First ML3: African Regulators Strong, Stable, Says NAFDAC, as Continent Moves to Boost Health Sovereignty

The National Agency for Food and Drug Administration and Control (NAFDAC) has said African regulators are capable and ready to drive health sovereignty adding that the efforts are at advance stage to boost the continent’s health systems security and speed up access to quality medicines and vaccines.

This follows the hosting of the first formal meeting of Africa’s Maturity Level 3 (ML3) National Regulatory Agencies (NRAs) in Abuja on Monday, by NAFDAC

In a statement issued on Monday, NAFDAC said the gathering brought together heads of seven other World Health Organization (WHO)-certified ML3 agencies to operationalise a shared reliance mechanism that will reduce duplication and regulatory bottlenecks across Africa.

“This is about showing that African regulators are now strong, stable, and ready to lead the drive for health sovereignty,” said NAFDAC Director-General, Professor Mojisola Adeyeye.

According to the agency, the participating countries include Ghana, Egypt, Tanzania, South Africa, Rwanda, Senegal, and Zimbabwe. Earlier this year, the agencies signed a Memorandum of Understanding to formalise their collaboration on product assessments, inspections, and market authorisations.

The Abuja meeting also inaugurated the ML3 NRAs Steering Committee, electing Mr Richard Rukwata of Zimbabwe as chair and Dr Ali Ghamrawy of Egypt as vice-chair.

Professor Adeyeye explained that the WHO Maturity Level system, initiated under its Global Benchmarking Tool, has transformed African regulatory agencies into globally recognised institutions capable of supporting continental health initiatives such as the African Medicines Agency (AMA).

“This mechanism promises faster access to quality-assured medicines, vaccines, and diagnostics for African populations, while also strengthening local manufacturing,” she said.

NAFDAC added that the ML3 Reliance mechanism is expected to reduce regulatory costs, build confidence in African pharmaceutical markets, and align with the African Union’s Agenda 2063 vision of an integrated and self-reliant continent.

The inaugural meeting was attended by representatives of Africa CDC, AUDA-NEPAD’s African Medicines Regulatory Harmonisation (AMRH) programme, and other partners, which Professor Adeyeye described as: “A turning point for African health security and development.”