MAA Regulatory Spotlight - 15
July 8, 2025
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
This edition of the Market Access Africa Regulatory Spotlight presents a consolidated overview of recent regulatory developments and collaborative initiatives taking place across the African continent. There has been significant progress in regional regulatory harmonisation, safety monitoring, digital transformation, and institutional capacity strengthening. Notable developments include the reconstitution of the African Blood Regulators Technical Committee, advancements in pharmacovigilance coordination under the African Medicines Regulatory Harmonisation (AMRH) initiative, and the 52nd session of the Zazibona collaborative medicines registration programme.
In addition, several regulatory authorities have taken concrete steps to align with international best practices. Ghana’s commencement of a vaccine lot release programme, Algeria’s safety update on pseudoephedrine-containing products, and the emergency use listing of a monkeypox diagnostic by SAHPRA using WHO reliance pathways all signal increasing regulatory maturity and responsiveness.
The continued push towards digitalisation is also evident. Burkina Faso is advancing the implementation of the AU Model Regulatory Information Management System (RIMS), while Tunisia and Benin are introducing new data submission frameworks to streamline regulatory processes. These initiatives reflect a shared commitment to improving regulatory efficiency and transparency through automation and standardisation. Institutional cooperation also remains a key theme with Egypt and Zambia reaffirming their commitment to strategic regulatory collaboration.
Kenya is set to host the East Africa Regional Centre of Excellence in Bioequivalence Studies and Pharmaceutical Research (EAC RCOEBPR) - the first institution in the East African Community (EAC) and Common Market for Eastern and Southern Africa (COMESA) regions dedicated to the synthesis of pharmaceutical raw materials and bioequivalence testing for generic medicines. The Centre was approved during the 25th Ordinary Meeting of the East Africa Sectoral Council of Ministers of Health and it will be hosted at the University of Nairobi. The aims of the Centre are to bridge critical gaps in the pharmaceutical manufacturing value chain and strengthen healthcare delivery across the region.
The EAC also launched Phase III of the Regional Network of Reference Laboratories for Communicable Diseases Project to strengthen laboratory capacities for pandemic prevention and response, in alignment with the One Health approach across the EAC region. This is part of a three-year project (July 2025 to July 2028) supported by the government of Germany through KfW, the German Development Bank, to address challenges posed by communicable diseases and enhance the region’s readiness to respond effectively to health emergencies. The project is also expected to help rapidly contain disease outbreaks and reduce the burden of infectious diseases with epidemic or pandemic potential in the region. More information on this project can be found here.
The African Union Development Agency – New Partnerships for Africa’s Development (AUDA-NEPAD), through the African Medicines Regulatory Harmonisation (AMRH) programme, is supporting Burkina Faso’s Agence Nationale de Régulation Pharmaceutique (ANRP) in digitising and automating its medicines regulatory processes. From 13 – 15 May 2025, experts from the AMRH Information Management System Technical Committee (IMS TC) were in the country to support implementation of the African Union (AU) Model Regulatory Information Management System (RIMS) and the Regulatory Information Sharing Portal (RISP). The intention of these efforts is to move toward more efficient, data-driven regulatory systems across the continent that are aligned with World Health Organization (WHO) Global Benchmarking Tool indicators.
A hybrid workshop was held in Nairobi, Kenya, from 13 – 15 May 2025 to reconstitute and operationalise the African Blood Regulators Technical Committee, initially established in 2019.
The workshop convened regulators and technical experts to advance blood product regulatory systems across the continent within the framework of the African Medicines Agency (AMA). Key objectives included reviewing national regulatory progress, finalising draft guidelines on blood regulation, electing new Technical Committee leadership, and identifying capacity-building needs across Africa.
The newly appointed leadership of the Technical Committee is as follows:
At the African Union Smart Safety Surveillance (AU-3S) Programme Steering Committee meeting held on 30 April 2025, a key decision was made to further institutionalise the coordination of pharmacovigilance efforts across the continent.
Going forward, the Vigilance Technical Committee will operate under the leadership of the African Medicines Regulatory Harmonisation (AMRH) initiative. It will report to the AMRH Steering Committee and collaborate with other Technical Committees to support the safety monitoring functions of the African Medicines Agency (AMA).
