MAA Regulatory Spotlight - 14
May 9, 2025
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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In this issue of the MAA Regulatory Spotlight, we bring you key highlights from various regulatory authorities and regional initiatives that reflect Africa’s growing momentum towards harmonised, transparent, and patient-centred health systems.
We begin with the official launch of the African Information Network on Pricing and Reimbursement, hosted in Dakar, Senegal. Supported by the EU-funded MAV+ project, this landmark event brought together 11 African countries to foster cooperation in medicine pricing and reimbursement - a crucial step toward ensuring equitable access to essential medicines. From South Africa, we report on SAHPRA’s call for industry comments on its updated guideline for interchangeability of biologicals and their announcement that ISO 13485 Certificates will now be a prerequisite for the approval of a Medical Device Establishment Licence.
In East Africa, the Pharmacy and Poisons Board (PPB) of Kenya has announced a new mandate requiring all PBRERs, PSURs, and ICSRs to be submitted through its Pharmacovigilance Electronic Reporting System (PvERS) starting from 15 April 2025, while Ethiopia’s EFDA has revised its Good Manufacturing Practice (GMP) re-inspection frequency from five to three years.
Other important updates include Tunisia’s ANMPS reminding marketing authorisation holders to appoint and register a local pharmacovigilance manager (QPPV/LSR) by 30 June 2025, and Algeria’s Ministry of Pharmaceutical Industry moving to digital-first processing of operating licence renewals via the TABADOL INTAJ platform.
These developments signal not only increased regulatory activity but also a shared commitment across the continent to strengthening regulatory systems and ultimately delivering safer, quality assured and effective health products to the public.
The official launch of the African Information Network on Pricing and Reimbursement of Pharmaceutical Products took place at the Azalaï Hotel in Dakar, Senegal on 22 April 2025, bringing together representatives from eleven African countries. The event was supported by the EU-funded MAV+ project.
The opening ceremony was chaired by Dr. Ibrahima Sy, Senegal’s Minister of Health, and Social Action, with participation from H.E. Hélène De Bock, Ambassador of Belgium; Dr. Alioune Ibnou A. T. Diouf, Director General of the ARP; Dr. Guy N'jambong, World Health Organization (WHO) Representative; and Catherina Habimana of the PPRI Africa Secretariat.
The meeting focused on sharing experiences and best practices in pharmaceutical pricing and reimbursement to enhance cooperation between countries, strengthen health systems, and improve equitable access to essential medicines across Africa.
The Algerian Ministry of Pharmaceutical Industry now requires that all renewal applications for operating licences (Agreements) be first submitted via the TABADOL INTAJ digital platform before any physical submission.
Pharmacists and Technical Directors of pharmaceutical manufacturing establishments must ensure that the digital submission of the renewal file is completed before delivering hard copies, which can be submitted on working days from 9:00 a.m. to 4:00 p.m.
Required Documents:
NB: For subcontracting arrangements, an updated manufacturing contract must also be included.
Files for both Pharmacy/Pharmacist Technical Directors and Assistant Pharmacists must be submitted via the TABADOL INTAJ platform.
Timely compliance with this updated process is essential to avoid delays in licence renewal.
A technical mission led by the African Union Development Agency (AUDA-NEPAD), in collaboration with consulting firm CMCOMMS, was held from 15 to 17 April 2025 in Abidjan. Held at the offices of the Ivorian Pharmaceutical Regulatory Authority (AIRP), the mission supported the implementation of Institutional Development Plans (IDPs) to enhance medical product regulation in Côte d'Ivoire.
As part of the African Medicines Regulatory Harmonisation (AMRH) initiative, AUDA-NEPAD deployed experts to assess AIRP’s progress, identify structural gaps, and propose actionable solutions. Côte d'Ivoire is one of five pilot countries selected for its commitment to improving its regulatory functions. Key activities of the mission included analysis of World Health Organization (WHO) Global Benchmarking Tool (GBT) assessment reports, review of the national legal and regulatory framework, and development of resource mobilisation strategies. Four priority areas were identified to improve medical product regulation in the country:
On 9 – 10 April 2025, the BfArM Global Health Protection Programme (GHPP) PharmTrain2 team held a workshop with the Medicines Control Agency (MCA) in The Gambia to review the implementation of key regulatory documents jointly developed over the past five years, including guidelines and standard operating procedures. GHPP is an initiative of the German Federal Ministry of Health, strengthening global health protection to prevent, detect, and respond to health crises more effectively. The PharmTrain2 project at BfArM contributes to developing regulatory capacities in African partner authorities and supports the harmonisation of medicine regulation across the continent.
Using the WHO GBT, the GHPP PharmTrain2 team noted considerable progress in MCA’s regulatory maturity. With strong regulatory foundations now in place, the partnership intends to enter its next phase, focusing on tailored training for clinical assessment of medical products.
Bioequivalence (BE) is a cornerstone of ensuring that generic medicines are as safe, effective, and high-quality as their innovator counterparts. In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) is enhancing public trust in generics by mandating Bioavailability/Bioequivalence (BA/BE) studies for all medicinal products.
