When a clinical trial in Africa stalls, the explanation is often immediate: “regulatory delay.”
It is a convenient phrase. It is also too often an incomplete one.
“Regulatory delay” can mean many different things. It can mean a regulator took longer than expected. It can mean a submission was incomplete. It can mean ethics, import permits, contracts, insurance, site activation, and sponsor decision-making were not aligned. It can also mean a sponsor expected a system to behave like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or Medicines and Healthcare products Regulatory Agency (MHRA) without first understanding the local pathway.
That distinction matters.
When every delay is attributed to “the regulator,” the problem is often misdiagnosed. We miss the operational work required to fix it. Sometimes the delay sits with the regulatory authority. But often, the issue lies earlier: in submission quality, sequencing, local pathway knowledge, or alignment between regulatory, ethics, contracting, logistics, and site-activation processes.
Strong regulators are expected to ask scientific, ethical, and procedural questions before patients are exposed to investigational products. The task is to distinguish legitimate regulatory review from preventable regulatory unreadiness.
Africa’s Regulatory Architecture Is Taking Shape
The conversation about clinical trial timelines in Africa needs to catch up with what is actually being built.
The African Medicines Agency (AMA) has moved from concept to institution-building. The AMA Treaty entered into force in 2021, and as of 2025, 31 African Union Member States had ratified it, according to a 2026 Frontiers in Medicine review of the agency’s evolution (1). The same review highlights AMA’s intended role in regulatory convergence, work-sharing, reliance, technical committees, scientific opinions, and continental coordination.
Across the continent, regulatory coordination is becoming more structured, even though implementation remains uneven. Regional and national regulators are increasingly using reliance, work-sharing, and harmonization models designed to reduce duplication and improve review efficiency.
In February 2025, Africa’s World Health Organization (WHO) Maturity Level 3 national regulatory authorities signed a Memorandum of Understanding (MoU) to strengthen reliance and information-sharing across agencies. Signatories included Ghana’s Food and Drugs Authority, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Rwanda Food and Drugs Authority, Senegal’s Pharmaceutical Regulatory Agency (ARP), the South African Health Products Regulatory Authority (SAHPRA), Tanzania Medicines and Medical Devices Authority (TMDA), and the Medicines Control Authority of Zimbabwe (MCAZ) (2). The agreement is designed to reduce duplication, support work-sharing, and improve timely regulatory decision-making.
These developments matter. They show that regulatory capacity is being actively built across parts of the continent.
But regulatory architecture is not the same as trial-specific readiness.
Stronger Pathways Do Not Fix Weak Submissions
A reliance pathway can improve review efficiency, but it does not write a protocol.
A scientific advice process does not repair a poor justification for endpoints, comparator choice, or population selection.
A continental regulatory framework does not automatically align budgets, contracts, import permits, indemnity language, ethics documentation, investigator files, pharmacy readiness, laboratory certifications, or safety reporting workflows.
That is where many trial timelines actually break down.
A regulator may receive the blame when the real issue is that the sponsor submitted a package with missing documents, inconsistent protocol language, unclear country-specific procedures, untranslated or unadapted consent materials, or assumptions copied from another region. A site may appear “slow” when it is waiting for contract terms, payment schedules, equipment, training, or a final delegation log. A country may be labeled “difficult” when the trial team has not mapped the national sequence of regulatory, ethics, customs, and institutional approvals.
In those cases, the delay is not regulatory obstruction.
It is regulatory unreadiness.
The Global Lesson: Reform Works When Preparation Improves Too
Africa is not the first region to face this perception gap.
India’s experience is instructive. Following clinical trial controversies and supreme court scrutiny in 2013, India tightened its clinical trial environment (3, 4). Researchers and sponsors often experienced the period as unpredictable, but the reforms were rooted in legitimate concerns around participant protection, compensation, consent, and oversight. Later, the New Drugs and Clinical Trials Rules, 2019 introduced clearer regulatory structure and timelines, helping improve predictability in the clinical research environment (5, 6).
China offers another useful comparison. Since 2015, China has undertaken substantial drug regulatory reforms aimed at shortening review timelines, clearing application backlogs, encouraging innovation, and reducing drug lag. Evidence from China’s regulatory reform experience shows that review-system improvements matter most when regulatory strategy is integrated early into clinical development planning (7, 8).
The pattern is clear: regulatory systems can improve quickly, but the benefit is co-produced.
Regulators modernize pathways. Sponsors modernize preparation.
When only one side changes, timelines remain fragile.
Where Time Really Goes in Trial Start-up
The clinical trial industry already knows that start-up delay is rarely caused by one factor.
A review in Therapeutic Innovation & Regulatory Science identified multiple drivers of start-up delay in global Phase III trials, including regulatory processes, contracts and budgets, insurance, clinical supplies, site identification, site activation, and inefficient internal processes (9).
