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By Daniel Adaji
Eight African countries with World Health Organisation (WHO) Maturity Level 3 (ML3) regulatory status have signed a Memorandum of Understanding (MoU) to strengthen cooperation on medicine and vaccine oversight.
The pact was formalised during a high-level meeting hosted by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) in Abuja on July 7, 2025.
According to a statement by NAFDAC on Monday, the agreement aims to establish a regulatory reliance mechanism that will streamline drug approvals, improve access to quality-assured medicines, and reduce duplication of regulatory efforts across the continent.
Speaking at the event, NAFDAC Director-General, Prof. Mojisola Adeyeye, described the MoU as “a significant milestone,” saying it represents “a collective intent to operationalize reliance-based regulatory practices and serve as a model of leadership for other NRAs across the continent.”
The participating agencies include: Tanzania Medicines and Medical Devices Authority (TMDA), Ghana Food and Drugs Authority (FDA), Egyptian Drug Authority (EDA), South African Health Products Regulatory Authority (SAHPRA), Agence Sénégalaise de Réglementation Pharmaceutique (Senegal), Medicines Control Authority of Zimbabwe (MCAZ), Rwanda Food and Drugs Authority (Rwanda FDA) and NAFDAC (Nigeria).
Each of these regulators has earned WHO’s ML3 designation, confirming they operate “a stable, well-functioning, and integrated regulatory system for medicines and imported vaccines.”
Nigeria attained its ML3 status in 2022 after implementing over 800 recommendations from WHO’s Global Benchmarking Tool (GBT), which began in the country in 2018.
The newly signed MoU aligns with key African Union health priorities, including the African Medicines Agency (AMA), the African Medicines Regulatory Harmonization (AMRH) programme, and the Pharmaceutical Manufacturing Plan for Africa (PMPA).
To guide the pact’s implementation, a Steering Committee composed of the eight heads of the ML3 agencies was inaugurated. Mr. Richard Tendayi Rukwata, Director-General of Zimbabwe’s MCAZ, was elected chair, while Dr. Ali Ghamrawy, Chairman of Egypt’s EDA, will serve as vice chair for the next two years.
The Steering Committee is tasked with “providing strategic leadership, addressing policy-level decisions, and ensuring alignment between national and regional regulatory priorities,” according to the agreement.
Also in attendance were representatives of the Africa Centres for Disease Control and Prevention (Africa CDC), AUDA-NEPAD, and the AMRH Programme, who will serve as non-voting members of the mechanism. An Operations Team has also been set up to support implementation.
The meeting allowed NRAs to share experiences, discuss challenges, and review a draft operational plan, including the proposed Regulatory Information Sharing Portal (RISP) and the role of ML3 agencies in the African Pooled Procurement Mechanism (APPM).
Adeyeye said the initiative will ensure “increased availability and timely access to quality-assured medicines, vaccines, and diagnostics” and will “reduce duplication and regulatory burden in Africa, resulting in cost savings and faster product approvals.”