Regulatory Spotlight - 11
February 14, 2025
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
Senegal and Rwanda have become the seventh and eighth African countries to achieve Maturity Level 3 (ML3) as per the World Health Organization's (WHO) global classification of national medicines regulatory authorities (NRAs). This significant milestone highlights their commitment to ensuring quality, safety and efficacy of medical products for their populations. That brings the total number of NRAs with maturity level 3 to 8 – the others are Egypt, Ghana, Nigeria, South Africa, Tanzania, and Zimbabwe.
The Rwanda Food & Drugs Authority (Rwanda FDA) hosted WHO’s Regulatory System Strengthening team to finalise its benchmarking exercise, which began on 12 December 2022. Similarly, from 29 April to 3 May 2024, WHO conducted formal benchmarking of Senegal’s Agence Sénégalaise de Réglementation Pharmaceutique (ARP), marking ARP as the first Francophone African NRA to undergo this evaluation.
Both NRAs reached ML3 through a rigorous assessment process using WHO’s Global Benchmarking Tool (GBT), which evaluates regulatory systems against over 250 indicators. ML3 signifies a stable, well-functioning, and integrated regulatory system, while ML4 represents an advanced system committed to continuous improvement. These achievements were finalised in collaboration with WHO’s Regional Office for Africa (AFRO) and country offices in Rwanda and Senegal.
The Medicines Control Authority of Zimbabwe (MCAZ) attained ML3 for the regulation of medicines and vaccines (non-producing), following a comprehensive benchmarking exercise. This achievement reflects MCAZ’s successful implementation of WHO recommendations; this made Zimbabwe the sixth African country to achieve ML3 status. The benchmarking process, conducted with WHO’s GBT, identified strengths and gaps, aiding in the formulation of institutional development plans (IDPs) to prioritise improvements.
MCAZ also made its WHO GBT Assessment Report publicly available; the report provides stakeholders with clear insights into MCAZ’s policies and operations and encourages informed decision-making. This move sets a benchmark for transparency, as other NRAs have yet to publish their assessment reports. Stakeholders are invited to review the report and provide feedback to support further development.
The Ghana Food and Drugs Authority (Ghana FDA) underwent re-benchmarking by a 16-member WHO delegation from 22 to 26 July 2024. The exercise assessed Ghana FDA’s maintenance of ML3 requirements, ensuring its continued compliance with WHO’s global standards for regulatory systems.
The Botswana Medicines Regulatory Authority (BoMRA) hosted WHO assessors and the WHO country office for a pre-benchmarking visit on 18-19 July 2024. This preliminary step provided WHO assessors with an overview of Botswana’s regulatory system and facilitated engagements with key stakeholders, including BoMRA’s Board and the Ministry of Health. BoMRA has been conducting annual self-benchmarking since 2020 and is working towards achieving ML3 status.
These advancements underscore the continued progress of regulatory system strengthening in Africa, positioning NRAs to ensure the safety, quality, and efficacy of medical products across the continent. WHO’s benchmarking process remains instrumental in supporting these efforts and fostering global health security.
The Ghana Food and Drugs Authority (Ghana FDA) has approved moxidectin 2 mg oral tablets for the treatment of river blindness (onchocerciasis) in adults and children aged 4 years and older. Ghana is the first river blindness-endemic country to approve moxidectin, paving the way for the MOMENTUM pilot program in January 2025 in the Twifo Atti-Morkwa district.
The MOMENTUM programme - a collaboration between the Ghana Health Service, the University of Health and Allied Sciences, the Bruyère Research Institute, the Access and Delivery Partnership, and Medicines Development for Global Health (MDGH) - aims to accelerate the elimination of river blindness. Moxidectin has been shown to reduce skin microfilariae levels more profoundly and for longer than ivermectin, which has been the primary treatment to date. MDGH will supply moxidectin tablets at cost-plus pricing for low- and middle-income countries.
River blindness is caused by the parasitic worm Onchocerca volvulus and can lead to severe skin damage and permanent blindness. The Ghana Health Service prioritised the Twifo Atti-Morkwa district for moxidectin following higher-than-expected disease prevalence despite rounds of ivermectin treatment.
The 2024 Annual Gates Foundation and AUDA-NEPAD Engagement and Planning Meeting provided a comprehensive update on programmes supported by the Gates Foundation. The meeting celebrated progress, addressed challenges, and explored opportunities for the two parties to enhance delivery in areas such as procurement, staffing, and hiring turnaround times. It also offered a platform for AUDA-NEPAD to receive feedback from the Gates Foundation on programme implementation.
