The regulation of health technologies is a critical component of any wellfunctioning health system, as it enables access to health technologies of assured quality, safety and efficacy. Recent shifts in the product development landscape have seen initiatives to develop products specifically for diseases predominantly prevalent in developing countries. While the prospect of sorely needed new health technologies is encouraging, their successful introduction into national health systems may require new skills or capacities, as well as robust policy and regulatory frameworks, and safety monitoring systems. In many low- and middle-income countries in Africa, such capacities remain underdeveloped.