The National Agency for Food and Drug Administration and Control (NAFDAC) has outlined significant achievements in the modernisation of Nigeria’s regulatory systems since 2018, reaffirming its commitment to safeguarding public health through science-driven, transparent, and internationally aligned regulation.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made this known during a Media Parley on Modernisation and Foundation Laying of NAFDAC Regulatory Systems (2018-Date): Reflections on 2025.
Prof. Adeyeye stated that the modernisation journey was anchored on the establishment of an agency-wide Quality Management System (QMS), strong legal frameworks, and the institutionalisation of Good Regulatory Practices. NAFDAC attained ISO 9001 certification in 2019 and has consistently sustained it, while strengthening over 28 regulations to enhance transparency, accountability, and evidence-based decision-making across all regulated products.
In medicines regulation, Nigeria achieved a major milestone with the World Health Organization (WHO) Global Benchmarking Tool, attaining Maturity Level 3 (ML3) in 2022 and becoming the first regulatory authority in Africa to be successfully re-benchmarked at ML3 in 2025. NAFDAC also expanded regulatory maturity to medical devices and, in November 2025, was admitted as the 24th full member of the International Council for Harmonisation (ICH), placing Nigeria among a select group of 25 global regulatory authorities.
The Director-General highlighted deliberate policies to promote local manufacturing, including the 5+5 Regulatory Directive and the Ceiling List, which have shifted production from import dependence to local manufacturing.
As of 2025, over 70 per cent of affected products are now produced locally, supported by increased facility approvals, technology transfer, and foreign partnerships. These measures, she noted, strengthen medicine security, improve quality compliance, and attract investment.
On food safety, veterinary medicines, and allied products, NAFDAC has adopted risk-based, technology-driven regulation, decentralised food registration, strengthened laboratory capacity, and enforced measures to reduce trans fats and harmful alcohol use. The Agency has also intensified antimicrobial resistance (AMR) initiatives under a One Health approach, while modernising enforcement through intelligence-led operations that have led to large-scale seizures and destruction of substandard and falsified products.
Prof. Adeyeye further underscored NAFDAC’s digital transformation, including platforms such as NAPAMS, LIMS, PIDCARMS, NTIS, and the Integrated Regulatory Information Management System (IRIMS), which have improved efficiency, traceability, and regulatory turnaround time. She reaffirmed the Agency’s commitment to advancing toward WHO Maturity Level 4, full digitalisation, artificial intelligence-driven regulation, and sustained workforce development to consolidate Nigeria’s leadership in regulatory excellence.
“Regulatory modernisation is a continuous process and remains central to protecting public health, fostering local industry growth, and ensuring that Nigerians have access to safe, quality, and effective regulated products” she concluded.