A key focus of the meeting was aligning priorities and strategies for 2025 to ensure sustainable and impactful outcomes. Discussions highlighted Gates Foundation’s support for the African Medicines Regulatory Harmonisation initiative, the African Union Smart Safety Surveillance Programme, and the newly established Substandard and Falsified Technical Committee.
The 6th Annual Meeting of the WHO National Control Laboratory Network (WHO-NNB) co-hosted with the Egyptian Drug Authority (EDA), took place from 26 – 28 November 2024 in Cairo, Egypt. The event brought together over 100 participants from 58 countries, including representatives from National Control Laboratories (NCLs), manufacturer associations (IFPMA and DCVMN), and technical and funding partners.
Themed “Reliance through Transparency and Trust”, the meeting emphasised collaboration and networking in vaccine testing and lot release. Dr. Ali Ghamrawy, Chairperson of EDA, opened the meeting by highlighting the importance of strengthening partnerships to enhance regulatory efficiency.
Established in 2017 with 15 members, WHO-NNB has expanded to 56 members as of 2024. The network promotes reliance for lot release, minimising redundant testing and increasing efficiency in regulatory oversight of vaccines. The meeting also welcomed four new associate members: Egypt, Ethiopia, Nigeria, and Serbia.
The Medicines Control Authority of Zimbabwe (MCAZ) hosted a delegation from the Ethiopian Food and Drug Authority (EFDA) as part of a knowledge-sharing and capacity-building initiative. During the visit, the EFDA delegation toured the Robert Mugabe International Airport to observe MCAZ’s market control activities as a WHO Maturity Level 3 (ML3) regulatory authority. The team received a detailed demonstration of MCAZ’s online medicines clearance system, which streamlined and enhanced the efficiency of medicines clearance processes.
As an ML3 regulatory authority, MCAZ has stated its commitment to capacity building, harmonisation, reliance, and work-sharing with other African national regulators. This collaboration with EFDA underscores MCAZ’s dedication to ensuring the quality, safety and efficacy of medicines both in Zimbabwe and across the continent.
The Global Harmonization Working Party (GHWP) was established as a non-profit organisation with the goal of studying and recommending ways to harmonise global medical device regulations. It also worked in coordination with the International Medical Device Regulators Forum (IMDRF) (and previously with the Global Harmonization Task Force), Asia-Pacific Economic Cooperation (APEC) and other international organisations to establish harmonised requirements, procedures and standards. GHWP consists of experts from medical device regulatory authorities and the medical device industry. Membership is open to representatives worldwide who support these goals.
At the 28th Annual Meeting, held from 9 – 12 December 2024 in Kuala Lumpur, Malaysia, Ghana FDA and the Botswana Medicines Regulatory Authority (BoMRA) joined as new members of GHWP, increasing the total membership to 38.
Burhani Simai and colleagues published a study on the 20-year evidence-based experience of the evolving medicine regulation in Zanzibar. This study evaluated the evolution of Zanzibar’s medicine regulatory system over the past two decades and identified the key factors contributing to its success by elaborating on the Zanzibar Food and Drug Agency, seeking the expertise of regional, continental, and global experts to assess its regulatory capacity and maturity level. This study revealed substantial legal provisions, organisational development, strategic planning, and resource allocation improvements. Notable achievements include establishing a structured organisational framework, developing a comprehensive strategic plan, and implementing a Quality Management System (ISO 9001:2015 certified). The ZFDA also addressed human resource limitations by creating job descriptions and a staff scheme of service, enhancing financial resources through revised fee regulations and government support, and improving infrastructure with new office and laboratory facilities. Zanzibar’s medicine regulations have evolved significantly, with marked regulatory capacity and infrastructure improvements. The full article can be accessed here.
In 2024, National Medicines Regulatory Authorities (NRAs) in Africa engaged in a series of partnerships and initiatives to strengthen regulatory systems, build capacity, and ensure the safety and efficacy of medical products across the continent.
The South African Health Products Regulatory Authority (SAHPRA) signed a series of Memoranda of Understanding (MoUs) aimed at enhancing regulatory collaboration, improving access to safe and efficacious medical products, and strengthening oversight systems:
During the Africa Health Excon, EDA and the Zambia Medicines Regulatory Authority (ZAMRA) signed an MoU aimed at improving medicine registration processes and marketing authorisation for medical and biological products. ZAMRA will rely on EDA for product approvals, leveraging WHO guidelines. The agreement also supports capacity building through training initiatives.
From 15 – 26 July 2024, Kenya’s PPB hosted a delegation from Malawi’s Southern Region Pharmacovigilance Centre. The visit focused on sharing best practices for pharmacovigilance, enhancing drug safety surveillance, and improving systems for identifying adverse drug reactions.
