The implementation of the African union model law on medical products regulation and the establishment of the African medicines agency

Abstract

Within Africa, there is insufficient access to quality, safe, efficacious and affordable medical products which can partly be attributed to lack of robust regulatory systems, a lack of competent regulatory professionals in national medicines regulatory authorities (NMRAs) and ineffective regional collaborations among NMRAs. In response to national regulatory challenges, a number of regional harmonisation efforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the African Union (AU) Model Law on Medical Products Regulation.