Backing The Enablers: Strengthening the foothold of African National Regulatory Authorities
September 29, 2026
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Africa’s regulators are being asked to do more, faster, and to a higher standard, yet most remain financially constrained. A clear-eyed look at the funding architecture suggests a workable path forward.
Across Africa, the spotlight on medicines regulation has rarely been brighter. The establishment of the African Medicines Agency, the steady expansion of local pharmaceutical manufacturing, and a growing pipeline of complex products, from biologicals to digital health technologies, have placed national medicines regulatory authorities (NRAs) at the centre of the continent’s public health and industrial policy agenda. Yet the financial foundations on which these institutions stand remain, in most countries, fragile and poorly aligned with the workload that they are now expected to carry. If this is left unaddressed, we risk the slow erosion of the quality, safety, and efficacy assurances NRAs were established to provide.
This article highlights the functions of NRAs, the current funding mechanisms, their limitations, and the interventions required to achieve financial sustainability. We argue that financial sustainability is less a question of NRAs finding new money; the real work lies in building the legal mandate, cost effective fee architecture, and operational efficiency needed to sustainably finance, retain, and reinvest resources in the regulatory services that underpin their public health mandate.
Financial sustainability should therefore be viewed as an institutional capability rather than simply a funding objective. It depends on appropriate legislation, effective governance, fit-for-purpose organizational structures, efficient regulatory processes, digital transformation, quality management systems, and sustainable financing mechanisms working together to enable regulators to consistently deliver their public health mandate.
National Regulatory Authorities exist to ensure the quality, safety, and efficacy of medical products circulating within a country. Their mandate cuts across medicines, vaccines, blood and blood products, medical devices and diagnostics, and traditional or herbal products. NRAs sit at the gate of the medical product supply chain, with core functions across the full product life cycle, from marketing authorisation, licensing of establishments, regulatory inspections, laboratory testing, clinical trials oversight, market surveillance, pharmacovigilance, and, where applicable, lot release of biological products.
When these functions are performed competently, patients benefit from safer, more effective treatments, public payers obtain better value, and manufacturers operate in a predictable environment. When they are not, the consequences range from the circulation of substandard and falsified medical products to lost investment and delayed access to innovation. The WHO Global Benchmarking Tool classifies NRA performance on a four-level maturity scale, with maturity level 3 (ML3) signalling a stable, well-functioning regulatory system and ML4 representing an advanced level of performance and continuous improvement. For most African NRAs, reaching and sustaining ML3 has become the defining institutional ambition of the decade.
African NRAs are typically funded through three channels, namely, direct government budgetary allocations, fees levied on regulated industry for services rendered, and, to varying degrees, donor or development partner contributions. The mix differs markedly from one country to another. Some authorities rely almost entirely on a single source - most often a government grant - while others draw on all three. Funding arrangements vary considerably across the continent. In some countries, NRAs remain dependent on government allocations and may be required to remit regulatory fees to the national treasury rather than retain them for regulatory operations.
A smaller group of African authorities operate closer to a cost-recovery model, in which fees charged for services finance a substantial share of operations. Even where African NRAs have a legal basis to retain the revenue that they generate, the proportion of operating costs covered by fees is often well below what is needed to sustain a modern, risk-based regulatory operation.
Donor funding remains an important, though variable, third pillar. Several authorities have benefited from targeted investments in infrastructure, training, and information systems, but such support is, by design, time-limited and cannot substitute for predictable, domestically generated revenue. The longstanding guidance is that external investment should strengthen systems and capabilities rather than underwrite recurrent operating costs.
The financial pressures facing African NRAs are real, but they are also more nuanced than a simple shortage of funds. In our work with African NRAs, we have seen six structural issues recur across the continent.
Translating these principles into practice requires a combination of legal, financial and operational reforms. Five interventions are particularly important.
The African Union Model Law on Medical Products Regulation provides a tested reference text that countries can domesticate to grant their NRAs explicit powers to levy, collect, and retain fees for services rendered. This is a foundational reform that NRAs should implement, and all subsequent measures rely on this being in place if they are to be successfully implemented.
