This article examines the strategic landscape facing the inaugural leadership of the African Medicines Agency. It outlines the core challenges constraining Africa’s pharmaceutical sector: fragmented regulatory frameworks, inadequate clinical trial regulation, limited capacity for drug development (notably for neglected and emerging diseases) and slow access to novel medicines. Drawing upon the history of regulatory harmonisation in Africa, international best practices, and current continental initiatives, the article proposes a comprehensive agenda for leadership and operational priorities designed to strengthen regulatory performance, support domestic manufacturing, ensure ethical and efficient trial oversight, and broaden access to innovation. The conclusion calls for multisectoral collaboration, innovative financing and sustained political commitment to realise the vision of Agenda 2063 and universal access to quality medical products in Africa.
Africa remains disproportionately burdened by infectious diseases, non-communicable illnesses and maternal and childhood mortality
The appointment of the inaugural Director General of the AMA marks a pivotal moment in Africa’s health governance.
This article systematically analyses the continental imperatives faced by regulatory authorities across the continent. It articulates strategic priorities to address drug development bottlenecks, regulatory fragmentation, ethical and operational weaknesses in clinical trial supervision and patchy access to innovative medicines. We focus on four key themes: strategic context, operational priorities, implementation pathways and concluding reflections. The core argument is that the new leadership can achieve a harmonised, capacity-enhancing, ethically robust, innovation-friendly and access-oriented regulatory architecture.
Since the 2009 establishment of the African Medicines Regulatory Harmonisation (AMRH) initiative, efforts have been made to align regulatory practices across Regional Economic Communities (RECs), yet progress has been uneven.
The AMA Treaty, adopted in February 2019 and entered into force on 05 November 2021 after ratification by 15 Member States, frames the agency’s remit, encompassing medicines, vaccines, medical devices, diagnostics and traditional therapies.
The need to streamline the transition of roles and handover of responsibilities to AMA is also an important consideration. The AMRH programme was started in 2009 as a response to addressing challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa. This initiative is housed by the African Union Development Agency – New Partnership for Africa’s Development (AUDA–NEPAD) in collaboration with the Africa Centres for Disease Control and Prevention (CDC), which will need to step back and transition all interventions to the new agency.
As the nascent agency commences operation, the following priorities should be considered by the new leadership of the AMA.
The agency will have to be the leadership’s most ardent advocate by ensuring that other African countries buy into the initiative and ratify the treaty. This is essential for establishing credibility and further solidifying the mandate of the organisation on the continent. Currently, only 29 countries have completed the ratification and deposited their instruments
Ratification status of the African Medicines Agency treaty among African Union member states (reference).
| Category | Number | Details |
|---|---|---|
| Total AU Member States | 55 | All AU countries. |
| Ratified the AMA Treaty | 31 | Countries that have completed ratification and deposited instruments. |
| Initial Ratifiers (2021) | 17 | Algeria, Benin, Burkina Faso, Cameroon, Chad, Gabon, Ghana, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leone, Tunisia and Zimbabwe. |
AU, African Union; AMA, Africa Medicines Agency.
The primary task of the Directorate is to deepen regional and continental harmonisation. This will involve finalising and promoting the adoption of the AU Model Law on Medical Products Regulation across Member States, a critical step to ensure regulatory coherence.
Aligning pathways for biosimilars and complex therapies demands investment in regulatory science, training and expert networks. Collaboration with the European Medicines Agency, the WHO-listed regulators and other agencies can facilitate regulatory reliance models and harmonised joint dossier assessments. Through such initiatives, the AMA can reduce approval timelines, increase transparency and contribute to continental trade integration under the African Continental Free Trade Area (AfCFTA).
Africa’s regulatory landscape exhibits significant variation in infrastructure, personnel and resources. Strengthening institutional resilience is therefore a top priority. African Medicines Agency’s mandate should include accreditation and oversight of Regional Centres of Regulatory Excellence (RCORE), where regulatory training, Good Laboratory Practice (GLP)-certified laboratories, pharmacovigilance systems and Good Manufacturing Practices (GMP) inspection will be co-ordinated. A strategic workforce development agenda encompassing training in regulatory science, translational research, legal aspects and technical competency (e.g., dossier assessment, clinical trial oversight) is critical.
Academia and professional bodies must be engaged in establishing curriculum standards for improved regulatory expertise and competencies. Postgraduate regulatory science programmes collaborating across universities will build Africa’s long-term capacity.
Robust clinical trial oversight lies at the intersection of science, ethics and public trust. Competition between national approval authorities and inconsistent standards has discouraged international research sponsorship.
Harmonised clinical trial regulations will attract sponsors, facilitate local innovation and reduce trial costs.
It is essential that ethical research practices and conduct be promoted. Strict penalties and transparency will lead to the avoidance of unethical research and corruption in clinical trials.
