MAA Regulatory Spotlight - 22
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 highlights recent developments in medicines regulation across multiple regions of Africa. In East Africa, Somalia’s House of the People approved the Somalia Medicines Bill, marking progress in the establishment of a national legal framework for medicines regulation, subject to completion of the remaining constitutional steps.
In Southern Africa, Zimbabwe’s Medicines Control Authority announced the introduction of post market surveillance screening of imported medicines at ports of entry, while Botswana’s Medicines Regulatory Authority obtained international laboratory accreditation, reinforcing medicines quality control and testing capacity in the region.
In North Africa, Tunisia’s National Agency for Medicines and Health Products Safety issued regulatory updates affecting both bioequivalence requirements and the digitalisation of marketing authorisation procedures, including revised acceptability criteria for bioequivalence centres and updated timelines for the implementation of electronic submissions.
At the continental level, the African Medicines Agency and the African Union Development Agency–NEPAD completed the transition of key continental medicines regulatory programmes to the African Medicines Agency, consolidating regulatory functions under a single institutional framework. Collectively, these updates reflect ongoing regulatory developments across national, regional and continental levels aimed at strengthening medicines oversight and coordination.
The House of the People of the Federal Parliament of Somalia approved the Somalia Medicines Bill during its 7th session, 25th sitting, held on 3 January 2026. The session focused on the third reading and vote on the Bill, which was prepared by the Ministry of Health and Social Care and reviewed by the House Committee on Social Services Development.
During the sitting, the Committee presented its report on the third reading and requested formal approval from the House. Following deliberations, the Bill was put to a vote. A total of 141 Members voted in favour, one Member abstained, and no votes were cast against, resulting in its approval.
The legislation establishes a framework for medicines regulation, with provisions aimed at public health protection, oversight of medicine quality, safety and efficacy, and measures to address substandard and falsified medical products.
The Somalia Medicines Bill will proceed to the remaining constitutional steps required for enactment, including review and approval by the Upper House of Parliament and signature by the President of the Federal Republic of Somalia.
The Medicines Control Authority of Zimbabwe (MCAZ) published Circular 03 of 2026 on 28 January 2026, notifying importers of the introduction of field screening of imported medicines at ports of entry. This initiative supports the Authority’s mandate to ensure the safety, quality and efficacy of medicines entering Zimbabwe.
Under the circular, MCAZ officers will conduct field screening of imported pharmaceutical products using detection and rapid screening technologies. Officers will be stationed at Robert Gabriel Mugabe International Airport, where sampling and screening will take place on site. Importers using other designated ports of entry will be required to submit samples to MCAZ offices as part of the physical examination process.
All screening activities will be carried out at the expense of the Authority. Importers and clearing agents are required to provide access to consignments to enable on-site sampling and testing. Where necessary, samples may also be taken for confirmatory laboratory analysis.
The measures aim to identify substandard and falsified medicines prior to their entry into the national supply chain.
The National Quality Control Laboratory of the Botswana Medicines Regulatory Authority was awarded ISO/IEC 17025:2017 accreditation in December 2025 by the Southern African Development Community Accreditation Service (SADCAS). The accreditation followed a comprehensive assessment of the laboratory’s management systems, technical competence and operational processes.
ISO/IEC 17025:2017 is an internationally recognised standard for testing and calibration laboratories, confirming that the accredited laboratory meets established requirements for accuracy, reliability and impartiality in testing activities. The accreditation formally recognises the laboratory’s compliance with global quality standards.
This development strengthens the role of the Authority’s laboratory in medicines quality control and public health protection. It also represents a step in the Authority’s ongoing efforts to progress towards World Health Organization Maturity Level 3 status.
The full press release can be found here.
The Agence Nationale des Médicaments et des Produits de Santé (ANMPS) issued an official statement on 27 January 2026 announcing an update to the acceptability criteria for bioequivalence centres. The revised criteria apply to bioequivalence studies submitted as part of Marketing Authorisation Applications.
Under the updated framework, bioequivalence studies will be accepted if they are conducted in centres authorised by the competent authority in their country of origin and approved or recognised by specified regulatory authorities or organisations. These include regulatory authorities in the European Union, the United Kingdom, the United States, Canada, Japan, Switzerland or Australia, as well as the Gulf Cooperation Council, the World Health Organization and the Tunisian Ministry of Health.
Bioequivalence centres may also be considered acceptable if they have conducted studies for pharmaceutical products that have already received marketing authorisation from one of the listed authorities for the same product submitted to the Agency.
The statement further specifies that the validity period of a centre’s accreditation, certification or inspection report must fully cover the period during which the bioequivalence study was conducted. The updated criteria will be applied by the competent authorities to all relevant bioequivalence studies submitted in accordance with the regulatory guidelines governing the registration and bioequivalence of human medicinal products.
The Tunisia Agence Nationale des Médicaments et des Produits de Santé (ANMPS) announced an update to the roadmap for the implementation of the electronic Common Technical Document format as part of the ongoing modernisation and digitisation of the marketing authorisation process. The update reflects the preliminary results of the eCTD portal test phase and responds to requests from economic operators to allow additional time for technical and organisational preparation.
From 1 April 2026, electronic submission will become mandatory for new marketing authorisation applications, renewals, and applications for variations and transfers. Submissions must be made exclusively in eCTD or e-submission format, in accordance with the applicable technical specifications. From 1 June 2026, all such submissions must be submitted exclusively in eCTD format.
The Agency also reiterated the provisions relating to backlog management, as previously communicated on 25 September 2025. Marketing authorisation applications submitted on or after 1 January 2025 that have not yet been evaluated, except for those granted prioritisation, must be resubmitted in eCTD format. Resubmission must be completed by 30 June 2026 and carried out in accordance with the terms set out in the communiqué of 21 October 2025. The original chronological order of submissions will be maintained.
Until the official launch of the eCTD portal, applications for new marketing authorisations, renewals, variations and transfers will continue to follow existing submission procedures, subject to the restrictions in force. Major variations remain suspended until the portal becomes operational, and no later than 1 April 2026, except for variations affecting product safety or market availability.
The official launch of the eCTD portal and the opening of regulatory submissions through the platform will be announced in a subsequent communication.
The African Medicines Agency (AMA) and the African Union Development Agency–NEPAD concluded the transition of continental medicines regulatory programmes on 23 January 2026 in Lusaka, Zambia, in accordance with the mandate of the African Union. The transition formally transfers the functions and assets of the African Medicines Regulatory Harmonisation and African Union Smart Safety Surveillance programmes to the African Medicines Agency.
The transition transfers the technical, financial, digital, operational, legal, and regulatory assets and functions of the African Medicines Regulatory Harmonisation (AMRH) and African Union Smart Safety Surveillance (AU3S) programmes to AMA. This consolidation places responsibility for continental medicines regulatory activities within the AMA and is intended to ensure continuity and coordination across continental, regional and national regulatory levels.
The transition event was held under the guidance of the High Commissioner of the Rwandan Mission to Zambia and the African Union Commissioner for Health, Humanitarian Affairs and Social Development. Their participation highlighted continued political and institutional support for the operationalisation of the AMA and for a coordinated continental regulatory framework.
Although the AMRH and AU-3S programmes were previously implemented under AUDA-NEPAD, their activities are now formally integrated into the AMA’s institutional framework. This integration is intended to strengthen regulatory coherence, accountability and sustainability under a single continental authority.
On the margins of the event, senior representatives from African health institutions reaffirmed their commitment to continued collaboration in support of medicines regulation, health security and patient protection across the continent.
