NAFDAC says it is aiming for the World Health Organisation’s highest regulatory ranking as it pushes ahead with reforms that include the use of artificial intelligence, complete digital processing and stronger support for local manufacturing.
Director-General of the agency, Prof Mojisola Adeyeye, disclosed the plan during a media briefing in Lagos, where she reviewed the progress made since 2018 and outlined the next phase of regulatory changes.
According to her, the agency wants to move from its current WHO Global Benchmarking Tool Maturity Level 3 status to Level 4, the top category reserved for highly advanced and efficient regulatory systems. She said the new targets also include upgrading to ISO 9001:2026 certification and expanding technology-driven oversight across the health sector.
Adeyeye said NAFDAC began its reform programme eight years ago with the goal of aligning Nigeria’s systems with international standards while improving public health protection.
She acknowledged that the process was difficult at the start but said the agency focused on building a strong foundation through quality management systems and a firmer legal framework for regulatory activities.
She explained that the reform strategy was built around leadership, best practices, product safety, supply chain monitoring and sound financial management.
One of the early achievements, she said, was the introduction of an agency-wide quality management system based on ISO 9001:2015, which led to certification in 2019. According to her, that framework helped standardise procedures, improve fairness and make decision-making more consistent.
Adeyeye described Nigeria’s engagement with the WHO benchmarking system as a major turning point. NAFDAC secured Maturity Level 3 for medicines regulation in 2022 and successfully retained the rating after another assessment in 2025.
She said the recognition placed Nigeria among countries with stable and dependable medicine regulatory systems, while also making NAFDAC the first regulatory authority in Africa to be re-benchmarked successfully at that level.
The agency also said Nigeria gained admission in November 2025 into the International Council for Harmonisation, a body that sets global standards for pharmaceutical regulation. Adeyeye noted that only a small number of regulators worldwide belong to the group.
On local production, she said policies introduced by NAFDAC had helped reduce reliance on imported products and encouraged investment in domestic manufacturing.
According to the agency, more than 70 per cent of products covered under key incentive programmes are now produced locally. She added that the balance between imported and locally made regulated products improved from 70:30 in 2019 to 60:40 in 2025.
She also said contract manufacturing partnerships rose sharply during the same period, showing growing collaboration within the pharmaceutical industry.
In food regulation, Adeyeye said decentralised registration systems, digital platforms and risk-based monitoring had made it easier for small and medium-scale producers to comply with regulations while improving efficiency.
Looking ahead, she said NAFDAC is moving beyond simple digital systems into what she described as “intelligent regulation,” where artificial intelligence and advanced data tools will be used to speed up approvals, monitor safety and improve oversight.
The reforms could have wide implications for Nigeria, including faster access to medicines, stronger confidence in locally produced products, improved exports and better protection for consumers if the plans are successfully implemented.
