MAA Regulatory Spotlight - 16
July 8, 2025
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
This edition of Market Access Africa’s Regulatory Spotlight highlights significant milestones in regulatory transparency, harmonisation, and capacity strengthening across the African medicines landscape.
We spotlight the expanding footprint of the African Medicines Agency, with the appointment of its first Director General and key meetings with the European Medicines Agency (EMA). EMA's direct and network-wide support to African regulatory systems - now backed by 11 new grants to EU national agencies - further underscores growing global partnerships in strengthening regulatory functions on the continent.
In Southern Africa, Zimbabwe’s Medicines Control Authority (MCAZ) has taken bold steps toward greater transparency by publishing public inspection and assessment reports for clinical trials and GMP inspections, aligning with WHO Maturity Level 4 requirements. Zimbabwe and Zambia have also formalised regulatory cooperation through a new MoU, setting a foundation for technical collaboration, mutual recognition, and regional innovation.
We feature Botswana’s hosting of the Zazibona GMP work-sharing meeting, where SADC inspectors finalised joint inspection outcomes and advanced preparations for the centralised procedure. In a complementary development, Egypt and South Africa launched the pilot phase of a Work Sharing Initiative for the registration of biological products, deepening bilateral reliance and alignment with WHO Good Reliance Practices.
Finally, Ethiopia’s revised GMP inspection frequency signals a move toward more agile and risk-based post-marketing oversight, enhancing regulatory responsiveness while maintaining standards.
Together, these developments demonstrate momentum towards more harmonised, transparent, and risk-proportionate regulatory practices, anchored in collaboration and driven by a shared commitment to public health.
From 3 – 6 June 2025, the Botswana Medicines Regulatory Authority (BoMRA) hosted a key Zazibona work-sharing meeting focused on Good Manufacturing Practice (GMP) inspections and regulatory collaboration. The meeting brought together inspectors from 11 Southern African Development Community (SADC) member states - Angola, Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe - with the aim of strengthening the regional medicines registration and approval process.
This meeting formed part of the broader Zazibona initiative, which promotes harmonisation and work-sharing among national medicines regulatory authorities (NRAs) in the SADC region to enhance access to quality-assured medicines. As part of the regulatory assessment process, GMP inspections are conducted by teams of inspectors from member states, with findings reviewed collaboratively to ensure alignment with international manufacturing standards. On average, between 30 and 40 manufacturing facilities are jointly inspected each year to support product registration efforts in participating countries.
During the meeting, inspectors presented and discussed findings from recent pharmaceutical manufacturing site inspections. Structured scientific discussions were held to reach consensus on the grading of observations, thereby promoting consistency, transparency, and harmonised regulatory decision-making prior to finalising inspection reports.
The forum also provided an opportunity for inspectors to assess manufacturers' responses to inspection findings. Proposed Corrective and Preventive Actions (CAPAs) were evaluated, with inspectors jointly determining their adequacy and making recommendations on appropriate follow-up actions. In addition, the inspectorate received a briefing on the pilot phase of the Zazibona Central Dossier Submission System and discussed its operational readiness for the full implementation of the new Centralised Procedure. This procedural evolution represents a significant step towards streamlining regulatory submissions and assessments. A further objective of the meeting was to define the level of regulatory oversight required for inspected manufacturing sites. Using a risk rating matrix, inspectors assessed the risk profile of each site and provided recommendations on the frequency of future inspections.
Read the full press release here.
The Zazibona initiative issued a call for Expressions of Interest (EOIs) for product evaluation through its Centralised Pathway (CP). This opportunity has been extended to applicants and pharmaceutical manufacturers seeking a collaborative and streamlined regulatory assessment process within the SADC region.
Through the Zazibona CP, applicants are offered the opportunity to receive a scientific opinion on the quality of their medicinal products. This scientific opinion serves as a non-binding recommendation to participating member states to support national decision-making processes. All 16 SADC member states participate in the initiative, either as active or non-active members - depending on their internal capacity to conduct assessments and current Good Manufacturing Practice (cGMP) inspections - or as observers.
Products receiving a positive recommendation through the CP become eligible for expedited review and registration in the active member states upon submission of a marketing authorisation application. The Heads of Medicines Regulatory Authorities across the region have committed to finalising such applications within 90 days of submission.
This call for EOIs applies to the period from July 2025 through December 2026, representing an 18-month window for manufacturers to engage with the pathway and support improved access to quality-assured medicines across the region.
The full document containing a process overview, fees, and requirements can be accessed here.
On 12 June 2025, the Medicines Control Authority of Zimbabwe (MCAZ) announced that it will be publishing summarised public assessment reports (PAR) for clinical trial applications and public inspection reports (PIR) for Good Clinical Trial Practice (GCP) inspections on the MCAZ website and/or e-Clinical Trial Registry Platform. All the clinical trial applications that were authorised or rejected from January 2025, and GCP inspections conducted from January 2025, will be impacted by this procedure.
