The African Medicines Agency does not replace NAFDAC registration. It layers on top of it. A NAFDAC Certificate of Registration remains the only legal basis for placing a medicinal product on the Nigerian market, and nothing about AMA's arrival changes a registered company's existing obligations on renewals, variations, pharmacovigilance or the resident Qualified Person for Pharmacovigilance. What AMA adds is a continental layer: joint scientific assessment of selected products, coordinated manufacturing inspections, and continental safety surveillance, all designed so that national regulators such as NAFDAC can rely on shared work when making their own decisions. For most companies registered in Nigeria the change is gradual, not sudden. For companies holding vaccines, biologics, oncology products or products for priority public health diseases, and for any company planning to sell beyond Nigeria, it is significant and it is already under way.
The short version
- AMA is a specialised agency of the African Union, headquartered in Kigali, Rwanda. It became operational in October 2025.
- AMA does not issue marketing authorisations that are valid in Nigeria. NAFDAC does. AMA issues scientific opinions and continental listings that national regulators can rely on.
- AMA focuses on complex products, vaccines and products of public health importance. Mature generics are largely outside its practical scope.
- In January 2026 AMA took over the continent's two flagship regulatory programmes, the African Medicines Regulatory Harmonisation programme and the African Union Smart Safety Surveillance programme, in which Nigeria was a founding country.
- Your NAFDAC obligations continue exactly as before. Your resident QPPV, your Pharmacovigilance System Master File and your reporting to NAFDAC are unaffected.
- The companies that benefit first will be those whose dossiers, manufacturing sites and pharmacovigilance systems are already built to a standard that travels across borders.
What is the African Medicines Agency?
The African Medicines Agency was established by the Treaty for the Establishment of the African Medicines Agency, adopted by the African Union Assembly on 11 February 2019. The treaty entered into force on 5 November 2021, thirty days after the fifteenth instrument of ratification was deposited. AMA is a specialised agency of the African Union with the aim of enhancing the capacity of States Parties and Regional Economic Communities to regulate medical products, so as to improve access to quality, safe and efficacious medical products across the continent.
Its governance follows the organs set out in the treaty: a Conference of States Parties, a Governing Board, a Secretariat based in Kigali, and technical committees. In June 2025 the Conference of States Parties appointed Dr. Delese Mimi Darko, formerly Chief Executive of the Food and Drugs Authority of Ghana, as the inaugural Director General. In a July 2026 interview with Health Policy Watch, Dr. Darko confirmed that AMA was operationalised in October 2025, and described technical committees for clinical trials, inspections, authorisation and safety, each made up of national regulatory authorities and their nominated focal persons.
Where AMA stands in September 2026
| Date | Milestone |
|---|---|
| 11 Feb 2019 | AMA Treaty adopted by the 32nd Ordinary Session of the African Union Assembly. |
| 5 Nov 2021 | Treaty enters into force following the fifteenth deposited ratification. |
| June 2025 | Dr. Delese Mimi Darko appointed inaugural Director General at the second Ordinary Session of the Conference of States Parties in Kigali. |
| Oct 2025 | AMA becomes operational in Kigali. |
| 23 Jan 2026 | AMRH and AU Smart Safety Surveillance programmes formally transferred from AUDA-NEPAD to AMA, including their technical, financial, digital, operational, legal and regulatory assets. |
| 21 May 2026 | WHO and AMA sign a Framework Agreement for Collaboration on the margins of the Seventy-ninth World Health Assembly. |
| July 2026 | AMA's Director General reports 33 of 55 African Union member states have ratified the treaty. |
The January 2026 transfer is the milestone most companies have missed. According to AMA's announcement of the transition, responsibility for continental medicines regulation — including the joint assessment work of the African Medicines Regulatory Harmonisation programme and the pharmacovigilance work of the African Union Smart Safety Surveillance programme — now sits inside AMA's institutional framework. The continental layer is no longer a set of donor-funded pilots. It is a treaty body.
