MAA Regulatory Spotlight - 17
September 2, 2025
Showcasing the latest developments, news, and updates from African national medicines regulatory authorities.
This edition of the Market Access Africa Regulatory Spotlight brings together significant regulatory developments across the African continent, reflecting the ongoing momentum toward strengthened health systems, regulatory harmonisation, and improved access to quality-assured medical products.
We begin with a historic convening in Abuja, where the Heads of Africa’s eight WHO Maturity Level 3 National Regulatory Authorities came together to operationalise the MoU on Regulatory Reliance. Supported by Africa CDC, AUDA-NEPAD, and the African Medicines Agency (AMA), this milestone signals a new era of regulatory collaboration on the continent.
In Sierra Leone, efforts to amend pharmaceutical legislation are advancing, with the review of two foundational Bills supported by the AMRH programme. These efforts underscore the importance of regulatory frameworks in addressing public health risks such as falsified medicines and antimicrobial resistance.
Leadership transitions also mark this period, with the Ghana FDA announcing the appointment of Professor Kwabena Frimpong-Manso Opuni as Acting CEO, and SAHPRA welcoming a new Board to steer its strategic direction from 2025 to 2030.
Elsewhere, regional collaboration continues to take shape. The Senegalese and Ivorian regulatory authorities formalised a bilateral partnership to enhance pharmaceutical regulation through joint inspections, data sharing and capacity building. Similarly, the Ghana FDA hosted BoMRA for a knowledge exchange on clinical trials, pharmacovigilance, and regulatory systems strengthening.
Rwanda FDA and BoMRA have both opened calls for public and stakeholder engagement. Rwanda FDA has released draft guidelines for the registration of innovative human medical products for comment, while BoMRA has launched Pilot Phase 1 of an expedited registration pathway for veterinary medicines. MCAZ in Zimbabwe has also launched Phase II of its own veterinary medicines expedited review.
In a major milestone for the African Medicines Regulatory Harmonisation (AMRH) programme, five additional medicinal products were granted continental listing during the July 2025 session, now featured in the Green Book (2nd Edition). These include three therapeutics, and for the first time, two in vitro diagnostic kits granted emergency use listing for Mpox, marking a breakthrough in the regulation of diagnostics in the region.
Finally, Tunisia’s ANPP has issued a directive requiring pharmaceutical companies to comply with updated packaging and labelling standards as of the next financial year, with a transitional phase granted to support industry compliance and ensure continued product availability.
Taken together, these developments reflect a strong and coordinated effort by African regulators to build a resilient, harmonised regulatory environment that supports innovation, safeguards public health, and ensures timely access to essential medical products.
NAFDAC, Nigeria hosts African ML3 National Regulatory Agencies Meeting in Abuja, Nigeria
On 7 July 2025, the Director-General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Professor Mojisola Adeyeye, welcomed the Heads of seven other World Health Organization (WHO) Maturity Level 3 (ML3) National Regulatory Authorities (NRAs) to Abuja for a high-level meeting focused on strengthening regulatory cooperation across the continent. The seven NRAs are Tanzania Medicines and Medical Devices Authority (TMDA), Ghana Food and Drugs Authority (FDA), Egyptian Drug Authority (EDA), South African Health Products Regulatory Authority (SAHPRA), Agence Sénégalaise de Réglementation Pharmaceutique (Senegal), Medicines Control Authority of Zimbabwe (MCAZ), and the Rwanda Food and Drugs Authority.
The gathering marked a pivotal step towards the operationalisation of the Memorandum of Understanding (MoU) on Regulatory Reliance, which was signed in February 2025 by the eight ML3 NRAs. The MoU reflects a shared commitment to advancing regulatory reliance and fostering regional collaboration. The initiative is supported by the African Union Development Agency-NEPAD (AUDA-NEPAD), the Africa Centres for Disease Control and Prevention (Africa CDC), and the African Medicines Agency (AMA). It aims to reduce duplication in regulatory effort, strengthen local manufacturing capacity, and accelerate the availability of critical health products.
