The National Agency for Food and Drug Administration and Control (NAFDAC) has said it is working towards the World Health Organisation Global Benchmarking Tool Maturity Level 4, alongside full digital regulation, the use of artificial intelligence in drug approval and safety monitoring, and stronger support for local manufacturing.

The Director General of NAFDAC, Prof Mojisola Adeyeye, disclosed this on Wednesday during a media parley in Lagos, where she spoke on the agency’s regulatory reforms from 2018 to date, under a presentation titled, “Modernisation and Foundation Laying of NAFDAC Regulatory Systems: Reflections on 2025.”

Adeyeye said the next phase would build on existing reforms and strengthen Nigeria’s standing in regional and global regulation.

“As we look to the future, our priorities are anchored on sustainability, innovation and public health protection. These include advancement to WHO GBT Maturity Level 4, transition to ISO 9001:2026 certification, full digitalisation of regulatory processes, and the use of artificial intelligence in drug approval, safety and efficacy monitoring,” she said.

She said the agency began its modernisation plan in January 2018, with a focus on aligning regulatory processes with international standards and improving public health protection.

“The road map was very steep and rough with a lot of challenges, but we resolved to start from the beginning by laying a solid foundation based on a Quality Management System and a strong legal framework for all regulatory activities,” Adeyeye noted.

According to her, the reforms rest on five pillars, including leadership and governance, institutionalising best practices, product safety and quality, monitoring across the supply chain, and improved financial and performance management.

She added that NAFDAC’s agency-wide Quality Management System, built around ISO 9001:2015, led to the organisation’s certification in 2019, which it has sustained.

“This enabled us to design and institutionalise systems, policies, guidelines and procedures that ensure fairness, consistency and preparedness in regulatory decision-making,” she said.

Speaking on medicines regulation, Adeyeye said the WHO benchmarking process helped the agency identify gaps and drive reforms, while regulatory reliance and harmonisation improved efficiency.

On local production, she said NAFDAC’s 5+5 initiative and the Ceiling List policy increased local manufacturing and reduced import dependence.

“More than 70 per cent of products under the 5+5 initiative and the Ceiling List are now locally manufactured, reflecting growing confidence and investment in the local pharmaceutical industry,” she said.

She added that the import-to-local-manufacturing ratio improved from 70:30 in 2019 to 60:40 in 2025, while contract manufacturing partnerships rose from 10 in 2019 to 87 in 2025.

Adeyeye also said reforms in food safety, including decentralised food registration and wider use of digital platforms, have improved speed and supported smaller food businesses.

“Modernisation is not merely aspirational; it is already delivering tangible, measurable results that are safeguarding the health of Nigerians and fostering trade and economic growth,” she said.

She added that NAFDAC is moving beyond basic digital tools to what she described as intelligent regulation, with advanced analytics, integrated systems and artificial intelligence expected to strengthen oversight.

“Our commitment remains to protect public health through science-driven, transparent and globally aligned regulatory oversight,” Adeyeye said.