Does AMA replace NAFDAC?
No. This is the single most important point in this article, and it is stated plainly by AMA itself.
The mechanism makes the relationship clear. When AMA's predecessor programme evaluated products at continental level, the resulting listing provided a consolidated scientific opinion but did not grant marketing authorisation in any participating country. National regulators retained full legal authority. As AUDA-NEPAD described the continental evaluation procedure, recommendations do not imply approval of products or manufacturing sites, which remains the prerogative of the national regulator of each member state.
For a company already registered in Nigeria, that means:
- Your NAFDAC Certificate of Registration remains your licence to market in Nigeria
- An AMA scientific opinion or continental listing is not a substitute for NAFDAC registration
- NAFDAC remains the authority that renews, varies, suspends or withdraws your registration
- NAFDAC remains the authority you report adverse reactions to and the authority that inspects your pharmacovigilance system
- Your post-registration obligations under NAFDAC's regulations are unchanged
Why AMA is not the European Medicines Agency
The comparison with the European Medicines Agency is natural and misleading in equal measure. In the European Union, a positive opinion under the centralised procedure leads to a single marketing authorisation valid across every member state. AMA does not work that way, and its leadership has been explicit that it is not simply copying the European model.
Africa has 55 member states with different legal systems, different regulatory capacity and different treaty status. AMA's model is coordinated assessment followed by national decision. The scientific work can be done once and shared. The legal authorisation remains national. For a company, that distinction determines everything about planning: a continental opinion shortens the path to a Nigerian registration, but it does not remove the need for one.
NAFDAC and AMA side by side
| Function | NAFDAC | African Medicines Agency |
|---|---|---|
| Legal basis | NAFDAC Act, Cap N1, Laws of the Federation of Nigeria 2004, and regulations made under it. | Treaty for the Establishment of the African Medicines Agency, binding on States Parties. |
| Marketing authorisation in Nigeria | Issues, renews, varies, suspends and withdraws the Certificate of Registration. | Does not grant Nigerian marketing authorisation. Issues scientific opinions and continental listings for reliance. |
| Product scope | All regulated products placed on the Nigerian market. | Selected products: complex products, vaccines and products of public health importance. |
| Manufacturing inspection | Inspects sites supplying the Nigerian market. | Coordinates joint GMP inspections drawing on African regulators' inspectors. |
| Pharmacovigilance reporting | Receives adverse reaction reports and ICSRs from Certificate of Registration Holders and healthcare professionals. | Coordinates continental safety surveillance through the programme inherited from AU Smart Safety Surveillance. |
| QPPV and master file | Requires a QPPV resident in Nigeria and a Pharmacovigilance System Master File held in Nigeria. | No equivalent company-level requirement published as of September 2026. |
| Clinical trials | Authorises and oversees trials conducted in Nigeria. | Coordinates joint reviews and scientific advice through a clinical trials technical committee. |
| Early scientific advice | Pre-submission engagement on national applications. | Regulatory Innovation and Market Readiness Office offers early scientific advice to sponsors and innovators. |
Which products AMA is built for
AMA does not intend to review everything. Dr. Darko set out the boundary directly. AMA focuses on complex products, vaccines and products of public health importance, and adds the most value where expertise is unevenly distributed across countries. Her own example was that a company making antibiotics or paracetamol may see no added value from AMA involvement, while a company working on vaccines, complex products, or tools for malaria or tuberculosis is where a centralised approach can help products reach patients faster.
The continental listing pilot, run under the African Medicines Regulatory Harmonisation programme between 2023 and 2025 to test the procedures AMA would inherit, shows what that scope looks like in practice. According to a 2026 evaluation of the pilot, the twelve products listed included an HPV vaccine, oncology monoclonal antibodies, a targeted oncology small molecule, an enzyme replacement therapy for a rare disease, a complement inhibitor, a combination paediatric vaccine and a zinc formulation. Nine of the twelve also held European Medicines Agency central approval.
