ArticlePharmaceutical medicine2025
The Economic Impact of Reliance on an African Medicines Regulatory Authority.
Article in Pharmaceutical medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Development and validation of an artificial intelligence proof-of-concept tool for risk-based quality assessment of generic medicines: a South African case study.Frontiers in medicine · 2026Article
- The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects.Frontiers in medicine · 2026Review
- Reliance into Action : Understanding EMA Documents to Streamline Reliance for Marketing Authorization Applications.Therapeutic innovation & regulatory science · 2025Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesThe 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.
methodsTo 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.
resultsThe 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 differentiation between full and reliance assessment. NRAs lack the financial resources 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.
conclusionsReliance 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 for patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.