In other words, regulatory review is one part of a wider start-up system, not the whole explanation.
That finding should reshape how we talk about Africa.
The right question is not: “Which regulator delayed the trial?”
The better question is: “Where did time accumulate, and why?”
Was the protocol locally relevant? Were regulator expectations understood before submission? Were ethics and regulatory activities sequenced intelligently? Were site documents complete? Were budgets negotiated early? Were importation requirements understood? Were local investigators involved before the final protocol was locked? Was there a country-specific activation plan, or merely a global timeline with assumptions about African settings inserted?
Without that level of analysis, “regulatory delay” becomes a catch-all phrase that hides correctable problems.
What Regulatory Readiness Should Look Like
For sponsors and contract research organizations (CROs) operating in Africa, readiness must become a discipline, not a final checklist.
It starts with scientific credibility. Protocols should anticipate the questions regulators are likely to ask: Why this comparator? Why this population? How will safety be monitored? Are the endpoints meaningful in the local care context? Are the inclusion and exclusion criteria realistic for the intended sites and participant populations?
It also requires operational credibility. A clean submission should be supported by complete site documentation, country-specific regulatory intelligence, ethics alignment, import and export planning, insurance clarity, contractual preparedness, pharmacy readiness, and a realistic view of activation timelines.
Then comes systems credibility. Sponsors need to measure where time is actually spent. Time-to-activation data should be tracked by country, site, study type, and approval milestone, even where it is initially used internally. Without transparent metrics, the industry will continue to rely on anecdote, frustration, and reputational shorthand.
The conversation should move beyond vague complaints about “slow regulators.”
What is needed is better evidence, stronger submissions, and clearer shared accountability.
ACRN’s Position: Regulator-Literate, Not Regulator-Defensive
At ACRN, our position is not that African regulatory systems are perfect. They are not. Capacity gaps remain. Digital infrastructure is uneven. Domestication of continental mechanisms is still progressing. Reliance models must continue to mature.
But it is equally inaccurate to describe Africa’s trial timeline challenges as if regulators are the default obstacle.
A regulator-literate approach begins with respect for what regulators are there to do: protect patients, assess scientific validity, ensure ethical conduct, and maintain public trust. It also recognizes that predictability is built before submission, not after queries arrive.
That is why ACRN’s role is to help translate regulatory readiness into regulatory predictability: supporting high-quality submissions, engaging emerging AMA and reliance pathways early where appropriate, aligning sites before activation pressure begins, and being transparent with sponsors about what the process requires.
The future of clinical trials in Africa will not be strengthened by treating regulators as the default explanation for every missed milestone.
It will be built by asking better questions earlier.
When a trial is delayed, the most useful question is not, “Who is slowing us down?”
It is, “What was not ready?”
That is the conversation Africa’s clinical research ecosystem deserves.
References
- Ismail AJ, Darko DM, Walker S, Salek S. The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects. Frontiers in Medicine. 2026;Volume 13 – 2026.
- (AUDA-NEPAD) AUDA. A Landmark Agreement Among Africa’s Leading National Medicines Regulatory Authorities to Foster Reliance 2025 [Available from: https://www.nepad.org/news/landmark-agreement-among-africas-leading-national-medicines-regulatory-authorities
- Barnes M, Flaherty J, Caron M, Naqvee A, Bierer B. The Evolving Regulatory Landscape for Clinical Trials in India 2018 [Available from: https://www.fdli.org/2018/11/the-evolving-regulatory-landscape-for-clinical-trials-in-india/
- Roy Chaudhury R, Mehta D. Regulatory developments in the conduct of clinical trials in India. Global Health, Epidemiology and Genomics. 2016;1:e4.
- Gunaseelan V. Indian New Drugs and Clinical Trial Rules. In: Arivazhahan A, Shah N, Sandhiya S, Raj GM, editors. Introduction to Basics of Pharmacology and Toxicology: Volume 4: Pharmacology and Therapeutics. Singapore: Springer Nature Singapore; 2025. p. 391–404.
- Central Drugs Standard Control Organization. The New Drugs and Clinical Trials Rules. Government of India. 2019.
- Ge Q, Xu L, DiMasi JA, Kaitin KI, Shao L. Impact of regulatory system changes on the availability of innovative drugs in China. Nat Rev Drug Discov. 2023;22(5):344–5.
- Xu L, Gao H, Kaitin KI, Shao L. Reforming China’s drug regulatory system. Nature Reviews Drug Discovery. 2018;17(12):858–9.
- Lai J, Forney L, Brinton DL, Simpson KN. Drivers of Start-Up Delays in Global Randomized Clinical Trials. Therapeutic Innovation & Regulatory Science. 2021;55(1):212–27.