The practical reading for a company registered with NAFDAC is a portfolio question, not a company question:
High-complexity, priority-disease products
Vaccines, biologics and biosimilars, monoclonal antibodies, oncology products, rare disease treatments, advanced therapies, and products for priority diseases such as malaria, tuberculosis and HIV.
Novel or public-health-relevant formulations
Novel formulations and fixed-dose combinations of public health importance, and paediatric formulations addressing unmet need.
Mature, well-established products
Mature generics, over-the-counter products and well-established molecules already widely registered across the continent.
A company whose Nigerian portfolio is entirely mature generics will see AMA's influence mainly through harmonised standards and continental safety surveillance, not through any change to how it registers products.
What the continental listing pilot tells us
The pilot is the best available evidence of how AMA's assessment and reliance model performs, because it was designed to test exactly the functions AMA now holds. The evaluation, authored by researchers from the University of Hertfordshire, the Centre for Innovation in Regulatory Science and AMA including Dr. Darko, was posted as a preprint in 2026.
| Measure | Pilot result |
|---|---|
| Expressions of interest received | 64 |
| Products entering full evaluation | 24 |
| Products receiving a positive continental opinion and listing | 12 |
| Median time from dossier acceptance to listing | 165 working days, range 148 to 233 |
| Listed products meeting the 210 working day target | 10 of 12 |
| GMP inspections conducted | 24, with no critical deficiencies identified |
| National uptake by full reliance | 7 products, 58% |
| National uptake by supplemented reliance | 3 products, 25% |
| National uptake by separate national review | 2 products, 17% |
| Median time from listing to national registration, full reliance | 77 working days, range 11 to 116 |
| National regulators using continental assessments directly | 16 |
Four findings matter for companies operating in Nigeria.
Nigeria has already acted on a continental opinion
For one of the listed vaccines, the evaluation records that both target countries, Nigeria and Egypt, issued positive scientific recommendations based on the continental assessment, with final administrative steps pending as of February 2026. NAFDAC is therefore not a future participant in continental reliance. It has already used it.
Dossier format was a gatekeeper
The reduction from 64 expressions of interest to 24 evaluated products was driven partly by applicants who could not provide dossiers in electronic Common Technical Document format, and by applicants unable to commit to on-site GMP inspection within the pilot timeline. The companies that could not enter were filtered out by readiness, not by science.
Administration, not science, drove delay
Scientific assessment ran close to its benchmark, with a median of 138 working days against a 150-day target. The longer end-to-end timelines accumulated in applicant response times, fixed scheduling of governance meetings and administrative processing. Where national uptake was slow, the evaluation attributes it to national legal authority for reliance, administrative requirements and applicant submission strategy.
Inspection findings followed a familiar pattern
Across the continental GMP inspections, 93% of deficiencies were classified as major, with recurring themes of contamination control, data integrity and quality system implementation. These are the same themes stringent regulators find worldwide. A site that would struggle in a European inspection will struggle in an AMA coordinated one.
What changes for pharmacovigilance
Pharmacovigilance is the area where AMA's arrival has the most direct and least discussed relevance to Nigeria, because Nigeria helped build the continental safety surveillance system AMA has now inherited. The African Union Smart Safety Surveillance programme was established with five founding countries: Ethiopia, Ghana, Kenya, Nigeria and South Africa. During the COVID-19 vaccine rollout it supported safety surveillance across countries accounting for roughly 35 percent of Africa's population, and its Joint Signal Management Group integrated adverse events following immunisation from all five countries to identify potential vaccine safety concerns across borders.
