MAA Regulatory Spotlight - 13
May 19, 2025
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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In this issue of MAA Regulatory Spotlight, we highlight key developments in Africa’s regulatory landscape. The inaugural African Regulatory Leadership Programme (ARLP) was hosted by Wits Business School, bringing together Heads of African National Medicines Regulatory Authorities to advance their leadership skills and co-create regulatory capacity strengthening plans. Meanwhile, SAHPRA, South Africa celebrated the graduation of the fourth cohort of the Clinical Assessors Short Course – a flagship programme aimed at strengthening regulatory capacity across the continent.
The African Union Smart Safety Surveillance (AU-3S) programme continues its mission to enhance safety surveillance for priority medical products across the continent. In March, the Medicines Control Authority of Zimbabwe (MCAZ) hosted an AUDA-NEPAD delegation for a two-day AU-3S workshop, while in Addis Ababa, Ethiopia, the 6th AU-3S Steering Committee Meeting discussed how to expand country participation, advance data integration, and support the operationalisation of the African Medicines Agency.
Across the continent, regulatory authorities are making strides towards achieving WHO Maturity Level 3. In East Africa, Uganda’s National Drug Authority (NDA) hosted an AMRH initiative delegation to assess progress in implementing Institutional Development Plans (IDPs) and identify priority interventions for strengthening regulatory functions. Ethiopia’s EFDA also announced bioequivalence as a mandatory requirement for local manufacturers. In Southern Africa, Ghana FDA visited BoMRA, Botswana to enhance regulatory systems and foster collaboration as part of the Grand Challenges project funded by the Gates Foundation. Finally, Botswana officially became the 30th state party to the African Medicines Agency treaty after depositing its ratification instrument during the AU Summit in February.
These efforts and milestones reflect Africa’s continued progress in strengthening regulatory systems to ensure the availability of quality-assured, safe, and effective medical products for its population.
The inaugural African Regulatory Leadership Programme (ARLP) was hosted by the University of the Witwatersrand and the Harvard T.H. Chan School of Public Health at the Wits Business School in Johannesburg, South Africa. The programme brought together the continent’s top regulators to advance their leadership skills and mutually map out how Africa can strengthen its regulatory capacity. This is a step towards regional harmonisation and establishment of the African Medicines Agency. The programme also explored themes such as leadership styles, regulatory innovation, leadership in different contexts, the role of communication in leadership and the transformative power of collaboration. For the next six months, Heads of African national medicines regulatory authorities (NRAs) will be paired with faculty members as mentors. This inaugural programme will extend to other health regulatory professionals in future.
Read more here.
The Medicines Control Authority of Zimbabwe (MCAZ) hosted AUDA-NEPAD delegates, Kenneth Onu, PPO/Coordinator and Kudakwashe Dandajena, PPO/Technology Strategy, for a 2-day African Union Smart Safety Surveillance (AU-3S) programme workshop. The aim of the AU-3S programme is to address limited health system and safety surveillance capacity across Africa, through efficiencies like technological innovation, capacity strengthening, pooling of resources, and work sharing. The programme was launched in 2020 with funding from the Gates Foundation as part of its long-term goal is to strengthen the safety surveillance of priority medical products across the African continent. The objectives of the 2-day visit to MCAZ were to introduce the AU-3S programme to the focal points in Zimbabwe, and to conduct a landscape assessment of the safety surveillance system in the country. Additionally, solutions that the AU-3S programme can offer to address the identified gaps were discussed. The visit also started the process of sub-delegation support to MCAZ.
Over the past five years, AU-3S has connected NRAs across multiple African countries, enhanced digital safety surveillance through platforms like AfriVigilance Lite, built partnerships and collaborations to support vigilance system strengthening, and facilitated signal management and data-driven decision-making for safer healthcare. As the programme looks ahead to its next phase of impact, it convened the 6th AU-3S Steering Committee Meeting in Addis Ababa, Ethiopia from 26 – 27 March 2025. The meeting discussed expanding country participation, advancing data integration and supporting the operationalisation of the African Medicines Agency.
The African Medicines Regulatory Harmonisation (AMRH) initiative, in collaboration with CMCOMMS, led an onsite mission in Uganda to identify key regulatory gaps using the World Health Organization (WHO) Global Benchmarking Tool (GBT), assess the National Drug Authority (NDA) of Uganda’s progress in implementing Institutional Development Plans, and outline priority interventions for enhancing regulatory functions which include resource mobilisation strategies. NDA is a designated Regional Centre of Regulatory Excellence for inspection and its Quality Control function has previously attained maturity level 4. AMRH’s visit to Uganda is part of its broader efforts to support NRAs achieve higher maturity levels and ensure medical products across Africa comply with quality, safety and efficacy standards. By providing additional technical and financial support to NDA, it is hoped that NDA will attain maturity level 3 and contribute more significantly to continental regulatory processes through the African Medicines Agency.