The AU-3S Programme will continue to expand its reach by engaging more countries, strengthening national pharmacovigilance capacity, optimising technology, implementing the AfriVigilance Roadmap, establishing and operationalising the AU Pharmacovigilance Risk Assessment Committee (AU-PRAC), and promoting active surveillance and other emerging safety initiatives.
The South African Health Products Regulatory Authority (SAHPRA), having applied reliance on the World Health Organization (WHO) Prequalification (PQ) assessment under Emergency Use Listing, has listed the first mpox (monkeypox) in vitro diagnostic (IVD). This is an important step in improving global access to mpox testing by using a reliance process.
The Alinity m MPX assay, developed by Abbott Molecular Inc. and licensed to Abbott Laboratories South Africa (Pty) Ltd, received emergency use approval from SAHPRA following the WHO PQ EUL assessment. This represents a critical advancement in expanding diagnostic capacity during mpox outbreaks, where timely and accurate testing is essential for early detection, rapid response, and containment.
Currently, only molecular RT-PCR (reverse transcription polymerase chain reaction) tests using nasal swabs are considered for approval by SAHPRA. The Africa Centres for Disease Control and Prevention (Africa CDC) and WHO have highlighted that no independently validated antigen rapid diagnostic tests (RDTs) have demonstrated the minimum clinical sensitivity of 80% required for mpox testing in Africa. As such, mpox antigen and antibody rapid test kits, including self-test kits, are not recommended for use.
Further regulatory requirements for mpox diagnostics are detailed in SAHPRA’s communication to industry (Issue No.: MD01-2024/25 v1), available here: SAHPRA Mpox Diagnostic Tests Communication.
Botswana recently hosted the 52nd meeting of the Zazibona initiative – a pivotal, week-long gathering of assessors from National Regulatory Authorities (NRAs) across the Southern African Development Community (SADC) region. This ongoing collaboration remains a cornerstone of efforts to improve access to essential medicines across Southern Africa.
Zazibona is widely recognised as a pioneering model of work-sharing in medicines regulation. Over the past decade, it has transformed regulatory practices in the region, improving access to safe, effective, and quality-assured medicines. Now in its 52nd session, Zazibona continues to promote regulatory efficiency by reducing duplication, harmonising regulatory requirements, and aligning decision-making processes across SADC.
Work-sharing platforms such as Zazibona are essential for strengthening regulatory systems. They enhance efficiency, build capacity, and accelerate the availability of quality-assured medicines. By pooling expertise and aligning standards, NRAs can make faster, more consistent decisions that directly benefit public health. These platforms also foster mutual trust, support technical development, and drive regulatory convergence – laying a strong foundation for regional health security and resilient health systems.
The Botswana Medicines Regulatory Authority (BOMRA) recently met with the World Health Organization (WHO) Country Office to review progress on the roadmap toward attaining WHO Maturity Level 3 (ML3). This follows a prior visit in July 2024 which conducted an overview of the status of BOMRA’s regulatory system against the WHO Global Benchmarking Tool (GBT).
Botswana is on course to achieve ML3 – a globally recognised benchmark of a stable, well-functioning, and high-performing regulatory system. Attaining ML3 is not only a technical achievement but also a strategic priority that aligns with the country's broader health and development goals, including improving access to safe, effective, and quality-assured medical products.
In September 2024, BOMRA joined the Coalition of Interested Parties (CIP), a WHO network of partners dedicated to strengthening regulatory systems. The CIP promotes cooperation on regulatory convergence, work-sharing, reliance mechanisms, and capacity building. Through engagement in the CIP network, BOMRA is implementing critical capacity-strengthening activities that directly contribute to progress in executing its ML3 roadmap.
From 14 – 15 May 2025, Heads of National Regulatory Authorities (NRAs) in the Intergovernmental Authority on Development (IGAD) region convened in Addis Ababa, Ethiopia, for a high-level meeting hosted by the Ethiopian Food and Drug Authority (EFDA). IGAD’s member states are Djibouti, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda. This gathering brought together leaders and technical experts to advance regional regulatory harmonisation and reliance mechanisms.