Over a two-day period, these regulatory leaders convened for the inaugural Steering Committee meeting of the ML3 NRAs Reliance Coordination Mechanism. The Committee was formally inaugurated during the meeting, with Mr Richard Tendayi Rukwata, Director-General of MCAZ, elected as Chair, and Dr Ali Ghamrawy, Chairman of EDA, elected as Vice-Chair for a two-year term. The Steering Committee is mandated to provide strategic leadership, address policy-level decisions and ensure alignment between national and regional regulatory priorities. Representatives of AMA, Africa CDC, and the AMRH Programme will serve as non-voting members of the Steering Committee, with observer status extended to support partner organisations as determined by the Committee. An Operations Team will support the implementation of activities under the mechanism.
Key outcomes from the Abuja meeting included endorsement of governance documents, agreement on concrete next steps aligned with the Continental Reliance Framework, and integration of the ML3 mechanism into the planned Regulatory Information Sharing Portal (RISP). Participating NRAs also exchanged experiences in applying reliance mechanisms and discussed opportunities and challenges encountered to date. In addition, the role of ML3 NRAs in ensuring quality assurance and expedited regulatory pathways under the African Pooled Procurement Mechanism (APPM), hosted by Africa CDC, was discussed. Discussions further addressed the alignment of ML3 NRA activities with AMA operations and the implementation of the AMRH initiative.
This month, the African Medicines Regulatory Harmonisation (AMRH) programme convened a workshop in Sierra Leone to support the legislative review of two important draft laws: the National Medicines Regulatory Authority Bill and the Pharmacy Council Bill. Both documents were developed by the Pharmacy Board of Sierra Leone as part of ongoing efforts to strengthen the country’s pharmaceutical regulatory framework.
The workshop brought together stakeholders to review and align the Bills with international best practices, the revised African Union (AU) Model Law on Medical Products Regulation, and the requirements of the AMA treaty.
Participants emphasised the urgency of passing and implementing the proposed legislation, citing ongoing challenges such as the widespread circulation of substandard and falsified medical products (SFMP), the growing threat of antimicrobial resistance, and the urgent need to ensure the availability of safe, effective, and quality-assured medicines.
The African Medicines Regulatory Harmonisation (AMRH) Steering Committee has approved five additional medicinal products for Continental Listing during its session held between 17–18 July 2025. The approvals were based on rigorous scientific evaluations conducted by the Evaluation of Medicinal Products Technical Committee (EMP-TC) and the GMP Technical Committee (GMP-TC) under the AMRH Continental Pilot Procedure.
These products have now been included in the Green Book (2nd Edition – July 2025), which serves as the official continental registry of human medicinal products granted a Positive Opinion.
Newly Listed Products:
The Committee also granted Continental Emergency Use Listing (EUL) for two Mpox (Monkeypox) diagnostic kits - Cobas® MPXV Kit and RADIONE Mpox Detection Kit. These are the first IVDs to be approved under the EUL mechanism.
All products were confirmed to be manufactured at GMP-compliant facilities and meet continental’s requirements for quality, safety, and efficacy.
See the full list and detailed information in the Green Book – 2nd Edition (July 2025).
During the inaugural meeting of the African Working Group on Substandard and Falsified Medical Products (SFMP), a leadership team was elected to guide this continental initiative.
The elected officials are as follows:
Each member of the leadership team brings extensive experience in health regulation, pharmaceutical governance and laboratory systems, and is well placed to drive forward the vision of a healthier, safer Africa.
The African Working Group on SFMP is tasked with overseeing the development and implementation of the Continental Plan to Combat Substandard and Falsified Medical Products. This initiative aims to strengthen regulatory systems, safeguard the integrity of health systems, and protect populations from the serious risks posed by unsafe and ineffective medical products.
The Rwanda Food and Drugs Authority has issued a notice to all stakeholders involved in the importation and registration of innovative human medical products, announcing the release of the Draft Guidelines for Registration of Innovative Human Medical Products for public consultation.
The draft guidelines are available on the official Rwanda FDA website (www.rwandafda.gov.rw) under the About FDA section (Stakeholders) and will remain accessible until 10 August 2025.
Stakeholders are invited to review the draft and provide feedback using Form No ODG/QMS/FMT/023. Completed forms should be submitted via email to info@rwandafda.gov.rw by the stated deadline to ensure inclusion in the upcoming stakeholder validation meeting.
