of clinical trial applications and to accelerate the research & development of medical products AVAREF convenes its first joint review of a clinical trial application for a phase III malaria vaccine
2007-2014	AVAREF holds annual meetings with Member States to review vaccine clinical trial applications
2014-2015	AVAREF holds joint reviews to expedite clinical trial applications for Ebola interventions
2016	AVAREF’s mandate under the AMRH Initiative expands to include clinical trial applications for all medical products, rather than just vaccines
2020	AVAREF introduces an emergency joint review process for COVID-19 interventions, reducing the length of the review process to only 10-15 days AVAREF approves a new Compassionate Use Guide

 

AVAREF Information Brochure

Download for One Pager Introduction of AVAREF (English)

Download for One Pager Introduction of AVAREF (Français)