NAFDAC's own account of its participation describes the landscape assessment and capacity building carried out in Nigeria under the programme, and the expansion of the Med Safety App to capture adverse events following immunisation. NAFDAC's Director General, Professor Mojisola Adeyeye, told the Ethiopian News Agency in May 2025 that joining the platform helped Nigeria tremendously, especially in reaching WHO Maturity Level 3. By its second phase the programme was supporting twelve African countries in building a continental database for the safety of essential medicines and vaccines. AUDA-NEPAD had also assigned it responsibility for establishing AMA's Pharmacovigilance Technical Committee, and a continental risk assessment body, the African Union Pharmacovigilance Risk Assessment Committee, was being established to take over joint signal management.
What does not change
None of this alters a Certificate of Registration Holder's obligations to NAFDAC. As of September 2026, AMA has not published any requirement for companies to submit individual case safety reports to it directly. Your reporting destination, your resident QPPV, your Pharmacovigilance System Master File held in Nigeria, your signal detection procedure and your inspection exposure all remain governed by NAFDAC. Our guides to NAFDAC pharmacovigilance requirements and GVP compliance in Nigeria set out those obligations in full.
What does change in practice
What changes is visibility. A regulator that participates in continental joint signal management sees safety data from other African markets alongside its own. A signal emerging in Ghana or Kenya for a molecule you also market in Nigeria is no longer confined to that country's national centre. That has three consequences for a company's pharmacovigilance system:
- Safety information for the same product should be consistent across every African market you supply. Divergent reference safety information or product information between countries becomes visible to regulators comparing notes.
- Signals arising outside Nigeria are already in scope under NAFDAC's framework, which requires evaluation of safety signals arising within and outside Nigeria. Continental surveillance makes the external signal more likely to reach NAFDAC before it reaches you.
- Case quality matters more than it did. Data pooled across countries is only as useful as the least complete contribution, which is why coding to a standardised terminology and pursuing follow up are becoming continental expectations rather than local good practice.
Our article on signal detection in pharmacovigilance in Nigeria explains why small national datasets gain disproportionate value when they are placed in regional and global context, and our walkthrough of what happens after you report an adverse event to NAFDAC traces how a Nigerian case already travels beyond the country.
Why NAFDAC's standing matters inside AMA
AMA does not build its scientific capacity from nothing. Dr. Darko stated that the network of African agencies operating at WHO Maturity Level 3 will form the initial backbone of AMA's work, and that when AMA gives a scientific opinion or recommendation, it will start with those agencies. NAFDAC attained Maturity Level 3 in 2022 for medicines and imported vaccines and has sustained that status through re-benchmarking. The pilot evaluation notes that only nine of 54 national regulatory authorities in the region operate at a maturity level sufficient to perform core regulatory functions consistently.
NAFDAC has also become a full Regulatory Member of the International Council for Harmonisation, which brings a defined implementation pathway for the Common Technical Document, MedDRA and the core ICH pharmacovigilance guidelines. Our comparison of ICH guidelines and NAFDAC requirements sets out what that pathway involves.
Ratification and why Nigeria's treaty status matters
Treaty status is not symbolic. Dr. Darko explained that for a country to benefit from a centralised AMA approval of a new vaccine through the general pathway, it would have to be a State Party, meaning it has signed and ratified the treaty, and that AMA can by legislation work on capacity building only with ratified countries. As of July 2026 she put the figure at 33 of 55 member states, and AMA's ratification tracker records the status of each.
Nigeria's path has been slower than its regulatory standing might suggest. When the treaty entered into force, Nigeria was among the large economies that had not signed. In February 2025 the Federal Executive Council approved Nigeria's ratification of the AMA Treaty, with the Minister of Health and Social Welfare, Professor Ali Pate, stating that the Council had directed that Nigeria ratify the treaty and take all necessary actions to implement it. The completion of the formal deposit process is recorded on AMA's tracker.
For companies, ratification matters in two ways. It determines whether a Nigerian national decision can draw on AMA's centralised pathway for products in AMA's scope, and it determines how fully Nigerian manufacturers can use continental listing to reach other State Party markets.