On closure of the GCP inspection and once the clinical trial application has been authorised or rejected, a copy of the PAR or PIR shall be sent to the Principal Investigator (PI) for comments, and if there are any comments, these should be submitted within ten working days of the receipt of the report. If no comments are received within ten working days, the Authority will proceed to publish the report. The public GCP inspection report shall remain valid until the next inspection following which the most recent inspection report will be published.
Publication of summarised PAR for clinical trial applications and PIR for GCP inspections shall be included as conditions of authorisation for all the clinical trials that will be authorised by MCAZ.
These new developments are in line with the World Health Organization (WHO) Global Benchmarking Maturity Level 4 requirements and international good regulatory practices to promote transparency, accountability and communication.
The circular can be accessed here.
On 12 June 2025, MCAZ issued another circular informing all its various stakeholders that in line with WHO Global Benchmarking Maturity Level 4 requirements, all inspections with a positive closure outcome will be uploaded on the Authority’s website as public inspection reports (PIR). This notification will affect all manufacturing facilities (local and foreign), pharmacies, dispensing medical practitioners, industrial clinics and wholesale dealers.
As part of the implementation of this procedure, MCAZ advises manufacturers to take note of the following:
The circular, containing an example of a PIR of a manufacturing facility in line with WHO recommendations, can be accessed here.
On 17 June 2025, the Medicines Control Authority of Zimbabwe (MCAZ) and the Zambia Medicines Regulatory Authority (ZAMRA) announced the signing of a Memorandum of Understanding (MoU) aimed at enhancing cooperation in the regulation of medical products between the two countries.
This strategic partnership aims to enhance regulatory functions through collaboration in areas such as the detection of substandard and falsified medicines, track-and-trace systems, nanotechnology and biotechnology for medicines, vaccine and Active Pharmaceutical Ingredient (API) production, and other emerging scientific and regulatory domains. This agreement underscores a shared commitment to advancing public health, fostering innovation, and ensuring access to safe, quality, and efficacious medical products for citizens of both nations.
The MoU establishes a robust framework for technical cooperation, including information sharing, capacity building, joint participation in international fora, mutual recognition of Good Manufacturing Practice (GMP) inspections, and fostering investment by pharmaceutical industries across both countries. The agreement is effective for five years and may be renewed upon mutual consent.
The press release can be accessed here.
On 25 June 2025, the Ethiopian Food and Drug Authority (EFDA) issued an official notice on the implementation of revised GMP inspection frequency from five years to three years and the implications on marketing authorisation (MA) applications.
The South African Health Products Regulatory Authority (SAHPRA) recently visited the Egyptian Drug Authority (EDA) at their Cairo offices for an intensive training programme to capacitate the regulator on how to achieve recognition for the World Health Organization (WHO) Global Benchmarking Tool (GBT) Maturity Level 3 (ML3) in medicines.
Having signed a Memorandum of Understanding with EDA in 2023, this three-day training allowed for knowledge exchange and capacity building on the continent.
EDA’s Centre for Continuing Professional Development conducted a training programme that provided critical knowledge and shared skills required to enhance SAHPRA’s regulatory governance, transparency, and performance monitoring. SAHPRA colleagues were drawn from various support units, namely the Quality Management System, the Office of the CEO, Human Resources, Risk and Internal Audit, Communication and Public Relations, as well as the Inspectorate.
The Egyptian Drug Authority (EDA) and the South African Health Products Regulatory Authority (SAHPRA) are jointly inviting industry partners to participate in the pilot phase of the Work Sharing Initiative (WSI) for the registration of biological products. This initiative aims to streamline the registration process through joint assessment procedures in both countries.
The EDA-SAHPRA WSI is a result of ongoing bilateral cooperation between Egypt and South Africa. The initiative is aligned with the World Health Organization (WHO) Good Reliance Practices (GRelP) and supports broader global efforts toward regulatory harmonisation and reliance.
In July 2023, the two authorities signed a Memorandum of Understanding (MoU) on mutual reliance covering pharmaceuticals, biological products, and medical devices. As part of the MoU’s implementation, the two agencies agreed to pilot this joint registration process as a practical application of their collaborative framework.
Industry stakeholders are encouraged to review the advert and concept note for more details on participation in this pilot. These documents can be accessed here.
The Benin Agency for Medicines and Health Products (ABMed) has introduced a new regulatory procedure requiring prior authorisation for all pharmaceutical advertising in Benin, in line with Decision No. ABMED/2025D/3712/DLVS/SSMUR/CJ/SA. This measure represents a significant step in enhancing transparency, upholding ethical standards, and public health protection in pharmaceutical communication.
As part of the application process, companies must submit a dossier that includes a signed request from the responsible pharmacist. This request should specify the name of the medicinal product, the targeted healthcare professional groups, the media formats and diffusion channels to be used (such as television, print, or digital platforms), and the contact details of the designated dossier focal point within the company.
