{"id":120622,"date":"2025-07-14T17:59:21","date_gmt":"2025-07-14T16:59:21","guid":{"rendered":"https:\/\/pointblanknews.com\/pbn\/?p=120622"},"modified":"2025-07-14T17:59:21","modified_gmt":"2025-07-14T16:59:21","slug":"eight-african-ml3-nations-sign-pact-for-drug-regulation","status":"publish","type":"post","link":"https:\/\/pointblanknews.com\/pbn\/news\/eight-african-ml3-nations-sign-pact-for-drug-regulation\/","title":{"rendered":"\u200eEight African ML3 Nations Sign Pact for Drug Regulation"},"content":{"rendered":"
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By Daniel Adaji<\/div>\n
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\u200eEight 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.<\/div>\n
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\u200eThe pact was formalised during a high-level meeting hosted by Nigeria\u2019s National Agency for Food and Drug Administration and Control (NAFDAC) in Abuja on July 7, 2025.<\/div>\n
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\u200eAccording 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.<\/div>\n
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\u200eSpeaking at the event, NAFDAC Director-General, Prof. Mojisola Adeyeye, described the MoU as \u201ca significant milestone,\u201d saying it represents \u201ca collective intent to operationalize reliance-based regulatory practices and serve as a model of leadership for other NRAs across the continent.\u201d<\/div>\n
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\u200eThe 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 S\u00e9n\u00e9galaise de R\u00e9glementation Pharmaceutique (Senegal), Medicines Control Authority of Zimbabwe (MCAZ), Rwanda Food and Drugs Authority (Rwanda FDA) and NAFDAC (Nigeria).<\/div>\n
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\u200eEach of these regulators has earned WHO\u2019s ML3 designation, confirming they operate \u201ca stable, well-functioning, and integrated regulatory system for medicines and imported vaccines.\u201d<\/div>\n
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\u200eNigeria attained its ML3 status in 2022 after implementing over 800 recommendations from WHO\u2019s Global Benchmarking Tool (GBT), which began in the country in 2018.<\/div>\n
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\u200eThe 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).<\/div>\n
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\u200eTo guide the pact\u2019s implementation, a Steering Committee composed of the eight heads of the ML3 agencies was inaugurated. Mr. Richard Tendayi Rukwata, Director-General of Zimbabwe\u2019s MCAZ, was elected chair, while Dr. Ali Ghamrawy, Chairman of Egypt\u2019s EDA, will serve as vice chair for the next two years.<\/div>\n
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\u200eThe Steering Committee is tasked with \u201cproviding strategic leadership, addressing policy-level decisions, and ensuring alignment between national and regional regulatory priorities,\u201d according to the agreement.<\/div>\n
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\u200eAlso 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.<\/div>\n
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\u200eThe 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).<\/div>\n
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\u200eAdeyeye said the initiative will ensure \u201cincreased availability and timely access to quality-assured medicines, vaccines, and diagnostics\u201d and will \u201creduce duplication and regulatory burden in Africa, resulting in cost savings and faster product approvals.\u201d<\/div>\n
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