What companies already registered with NAFDAC should prepare for
Your NAFDAC obligations continue unchanged
Renewals fall due on their existing cycle. Variations follow NAFDAC's procedures. Labelling, import permits, pharmacovigilance and post-marketing surveillance obligations all continue. Nothing in AMA's operationalisation creates a grace period or a parallel route that excuses any of them. Our NAFDAC product registration guide covers the post-registration obligations in detail.
Triage the portfolio against AMA's scope
Sort registered and pipeline products into the likely, possible and unlikely categories set out above. For products in the likely category, a continental opinion may become the fastest route into additional African markets, and in some cases a route that national regulators will expect companies to use.
Build dossiers once, in a format that travels
The pilot filtered out applicants who could not provide electronic Common Technical Document dossiers. A dossier built in CTD structure, maintained in electronic format and kept consistent across markets can be submitted to NAFDAC, to a continental procedure and to other national regulators with minimal rework. Our registration preparation guide covers dossier readiness for NAFDAC submissions.
Prepare manufacturing sites for joint inspection
Continental GMP inspections draw on inspectors from several African regulators and apply international standards. The recurring pilot findings on contamination control, data integrity and quality system implementation are the areas to test first. For manufacturers outside Nigeria supplying the Nigerian market, a single continental inspection may eventually serve several regulators, which raises the stakes of any one outcome.
Align pharmacovigilance across markets
Harmonise reference safety information and product information across African markets for the same product. Code cases to a standardised terminology. Ensure the Risk Management Plan is consistent where the same product is registered in more than one country, while retaining the Nigerian epidemiology NAFDAC requires. Where the Pharmacovigilance System Master File covers a multi-country operation, it should describe clearly how safety data flows between countries and who holds each responsibility. Our PV Readiness Guide and QPPV Support Essentials cover the governance side.
Plan expansion beyond Nigeria through reliance
For companies using Nigeria as a base for West African or continental expansion, continental listing sits alongside regional work sharing through the Economic Community of West African States and bilateral reliance. The pilot showed products with broad market strategies achieving registration in up to 23 African countries. Our market entry and compliance overview sets out the Nigerian starting point.
Treat AMA guidance as a change control trigger
AMA is publishing its procedures progressively. Each new guideline, procedure or safety alert is a potential change to how a product is supported across Africa. AMA's alerts page carries its safety communications. Our regulatory change briefs set out a framework for turning regulatory developments into controlled implementation steps.
Readiness checklist
Preparation for AMA's expanding role
- All NAFDAC renewal dates, variation commitments and post-registration obligations tracked and current
- Portfolio triaged against AMA scope, with likely and possible products identified
- Registration dossiers available in CTD structure and electronic format
- Dossier content consistent across African markets for the same product
- Manufacturing sites assessed against contamination control, data integrity and quality system expectations
- Resident QPPV and deputy in place, with authority over the Nigerian pharmacovigilance system
- Pharmacovigilance System Master File current and held in Nigeria
- Reference safety information aligned across African markets
- Cases coded to a standardised medical terminology
- Signal detection procedure covering signals arising outside Nigeria
- Multi-country safety data flows documented
- A named owner monitoring AMA guidance and alerts
Pair this with the NAFDAC QPPV Compliance Checklist for a complete pharmacovigilance self-assessment.
Download the Checklist PDFCommon misconceptions about AMA
“We will need to re-register our products with AMA.”
No. AMA does not register products for the Nigerian market, and existing NAFDAC registrations are unaffected.
“An AMA listing gives us access to all 55 markets.”
No. A listing supports national decisions. Each country still issues its own authorisation, and speed of uptake depends on that country's reliance procedures.
“AMA will review every medicine sold in Africa.”
No. AMA's focus is complex products, vaccines and products of public health importance.
“Adverse reaction reports now go to Kigali.”
No. Reporting obligations for Certificate of Registration Holders remain with NAFDAC.
“We no longer need a local QPPV because regulation is going continental.”
No. The Nigerian QPPV residency requirement is a national requirement and remains in force.