In addition to the request letter, applicants are required to submit two original copies of all promotional materials. These may include print visuals, audio content, and digital or web-based content. For submissions involving multiple products, materials should be grouped according to pharmacotherapeutic category. Furthermore, if the promotional content is in audiovisual format, a detailed script must be provided to accompany the materials.
Under the GHPP-PharmTrain2 project, a training workshop was recently held in collaboration with the Pharmacy and Poisons Board (PPB) of Kenya. The event formed part of ongoing efforts to strengthen regulatory capacity in the assessment of clinical and bioequivalence (BE) studies across the region.
The workshop brought together three fellows of the PharmTrain2 clinical fellowship (Margaret Malatji, Eric Owusu, and Asare Yeboah) who served as trainers. They were joined by staff from PPB and regulatory representatives from Egypt (Egyptian Drug Authority), Ethiopia (Ethiopian Food and Drug Authority), Rwanda (Rwanda Food and Drugs Authority), Tanzania (Tanzania Medicines and Medical Devices Authority), Uganda (National Drug Authority), and Zanzibar (Zanzibar Food and Drugs Authority).
The training focused on enhancing technical competencies in BE study design, bioanalytical method validation, sample analysis, and the use of biowaivers. It also served to foster cross-country collaboration and knowledge-sharing among regulators from the East African Community and beyond. Participants demonstrated measurable improvements in understanding and engagement in all technical areas covered.
On 11 June 2025, Tunisia’s regulatory authority announced a revised analytical control strategy for medicinal products, aligning with international standards. The update applies to both registration and post-marketing phases and will take effect with the 2025 version of the national registration guide.
Key Highlights:
The analytical control strategy can be read here.
The Conference of State Parties (CoSP) of the African Medicines Agency (AMA) announced the appointment of Dr Delese Mimi Darko of the Republic of Ghana as the inaugural Director General of the AMA. The announcement was made on 4 June 2025 during the 2nd Ordinary Session of the CoSP, held from 2 - 4 June 2025 in Kigali, Rwanda.
Dr Darko, widely recognised for her outstanding leadership as Chief Executive Officer of the Ghana Food and Drugs Authority (FDA), brings to the role a wealth of regulatory experience and a distinguished track record in advancing medicines regulation. Her appointment marks a significant milestone in the operationalisation of the AMA and is expected to enhance regulatory oversight, promote access to quality-assured, safe, and efficacious medicines, and support pharmaceutical innovation across the continent.
During the three-day session, the CoSP also elected a new Bureau to lead its future work and endorsed an additional member to the AMA Governing Board. These developments reinforce the governance framework of the AMA and support its continued strategic growth and effectiveness.
The AMA Governing Board is responsible for providing strategic direction, technical decision-making, and performance oversight of the Agency. Its members include:
The official press release from the African Union can be accessed here.
The Management Board of the European Medicines Agency (EMA) welcomed the African Medicines Agency (AMA) Governing Board and heads of African national regulatory authorities as observers in a first-of-its-kind meeting between the European and African regulatory networks.
The African delegation was led by Dr Yossounon Chabi, Chair of the AMA Governing Board and Director-General of the Benin Agency for Medicines and Health Products. The delegation also included Dr Delese Mimi Darko, the newly elected AMA Director-General and Chief Executive Officer of the Ghana Food and Drugs Authority (FDA).
Observing the meeting gave the AMA delegation the opportunity to gain insights into the governance and supervisory role of the EMA Management Board across a broad range of activities, including strategic, financial and operational matters. Representatives from the European Commission’s Directorate-General for International Partnerships (DG INTPA) and the World Health Organization (WHO) also took part in the meeting.
This engagement formed part of EMA and the European regulatory network’s broader commitment to supporting the AMA and strengthening regulatory systems in Africa. The initiative was organised by EMA and is funded through the European Union (EU) Global Gateway Initiative.
The European Medicines Agency (EMA) has reinforced its commitment to supporting regulatory systems in Africa by awarding 11 grants to National Competent Authorities (NCAs) within the European Union medicines regulatory network (EMRN). These grants will support capacity building and technical assistance to national, regional, and continental regulatory bodies across Sub-Saharan Africa. This announcement follows the meeting between the AMA Governing Board and the EMA Management Board.
The awarded NCAs (representing Portugal, Malta, Ireland, Sweden, Poland, Germany, Spain, and Italy) will provide regulatory training to assessors and regulatory professionals in Botswana, Cape Verde, Lesotho, Ethiopia, Mozambique, Uganda, and Zimbabwe. These activities will span through 2027 and cover a broad scope of regulatory functions, including quality and clinical assessment methods, pharmacovigilance, and inspection procedures.
While EMA continues to engage directly with the AMA at the continental level, this initiative highlights the essential role of national expertise in delivering regulatory support, reflecting the European model where national contributions underpin the strength of the broader network.
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