er Excellency Dr. Delese Mimi Darko became the inaugural Director General (DG) of the African Medicines Agency (AMA) in October 2025. Dr. Darko engaged with Global Forum African Regional Editor Lorraine Danks on the Agency’s vision and strategic priorities, and how AMA could be a game-changer for access to medicines in Africa.
Lorraine Danks: It was wonderful to see you in June in Philadelphia for the DIA 2026 Global Annual Meeting and to hear you speak about the African Medicines Agency. What was the significance of AMA’s presence there, and what conversations stood out to you?
DG Dr. Darko: AMA’s presence at the DIA Global Annual Meeting is significant because it ensures that Africa is not only participating in global regulatory discussions but actively helping to shape them. For AMA, this is particularly important as we operationalize a continental regulatory system for Africa. It gives us an opportunity to communicate Africa’s regulatory priorities, strengthen relationships with other mature regulatory authorities and industry, and ensure that global product development strategies increasingly consider African regulatory requirements and the needs of African patients from an early stage.
It is also about positioning Africa as a pioneer in regulatory science and innovation, rather than simply a recipient of products developed elsewhere. Through platforms such as DIA conferences, AMA can promote regulatory convergence, reliance, and greater predictability for developers interested in Africa while ensuring that quality, safety, and efficacy remain at the center of access to medical products across the continent.
Lorraine Danks: What is your personal vision for AMA and what would success look like at the end of your tenure?
DG Dr. Darko: My vision is an AMA that is owned and driven by National Regulatory Authorities (NRAs) in Africa. AMA does not replace NRAs; we complement them and amplify their work. Together with Heads of NRAs, we have developed a clear vision, which is to enable a healthy, self-reliant Africa with quality, safe, and efficacious medical products supported by trusted, harmonized regulatory excellence.
That vision is one that is guiding our AMA Five-Year Strategic Plan. Our ambition is to become a credible, 100% ratified, World Health Organization (WHO)-Listed Authority with financial self-reliance by 2030. The public version of the five-year strategic plan is not yet available. It will be made available after approval through internal AMA processes.
Lorraine Danks: What are your immediate priorities for AMA?
DG Dr. Darko: I have previously spoken about three immediate priorities for AMA. The first is universal ratification of the AMA Treaty to bring all 55 AU Member States on board. Currently, 34 countries have ratified.
The second is capacity building for NRAs, which is the objective of AMA.
The third is to support local African manufacturing of medical products, an essential part of our health security and sovereignty.
Lorraine Danks: What are the one or two things you most want DIA members (many of whom are industry, regulatory, and clinical research professionals) to understand about AMA today?
DG Dr. Darko: AMA is building a coherent continental regulatory architecture that supports scientific innovation and provides DIA members with a more predictable and streamlined regulatory pathway to the African market, reducing the need to navigate 55 separate regulatory systems, requirements, and processes.
Lorraine Danks: A core promise of AMA is faster access to safe, effective, quality medicines. What specific mechanisms, such as joint reviews, reliance pathways, or harmonized standards, are already reducing timelines for African patients?
DG Dr. Darko: As stated previously, AMA is not starting from scratch. AMA’s foundation, the African Medicines Regulatory Harmonization (AMRH) program, has already successfully undertaken a continental listing of 12 products based on expression of interest. Through reliance on work done by Continental Technical Committees (TCs), the national approval timelines for some products have been reduced by more than 30%.
From Q4 this year, AMA will put out another expression of interest for manufacturers who want their products to be continentally listed.
We also have our Reference Agencies Network, which facilitates reliance amongst the ML3 (Maturity Level 3) agencies on the continent and also acts as a scientific backbone for AMA.
Lorraine Danks: How is AMA thinking about regulatory pathways for health product innovation, including support for African-led R&D and manufacturing, rather than just approving products developed elsewhere?