These studies confirm that generics deliver comparable therapeutic outcomes, establishing their interchangeability with branded drugs. This initiative is crucial in combating substandard medicines, reducing therapeutic failures, and reinforcing confidence in the healthcare system.
To support implementation, NAFDAC has developed a strategic roadmap, which includes:
This press briefing is part of a broader stakeholder engagement strategy aimed at ensuring a smooth, transparent, and sustainable rollout of BE requirements.
NAFDAC reaffirms its commitment to public health through science-based regulation and urges all stakeholders to support the use of NAFDAC-approved generics that meet stringent BE standards. The full press briefing can be accessed here.
On 10 April 2025, the National Agency for Medicines and Health Products (ANMPS), under the Ministry of Health, issued a notice to all Marketing Authorisation (MA) holders in Tunisia, both local and multinational.
In line with the Decree of 23 August 2022, which established the Tunisian Guidelines for Good Pharmacovigilance Practices, MA holders are reminded to submit the name of their Pharmacovigilance Manager (Qualified Person for Pharmacovigilance (QPPV) or LSR) based in Tunisia, by 30 June 2025. Submissions must be made to both the ANMPS and the Chalbi Belkahia National Pharmacovigilance Centre.
This submission should be accompanied with one of the following documents:
The ANMPS emphasises that full compliance with these requirements is essential for ensuring effective drug safety management and compliance with both national and international standards.
On 14 April 2025, the Ethiopian Food and Drug Authority (EFDA), under its legal mandate granted by Proclamation 1112/2019, announced a major revision to its Good Manufacturing Practice (GMP) inspection procedures.
Effective immediately, Directive No. 1055/2025 replaces Directive No. 999/2024, reducing the GMP re-inspection cycle for pharmaceutical manufacturers from 5 years to 3 years. This change is part of EFDA’s efforts to align its regulatory framework with internationally accepted standards and strengthen oversight of pharmaceutical quality, safety, and efficacy.
Key updates under the new directive:
EFDA will contact relevant manufacturers to guide them through the re-application process based on the updated cGMP validity requirements.
The Pharmacy and Poisons Board (PPB) of Kenya announced that beginning 15 April 2025, all aggregate reports (Periodic Benefit-Risk Evaluation Reports – PBRERs, Periodic Safety Update Reports - PSURs) and Individual Case Safety Reports (ICSRs) in E2B format must be submitted exclusively via the Pharmacovigilance Electronic Reporting System (PvERS). E2B is a structured electronic format developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to standardise pharmacovigilance reporting. It is specifically designed for the electronic transmission of ICSRs between NRAs, pharmaceutical companies, and other stakeholders.
This requirement is part of PPB’s continuous efforts to enhance the safety surveillance of health products and technologies in Kenya. Marketing authorisation holders are reminded to ensure timely and accurate reporting in line with the 'Guidelines on the Safety and Vigilance of Health Products and Technologies'.
For queries or support, stakeholders can contact:
The international standard ISO 13485 for a quality management system (QMS) is recognised globally for ensuring minimum regulatory requirements for medical devices and in vitro diagnostics (IVDs). The standard outlines the requirements for manufacturers and suppliers of medical devices and IVDs, and it establishes a minimum quality assurance framework to ensure medical devices and IVDs are managed appropriately with the intention to provide tools which are safe and perform as intended by the manufacturer.
On 7 April 2025, the South African Health Products Regulatory Authority (SAHPRA) published a communication to stakeholders whose purpose is to outline the phased process which SAHPRA has followed to date, and will follow from 1 June 2025 to verify ISO 13485 certificates, and to provide stakeholders with clarity of the requirements.
It is noted that from 1 June 2025:
SAHPRA plans to have completed the verification of ISO 13485:2016 certificates held by all holders of a medical device establishment licence by 1 April 2028.
More detailed information on the implementation of this requirement can be found here.
The South African Health Products Regulatory Authority (SAHPRA) has joined the Medical Device Single Audit Programme (MDSAP), an international audit programme of medicines and medical device regulators aimed at improving efficiencies in the regulation of medical device manufacturers by engaging in work sharing and collaboration. SAHPRA joins MDSAP as an affiliate member, which expands its ability to monitor the manufacturing of medical devices beyond South Africa’s borders.
The MDSAP membership will result in the improved regulation of medical devices and in-vitro diagnostics (IVDs) as it increases SAHPRA regulatory reach and ensures that SAHPRA can leverage the resources of other regulators that participate in the MDSAP to both audit and monitor adherence to quality standards by medical device manufacturers in several countries globally.
The media release can be read here.
The South African Health Products Regulatory Authority (SAHPRA) is inviting stakeholders to review and comment on its updated guideline, “SAHPGL-PEM-BIO-02_v5-Biosimilar Medicines Quality Non-Clinical and Clinical Requirements”.
This amendment specifically addresses the interchangeability of biologicals and biosimilars and by inviting stakeholders to provide input on the guideline, SAHPRA aims to enhance transparency and stakeholder engagement in regulatory decision making. The deadline for comments is 30 May 2025.
The comments form and submission details can be found here.
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