This consultation forms part of Rwanda FDA’s commitment to transparent regulatory processes and stakeholder engagement in strengthening the national framework for the regulation of innovative medical products.
The Food and Drugs Authority (FDA) of Ghana has announced the appointment of Professor Kwabena Frimpong-Manso Opuni as its new Acting Chief Executive Officer, effective Monday 14 July 2025.
Prior to this appointment, Prof. Opuni served as the Board Chairman of the FDA. He succeeds Dr. Delese Darko, who led the FDA from 2017 and was recently appointed Director General of the African Medicines Agency (AMA).
The Food and Drugs Authority (FDA) of Ghana hosted a delegation from the Botswana Medicines Regulatory Authority (BoMRA) for a five-day study visit, taking place as part of the Gates Foundation Grand Challenge project.
The study visit focused on key regulatory areas including Clinical Trials, Pharmacovigilance, Drug Registration, Information Technology, Strategy, and Quality Management. It aimed to promote the exchange of best practices and operational insights, contributing to the strengthening of South-to-South collaboration among African National Regulatory Authorities (NRAs).
The Botswana Medicines Regulatory Authority (BoMRA) has announced a major step towards improving regulatory efficiency by streamlining its registration processes. This initiative aims to facilitate faster access to safe, effective and quality-assured medical products on the Botswana market, including human and veterinary medicines, complementary medicines, and medical devices (including in vitro diagnostics).
Effective 1 October 2025, BoMRA will implement a combined registration process that integrates screening and evaluation, accompanied by a single, consolidated registration fee. As part of the transition, BoMRA is calling on all applicants with products that have successfully passed the screening phase to submit their applications for the registration procedure by no later than 30 September 2025. Submissions received after this date will be subject to the revised submission requirements under the new system.
In addition, BoMRA has clarified that screening applications that have received a List of Questions (LoQs) from the Authority and have exceeded the response deadline will be automatically closed, as outlined in the respective LoQ letters.
The submissions are made online using the BRIMS self-service portal at: https://brims.bomra.co.bw/
For any system queries kindly contact helpdesk@bomra.co.bw
On 2 July 2025, the South African Health Products Regulatory Authority (SAHPRA) announced the appointment of its new Board Members. The appointments were made by the Minister of the National Department of Health, Dr Aaron Motsoaledi, in accordance with section 2C(2) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as amended.
The Board members have been appointed for a five-year term, effective from 1 July 2025 to 30 June 2030.
The new Board members are Dr Thapelo Motshudi (Chairperson), Professor Glenda Gray (Vice-Chairperson), Dr Alfred Kgasi, Dr Chevon Clark, Dr Johanna Gouws, Dr Thobeka Boltina, Ms Mmatebogo Nkoenyane, Mr Anthony Ngcezula, Mr Rajesh Mahabeer, Mr Nkosenhle Ngongoma, and Mr Moses Moselekwa.
Press release can be downloaded here.
The Botswana Medicines Regulatory Authority (BoMRA) has announced the commencement of Pilot Phase 1 of its Expedited Registration Pathway for veterinary medicinal products (VMPs). This initiative invites principals, manufacturers, and marketing authorisation holders (MAHs) to submit dossiers for regulatory review under a streamlined process designed to accelerate access to veterinary medicines in Botswana.
This pilot is guided by BoMRA’s Reliance Policy, which leverages the regulatory decisions of competent NRAs with established regulatory systems. Products submitted under this pathway will benefit from a significantly shortened evaluation timeline of four calendar months from the date of submission.
Key Details of Expedited Review Window – Pilot Phase 1:
More information is available here.
The Medicines Control Authority of Zimbabwe (MCAZ) invites interested applicants to submit applications for registration of veterinary medicinal products through the expedited pathway, effective 14 July to 15 August 2025. The products must be registered in countries that have national regulatory authorities that have been listed by the World Health Organization (WHO) as WHO-listed Authorities (WLA) and those operating at maturity level 3 or 4. Products approved in South Africa by the South Africa Health Products Regulatory Authority (SAHPRA) through the Medicines and Related Substances Act (Act No. 101 of 1965) and the Department of Agriculture, Land Reform and Rural Development (DALRRD) through Fertilizers, Farm Feeds, Seeds and Remedies Act 36 of 1947 are also eligible. This move aims to enhance efficiency and responsiveness to the growing demand for wider treatment options for veterinary medicinal products using the MCAZ Policy on Reliance.
