African Vaccine Regulatory Forum: Strengthening Ethics and Regulatory Capacity in Clinical Trials Oversight of Complex Products in Africa

This proposal aims to optimize the regulatory and ethical oversight for African clinical trials, including better clarity of processes for sponsors, involving national regulatory authorities and ethics committees, addressing disparate national requirements, as well as enhancing regulatory readiness for R&D during public health emergencies. While a lot of work has gone into developing harmonized requirements across Africa, as well as work-sharing through the African Vaccine Regulatory Forum (AVAREF) joint reviews, challenges prevail. Several countries have fully implemented AVAREF processes and guidelines, however, a significant number have not. The investment will further consolidate the gains made over the years and promote efficiency through reliance, work-sharing, and resource-sharing across Africa and align with the newly established African Medicine Agency to build convergence and harmonization in trials. It will also improve capacity to address complex clinical trials within Africa. Complex products are under development to address public health priorities. These products, including treatments for snakebites and human infection studies, require non-traditional clinical trial designs. Expertise, workshops, technical advice sessions, guidance documents, monitoring and evaluation of impact and institutionalization for sustainability would be required. The goal of all these activities is to increase equitable access to safe and effective medical products of assured quality.