MAA Regulatory Spotlight - 21
February 5, 2026
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
This edition of the Market Access Africa Regulatory Spotlight brings together a wide range of regulatory developments from across the continent, reflecting significant progress in harmonisation and regulatory systems strengthening.
At the global level, two African regulatory authorities were accepted as new Members of the International Council for Harmonisation, marking an important step in expanding Africa’s participation in international standard setting. In parallel, national digital transformation efforts continue, with Zimbabwe launching its new online medicines registration platform, designed to streamline processes and enhance transparency.
Regional cooperation has also advanced. The ML3 National Regulatory Authorities Reliance Mechanism has been operationalised, creating a structured framework for reliance, information exchange, and work sharing among eight African authorities. Capacity building remains a priority, illustrated by the training programme hosted by The Gambia’s Medicines Control Agency on biological product dossier evaluation.
Bilateral collaboration is evident through Rwanda FDA’s hosting of a delegation from Benin’s ABMed for a study visit. Kenya has announced a phased roll-out of its national Track and Trace system, aimed at strengthening supply chain security and aligning with global best practice. In addition, Zambia has issued a reminder to all foreign based applicants on the legal requirement to appoint a Local Responsible Person, reinforcing accountability in regulatory interactions.
The edition also reviews key outcomes from the seventh SCoMRA held in Mombasa, which highlighted progress in regulatory harmonisation, the transition of the African Medicines Regulatory Harmonisation initiative to the African Medicines Agency, and the successful pilot of the continental listing process for medicinal products.
Together, these developments underscore Africa’s growing regulatory maturity and the collective efforts shaping a more harmonised, efficient, and resilient regulatory ecosystem across the continent
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced on 27 November 2025 that two African regulatory authorities have been accepted as Members. The National Agency for Food and Drug Administration and Control of Nigeria and the South African Health Products Regulatory Authority have joined the organisation following confirmation at the fifty first ICH Assembly in Singapore.
During the same meeting, the Directorate General of Medicines, Supplies and Drugs of the Dominican Republic and the Philippine Food and Drug Administration were accepted as Observers. The additions bring ICH participation to a total of 25 Members and 41Observers.
The Assembly convened in person on 18 - 19 November in Singapore, marking the second in person meeting of the year. Membership for national regulatory authorities is subject to several criteria, including implementation of at least the three Tier 1 ICH Guidelines (Q1 Stability Testing Guidelines, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice Guideline), participation in ICH biannual meetings, and a plan for implementing all ICH Guidelines.
ICH brings together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development. ICH produces harmonised technical requirements to ensure the development and registration of safe, effective and high-quality medicines for human use. Established in 1990, the organisation was registered as a non-profit association under Swiss law in 2015.
The press release can be accessed on the ICH website.
The Medicines Control Authority of Zimbabwe (MCAZ) has announced the introduction of the Zimbabwe Drug Information System (ZIMDIS), a digital platform for the online submission of applications for the registration of medicines. From 27 October 2025, all registration applications are required to be submitted exclusively through ZIMDIS.
The initiative forms part of the authority’s wider digital transformation programme aimed at modernising regulatory processes, enhancing efficiency and transparency, and reducing decision timelines. The platform includes functionality that allows applicants to track the progress of their submissions in real time, addressing a previously reported pain point faced by applicants.
To support the transition, training materials and user guidance have been made available. The authority has also indicated that the initial implementation phase will be monitored closely and that feedback from applicants will be used to refine the system. Feedback can be submitted via email to ictsupport@mcaz.co.zw and the same email address can be used for technical assistance.
The Medicines Control Authority of Zimbabwe (MCAZ) has announced the operationalisation of the ML3 National Regulatory Authorities Reliance Mechanism, marking an important step in regulatory cooperation across the continent. The initiative was launched in collaboration with AUDA-NEPAD and eight other World Health Organization (WHO) Maturity Level 3 regulatory authorities across Africa. It is founded on a memorandum of understanding signed in early 2025, which provides a structured basis for regulatory reliance, information exchange, and work sharing among the participating authorities. The mechanism is intended to promote regulatory efficiency, avoid duplication of assessment activities, and enable participating authorities to draw upon the technical evaluations and regulatory decisions of trusted counterparts. The formal launch occurred during the inaugural Steering Committee meeting held in Abuja, Nigeria, on 7 and 8 July 2025. During the meeting, governance arrangements were agreed, leadership was appointed, and key operational documents were endorsed.
The initiative supports wider continental objectives, including those related to the African Medicines Agency, the African Medicines Regulatory Harmonisation programme, and the Pharmaceutical Manufacturing Plan for Africa. It is expected to accelerate access to safe, effective, and quality assured medical products across African markets, support local pharmaceutical manufacturing and strengthen intra-African trade, improve regulatory responsiveness during public health emergencies, and enhance confidence in African regulatory systems through transparency and harmonised standards.
The participating authorities are the Agence Sénégalaise de Réglementation Pharmaceutique of Senegal, the Egyptian Drug Authority, the Food and Drugs Authority of Ghana, the Medicines Control Authority of Zimbabwe, the National Agency for Food and Drug Administration and Control of Nigeria, the Rwanda Food and Drugs Authority, the South African Health Products Regulatory Authority, and the Tanzania Medicines and Medical Devices Authority.
Detailed operational procedures for the reliance mechanism are in the final stages of development. MCAZ will issue subsequent circulars with specific guidance on application processes and eligibility requirements once these procedures have been completed. Existing fast track pathways for products approved by WHO listed and ML3 or ML4 authorities remain in effect.
More information can be accessed here.