Key topics discussed included:
The meeting reinforced the importance of collaborative regulatory systems to ensure access to safe, effective, and quality-assured medicines across the region. These efforts are vital to achieving the African Union’s Agenda 2063 and the continent’s goal of producing 60% of its vaccines locally by 2040.
The Food and Drugs Authority (FDA) Ghana announces the official commencement of its Vaccine Lot Release Programme, effective 1 June 2025. This initiative underscores FDA Ghana’s commitment to safeguarding public health by ensuring the safety, quality, and efficacy of vaccines used in the country.
As part of the phased implementation, the lot release process will initially apply to vaccines intended for the Expanded Programme on Immunisation (EPI).
All stakeholders are kindly urged to take note of this development and ensure full compliance with the lot release requirements.
Comprehensive details regarding submission procedures, timelines, and required documentation are available on the FDA Ghana website.
Dr. Ali El-Ghamrawy, Chairman of the Egyptian Drug Authority (EDA), held a virtual meeting with Dr. Makomani Siyanga, Director General of the Zambia Medicines Regulatory Authority (ZAMRA), to discuss the operationalisation of the Memorandum of Understanding (MoU) signed between the two agencies in June 2024. The meeting focused on aligning technical perspectives for implementing the MoU, with the goal of officially activating it soon to advance mutual interests and strengthen regulatory collaboration.
Dr. El-Ghamrawy reaffirmed Egypt’s commitment to supporting Zambia’s access to quality-assured Egyptian pharmaceutical products and enhancing ZAMRA’s regulatory capacity. He emphasised Egypt’s readiness to provide technical expertise and training aligned with international best practices, drawing on the EDA’s achievement of WHO Maturity Level 3 in both vaccine and medicine regulation.
The MoU reflects a shared strategic vision to promote public health and pharmaceutical development across the continent. It outlines key areas of cooperation, including regulatory reliance by Zambia on the EDA for the registration and marketing authorisation of pharmaceutical and biological products, in line with WHO guidelines. It also provides for the launch of capacity-building initiatives such as virtual and in-person training for Zambian regulatory staff.
The Egyptian Drug Authority (EDA), through the General Administration of Veterinary Products within the Central Administration of Pharmaceutical Products, has released a draft proposal for the first edition of the Egyptian guideline on conducting bioequivalence studies for generic veterinary medicinal products.
This initiative reflects the EDA’s ongoing commitment to transparent engagement and effective communication with veterinary pharmaceutical stakeholders.
Stakeholders are invited to review the proposed guideline and submit feedback or suggestions via the links below:
The EDA welcomes constructive input to ensure the guideline is comprehensive, practical, and aligned with international best practices.
The National Agency for Medicines and Health Products (ANMPS) of Tunisia is updating its product information database as part of its broader digital transformation. All Marketing Authorisation (MA) holders are required to submit updated product information for each approved product by 6 June 2025.
What to Submit:
Submission Options:
File Naming Requirements:
All files must be submitted in lowercase using the following naming convention:
MA number-rcp
MA number-notice
MA number-maquette
MA number-etiquetage
The Beninese Agency for Medicines and Other Health Products (ABMed) has introduced new standardised templates for Marketing Authorisation (MA) and Marketing Certificate (MC) application submissions. Target stakeholders include medical promotion agencies and pharmaceutical company representatives or affiliates.
This initiative aims to harmonise regulatory submissions and strengthen alignment with Benin’s national regulatory standards, marking a significant step toward a modern regulatory system and improved access to quality-assured health products.
MA and MC applicants are now required to use the newly implemented:
The templates can be downloaded directly via this link.
Applicants are encouraged to ensure full compliance with these updated requirements when preparing their application dossiers.
The Algerian National Agency for Pharmaceutical Products (ANPP) has issued an official note directed to all technical directors of pharmaceutical establishments, calling for urgent updates to product information for pseudoephedrine-containing medicines.
In line with recent safety reviews, Summary of Product Characteristics (SmPCs) and package inserts (leaflets) must now include new contraindications and warnings regarding the rare but serious risks of:
Pharmaceutical establishments are required to submit variation files within 30 days of the note’s publication (i.e. 19 June 2025) to the Registration Directorate, following the established procedures.
This update underscores ANPP’s commitment to safeguarding public health through timely risk communication and regulatory action.
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