| Notes |
Overview
In the past decade-and-a-half Africa has witnessed an increase in the level of sophistication of biomedical research and the number of products being tested for diseases endemic to the continent, for which no prior knowledge and evidence base exists in more developed economies.
The changing landscape of biomedical research and product testing necessitated the creation of a regulatory platform whose objective is to promote human resource capacity, best practices, common technical requirements and the efficiency and transparency of regulatory processes.
In 2006 the World Health Organization (WHO) created the African Vaccine Regulatory Forum (AVAREF) as an informal capacity-building platform aimed at improving the regulatory oversight of interventional clinical trials being conducted in Africa.
Over the years this platform has demonstrated its value in strengthening regulatory and ethics reviews, promoting harmonized standards and approaches and accelerating the review of vaccines of high public health value – most recently in relation to vaccines against Ebola – among member countries. It has also shed light on the growing complexity of biomedical research, which calls for increased cooperation between partners including donors, researchers, product developers, regulators and the medical ethics community. |