Strengthening African National Regulatory Authorities Data Systems to Enhance and Track Performance

The Opportunity
Insufficient access to quality, safe, efficacious, and affordable medical products in Africa has posed a significant challenge to public health for decades. The establishment of the African Medicines Agency (AMA)[1] will help to facilitate coordination of regulatory activities and further harmonization across Member States and help drive access.

Over the last decade, the Bill & Melinda Gates Foundation (the Foundation) among other funders and stakeholders has supported the harmonization of regulatory technical standards and optimization of regulatory processes in Africa. The Foundation's Africa regulatory systems strategy addresses all aspects of the newly emerging African tri-level regulatory ecosystem – continental, regional (Regional Economic Communities (RECs)), and national. While AMA will be a key catalyst of Africa's new regulatory ecosystem, it is designed to work within a regulatory network drawing on expertise and other resources from the RECs and National Regulatory Authorities (NRAs). Without strong NRAs, this ecosystem cannot function. At the national level, the Foundation is supporting a number of NRAs to reach WHO maturity level 3 (ML3), and ultimately to become WHO listed Authorities (WLA). This important effort is supported by African governments, the African Union, WHO, and several international partners. As part of the process to attain ML3 and WLA, NRAs need to establish clear Key Performance Indicators (KPIs), and to track and publish these in a transparent manner.