MAA Regulatory Spotlight - 12
March 4, 2025
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In this issue of Market Access Africa's Regulatory Spotlight, Africa’s regulatory landscape continues to evolve through increased collaboration, digital innovation, and capacity building. A landmark moment has been the signing of a Memorandum of Understanding by Africa’s WHO Maturity Level 3 National Regulatory Authorities (NRAs), establishing a structured framework for reliance on regulatory decisions. This milestone not only fosters collaboration but also supports the local pharmaceutical production ecosystem. Similarly, the launch of the North African Medicines Regulatory Harmonisation (NA-MRH) Initiative and Tunisia’s adoption of the electronic Common Technical Document (eCTD) signal progress in regulatory harmonisation and efficiency. Meanwhile, AUDA-NEPAD’s ongoing efforts in Mpox IVDs and its cooperation with PIC/S for GMP training highlight Africa’s proactive approach to public health. The SADC Veterinary Medicines Zazibona Initiative has also expanded its scope, now piloting a joint assessment procedure for veterinary medicinal products - an important step in ensuring animal health. Finally, financial sustainability remains a critical issue for African NRAs, with SAHPRA’s update to its fee regulations reflecting ongoing efforts to align fees with regulatory workload. As Africa moves towards a more harmonised and efficient regulatory environment, these developments play an important role in ensuring timely access to quality-assured, safe and effective medical products for all.
Africa’s World Health Organization (WHO) Maturity Level 3 National Medicines Regulatory Authorities (NRAs) signed a Memorandum of Understanding (MoU) to establish a structured framework for reliance on regulatory decisions to expedite the approval processes for medicines, vaccines, and medical devices as well as to foster collaboration on the vaccine lot release function. The MoU was signed in Cairo, Egypt by Ghana’s Food and Drugs Authority (FDA), the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria, Rwanda Food and Drugs Authority (FDA), the Senegalese Pharmaceutical Regulatory Agency (ARP), South African Health Products Regulatory Authority (SAHPRA), Tanzania Medicines & Medical Devices Authority (TMDA), and Medicines Control Authority of Zimbabwe (MCAZ).
Through this agreement, the seven NRAs commit to streamlining application submission and evaluation processes to expedite regulatory processes, reduce costs, and ensure timely decision-making. This will be achieved through information sharing, work-sharing, and reliance (partial or full) on assessment reports generated by the participating NRAs. Under this framework, reliance can be unilateral, bilateral, mutual, or multilateral, allowing each authority to use shared regulatory data based on its national requirements while ensuring compliance with regional and international standards. The MoU also establishes mechanisms to ensure that authorised products and clinical trials meet internationally accepted regulatory standards.
Tunisia has officially adopted the electronic Common Technical Document (eCTD), becoming the second African country to implement this system after South Africa. Notably, Tunisia achieved this transition within a short period of nine months.
The eCTD system, which aligns with international guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), facilitates the online submission of marketing authorisation applications. This adoption enhances the efficiency, security, and transparency of regulatory processes.
This milestone aligns with Tunisia’s commitment to patient welfare by expediting access to safe, high-quality medicines. Additionally, it strengthens regulatory governance and enhances the international competitiveness of the country's pharmaceutical sector.
In August 2024, the Africa Centres for Disease Control and Prevention (Africa CDC) declared Mpox a Public Health Emergency of Continental Security (PHECS). The outbreak has resulted in a substantial increase in cases and fatalities across the continent, with the Democratic Republic of Congo (DRC) accounting for 96% of all reported cases and 97% of all Mpox-related deaths in 2024.
To address the urgent need for reliable diagnostic tools, the African Union Development Agency-NEPAD (AUDA-NEPAD), through the African Medicines Regulatory Harmonisation (AMRH) initiative, convened the 2nd Meeting of the Emergency Use Listing (EUL) Product Evaluation Group for In Vitro Diagnostics (IVDs) from 10 to 14 February 2025 in Kigali, Rwanda. The meeting brought together medical device experts from 14 African NRAs, members of the AMRH Technical Committees on Medical Devices Assessments, Africa CDC’s Diagnostics Advisory Committee (DAC), and WHO representatives, among others.
Key objectives of the meeting included:
This initiative aims to strengthen the regulatory framework for diagnostic tools, ensuring timely access to high-quality, safe, and effective in vitro diagnostics for Mpox detection and management. The convening was jointly supported by GIZ’s Strengthening Crisis and Pandemic Response in Africa programme and AUDA-NEPAD.
In 2024, Tunisia, in collaboration with AUDA-NEPAD and WHO, hosted a meeting to establish the North African Medicines Regulatory Harmonisation Initiative (NA-MRH). This initiative forms part of the broader African Medicines Regulatory Harmonisation (AMRH) programme, aimed at strengthening regulatory systems across the continent. Tunisia was designated to host the interim Secretariat as discussions on implementation continued until June 2024.
