The African Medicines Agency (AMA) has been widely celebrated as a turning point for African regulatory sovereignty. Headquartered in Kigali, Rwanda, and part of the African Union (AU), it exists to harmonize regulatory standards, accelerate approvals, and orchestrate emergency responses across the continent. But while politically significant, AMA is still assembling the machinery for most of its functions. As AMA moves from mandate to implementation, potential donors should treat its build-out as a high-leverage foundational investment for the future where pandemics are more common and where AI-enabled R&D accelerates the discovery of biomedical discovery. AMA itself must also show that it can turn new investments into emergency response architecture.
The case for AMA as infrastructure
Across Africa’s regulatory landscape, there are tens of thousands of medicine registration applications that are stuck in backlogs. AMA’s mission is to reduce those delays at a continental level, complementing Africa CDC, which handles surveillance and outbreak response. But AMA is still a young organization. Its strategic plan, digital infrastructure, technical committees, and sustainability model all remain in development. Just 32 of the AU’s 55 member states have ratified the AMA treaty, and the agency still depends largely on donors to fund its internal operations.
Transformative AI may dramatically accelerate the upstream biomedical pipeline while leaving regulatory institutions comparatively slow. The existing capacity constraints across Afrcia will become more consequential if AI increases the number, speed, and complexity of products entering clinical development. Without corresponding improvements in regulatory capacity, approval systems could become a binding bottleneck that delays access to new medicines in African countries.
The current shifts in the development funding environment make AMA’s institution building even harder. Official development assistance for health fell by 23.1% in 2025, with the United States accounting for three-quarters of this decline. This contraction of US foreign assistance has been especially consequential to developmental efforts across Africa. USAID’s MTaPS programme, for example, has long supported regulatory strengthening across Africa, including work on regulatory information management at Africa Medicines Regulatory Harmonization (AMRH) initiative, AMA’s predecessor programme. MTaPS’ closure left a gap that no comparable programme has yet filled.
In this landscape, donor funding should concentrate on sustainable initiatives that can last beyond the initial investment period. AMA is one of the few institutions positioned to deliver exactly that. National Regulatory Authority (NRA) funding remains essential, but investment in AMA can multiply these gains: every dollar spent on AMA builds shared infrastructure that delivers faster medicine access, less duplication, more local manufacturing, and centrally coordinated emergency response.
From treaty body to emergency regulator
To become a pandemic-ready institution as fast as possible, AMA needs focused support across three main streams.
First, AMA must be able to issue scientific guidance and ethics evaluations quickly for new clinical trials. This includes human challenge trials, which can be especially valuable in pandemics if regulatory groundwork is laid in advance. Funding should support emergency standard operating procedures, ethical review templates, pre-cleared expert rosters, and collaboration with the Africa CDC Directorate of Science and Innovation, which oversees clinical trials across member states.
Second, medicines authorization and pharmacovigilance. AMA’s emergency value depends on whether it can help national regulators move faster without lowering standards. Support here should build AMA’s capacity to receive dossiers, coordinate joint scientific assessments, organize GMP inspections, and produce regulatory guidance that national authorities can rapidly adopt. This can be achieved by integrating the African Vaccines Regulatory Forum’s (AVAREF) experience into AMA pathways, which has already proven valuable in accelerating product registration in the past.
Third, digital infrastructure. To be able to respond quickly, AMA needs secure regulatory information management systems to receive applications, track timelines, preserve audit trails, and integrate pharmacovigilance data. This should come with AI-assisted tools that extend these platforms and support human regulatory judgment.
The funding required at this stage is modest. A realistic two-year scale-up package would be in the range of $10-20 million, followed by an annual operating base of roughly $8-12 million. Once foundational systems are in place, AMA’s model should shift toward a mix of member contributions, transitional partner support, and user fees.
Making AMA More Appealing to Investors
Few investments in African health security promise as much payoff per dollar as AMA. But to be more appealing to investors, the new continental regulator will have to show that it is effective at turning any new funding into lasting gains. It has already demonstrated its relevance in the 2026 Bundibugyo Ebola outbreak in the DRC and Uganda, declared a public health emergency of international concern in May. AMA was able to quickly join forces with EMA to accelerate clinical trials for countermeasures targeting this strain. This type of timely action would be a game changer for the independent continental response in future global emergencies.
As a priority, AMA needs to constitute its technical committees, define their mandates, and adopt emergency-review SOPs in advance. It should build surge rosters of pre-cleared assessors, inspectors, and safety specialists who can be activated at notice in the event of an outbreak.
Donors will also want to know what is operational, what gaps remain, and how progress is measured. AMA should strengthen its transparency around its operations. It should publicly share performance metrics, such as application volumes and timelines, inspection outputs, and safety signals reviewed. Transparent reporting and open access to information will help funders appreciate the value of the agency’s work.
AMA must show that it can craft unified policy and help member states translate continental perspectives into plans of action at the national level. Done well, this will improve response times and harmonize quality control for products across the continent. To make it work, member states should adopt the AMA treaty, designate national focal points, adopt reliance templates, and agree on mechanisms for emergency regulatory decisions to translate from AMA to national authorities.
Finally, AMA needs a sustainable funding model that donors can believe in. External funders can cover startup costs, initial infrastructure, and capacity-building costs. But AMA needs a predictable stream of funding from the member states and the member states themselves need to demonstrate political ownership of the continental response mechanism that the agency provides.