MCAZ believes that increasing more treatment options for safe, efficacious and high-quality veterinary vaccines, pharmaceutical products and acaricides is essential in ensuring food safety, animal health and public health. MCAZ invites submission of thirty applications which will be processed within 90 days (MCAZ time) though this pathway.
More information on requirements for registration through the expedited pathway and the accompanying fees can be found here.
The Medicines Control Authority of Zimbabwe (MCAZ) Guidelines for implementing traceability for medical products in Zimbabwe (MCAZ/LED/GL-22) officially came into effect on 18 July 2025. These guidelines apply to all medical products that are manufactured, imported, exported, advertised, sold, distributed or used in Zimbabwe and are aimed at ensuring that such products are traceable throughout the entire supply chain. The traceability framework is expected to reduce the circulation of falsified medicines, strengthen recall mechanisms and promote public confidence in the quality of medical products available on the market.
The guidelines are issued pursuant to Section 37 of the Medicines and Allied Substances Control (General) Regulations, 1991 (SI 150 of 1991), which empowers the Authority to prescribe labelling and traceability requirements for medical products.
Implementation will be conducted in a phased approach:
Key requirements include:
MCAZ will provide technical assistance, stakeholder training, and regular updates to facilitate the smooth adoption of this traceability framework. A full copy of the guideline is available upon request or can be accessed via the Authority’s website: www.mcaz.co.zw
The Medicines Control Authority of Zimbabwe (MCAZ) published Circular 18 of 2025 on 3 July to formally announce the launch of the Online Licensing System – New License Issuance Module. This is part of MCAZ’s ongoing efforts to enhance efficiency, transparency and accessibility in the licensing process for all stakeholders within the pharmaceutical and health sectors. The newly introduced online platform is designed to streamline the application process for new licenses, enabling stakeholders to submit, track and manage their applications electronically from any location. Instructions on how to initiate the application process are detailed in this document.
On 25 July 2025, in Abidjan, the Senegalese Pharmaceutical Regulatory Agency (ARP) and the Ivorian Pharmaceutical Regulatory Authority (AIRP) formalised a strategic partnership aimed at strengthening pharmaceutical regulation across the West African sub-region.
The Memorandum of Understanding (MoU) was signed by Dr Alioune Ibnou Abou Talib Diouf, Director General of ARP, and Dr Assane Coulibaly, Director General of AIRP. The agreement provides for joint inspections and evaluations, strategic information exchange, and training and capacity building programmes.
This partnership reflects a shared commitment to South–South cooperation and the harmonisation of regulatory practices in response to regional public health priorities. The presence of Dr Ayoub Moussa Abderaman Haggar, representing Chad’s national regulatory authority, further underscored the momentum towards coordinated and effective regulation at a regional level.
By entering into this agreement, ARP and AIRP commit to promote rigorous, ethical and collaborative regulation, with the aim of safeguarding the quality, safety and efficacy of pharmaceutical products across West Africa.
The National Agency for Pharmaceutical Products (ANPP) of Tunisia has issued a new directive to pharmaceutical establishments, reinforcing compliance with national labelling requirements for pharmaceutical products and medical devices.
Effective from the next fiscal year, pharmaceutical companies must ensure that only products with fully compliant packaging (including primary and secondary packaging, as well as the package leaflet) are imported into the Tunisian market. This measure forms part of the regulatory requirements governing the mandatory information that must appear on packaging materials.
The directive specifically applies to pharmaceutical companies holding and/or operating a DE/DH. Compliance with the updated packaging requirements will be assessed during any application for renewal or amendment of a product’s registration or marketing authorisation and must align with the import programme for the forthcoming financial year.
To facilitate implementation, the ANPP has introduced a transitional phase allowing for the use of previously printed packaging materials, provided that:
The ANPP has indicated that support measures may be offered on a case-by-case basis to ensure a smooth transition and uninterrupted product availability. However, these will depend on timely and complete submissions by pharmaceutical companies and strict adherence to the implementation deadlines.
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