The Medicines Control Agency of The Gambia, with support from the World Health Organization Country Office, has completed a five-day capacity building programme for staff of the Directorate of Evaluation and Registration. The training, which focused on the evaluation of biological product dossiers, was held at the Epidemiology and Disease Control Conference Hall in Kotu East from 17 - 21 November 2025.
The programme was intended to strengthen staff competence in an area that is increasingly central to the regulation of medical products. Opening the session, the Director of Evaluation and Registration, Ms. Mariama Simah, highlighted the importance of the initiative, noting that it was the first training of its type in eight years. She stated that the knowledge gained would support productivity and contribute to the agency’s ambition to achieve WHO Maturity Level 3.
Regulatory officers participating in the training expressed appreciation for the opportunity, explaining that it provided valuable skills in the evaluation, analysis, and reporting of biological products. The sessions covered key elements of biological product assessment, including the generation of genetic material derived from living organisms, manufacturing processes, transport and storage requirements, stability considerations, and batch verification.
The competencies developed through the programme are expected to strengthen the agency’s capacity to detect substandard and falsified medical products and to align regulatory practice with international safety standards.
Rwanda Food and Drugs Authority welcomed a delegation from Agence Béninoise du Médicament et des autres produits de santé (ABMed) for a three-day study visit aimed at advancing regulatory cooperation. The visit builds on the existing collaboration between the two authorities. The visit focused on marketing authorisation, pharmacovigilance and regulatory systems strengthening.
The Zambia Medicines Regulatory Authority (ZAMRA) has issued a notice reminding all foreign based applicants and marketing authorisation holders of the requirement to appoint a Local Responsible Person, as set out in Regulation 17 of Statutory Instrument Number 79 of 2019.
Foreign based applicants and authorisation holders must designate an individual resident in Zambia to act on their behalf. The Local Responsible Person is responsible for submitting applications, documents, and product samples; receiving decisions issued by the authority; and implementing the pharmacovigilance plan associated with the relevant product.
The authority has stated that failure to appoint a Local Responsible Person may lead to regulatory action. This may include suspension or revocation of a marketing authorisation or rejection of an application.
Foreign based applicants are required to include in their submissions the full name, designation, and contact details of the designated Local Responsible Person. Existing foreign based marketing authorisation holders must submit the details of their Local Responsible Person, including their name, qualifications, contact information, and assigned responsibilities, by 31 December 2025 via email: pharmacy@zamra.co.zm and addinfoma@zamra.co.zm
The Pharmacy and Poisons Board (PPB) has announced the phased implementation of the Track and Trace Standards for Authentication and Traceability of Health Products and Technologies in Kenya. The initiative is aligned with the national digitization of healthcare sector agenda and global best practices.
The first phase, which will focus on batch tracing, is scheduled to commence in January 2026. It will require reporting of batch numbers for imported products. The authority has already conducted a series of awareness and sensitisation sessions on batch tracing requirements to support stakeholders in preparing for these requirements.
Further phases will be introduced in due course. These will include serialisation through the assignment of unique serial numbers to each saleable unit, aggregation through the hierarchical linking of individual units and packaging levels, and the introduction of reporting and verification processes involving real-time data upload and verification across the supply chain. Timelines for these subsequent phases have not yet been confirmed.
The initiative is expected to expand the responsibilities of regulatory professionals, including in areas related to product packaging compliance, serialisation data management and master data accuracy, validation of aggregation events, reporting obligations for marketing authorisation holders, and the management of alerts, recalls, and verification requests.
A well-designed track and trace system is anticipated to strengthen pharmaceutical oversight by reducing the circulation of counterfeit and substandard medicines, improving recall efficiency, supporting pharmacovigilance through clearer batch identification, and contributing to Kenya’s position as a regional leader in pharmaceutical governance and supply-chain security. The draft guidelines can be accessed here.
The seventh Scientific Conference on Medical Products Regulation was held in Mombasa, Kenya from 11 - 13 November 2025. Convened under the theme “Regulatory Harmonisation: Unlocking Africa’s Potential in Health Product Manufacturing and Trade”, the conference provided a platform for stakeholders to review advances in regulatory science and discuss priorities for strengthening and harmonising regulatory systems across the continent.
SCoMRA brings together regulators, industry representatives, technical partners, and other stakeholders to exchange experiences and best practice. The forum supports evidence-based decision making and contributes to preparedness for future public health emergencies by informing approaches to medical product oversight. The 2025 meeting also provided an opportunity to refine priorities for the African Medicines Regulatory Harmonisation (AMRH) initiative, which underpins the establishment of the African Medicines Agency (AMA).
During the conference, Mr. Symerre Grey Johnson (Director, AUDA-NEPAD), formally handed over the AMRH report to the AMA Director General, H.E. Dr. Delese Mimi Darko. The report captures sixteen years of progress in strengthening regulatory systems across Africa. The handover symbolised the transition of the initiative to the AMA and reflected the collaborative efforts of partners working to advance access to safe, effective, and quality assured medicines.
A further development highlighted at the event was the successful piloting of the continental listing process for human medicinal products. Through the Evaluation of Medicinal Products and Good Manufacturing Practice technical committees, twelve products were listed and published in the Green Book. This achievement has supported accelerated national regulatory approvals and improved access to quality assured products.
An Industry Engagement Day was held alongside the conference, bringing together regulators, industry, and partners to review lessons from the pilot and to outline next steps under the AMA. Discussions also covered the planned launch of the continental listing process for in vitro diagnostics in 2026 and considerations for a sustainable fee for service model to support ongoing operations.
The eighth SCoMRA is scheduled to take place in Dakar, Senegal in 2027.
