A Bold Initiative to Streamline Africa’s Fragmented Medicines Regulation
The establishment of the African Medicines Agency (AMA) in Kigali, Rwanda, in October 2025 marked a pivotal moment in Africa’s healthcare landscape. Unlike previous regional efforts, the AMA was designed not merely as another approval pathway but as a coordinating hub aimed at eliminating the long-standing fragmentation in drug regulation across the 55 African Union member states. For decades, African nations have relied on a patchwork of national regulators, regional harmonization initiatives, WHO prequalification programs, and external reliance mechanisms—such as Switzerland’s Marketing Authorisation for Global Health Products (MAGHP)—to expedite access to essential medicines. While these systems have accelerated approvals for certain products, they have failed to address the core issue of regulatory inconsistency and inefficiency plaguing the continent.
Dr. Delese Mimi Darko, the inaugural Director General of the AMA, emphasizes that the agency’s primary mandate is not to replace national regulators but to amplify their collective strength through strategic coordination. In an exclusive interview with a global health policy publication, Darko outlined the AMA’s operational framework, its distinct advantages over existing reliance pathways, and its role in strengthening national regulatory capacities—particularly in the context of emerging health crises like the Bundibugyo Ebola outbreak.
Operational Reality: AMA’s Early Impact and Challenges
Contrary to initial skepticism, the AMA has been fully operational since its launch, with 33 member states having ratified the founding treaty—a critical milestone for its legitimacy and effectiveness. However, full continental adoption remains elusive, as 22 states have yet to ratify, leaving the agency’s potential impact incomplete without universal participation.
Darko underscores that ratification is non-negotiable for the AMA to fulfill its vision of a unified regulatory system. Without it, the agency’s ability to provide continental approvals for high-priority products—such as vaccines, complex biologics, and public health tools—is limited to ratified states. This means that while the AMA can streamline approvals for public health emergencies or innovative therapies, non-ratified countries miss out on the efficiency gains, forcing them to rely on separate national or regional processes.
The AMA’s primary focus lies in centralized approvals for critical products, particularly those requiring specialized expertise—such as vaccines, antibiotics, and treatments for neglected tropical diseases. For simpler, widely available medications (e.g., paracetamol or generic antibiotics), national regulators may still handle approvals independently, as the added value of continental coordination is minimal.
Beyond Reliance Pathways: How AMA Differentiates Itself
While mechanisms like the WHO Collaborative Registration Procedure (CRP) and Swissmedic’s MAGHP have played a role in accelerating drug access, the AMA adopts a fundamentally different approach. Unlike these external reliance models, which depend on trusted third-party assessments, the AMA is built by and for African regulators, ensuring local ownership and expertise integration.
Darko clarifies:
“AMA is not just another external pathway. It is a treaty-based African institution where national regulators are active participants, not passive observers. The goal is to leverage Africa’s existing regulatory talent—many of whom already contribute to WHO prequalification—while ensuring their input is systematically incorporated into decision-making.”
A key innovation is the Regulatory Innovation and Market Readiness Office, which facilitates early scientific advice for pharmaceutical developers. By engaging regulators during the product development phase, rather than at the end of the pipeline, the AMA aims to prevent regulatory delays and align expectations between sponsors and national authorities.
This proactive approach contrasts sharply with traditional reliance pathways, where assessments are often conducted after a product is nearly finalized, leading to unnecessary bottlenecks. The AMA’s model seeks to integrate African regulators into the innovation process, fostering collaboration rather than competition.
Institutional Structure: A Networked Approach to Regulatory Excellence
The AMA operates through a multi-layered governance framework, as outlined in its founding treaty:
- Conference of State Parties – The highest decision-making body, comprising representatives from all member states.
- Governing Board – Oversees day-to-day operations and strategic direction.
- Secretariat (Kigali-based) – Manages administrative and technical functions.
- Technical Committees – Specialized bodies (e.g., clinical trials, inspections, safety monitoring) composed of national regulatory focal points.
Unlike the European Medicines Agency (EMA), which operates as a centralized single-review body, the AMA does not aim to replace national regulators. Instead, it coordinates their efforts, ensuring that high-capacity agencies (WHO Maturity Level 3) serve as the initial backbone for continental assessments.
The agency also leverages expertise from lower-capacity regulators in niche areas—such as good manufacturing practice (GMP) inspections or clinical trial oversight—ensuring a broad, continent-wide input rather than relying solely on a few advanced nations.
Sustainability and Funding: Balancing Independence and Collaboration
While the AMA’s long-term funding model remains under development, Darko emphasizes that financial sustainability is tied to the strength of national regulators. The agency’s budget is structured through:
– Annual and special contributions from state parties (as mandated by the treaty).
– Seed funding from member states and development partners during the operationalization phase.
– Potential revenue streams from regulatory fees (e.g., for centralized approvals).
However, the real challenge lies in ensuring that national regulatory authorities (NRAs) are adequately resourced. A weak NRA network undermines the AMA’s effectiveness, as local enforcement remains critical for quality control, safety monitoring, and supply chain integrity.
