African ML3 Regulators Inaugurates Steering Committee to Enhance Reliance Mechanism

African WHO Maturity Level 3 (ML3) agencies including the National Agency for Food and Drugs Administration Control (NAFDAC) with seven other agencies on Monday, 7 July, inaugurated a steering committee to improve reliance mechanism in healthcare delivery.

The steering committee is composed of the heads of eight ML3 African National Regulatory Authorities (NRAs) with the election of the Director-General of Medicines Control Authority of Zimbabwe (MCAZ), Mr Richard Tendayi Rukwata as the chair, and the Chairman of Egyptian Drug Authority (EDA), Dr Ali Ghamrawy as the vice- chair for the next two years. The non-voting members are African Medicines Regulatory (AMA), African Medicines Regulatory Harmonisation (AMRH) Programme and the Africa Centres for Disease Control and Prevention (Africa CDC).

The committee is tasked with providing strategic leadership, addressing policy-level decisions, and ensuring alignment between national and regional regulatory priorities.

NAFDAC Director General, Prof. Moji Adeyeye, disclosed the agencies signed a Memorandum of Understanding (MoU) earlier in the year, signalling a collective intent to operationalise reliance-based regulatory practices and serve as a model of leadership for other NRAs across the continent.

The committee also ensures the objectives of the MoU and reliance mechanism are achieved through accountability, stakeholder’s engagement, and sustained political and institutional support.

The MoU, she said outlines shared principles, responsibilities, and a vision for coordinated regulatory activities that contribute to broader African Union (AU) health strategies, including Agenda 2063 (“The Africa We Want”) and the drive toward health sovereignty through local manufacturing and streamlined market access.

The meeting enabled some of the NRAs to share their experiences with reliance on other NRAs in Africa and to highlight the opportunities & challenges observed in the reliance activities.

She further hinted on the deliberations of the meeting, noting it featured the role of the ML3 NRAs in implementing the proposed Continental Reliance Framework, as well as the draft operational plan for the reliance mechanism and the integration of the ML3 reliance programme into the planned Regulatory Information Sharing Portal (RISP).

The role of ML3 NRAs and the regulatory reliance mechanism in quality assurance & expedited regulatory pathways within the African Pooled Procurement Mechanism (APPM), was clearly spelt out, she said, and hosted by the Africa CDC, as well as the role of ML3 NRAs in supporting AMA operations, was discussed and agreed upon.

The other ML3 agencies in at the meeting are as follows :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 of Senegal Medicines Control Authority of Zimbabwe (MCAZ), and  Rwanda Food and Drugs Authority (Rwanda FDA).