The Pharmacy and Poisons Board (PPB) of Kenya signed a Confidentiality Commitment with the USFDA on 15 March 2024 in Washington, D.C., marking the first such agreement between the USFDA and an African regulator. The partnership facilitates the exchange of non-public information and enhances regulatory harmonisation in medical devices and diagnostics.
These partnerships underscore Africa’s collective efforts to enhance regulatory systems, promote reliance, and foster global collaboration to ensure the quality, safety, and efficacy of medical products.
Zanzibar became the 157th member of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM), established in 1968. The PIDM plays a critical role in collecting global evidence on adverse effects of medicines and vaccines, helping countries detect emerging patterns of harm that might not be evident locally. Members collaborate internationally to establish pharmacovigilance systems and standards, ensuring patient safety worldwide. The updated list of full and associate members can be accessed here.
The Pharmacy and Poisons Board (PPB) of Kenya became the first African NRA to join the Medical Device Single Audit Program (MDSAP) as an affiliate member. MDSAP, developed by the International Medical Device Regulators Forum (IMDRF), allows for a single audit of medical device manufacturers to meet the regulatory requirements of multiple participating authorities. This milestone enhances Kenya's role in global medical device oversight. More details about MDSAP can be found here.
African NRAs have made significant progress in leveraging WHO's Collaborative Registration Procedures (CRPs) to accelerate access to medicines, vaccines, and diagnostics. The CRPs—designed for prequalified medicines or vaccines (PQ CRP), in vitro diagnostics (PQ CRP IVDs), and products approved by stringent regulatory authorities (SRA CRP)—support timely registration in resource-limited settings. In 2024, African additions included:
Currently, 65 NRAs participate in PQ CRP for medicines, 33 in PQ CRP IVDs, and 59 NRAs (plus one regional economic community) in the SRA CRP. These efforts have collectively facilitated nearly 1,200 product registrations. A pilot CRP for WHO-prequalified vector control products was also announced to be underway in six African countries: Democratic Republic of Congo, Ghana, Kenya, Nigeria, Rwanda, and Tanzania. Full lists of participating countries can be accessed here: PQ CRP medicines, PQ CRP IVDs and SRA CRP.
Zazibona, a work-sharing initiative among 13 national medicines regulatory authorities in the Southern African Development Community (SADC), transitioned to a centralised process that replaced the previous procedure requiring submission of applications in at least two participating countries. Under the new centralised procedure, products are submitted for joint review, and the resulting recommendation can be used to support product applications in countries participating in the initiative. Stakeholders were invited to attend an orientation session in February 2024, which covered the submission process, timelines, payment methods, and handling of queries. Following the orientation, the online submission portal for applications was launched. The first joint assessment session for the year was held from 26 February to 1 March 2024, with the aim of concluding pending applications.
Somalia deposited its ratification instrument of the Treaty of Accession to the East African Community (EAC) on 4 March 2024 in Arusha, Tanzania. The country became the regional bloc’s eighth partner state. The other seven partners are Burundi, the Democratic Republic of Congo, Kenya, Rwanda, South Sudan, Uganda and Tanzania. The EAC has the oldest medicines regulatory harmonisation initiative in Africa, and it facilitates access to safe, efficacious and quality essential medical products for treatment, management and diagnosis of conditions of public health importance. The programme does this through harmonisation of regulatory requirements, guidelines, standards and tools for NRAs in the EAC. Among other benefits of EAC membership, Somalia is expected to benefit from the regional regulatory harmonisation initiative.
In collaboration with the African Union Development Agency - New Partnerships for Africa's Development (AUDA-NEPAD) and the World Health Organization (WHO), Tunisia hosted a preliminary meeting towards establishment of the North African Medicines Regulatory Harmonisation Initiative (NA-MRH). The NA-MRH will form part of the broader African Medicines Regulatory Harmonisation (AMRH) initiative. Tunisia was appointed to host the interim Secretariat, with discussions on implementation continuing until June 2024.
The initiative aims to streamline regulatory processes in North Africa by shifting from a country-specific approach to a collaborative regional framework, aligning with similar initiatives in five other African Union blocs: SADC, EAC, ECOWAS, ECCAS, and IGAD. Establishing NA-MRH is critical for addressingthe increasing complexity of global pharmaceutical production and trade, helping national regulatory authorities manage shared responsibilities and strengthen oversight of medical products.
In 2024, significant progress was made in establishing the African Medicines Agency (AMA), a key initiative of the African Union (AU) aimed at improving access to quality, safe, and effective medical products across Africa.
