Efforts to strengthen local pharmaceutical manufacturing in Nigeria are gaining momentum, driven by regulatory reforms aimed at reducing dependence on imported medicines and improving access to affordable drugs.
The National Agency for Food and Drug Administration and Control (NAFDAC), under the leadership of Mojisola Adeyeye, has introduced policies designed to encourage domestic production, with industry data indicating an increase in local manufacturing from about 30 per cent to 50 per cent in recent years.
Central to this shift is the agency’s “Five Plus Five-Year Validity” (5+5) policy, which mandates foreign pharmaceutical companies to establish partnerships with Nigerian firms or set up local manufacturing facilities within a defined timeline.
The policy ties product registration renewals to measurable progress in local production, with penalties including possible de-registration for non-compliance.
Under the framework, companies are required to submit verifiable plans for local manufacturing before renewal of their licences, while regulatory authorities monitor the transition from importation to domestic production over time.
Industry stakeholders say the policy is gradually reshaping Nigeria’s pharmaceutical landscape, encouraging investment in local production of finished pharmaceutical products, active pharmaceutical ingredients, and packaging materials.
In addition to local manufacturing reforms, Nigeria’s regulatory system has recorded progress on the global stage.
NAFDAC attained Maturity Level 3 (ML3) status under the World Health Organization Global Benchmarking Tool, indicating a stable and well-functioning regulatory system that meets international standards.
The ranking places Nigeria among a limited number of African countries, including Ghana, Tanzania, and Egypt, with similarly rated regulatory systems.
Globally, fewer than 30 per cent of national regulatory authorities meet this level of effectiveness.
Health sector analysts note that achieving and sustaining this rating could enhance Nigeria’s capacity to attract investment, strengthen drug safety systems, and support future vaccine manufacturing.
The combined impact of regulatory reforms and increased local production is expected to improve medicine availability, reduce costs, and enhance the resilience of Nigeria’s healthcare system.