The United States Pharmacopoeia (USP) co-hosted the 13th Meeting of the Regional Economic Communities (RECs) Medicines Regulatory Harmonisation in Africa with AUDA-NEPAD Health Programmes team. The meeting discussed the integral role RECs play in supporting the operationalisation of the African Medicines Agency and ensuring patients across Africa have access to safe, effective, and quality medical products. This can be through regulatory capacity strengthening at national and regional level and implementing a cohesive continental regulatory ecosystem.
The Ethiopian Food and Drug Authority (EFDA) is mandated to ensure the safety, efficacy and quality of medicines available in the Ethiopian market, in accordance with the Food and Drug Administration Proclamation No. 1112/2019, Article 20. Bioequivalence (BE) studies serve as a critical surrogate marker for assessing the therapeutic equivalence of multisource (generic) medicines and have always been an essential requirement in the dossier assessment process for pharmaceutical product registration and marketing authorisation. EFDA therefore notifies all local manufacturers that, effective immediately, the submission of a BE study report is a mandatory requirement for the registration and marketing authorisation of pharmaceutical products that require BE studies. Any dossier submitted without the BE study data will not be considered for evaluation.
Read more about EFDA BE requirements here.
The South African Health Products Regulatory Authority (SAHPRA), in partnership with Pharmacometrics Africa and the Department of Pharmacy and Pharmacology at the University of the Witwatersrand, announced the graduation of the fourth cohort of the Clinical Assessors Short Course — a flagship programme designed to strengthen regulatory capacity across Africa. The 14-week certified course continues to play a pivotal role in addressing the growing demand for regulatory science expertise across the continent, ultimately contributing to improved patient safety, access to quality medicines, and regulatory efficiency. The programme is accredited by the University of the Witwatersrand and the course content is designed to fill critical knowledge gaps in the evaluation of clinical sections of regulatory submissions dossiers’ data, with a focus on the risk-benefit assessment of medicines. Although the course has a primary focus on the development of professionals working in African NRAs, it also welcomes academics, patient advocates, and industry stakeholders to promote shared understanding and practical skills in clinical assessment. Participants in this year’s cohort included assessors from NRAs in Botswana, Ethiopia, Ghana, Kenya, Namibia, Rwanda, South Africa, Tanzania, Zambia and Zimbabwe.
The recording of the graduation ceremony can be accessed here.
The Botswana Medicines Regulatory Authority (BOMRA) has extended previously proposed timelines related to medical devices, including IVDs registration and retention.
Key dates to note are as follows:
It is important to note that retention for registered medical devices including IVDs is on their yearly anniversary date. For medical devices (including IVDs) called for registration, only one exemption cycle will be allowed, with the second one considered only when the registration application has been submitted. The full notice can be read here.
A delegation from the Ghana Food and Drugs Authority (FDA) visited the Botswana Medicines Regulatory Authority (BoMRA) to assess BoMRA’s regulatory systems, facilitate discussions on areas for improvement, and develop a detailed collaboration plan between the two regulatory authorities. Through structured meetings, Ghana FDA and BoMRA identified areas of improvement across market authorisation (MA), pharmacovigilance (PV), clinical trials (CT), data system harmonisation, and monitoring and evaluation (M&E), while also defining joint actions to enhance these systems.
This visit was part of ongoing efforts to strengthen regulatory frameworks and support the achievement of WHO Maturity Level 3 status for BoMRA, under the Grand Challenges Project supported by the Gates Foundation. Ghana FDA and BoMRA also have a standing Memorandum of Understanding (MoU) that formalises their ongoing collaboration in the regulation of medicines. This MoU ensures continued cooperation in enhancing the safety, efficacy, and regulatory oversight of medicines.
The African Medicines Agency (AMA) Treaty was adopted by African Heads of States and Government during their 32nd Ordinary Session of the Assembly on 11 February 2019 in Addis Ababa, Ethiopia. Among other aspirations, the AMA aims to enhance the capacity of national medicines regulatory authorities (NRAs) and regional blocs in Africa to regulate medical products and to improve access to quality, safe and efficacious medical products. AMA builds on the African Medicines Regulatory Harmonization (AMRH) initiative, which was established in 2009, and is currently led by AUDA-NEPAD. Botswana’s deposition of its AMA Treaty ratification instrument on 14 February 2025 during the African Union (AU) Summit brings to 30 the number of African countries that have completed the AMA treaty ratification process.
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