Innovating for public health: Towards harmonized medicines regulatory systems in Africa

Abstract

Abstract Harmonization of activities in various facets of health systems is an area of considerable historical and current policy and practice interest in Africa. This article emanates from a two-year analysis of processes towards harmonization of medicines regulatory systems in Sub-Saharan Africa. Indeed due to low levels of regulatory expertise, high regulatory costs and increasing prevalence of unregistered and counterfeit medicines, African countries are pursuing the feasibility of harmonization of their medicines regulatory systems as a policy option. Some of the challenges for attainment of harmonized cross-national regulatory systems include perennial weaknesses in national medicines regulatory systems and continuous changes in stakeholders, champions, motivations and models for the processes and outputs of harmonization. Confirming the presence of an active agenda towards harmonization of medicines regulatory systems in Africa, this article cautions though that harmonization should not be an isolated activity, but should leverage existing regional integration agendas and political legitimacy, while balancing between commercial and health care interests.