Understanding the role of Regional Centres of Regulatory Excellence in strengthening medicines regulation in Africa


The medical products regulation and harmonisation agenda in Africa is largely motivated by a need to increase access to essential health technologies and bolster continental innovation. An adequate health care workforce and medicines regulatory science expertise are essential factors in contributing to the realisation of this need, as well as in evaluating the efficacy, safety, quality, and performance of medical products. However, human and institutional capacity and regulatory standards and practices continue to lag behind in Africa. In addition, an inadequate and sometimes lack of health care workforce, incoherent ad hoc training of a regulatory workforce, weak infrastructure, and unsustainable health care financing mechanisms have exacerbated the situation. As a result, many African countries still face challenges related to the delivery of quality health care.