“AMA is years away from mattering.”
No. AMA is operational, holds the continent's joint assessment and safety surveillance programmes, and NAFDAC has already acted on a continental scientific opinion.
Key takeaways
- AMA layers on top of NAFDAC registration. It does not replace it, and a NAFDAC Certificate of Registration remains the legal basis for marketing in Nigeria.
- AMA is operational and now holds the continent's joint assessment and safety surveillance programmes.
- Its scope is selective: vaccines, complex products and products of public health importance.
- NAFDAC has already acted on a continental scientific opinion, and as a Maturity Level 3 regulator sits within the group AMA describes as its initial backbone.
- Pharmacovigilance obligations to NAFDAC are unchanged, but cross-border safety visibility is increasing.
- Readiness, in dossier format, manufacturing quality and pharmacovigilance consistency, determines which companies benefit first.
How MedNova supports companies registered with NAFDAC
MedNova Lifesciences provides regulatory affairs support in Nigeria spanning NAFDAC product registration, dossier preparation in CTD format, renewals, variations, import permits and lifecycle management, together with regulatory strategy for companies expanding from Nigeria into other African markets. Our pharmacovigilance services in Nigeria cover pharmacovigilance system setup and SOPs, ICSR intake and case processing, aggregate reporting, signal detection and risk management, literature surveillance, inspection readiness, and local QPPV representation for Marketing Authorisation Holders. We also provide clinical development services and training and consulting for regulatory and pharmacovigilance teams.
Related reading: NAFDAC pharmacovigilance requirements, what GVP compliance means in Nigeria, ICH guidelines compared with NAFDAC requirements, signal detection in pharmacovigilance, what happens after you report an adverse event to NAFDAC, the regulatory affairs primer and our overview of clinical development readiness in Nigeria and West Africa. For our full scope of work, see the MedNova capability statement or browse the resources library.
Next step: download the NAFDAC QPPV Compliance Checklist, or contact our team to discuss a regulatory and pharmacovigilance readiness review for your portfolio.
Planning for AMA while staying current with NAFDAC?
MedNova Lifesciences helps companies keep NAFDAC obligations current while preparing dossiers, sites and pharmacovigilance systems for a continent that is regulating in a more connected way, in Nigeria and across Africa.
Contact MedNova LifesciencesRelated resources
Frequently asked questions
What is the African Medicines Agency?
The African Medicines Agency is a specialised agency of the African Union, established by treaty and headquartered in Kigali, Rwanda. It became operational in October 2025 and exists to strengthen the capacity of African regulators, coordinate joint scientific assessments and inspections, and coordinate continental safety surveillance.
Does the African Medicines Agency replace NAFDAC?
No. AMA coordinates national regulators rather than replacing them, and the treaty stipulates that it shall not supplant national regulatory authorities. NAFDAC remains the authority that grants, renews, varies and withdraws marketing authorisation in Nigeria.
Do companies already registered with NAFDAC need to register with AMA?
No. AMA does not register products for the Nigerian market. An existing NAFDAC Certificate of Registration remains valid and remains the legal basis for marketing in Nigeria.
What is the difference between AMA and NAFDAC?
NAFDAC is Nigeria's national regulator with legal authority over products on the Nigerian market. AMA is a continental coordinating agency that produces scientific opinions, coordinates joint inspections and safety surveillance, and builds regulatory capacity. National regulators such as NAFDAC can rely on AMA's work when making their own decisions.
Which products will AMA evaluate?
AMA focuses on complex products, vaccines and products of public health importance, including tools for diseases such as malaria and tuberculosis. Its Director General has indicated that products such as common antibiotics or paracetamol are unlikely to benefit from AMA involvement.
Can an AMA listing speed up NAFDAC registration?
It can. In the continental listing pilot, products processed through full reliance reached national registration a median of 77 working days after listing, and Nigeria issued a positive scientific recommendation for one listed vaccine based on the continental assessment.
