When we discuss the advancement of clinical trials in Africa, the conversation often gravitates toward infrastructure: genomic sequencing capacity, biobanking facilities, or electronic data capture systems. While these physical assets are vital, there is an equally critical, though often less visible, infrastructure being built across the continent: the architecture of regulatory science.
As the Africa Clinical Research Network (ACRN), we recognize that regulatory science is a foundational pillar of a functional research ecosystem. The progress unfolding across African regulatory authorities is not incidental, it reflects sustained national investment, coordinated regional action, and continental leadership.
For years, the narrative surrounding African regulatory environments focused on fragmentation and delay. Today, that narrative is outdated. A quiet but steady transformation is underway, characterized by increased harmonization, stronger national stewardship, and a clear vision for continental integration.
The Shift from Fragmentation to Harmonization
Historically, a multi-country clinical trial in Africa required navigating a complex patchwork of distinct national regulatory requirements. This often meant disparate timelines, varying ethical review standards, and duplicated administrative burdens that slowed the pace of essential health research.
However, recent years have seen a definitive shift toward regional harmonization. Initiatives such as the African Medicines Regulatory Harmonization (AMRH) have laid the groundwork for regulators to share data, align standards, and conduct joint reviews (1). This does not erode national sovereignty; rather, it amplifies national capacity. When regulators in East Africa or West Africa collaborate on the review of a new therapeutic, they leverage collective expertise, resulting in faster, robust decisions that protect patient safety without stifling innovation. Harmonization also aligns with the African Union’s broader vision for regulatory cooperation, including shared assessment procedures, reliance models, and joint inspections. These mechanisms strengthen national oversight while reducing duplication across clinical trials.
This collaborative foundation is central to the operationalization of the African Medicines Agency (AMA), a specialized agency of the African Union (AU), mandated to enhance regulatory coordination, promote reliance approaches, and strengthen quality oversight of medical products across the continent (2,3). AMA does not replace national regulators; rather, it supports them by providing technical guidance, shared platforms, and mechanisms to streamline regulatory decision making.
Strengthening National Foundations
Regional success depends entirely on strong national foundations. We are observing National Medicines Regulatory Authorities (NMRAs) across the continent achieving higher maturity levels through the World Health Organization (WHO) Global Benchmarking Tool, which assesses regulatory systems for quality, transparency, and performance (4). From Ghana to Tanzania, and South Africa to Egypt, national regulators are investing in workforce development and quality management systems (5).
For ACRN, these developments are central to responsible and high-quality clinical research. We recognize that robust regulation is not a hurdle to research but its safety net. A capable regulator ensures that data generated in African sites meets global standards of integrity, making African research sites attractive partners for global clinical development programs.
The Role of Public Health Leadership
The ecosystem is further strengthened by the strategic leadership of the Africa Centres for Disease Control and Prevention (Africa CDC). By championing health security and disease surveillance, the Africa CDC provides the public health context within which regulators operate. Their “New Public Health Order” underscores the importance of trusted local institutions and resilient health security systems, efforts that depend on strong regulatory capacity to ensure the safety, quality, and effectiveness of medical products (6).
Why This Matters for Stakeholders
For funders and global partners, this progress signals a reduction in the operational risk traditionally associated with African clinical trials. The regulatory pathway is becoming clearer and more predictable. Regulatory engagement is no longer peripheral; it is strategic. Early dialogue with NMRAs can reduce timelines, clarify technical expectations, and ensure alignment with national and regional regulatory pathways.
For researchers and sponsors, it emphasizes the need for regulatory literacy. Engaging with regulators early in the protocol development process, rather than viewing submission as a mere administrative box-tick, is now a best practice.
For policymakers, it reinforces the economic argument for regulation. Efficient regulation attracts research and development (R&D) investment, fosters a local pharmaceutical manufacturing sector, and ultimately strengthens health security.
A Call for Sustained Collaboration
While the progress is real, the work is not finished. Achieving WHO Listed Authority (WLA) status for more African regulators requires sustained investment, not just in funding, but in technical exchange and South-South collaboration.
At ACRN, we remain committed to engaging with regulatory systems in a manner that is respectful, transparent, and aligned with national priorities. We support African-led regulatory decisionmaking and emphasize operational alignment with both national and regional standards. By integrating regulatory best practices into our research operations, we contribute to a sustainable environment where clinical research strengthens, not bypasses, local oversight systems.
References
- | AUDA-NEPAD [Internet]. [cited 2026 Mar 11]. Available from: https://www.nepad.org/programme-details/998
- Ismail AJ, Darko DM, Walker S, Salek S. The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects. Front Med. 13:1763261. doi:10.3389/fmed.2026.1763261 PubMed PMID: 41716803; PubMed Central PMCID: PMC12913070.
- African Medicines Agency (AMA) | AUDA-NEPAD [Internet]. Available from: https://www.nepad.org/microsite/african-medicines-agency-ama
- WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products – Revision VI [Internet]. Available from: https://www.who.int/publications/i/item/9789240020245
- list-of-nras-operating-at-ml3-and-ml4.pdf [Internet]. Available from: https://cdn.who.int/media/docs/default-source/medicines/regulatory-systems/wla/list-of-nras-operating-at-ml3-and-ml4.pdf?sfvrsn=ee93064f_23&download=true
- Africa Calls for New Public Health Order – Africa CDC [Internet]. Available from: https://africacdc.org/news-item/africa-calls-for-new-public-health-order/