NRAs should design fees to be transparent and proportionate to the regulatory workload involved. Building a defensible fee structure from a costing exercise - one that captures assessor time, infrastructure, laboratory support, administrative effort, IT overheads and post-market activities - improves cost recovery and signals professionalism to industry. Activity-based costing gives NRAs a transparent basis for fee revision, while strengthening accountability and stakeholder confidence. At the same time, greater reliance on regulatory fees should be supported by transparent governance, appropriate public-interest exemptions or fee waivers, and safeguards that preserve regulatory independence and ensure that essential public-health functions are not determined by an authority’s ability to generate revenue. Evidence from industry consultations suggests that companies are willing to consider higher regulatory fees where these are accompanied by predictable service levels and authorities adhere to published timelines (Danks et al., 2025).
NRAs should use reliance (the practice of giving significant weight to assessments performed by another trusted regulatory authority or other authoritative source when reaching their own decisions) as a lever for both faster decisions and lower cost. The South African Health Products Regulatory Authority's backlog clearance project offers a compelling data point: the authority completed abridged reviews of new chemical entity applications in a median of 19.4 hours, against 60.5 hours for full reviews, cutting assessor costs from a median of US$2,773 to US$636 per application - a 77% reduction. For generic applications, abridged reviews cost a median of US$855 against US$4,602 for full reviews - an 81% reduction. Across the cohort analysed, the authority cut total assessor costs from US$358,270 to US$80,857, a saving of US$277,413 (Danks et al., 2025). NRAs can redirect funds released in this way to vigilance, post-market surveillance, border control of medicines, and the specialised capabilities required for biologicals, digital health technologies, and artificial intelligence enabled devices.
Where resources are constrained, NRAs should resist spreading effort evenly across all functions and product categories. They should channel effort instead towards the activities most likely to catch high-risk quality problems, and those that cannot be delegated to other regulators, such as clinical trial oversight, in-country manufacturing inspections, vigilance, and supply chain security. Doing so maximises the public health return on each unit of regulatory investment.
NRAs should translate their institutional development plan, derived from a GBT assessment, into a credible multi-year financial blueprint. This plan should set out the cost of reaching the desired maturity level, the mix of revenue sources required to sustain it, the legal and governance reforms needed, and the indicators against which they will track progress. It should extend beyond financial projections to cover organizational development priorities, workforce planning, implementation milestones, key performance indicators, governance reforms, digital transformation initiatives, risk management measures, and resource mobilization strategies. Together, these components give NRAs a practical roadmap for achieving and sustaining WHO GBT maturity objectives. When they back the plan with robust data and realistic assumptions, NRAs gain an important advocacy and decision-making tool for engaging ministries of health and finance, parliaments, regulated industry and development partners around a shared evidence base.
The benefits of a financially sustainable NRA extend well beyond the regulator itself. Quality-assured medicines reach patients faster, predictable timelines support investment by both local manufacturers and global originators, and the country positions itself to participate meaningfully in continental initiatives such as the African Medicines Agency. Conversely, an underfunded regulator becomes a constraint on health system performance, on industrial policy, and on the credibility of the broader pharmaceutical ecosystem.
The instruments required to put African NRAs on a sustainable financial footing are well understood. The AU Model Law on Medical Products Regulation provides the legal template, reliance offers a demonstrated route to cost reduction, the GBT supplies the diagnostic, and a growing body of practice on the continent shows what implementation looks like. What remains is the political will to legislate, the institutional discipline to cost services properly, and the operational commitment to redirect savings into the capabilities that will define the next generation of African regulation.
For NRAs, ministries of health, and development partners considering how to sequence reform, the question is no longer whether financial sustainability is achievable. It is how quickly the building blocks can be put in place.
Drawing on Market Access Africa's experience supporting African National Regulatory Authorities, a comprehensive financial sustainability programme typically includes:
By: Bakani Ncube, Loice Kikwai, and Kudzai Makomva.