Has Nigeria ratified the AMA Treaty?
Nigeria's Federal Executive Council approved ratification of the AMA Treaty in February 2025. AMA's ratification tracker records the current status of each African Union member state.
Why does treaty ratification matter to companies?
AMA's Director General has stated that countries need to be States Parties to benefit from centralised AMA approvals through the general pathway, and that AMA can by legislation work on capacity building only with ratified countries.
Does AMA change pharmacovigilance reporting in Nigeria?
Not for Certificate of Registration Holders. As of September 2026, reporting obligations remain with NAFDAC, and AMA has not published a requirement for companies to report individual cases to it directly. AMA does now hold the continental safety surveillance programme in which Nigeria was a founding country.
What was the AU Smart Safety Surveillance programme?
It was a continental pharmacovigilance programme established with Ethiopia, Ghana, Kenya, Nigeria and South Africa as founding countries. It supported cross-border vaccine safety surveillance during the COVID-19 rollout and was transferred to AMA in January 2026.
Does the Nigerian QPPV requirement still apply?
Yes. NAFDAC's requirement for a Qualified Person for Pharmacovigilance resident in Nigeria is a national requirement and is unaffected by AMA's operationalisation.
What should a NAFDAC registered company do now?
Keep NAFDAC obligations current, triage products against AMA's scope, maintain dossiers in electronic CTD format, prepare manufacturing sites for joint inspection, align pharmacovigilance and safety information across African markets, and monitor AMA guidance as it is published.
References
- African Union. Treaty for the establishment of the African Medicines Agency enters into force, 9 November 2021.
- African Union. Dr. Delese Mimi Darko appointed inaugural Director General of the African Medicines Agency, 4 June 2025.
- African Medicines Agency. AMA and AUDA-NEPAD conclude the transition of continental medicines regulatory programmes, 23 January 2026.
- African Medicines Agency. Ratifications tracker.
- African Medicines Agency. Alerts.
- Adepoju P. Africa's new medicines regulator wants to be more than another approval channel, Health Policy Watch, 27 July 2026.
- World Health Organization. WHO and African Medicines Agency launch landmark framework to strengthen access to quality assured health products in Africa, 21 May 2026.
- Ismail AJ, Moeti L, Darko DM, Walker S, Salek S. Operationalisation of the African Medicines Agency: retrospective evaluation of the continental centralized pilot procedure. medRxiv preprint, 2026.
- 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. PubMed Central PMC12913070.
- AUDA-NEPAD. Evaluation of Medicinal Products Technical Committee continental procedure.
- AUDA-NEPAD. African Union Smart Safety Surveillance (AU-3S).
- Empowering African expertise: enhancing safety data integration and signal detection for COVID-19 vaccines through the African Union Smart Safety Surveillance Joint Signal Management Group. Drug Safety, 2025. PubMed record 39843797.
- National Agency for Food and Drug Administration and Control. African Union Smart Safety Surveillance (AU3S) programme in Nigeria.
- Ethiopian News Agency. AU-3S expands drug safety surveillance across Africa with continental database, 5 May 2025.
- Nigerian NewsDirect. FG approves African Medicines Agency Treaty ratification, February 2025.
- World Health Organization. Egypt and Nigeria medicines regulators achieve high maturity level in WHO classification, 30 March 2022.
- National Agency for Food and Drug Administration and Control. NAFDAC's WHO ML3 re-benchmarking success.
- National Agency for Food and Drug Administration and Control. NAFDAC announces a transition from observer status to full membership of the International Council for Harmonisation.
- National Agency for Food and Drug Administration and Control. NAFDAC Good Pharmacovigilance Practice Guidelines (Doc. Ref. PV/PMS-GDL-017-01).
- Africa Clinical Research Network. The African Medicines Agency: what continental regulatory harmonization actually changes, 13 August 2026.
- MedNova Lifesciences. Regulatory affairs services, Nigeria and Africa. mednovalife.com/regulatory.html