A multi-country clinical trial can follow one protocol, test one investigational product, and pursue one scientific question, yet encounter different submission formats, review requirements, amendment procedures, and decision timelines in every participating country.
The African Medicines Agency (AMA) was established to help address this fragmentation. Its significance, however, does not lie in creating a single authorization for the continent. It lies in changing how regulatory work can be shared, trusted, and used across jurisdictions.
That distinction matters. Harmonization will succeed only when continental coordination produces faster, more predictable national decisions without weakening regulatory accountability or participant protection.
From institution-building to implementation
The African Union adopted the Treaty for the Establishment of the AMA in February 2019, and the Treaty entered into force in November 2021. An interim secretariat began operating in Kigali in 2024, Dr. Delese Mimi Darko was appointed as the Agency’s inaugural Director-General in June 2025, and the formal transfer of regulatory harmonization and safety-surveillance functions from AUDA-NEPAD to the AMA took place in January 2026 (1-4).
These milestones mark substantial institutional progress. They do not mean that Africa now has a single, fully integrated regulatory system.
The AMA is a specialized agency of the African Union established to strengthen the capacity of State Parties and regional economic communities to regulate medical products. Its mandate includes coordinating joint regulatory activities, promoting common standards and scientific guidelines, supporting inspections and safety monitoring, facilitating information-sharing, and encouraging reliance on trusted regulatory work (1).
National Regulatory Authorities (NRAs) remain responsible under domestic law for authorizing and overseeing clinical trials in their jurisdictions. The AMA does not issue one clinical trial authorization that automatically applies across Africa, nor does it override national decisions.
The emerging model is therefore one of coordinated assessment and national authority. Scientific work may be conducted jointly or relied upon across countries, but legal authorization remains national.
The real value is not centralization, but reduced repetition
Much of the discussion around regulatory harmonization focuses on the prospect of shorter approval timelines. That is important, but it is not the whole opportunity.
The deeper benefit is a more coherent division of regulatory work.
When several authorities independently assess the same protocol, manufacturing information, investigator’s brochure, or safety data, scarce expertise is repeatedly applied to the same questions. A credible reliance system allows participating authorities to use trusted assessments while directing more attention to matters that genuinely require national scrutiny.
These may include the suitability of local trial sites, investigator oversight, participant information and consent, import requirements, insurance, language, safety reporting, and the capacity of national systems to supervise the study after authorization.
Reliance should not mean passive acceptance. It is a structured regulatory decision in which an authority considers and gives significant weight to work performed by another trusted body while retaining responsibility for its own decision. Clear policies must define whose work can be relied upon, what additional review is required, and how accountability is documented.
This is where harmonization becomes more than administrative tidiness. It allows regulatory capacity to be allocated according to risk rather than repeatedly consumed by procedural duplication.
What changes for clinical trial sponsors
For sponsors, the immediate opportunity is not a single continental submission. It is greater predictability.
Common templates, aligned evidence requirements, coordinated scientific reviews, and transparent reliance pathways could reduce conflicting questions and repeated technical assessments across participating countries. They could also make it easier to plan multi-country studies and manage protocol amendments consistently.
But shared assessment does not automatically produce faster site activation.
If a joint scientific recommendation is followed by lengthy national administrative procedures, the duplication may decline while the overall timeline remains largely unchanged. Sponsors should therefore distinguish among three separate milestones:
- Completion of a joint or continental assessment
- Issuance of each national regulatory authorization
- Completion of ethics, import, contracting, and site-readiness requirements
Only the first falls directly within a harmonized scientific review. The time that matters operationally is the period from submission to an activated, recruitment-ready site.
Sponsor confidence will consequently depend less on policy declarations than on observable performance. Useful indicators will include published requirements, predictable review clocks, consistent management of regulatory questions and amendments, secure submission systems, transparent national adoption of shared recommendations, and regular reporting of actual timelines.
Until these mechanisms are functioning consistently, sponsors should continue planning for national authorization, country-specific legal requirements, and separate ethics review. The AMA adds an increasingly important continental layer, but it does not remove the need for a country-level regulatory strategy.
What changes for national regulators
Harmonization does not transfer the legal mandates of NRAs to the AMA. It changes the options available to them.
Authorities with established specialist capacity can contribute reviewers, inspection expertise, and scientific leadership to joint procedures. Authorities with fewer resources can use trusted assessments rather than recreating every component of a review, while retaining responsibility for nationally relevant questions and post-authorization oversight (5).
This model can strengthen national regulation, but only if reliance is accompanied by investment.