Darko states:
“AMA is only as strong as its weakest regulator. If a country’s NRA lacks capacity, the entire system suffers. Our priority is equitable capacity building—not just for high-capacity nations, but for every African state.”
Can AMA Function as a Single Continental Regulator?
While the aspiration is to reduce duplication—where manufacturers currently face 55 separate approval processes—the AMA’s current operational reality is more nuanced. Due to varying legal frameworks, regulatory maturity, and treaty status, a fully unified approval system is not yet feasible.
Instead, the AMA is building a networked model where:
– One continental application can serve multiple countries (if they are ratified members).
– National regulators retain final authority but benefit from AMA’s scientific opinions and coordination.
– Public health emergencies (e.g., Ebola outbreaks) trigger rapid, continent-wide regulatory alignment.
Darko explains:
“The goal is not to create a ‘one-size-fits-all’ system but to harmonize processes so that manufacturers don’t have to navigate 55 different pathways. For complex products—like vaccines or tuberculosis treatments—AMA’s centralized input accelerates access without sacrificing safety.”
Why Treaty Ratification Matters: The Case for Continental Unity
The slow pace of ratification—particularly in large, high-capacity nations—poses a significant hurdle. Darko highlights that non-ratified countries (e.g., South Africa) still benefit from AMA’s capacity-building initiatives, but they cannot participate in continental approvals.
During the COVID-19 and Ebola crises, she notes, regulatory fragmentation became painfully evident. When Bundibugyo Ebola emerged, African nations had to operate in silos, delaying vaccine and antiviral trials. The AMA’s role in coordinating with the EMA and African NRAs demonstrates its potential to prevent future regulatory disarray—but only if all states engage.
Darko stresses:
“Africa cannot afford to be divided. If a country like the DRC faces an outbreak, the speed of response depends on whether it is a ratified member. We need unity—not just for efficiency, but for health security.”
Addressing Regulatory Anxiety: National Agencies’ Role in the AMA Ecosystem
Some national regulators have expressed concerns that the AMA could undermine their authority. Darko dismisses this as a misunderstanding, arguing that the agency’s five-year strategy was developed in collaboration with NRA heads.
Key measures to reassure and integrate national regulators include:
– Inclusive strategy development (e.g., IT and capacity-building plans co-designed with NRAs).
– Transparent communication on how AMA enhances—not replaces—national roles.
– Demonstrating value addition (e.g., faster approvals for complex products without compromising safety).
Darko asserts:
“We are not working against national regulators; we are working with them. The process has been bottom-up, ensuring that every agency sees AMA as a partner, not a competitor.”
Top Priority: Strengthening National Regulatory Capacities
For the AMA, capacity building remains the cornerstone of its mission. Without strong, well-resourced NRAs, the agency’s centralized efforts risk being ineffective.
Darko’s clearest message is that regulatory excellence is the foundation of all other goals:
– Faster product approvals depend on competent NRAs.
– Safety monitoring requires local expertise.
– Supply chain integrity relies on national enforcement.
She concludes:
“If we want Africa to lead in medical innovation, we must first ensure that every regulator—from Lagos to Lusaka—has the tools to do their job. Once that is achieved, everything else follows: health security, equitable access, and patient trust.”
AMA’s Role in the Bundibugyo Ebola Outbreak: A Test of Continental Coordination
The recent Bundibugyo Ebola outbreak has provided an early litmus test for the AMA’s ability to unify African regulatory responses during a public health emergency.
In collaboration with the European Medicines Agency (EMA), WHO AFRO, and national regulators, the AMA has:
– Facilitated discussions on clinical trial designs for antivirals and vaccine candidates.
– Prepared regulatory pathways to ensure rapid but rigorous evaluations.
– Coordinated with the AMA’s Emergency Task Force to align evidence requirements before trials begin.
Darko explains:
“In an outbreak like Ebola, time is critical, but science must not be sacrificed. The AMA’s role is to bring regulators together early, so that developers know what data is needed—and when—before the crisis escalates. This is exactly the kind of coordination that will save lives.”
The Bundibugyo response is a proof of concept for the AMA’s ability to operate as a continental regulatory network—not just in peacetime, but in emergencies.
What Success Looks Like: A Vision for the Next Decade
Looking ahead, Darko outlines three critical success metrics for the AMA:
- Universal Ratification – Ensuring all 55 member states sign and ratify the treaty to maximize continental impact.
- Equitable Capacity Building – Closing the regulatory gap between high- and low-capacity nations through targeted training, funding, and technology transfer.
- Streamlined Approvals for High-Impact Products – Vaccines, antibiotics, and neglected disease treatments should move through centralized or harmonized pathways, reducing delays and costs for manufacturers.
Ultimately, Darko’s vision is patient-centered:
“At its core, the AMA exists to ensure that every African patient—whether in Nairobi or Niamey—receives the right medicine, at the right time, with the right safety guarantees. That is the true measure of success.”
As the agency continues to expand its influence, its ability to balance coordination with national autonomy will determine whether Africa’s medicines regulation finally achieves the efficiency, trust, and equity it has long sought.
