The History of Who We Are and Where We Are Going
The Abuja ML3 NRAs Meeting: The Director-General of NAFDAC, Prof. Mojisola Adeyeye, welcomed Heads of seven other WHO Maturity Level 3 agencies to Abuja on Monday, July 7, 2025. In her Opening Remarks, she went down memory lane on the history of the WHO Regulatory Systems Strengthening program and the Maturity Levels classification of regulatory authorities, and the journey for African National Regulatory Authorities (NRAs), as explained below.
The History and Who We Are: In 2014, the Sixty-Seventh World Health Assembly (WHA) Resolution 67.20 called for the development of the WHO Global Benchmarking Tool (GBT) to assess the maturity and performance of national regulatory systems for medical products. The GBT is a standardized tool used to evaluate regulatory functions, identify gaps, and facilitate improvements in NRAs. It’s a key instrument in the WHO’s efforts to strengthen regulatory systems for medical products globally.
The WHO began benchmarking regulatory systems in 1997, with an initial focus on vaccines. The organization later started unifying and harmonizing the GBT tools for medicines and vaccines in 2013, and a year later, the WHO passed Resolution 67.20. In 2018, Revision 1 of the tool was published to serve as a global standard for the objective assessment of regulatory frameworks and capacities of national regulatory authorities for medicines and vaccines.
Nigeria started the benchmarking in 2018 with over 260 sub-indicators, resulting in over 800 recommendations to satisfy eight regulatory functions of the WHO GBT Tool, namely the overall National Regulatory System (or how strong the regulatory environment is), Registration and Market Authorization, Market Surveillance and Control, Regulatory Inspection, Clinical Trial Oversight, Laboratory Testing, Vigilance, and Licensing Establishments (by Pharmacy Council of Nigeria). These recommendations were implemented, and in 2022, NAFDAC was recognized as operating at Maturity Level 3, characterized as a stable, well-functioning, and integrated regulatory system for medicines and imported vaccines.
Seven other African NRAs also passed through this WHA-mandated rigorous assessment and were pronounced as ML3 regulatory authorities as follows:
- Tanzania Medicines and Medical Devices Authority (TMDA) – 2018 (medicines and imported vaccines)
- Ghana Food and Drugs Authority (FDA) – 2020 (medicines and imported vaccines)
- Egyptian Drug Authority (EDA) – 2022 (vaccines); 2024 (medicines/imported and local)
- South African Health Products Regulatory Authority (SAHPRA) – 2022 (imported/local vaccines)
- Agence sénégalaise de Réglementation Pharmaceutique of Senegal – 2024 (imported/local vaccines)
- Medicines Control Authority of Zimbabwe (MCAZ) – 2024 (medicines and imported vaccines)
- Rwanda Food and Drugs Authority (Rwanda FDA) – 2024 (medicines and imported vaccines)
Where We Are: These agencies signed a Memorandum of Understanding (MoU) in February 2025, to establish a reliance mechanism, formalize their commitment to collaborative regulatory work, shared assessments, data exchange, and alignment with continental goals such as those of the African Medicines Agency (AMA), the African Medicines Regulatory Harmonization (AMRH) programme, Pharmaceutical Manufacturing Plan for Africa (PMPA), Partnership for African Vaccine Manufacturing (PAVM), and the Platform for Harmonized African Health Products Manufacturing (PHAHM).
The signing of the MoU marked a significant milestone, signalling a collective intent to operationalize reliance-based regulatory practices and serve as a model of leadership for other NRAs across the continent. The MoU 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.
To guide and oversee the effective implementation of this reliance mechanism, a Steering Committee composed of the heads of the eight ML3 NRAs was formally inaugurated on 7th July 2025 in Abuja, Nigeria, with the election of the Director-General of MCAZ, Mr. Richard Tendayi Rukwata as the chair of the committee and the Chairman of EDA, Dr. Ali Ghamrawy as the vice chair for the next two years.
The Committee is tasked with providing strategic leadership, addressing policy-level decisions, and ensuring alignment between national and regional regulatory priorities. It plays a pivotal role in ensuring that the objectives of the MoU and the reliance mechanism are realized through accountability, stakeholder engagement, and sustained political and institutional support.
Representatives of the AMA, AMRH Programme, and the Africa Centres for Disease Control and Prevention (Africa CDC) will serve as non-voting members. Members of support partner organizations may be invited as observers, as decided by the Steering Committee. The mechanism also has an Operations Team to support the Steering Committee in implementing its activities.
The inaugural meeting of the ML3 Reliance mechanism was also attended by representatives of the AMRH Program under AUDA-NEPAD and the Africa CDC.
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.
The role of the ML3 NRAs in implementing the proposed Continental Reliance Framework was discussed, as well as the draft operational plan for the reliance mechanism and the integration of the ML3 reliance program 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), hosted by the Africa CDC, as well as the role of ML3 NRAs in supporting AMA operations, was discussed and agreed upon.
The ML3 Reliance mechanism promises to ensure increased availability and timely access to quality-assured medicines, vaccines, and diagnostics, reducing duplication and regulatory burden in Africa, resulting in cost savings and faster product approvals across participating countries. The mechanism also established a robust and reliable regulatory network that can serve as a model for other regions, enhancing Africa’s self-reliance. This will support the African Union’s strategy and bring its Pharmaceutical Manufacturing Plan for Africa to reality.
Prof Mojisola Adeyeye,
Director-General (NAFDAC)