National legislation and procedures must permit the use of external assessments. Regulators need staff who can evaluate whether another authority’s work is relevant to their context. Digital systems must allow information to move securely. Sustainable financing is needed so that participation in joint work does not depend indefinitely on externally funded projects.
The balance of authority will therefore be negotiated through law, procedure, and practice rather than settled by the existence of the AMA alone. National sovereignty should not become a justification for unnecessary duplication, but harmonization should not obscure who remains accountable for a decision.
The regional layer cannot be bypassed
Continental harmonization is not starting from zero. Regional economic communities and the African Medicines Regulatory Harmonization initiative have spent years developing joint assessment procedures, shared technical guidelines, and regulatory collaboration (6).
The AMA’s task is not to replace these systems with another layer. It is to connect and strengthen them.
This will require clarity about how continental procedures interact with programs operating through the East African Community, the Southern African Development Community, the Economic Community of West African States, and other regional structures. Sponsors and regulators need to know which pathway applies, how work moves between regional and continental levels, and whether one assessment can be used without creating another sequence of reviews.
If these interfaces remain unclear, harmonization could inadvertently add procedure. If they are designed well, regional experience can provide the operational foundation for continental coordination.
What clinical research networks should do now
Pan-African clinical research networks are well placed to test whether harmonization works in practice. Their value is not simply that they operate in several countries, but that they can identify where ostensibly aligned requirements still diverge during implementation.
Networks should maintain current regulatory intelligence across participating countries, use controlled submission templates, align quality systems, and document differences among continental, regional, and national requirements. They should track not only approval dates, but also the causes of delay, repeated questions, amendment processing, and the interval between regulatory recommendation and site activation.
Preparation must remain dual. Networks should standardize documentation and processes wherever possible while preserving credible country-level expertise. National law, ethics requirements, import processes, insurance provisions, language needs, and safety-reporting arrangements will continue to require local knowledge.
The resulting operational evidence should be shared constructively with regulators. Harmonization will improve faster if implementation problems are documented as system issues rather than repeatedly solved within individual studies and then forgotten.
The test is performance
The AMA has moved beyond being only a treaty commitment. It now has leadership, an institutional base, and transferred regulatory functions. The next test is whether these foundations produce measurable changes in regulatory practice.
Several questions should guide that assessment:
- Are countries formally adopting reliance pathways?
- Are shared assessments reducing repeated scientific review?
- Are national decisions being issued sooner and more consistently?
- Are amendments and safety information handled coherently across jurisdictions?
- Are regional and continental procedures complementing one another?
- Are national authorities being strengthened as responsibilities are shared?
- Are participant protection and post-authorization oversight improving alongside efficiency?
For ACRN, regulatory harmonization should be treated as an infrastructure agenda, not as an endpoint. The practical priority is to prepare research institutions for the system being built while remaining effective within the systems that exist today. That means aligning documentation and quality processes, retaining national expertise, developing stronger regulatory intelligence, and contributing implementation evidence to national, regional, and continental discussions.
The AMA will not prove its value by removing national authority. It will prove its value by enabling national authorities to make rigorous decisions with less avoidable repetition and greater predictability.
That is what continental regulatory harmonization can change: not who is accountable, but how effectively Africa’s regulatory institutions work together.
References
- African Union. Treaty for the Establishment of the African Medicines Agency. In: Commission AU, editor. Addis Ababa: African Union; 2019.
- African Union. Dr. Delese Mimi Darko Appointed Inaugural Director General of the African Medicines Agency (AMA): African Union; Available from:https://au.int/en/pressreleases/20250604/dr-delese-mimi-darko-appointed-inaugural-director-general-african-medicines
- African Medicines Agency. AMA and AUDA-NEPAD Conclude the Transition of Continental Medicines Regulatory Programmes: African Medicines Agency; 2026 Available from:https://au-ama.africa/news_events/ama-and-auda-nepad-conclude-the-transition-of-continental-medicines-regulatory-programmes/
- African Union Development Agency-NEPAD. Operationalising the African Medicines Agency (AMA): African Union Development Agency-NEPAD; Available from:https://www.nepad.org/publication/operationalising-african-medicines-agency-ama
- World Health Organization. Regional Office for Africa. Progress report on the implementation of the Regional strategy on regulation of medical products in the African Region, 2016–2025. World Health Organization Regional Office for Africa; 2025. Report No.: AFR/RC75/INF.DOC/8.
- African Union Development Agency-NEPAD. AMRH Updates 2024: Highlights Edition. African Union Development Agency-NEPAD; 2024.