The inaugural meeting of NA-MRH was subsequently held from 18 – 20 February 2025 in Egypt, marking a significant step toward streamlining regulatory processes in North Africa. The initiative seeks to transition from country-specific regulatory approaches to a collaborative regional framework, aligning with existing AMRH initiatives in five other African Union regional blocs: SADC, EAC, ECOWAS, ECCAS, and IGAD. The Bureau of the Steering Committee was constituted at the inaugural meeting with Egypt as Chair, Morocco as Vice Chair and Tunisia as the Secretariat. The terms of reference and road map of the initiative have been approved by the Steering Committee. Additionally, the lead and co-lead NRAs for each of the priority regulatory functions were designated.
The establishment of NA-MRH is a critical response to the increasing complexity of global pharmaceutical production and trade, supporting NRAs in managing shared responsibilities and strengthening oversight of medical products. By fostering regional cooperation, the initiative aims to enhance efficiency, regulatory convergence, and access to quality assured and safe medicines across the region.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has announced a new agreement with AUDA-NEPAD to facilitate the exchange of information on Good Manufacturing Practices (GMP) for pharmaceuticals and active pharmaceutical ingredients. This collaboration aims to enhance capacity building for GMPs among African NRAs, providing training for inspectors, and participating in each other’s meetings.
As part of this agreement, AUDA-NEPAD has been granted Associate Member status, marking the initial step towards becoming a PIC/S Participating Authority. Additionally, the scope of cooperation includes supporting NRAs that are members of the African Medicines Agency in their pre-accession and accession processes to PIC/S. Currently, South Africa remains the only African country with PIC/S membership.
The Veterinary Medicines Zazibona, the Southern African Development Community (SADC) Veterinary Medicinal Products (VMPs) Collaborative Procedure, has invited interested applicants to submit Expressions of Interest (EoIs) and dossiers for review under the second pilot phase of the SADC VMP joint assessment procedure.
This initiative aims to enhance regional collaboration in the registration and regulation of veterinary medicinal products within the SADC region, ensuring that only safe, efficacious, and high-quality veterinary medicines are available for use. The project will be executed in collaboration with SADC NRAs from actively participating member states, alongside the Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE), WHO, and other global partners.
Key Features of the SADC VMP Joint Assessment Procedure
Targeted Veterinary Diseases for Registration Applications
The initiative will consider applications for VMPs used in the treatment and prevention of the following priority animal diseases, as identified in Status of Animal Health in SADC Region Bulletins: rabies, lumpy skin disease, heartwater, fowl pox, blackleg, brucellosis, anaplasmosis, African Swine Fever, theileriosis, Peste des Petits Ruminants, Newcastle Disease, contagious bovine pleuropneumonia, African Horse Sickness, foot rot, babesiosis, contagious pustular dermatitis, and rift valley fever.
The SADC VMP joint assessment procedure is designed to achieve regulatory approval or registration decisions within 12 months, with a maximum of two review cycles. More information on the pilot can be found here.
The Botswana Medicines Regulatory Authority (BoMRA) has officially joined the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party Towards Medical Device Harmonization. The IMDRF Management Committee welcomed BoMRA as an affiliate member during the 26th session of the IMDRF that was held from 16 – 20 September 2024. Similarly, BoMRA’s membership to GHWP was endorsed at the 28th GHWP Annual and Technical Committee meeting held from the 9 – 12 December 2024.
IMDRF and GHWP play pivotal roles in accelerating international medical device regulatory convergence and harmonisation to promote an efficient and effective regulatory model for medical devices.
BoMRA, as a member of GHWP and IMDRF, will:
This marks an important milestone for BoMRA, as the NRA continues to work towards fostering collaboration, innovation, and global alignment in the regulation of medical devices. The press statement can be accessed here.
The South African Minister of Health, in consultation with the Minister of Finance and SAHPRA, has approved updates to the Regulations Regarding Fees Payable in Terms of the Provisions of Medicines and Related Substances Act, 1965 (Act No. 101 of 1965). These updates were approved in accordance with Section 35(1)(xxxi) and (xxxii), read together with Section 35(4) of Medicines and Related Substances, 1965 (Act No. 101 of 1965).
On 12 February 2025, SAHPRA published an official communication to stakeholders announcing the newly gazetted fee regulations, which came into effect on 13 February 2025. As a result, all applications submitted from 13 February 2025 onwards must comply with the new fee structure and the revised Payment Guideline.
The European Medicines Agency (EMA) hosted over 100 good manufacturing practice (GMP) inspectors from Europe and around the world for a joint training on quality risk management (QRM). Fifteen participants were from African NRAs and attended the training as part of the EMA’s ongoing support for the operationalisation of the African Medicines Agency.
The training aimed to familiarise GMP inspectors with the 2023 revisions to the ICH Q9(R1) guideline and related training materials. The principles and examples of tools apply to various aspects of pharmaceutical quality and help inspectors better evaluate whether and how manufacturers assess risks related to quality of medicines.
The training was organised by EMA and the Pharmaceutical Inspections Collaboration Scheme (PIC/S). This marks an important milestone for EMA, in their regulatory systems strengthening efforts in Africa by sharing their expertise and experience.
