… As NAFDAC hosts inaugural meeting of ML3, NRAs

By Chioma Obinna

Africa’s highest-rated drug regulatory authorities have inaugurated a landmark Steering Committee to operationalise a shared reliance mechanism, aimed at fast-tracking access to quality-assured medicines and vaccines across the continent.

The announcement came during the inaugural meeting of the Maturity Level 3 (ML3) National Regulatory Authorities, NRAs, hosted by Nigeria’s National Agency for Food and Drug Administration and Control, NAFDAC, recently in Abuja.

The Steering Committee, made up of the heads of eight WHO-certified ML3 regulatory agencies, will provide strategic leadership and policy direction for the newly established reliance mechanism. Director-General of the Medicines Control Authority of Zimbabwe (MCAZ), Mr. Richard Tendayi Rukwata, was elected Chair, while the Chairman of the Egyptian Drug Authority (EDA), Dr. Ali Ghamrawy, was named Vice Chair for a two-year term.

“This mechanism is a turning point for Africa. It reduces duplication, shortens approval timelines, and delivers real public health value,” Rukwata said.

The ML3 Reliance Mechanism was formalised through a Memorandum of Understanding (MoU) signed in February 2025. It encourages collaborative regulatory assessments, sharing of data, joint inspections, and alignment with continental initiatives such as the African Medicines Agency (AMA), the African Union’s Agenda 2063, and the Pharmaceutical Manufacturing Plan for Africa (PMPA).

Speaking at the opening session, NAFDAC Director-General, Prof. Mojisola Adeyeye, described the collaboration as a defining moment in the journey towards Africa’s health sovereignty.

 “The WHO Global Benchmarking Tool guided us through over 800 recommendations.Our journey to ML3 status in 2022 was not accidental, it was intentional and rigorous. Today, that hard work is paying off. We are no longer followers in global regulatory systems. Africa is now setting the pace.”

The meeting brought together senior representatives from the Africa Centres for Disease Control and Prevention, Africa CDC, the African Medicines Regulatory Harmonisation, AMRH, programme under AUDA-NEPAD, and other key development partners. These stakeholders will support the mechanism as observers or technical advisers, while a dedicated Operations Team will assist the Steering Committee with implementation.

The delegates discussed the integration of the ML3 Reliance Mechanism into the planned Regulatory Information Sharing Portal, RISP, as well as its role in supporting the African Pooled Procurement Mechanism, APPM. National regulators shared their experiences and lessons from implementing reliance frameworks, identifying both opportunities and persistent challenges.

The eight ML3 NRAs participating in the meeting included NAFDAC Nigeria, the Tanzania Medicines and Medical Devices Authority, Ghana Food and Drugs Authority, Egyptian Drug Authority, South African Health Products Regulatory Authority, Agence Sénégalaise de Réglementation Pharmaceutique, Medicines Control Authority of Zimbabwe, and Rwanda Food and Drugs Authority.

The Vice Chair of the Steering Committee, Dr. Ghamrawy, emphasised the collective value of the new structure. “We’re building a continent-wide safety net for health products, one that promotes equity, quality, and speed,” he said.

The ML3 Reliance Mechanism is expected to accelerate product approvals, reduce regulatory costs, streamline oversight, and boost Africa’s ability to manufacture and distribute its own medical products. It also provides a replicable framework for other regions seeking to strengthen regulatory systems through cooperation and shared accountability.