The Economic Impact of Reliance on an African Medicines Regulatory Authority

Background and Objectives The inherited backlog of 16,000 medicines applications of the South African Health Products Regulatory Authority (SAHPRA) was cleared through facilitated review pathways that included reliance on prior work by trusted regulators. This research aimed at determining the economic impact of reliance on national regulatory authorities (NRAs) in terms of lower assessors’ costs, especially to offset the financial efforts required to attain a higher World Health Organization (WHO) maturity level and understanding the way fees can sustain NRA activities.