The AMA has a mandate to catalyse industrial-scale pharmaceutical manufacturing across the continent. To this end, it should collaborate with national regulatory bodies and manufacturers to enable technology transfer, expedite local approval of WHO-prequalified products and establish manufacturing partnerships across RECs.
Regulatory flexibility to support regional drug production includes accepting clinical data from comparable jurisdictions, fast-track approvals for innovations addressing neglected or epidemic diseases and supply chain resilience protocols.
Systems for supporting new in-class technological platforms, diagnostic innovations and digital innovations are essential. Promotion of culturally relevant health products and consideration of excipients that may have an impact on the use and acceptance of products need to be catalogued and understood. Public–private dialogues, incentives and GMP certification of African manufacturing facilities by the AMA will enhance confidence, reduce imports and drive economies of scale.
Africa’s access to novel treatments, such as Messenger ribonucleic acid (mRNA) vaccines, oncology therapies and advanced biologics, is limited by regulatory roadblocks, high prices, and supply challenges.
The role of AMA in negotiating pooled procurement should be considered very closely and guided by transparency, and with the best interests of the continent at the centre of any such proposals.
Coordination with donor agencies, Gavi, Coalition for Epidemic Preparedness Innovations (CEPI) and continental health financing instruments can enable tiered pricing and licence agreements appropriate to African markets. The expertise and experience of the new leadership with Ghana’s Food and Drugs Authority and global research and development advisory boards provide a unique opportunity to lead on acceleration schemes for product evaluation and approval in Africa.
In order to move this aspiration forward, we have identified good governance, digital platforms, political will and transparency as critical enablers that underpin all operational priorities.
Firstly, the AMA’s governance must balance AU representation, including Africa CDC and AUDA-NEPAD, regulatory independence, technical competence and stakeholder inclusivity. The Governing Board should incorporate RECs, Medicine Regulatory Authorities (MRAs), industry groups, civil society and academic leaders. An efficient Secretariat that routinely reports clear performance indicators and regional representation offices will boost effectiveness and accountability. Systems for the separation of powers and effective oversight of the executive and technical functions will build trust and accountability. In addition, the transition of AMRH activities to the AMA should be clearly articulated, and we call for close collaboration with AU agencies to lead or co-lead specific activities, fostering a spirit of partnership while minimising duplication and overlap.
Secondly, the deployment of interoperable, cloud-based, digital platforms for dossier submission, pharmacovigilance, GMP tracking and joint clinical trial reviews can dramatically increase efficiency and reduce administrative overhead. Existing systems such as the Afrivigilance
Raising political will among AU Member States remains critical. The AMA should articulate clear and critical value propositions, such as time-savings, cost-effectiveness and public health impact to justify sustained financing for its activities. Blended funding models combining Member State fees, donor grants and revenue from services should be explored. Demonstrating early successes, such as reduced approval times, quality improvements or expanded trial activity, will catalyse further support.
The AMA is a gateway to the health of citizens and the health economies of the countries of Africa. This makes it doubly important to ensure that the interests of the Member States are central to the work that the agency does. Avoiding donor dependence or a situation where the agency’s major funders have vested interests will ensure that the agency’s outcomes can be independent and trustworthy. Clear and frequent communication via well-established channels has to be the norm. This is critical to avoiding misinformation and disinformation, which in the long run can damage the credibility and acceptance of the guidance from the AMA.
The COVID-19 pandemic and emerging epidemics have underscored the urgency of continental self-reliance in health. The AMA has the potential to prevent future supply disruptions, reduce drug costs and stimulate Africa-led research. By embedding ethical, scientific, and innovation-driven values, the AMA can transform health outcomes and elevate Africa’s standing in global pharmaceutical development. Success will align Africa with Agenda 2063 goals, drive universal health coverage and inspire confidence in the continent’s capability to oversee its pharmaceutical destiny. The success of AMA hinges on delivering strategic wins across regulatory harmonisation, capacity development, trial oversight and equitable access.
The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article. The author, Emmanuel Agogo, serves as an editorial board member of this journal. The peer review process for this submission was handled independently, and the author had no involvement in the editorial decision-making process for this article. The authors have no other competing interests to declare.
Olawale Salami: Conceptualisation, Formal analysis, Investigation, Methodology, Writing – original draft, Writing – review & editing. Emmanuel Agogo: Conceptualisation, Formal analysis, Investigation, Methodology, Writing – review & editing. All authors reviewed the article, contributed to the discussion of results, approved the final version for submission and publication, and take responsibility for the integrity of its findings.
This article followed all ethical standards for research without direct contact with human or animal subjects.
Data sharing is not applicable to this article as no new data were created or analysed in this study.
The views and opinions expressed in this article are those of the authors and are the product of professional research. It does not necessarily reflect the official policy or position of any affiliated institution, funder, agency or the publisher. The authors are responsible for this article’s results, findings and content.