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.
Methods
To this end, the assessor costs associated with reliance and full review applications were calculated and compared. A high-level review of African NRA fee structures was also carried out and pharmaceutical industry input was solicited regarding the feasibility of alternative tariff modalities for low- and middle-income (LMIC) NRAs.
Results
The investigation showed a marked reduction in time spent in reliance assessments compared to full reviews, with an associated decrease in reviewers’ costs; SAHPRA conserved US$277,413 across the 188 applications applying reliance principles. The NRA fee structure review revealed outdated fees with little diffeentiation between full and reliance assess-ment. NRAs lack the financial esources to strengthen regulatory systems; WHO Global Benchmarking Tool activities are not directly covered by levied fees. Overall, the pharmaceutical industry was supportive of advancing the maturity of African NRAs and was willing to pay increased fees for reliance reviews when authorities adhere to published timelines. More expensive fast-track services were cited, making an argument for higher fees for reliance assessment when this enables medicines to reach markets quicker.
Conclusions
Reliance is a tool to safeguard NRA resources and support regulatory and information systems strengthening. The study illustrates the return on investment of reliance for NRAs and, if optimally implemented, the benefits or patients.
Danks, L., Semete-Makokotlela, B., Gouws, R., Otwombe, K., Walker, S. & Salek, S. The Economic Impact of Reliance on an African Medicines Regulatory Authority. Pharm Med (2025). https://doi.org/10.1007/s40290-025-00553-2