DG Dr. Darko: AMA is intentional about supporting innovation and manufacturing of medical products in Africa. The Regulatory Innovation and Manufacturing Readiness Hub, which was officially launched during the inaugural AMA Week in October 2026 in Kigali, Rwanda, is intended to help speed up access by removing regulatory uncertainties through early engagement.
This is complemented by the work of the AMA Capacity Strengthening Hub, also launched during AMA week, which coordinates capacity strengthening for regulatory authorities, including strengthening clinical trial reviews and monitoring. For example, AMA has put together a team of experts from ML3 regulatory agencies to provide a scientific opinion to an Egyptian company that is developing an Ebola vaccine.
DG Dr. Darko: The greatest opportunity is closing the gap between where these products are discovered and where they’re actually needed by embedding Africa earlier in the development pipeline, not just at the point of registration.
Lorraine Danks: How does AMA see its coordinating role differently from or similarly to the European Medicines Agency (EMA) model in Europe?
DG Dr. Darko: Like the EMA, AMA provides a platform for countries to pool scientific expertise, conduct joint assessments, and avoid duplicating high-quality regulatory work.
The key difference lies in the legal and institutional context. AMA does not replace Africa’s national regulatory authorities or take away their decision-making powers. It coordinates regulatory cooperation across the continent and issues rigorous scientific opinions that countries can rely on when making their own sovereign regulatory decisions.
Lorraine Danks: What does AMA add for a multinational sponsor that is already navigating multiple African NRAs; what’s the tangible efficiency gain?
DG Dr. Darko: One application, one rigorous scientific review, and access to multiple markets. Instead of submitting substantially dissimilar dossiers and responding to overlapping questions across numerous regulatory authorities, sponsors can benefit from coordinated assessment, shared scientific expertise, and more consistent requirements and timelines.
Lorraine Danks: How is AMA building trust with NRAs so that the agency is seen as complementary to rather than competing with national jurisdictions?
DG Dr. Darko: NRAs are the backbone of AMA’s mandate, so we work with them on every major strategy and build with them, not around them. A concrete example: In January, we convened the first Heads of NRAs and Regional Economic Communities (RECs) Forum under the theme “Building the African Medicines Agency Together.”
Bringing authority leadership into the room to shape the agency’s direction is how we ensure that there is ownership. It’s those same Heads of Agencies, increasingly, who carry the case for AMA to their own governments.
Lorraine Danks: AMA has drawn significant support from funding and technical partners (including the European Union) to speed up its operationalization. How is AMA planning for long-term, sustainable funding beyond this initial support?
DG Dr. Darko: AMA has a clearly articulated strategy to be financially self-sustaining through fees from its services as well as contributions from AMA States Parties as clarified in the AMA Five-Year Strategic Plan (to be issued at a future date).
The goal is to ensure that AMA, like the EMA, obtains its majority funds from fees charged to industry for continental listing, scientific advice, regulatory inspections, and variations.
Lorraine Danks: What should pharmaceutical companies, CROs, and other DIA members be doing now to prepare for a more harmonized African regulatory environment?
DG Dr. Darko: Engage early with the AMA Regulatory Innovation & Manufacturing Readiness Hub through rimr@au-ama.africa and align to harmonized standards. Sponsors who build dossiers with continental reliance in mind and coordinate with the Hub early have the greatest chance of success.
Lorraine Danks: What role do you see for patient advocacy groups and civil society in AMA’s work going forward?
DG Dr. Darko: It is central. Patients are why AMA exists, and advocates keep us honest about whether access is genuinely improving on the ground. We see them as partners who shape priorities and who tell the human stories that demonstrate the impact of our regulatory work. Those stories are ultimately how the public comes to trust an institution like ours.
Lorraine Danks: Is increasing the volume and frequency of clinical trials conducted in African countries one of your priorities, or do you leave that to the individual Member States?
DG Dr. Darko: Yes, increasing both the number and diversity of clinical trials conducted in Africa is a priority for AMA. Africa remains significantly under-represented in global clinical research, and the number of early-phase trials conducted on the continent is still very low, particularly beyond large public-health trials.