Regulatory Spotlight - 08
December 16, 2024
Showcasing the latest developments, news and updates from African national medicines regulatory authorities.
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The African Union Development Agency-NEPAD's African Medicines Regulatory Harmonisation (AMRH) initiative reviewed the Somali Medicines Bill as part of its support for the newly established Somali Interim National Medicines Regulatory Authority. According to the World Health Organization (WHO), a well-functioning NRA should be capable of executing all essential regulatory functions. The AMRH initiative and Somali representatives discussed strategies to operationalise core regulatory functions of the Authority, such as conducting inspections, market surveillance, licensing facilities, registering medicines, granting marketing authorisations, overseeing laboratory testing and clinical trials, and managing lot releases. Discussions also centered on alignment with the African Union model law on medical products regulation and ratification of the treaty for the establishment of the African Medicines Agency.
The Medicines Control Authority Of Zimbabwe (MCAZ) and the Botswana Medicines Regulatory Authority(BoMRA) announced the renewal of their Memorandum of Understanding (MoU). The MoU's objective is to promote and develop cooperation in medical products regulatory functions in the two countries. Through the partnership, the regulators will collaborate on several activities, including the regulation of medical devices, detection of substandard and falsified medicines, and the advancement of biotechnology and vaccine production. The collaboration will also enable the NRAs to exchange information, support capacity building initiatives and foster mutual understanding of regulatory standards.
The media release can be read here.
The 5th meeting of the African Union (AU) Smart Safety Surveillance (AU-3S) Steering Committee was held in Mombasa, Kenya, on 12 – 13 September 2024. This two-day hybrid event provided strategic leadership on three key focus areas: the Technical Committee on Vigilance (VL) to support the operationalisation of the African Medicines Agency in collaboration with the AMRH initiative and other technical committees; the AU Pharmacovigilance Risk Assessment Committee (AU-PRAC) to address risks associated with priority medical products; and the roadmap for establishing AfriVigilance, a continent-wide database for adverse event reports and analysis. Bringing together key regulatory experts from across Africa and international health organisations, including the Bill & Melinda Gates Foundation, UK Medicines and Healthcare products Regulatory Agency (MHRA), WHO, US FDA, and African Union Development Agency-NEPAD, the meeting aimed to strengthen the safety of medical products across Africa. Initially launched with five founding countries, the AU-3S programme has now expanded to include 12 African nations, reflecting significant progress in pharmacovigilance efforts.
African Union Development Agency-NEPAD recently concluded the second round of the Laboratory Twinning Programme in Dakar, Senegal, under the African Medicines Regulatory Harmonisation (AMRH) initiative. The Laboratory Twinning Programme aims to foster cooperation among African regulatory authorities to ensure the quality and safety of vaccines according to international standards. Experts from the Agence sénégalaise de Réglementation pharmaceutique (ARP), Egyptian Drug Authority (EDA), and Botswana Medicines Regulatory Authority (BoMRA) collaborated on strengthening vaccine testing infrastructure, conducting quality control workshops, and sharing experiences in vaccine lot release. Participants discussed challenges in vaccine quality control, shared best practices, and toured Senegal’s regulatory laboratories, contributing to a deeper understanding of procedures for ensuring vaccine safety and efficacy. Key achievements included drafting action plans to enhance laboratory capacity across Africa, marking a significant step forward in regulatory harmonisation.
The Egyptian Drug Authority (EDA) participated in the consultative meeting of experts organised by the World Health Organization (WHO), held in Riyadh, Saudi Arabia, from 17 - 19 September 2024. The event was co-hosted by the National Center for Complementary and Alternative Medicine of Saudi Arabia and the WHO Regional Office for the Eastern Mediterranean. Key attendees included Dr. Abdullah bin Obaid Al-Enezi, Chairman of the Organizing Committee, Dr. Abdulrahman bin Hamoud Al-Sahbi, Executive Director General of the Center, and various experts from WHO headquarters in Geneva, along with specialists from member states. During the meeting, the final draft of the WHO Strategy for Traditional, Complementary, and Integrative Medicine 2025-2034 was discussed, incorporating member state feedback to facilitate its adoption by the Seventy-eighth World Health Assembly in 2025 and subsequent implementation across the Eastern Mediterranean. The EDA’s participation underscores its commitment to promoting collaboration, sharing expertise, and strengthening cooperation with international and regional organisations, particularly the WHO.
On 17 September 2024, Team Europe in Rwanda signed four contracts totaling €40 million, marking a significant milestone in the European Union’s support for strengthening Rwanda's pharmaceutical sector and manufacturing health products. This follows a commitment made in December 2023, when European Commission President Ursula von der Leyen and President Paul Kagame witnessed the signing of the €40 million financial agreement to boost local manufacturing and equitable access to quality, safe, and affordable health products in Rwanda. The four projects under this initiative will support the Rwandan government in pharmaceutical research and development (R&D), skills development, entrepreneurship, supply chains, and regulatory strengthening, further solidifying the partnership between Team Europe and Rwanda. This funding complements ongoing efforts under the Team Europe Initiative on Manufacturing and Access to Vaccines, Medicines, and Health Technologies in Africa (MAV+), a flagship of the EU's Global Gateway strategy. The contracts were signed during the second East Africa Pharma and Biotech Conference in Kigali, hosted by the Rwanda Biomedical Center and Africa CDC , with support from German Development Cooperation(giz) as part of the MAV+ Team Europe Initiative.
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