Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) is the primary regulatory authority responsible for the registration, regulation, and control of health products in Nigeria, including pharmaceuticals, medical devices, diagnostics, and digital health solutions. NAFDAC operates under the NAFDAC Act (Cap N1, Laws of the Federation of Nigeria 2004) and related subsidiary legislation. The general approval process involves submission of a registration dossier, product evaluation by NAFDAC technical reviewers, facility inspection (where applicable), and issuance of a Certificate of Registration. Products must be registered before they can be legally imported, manufactured, advertised, sold, or distributed in Nigeria. NAFDAC has also established a fast-track review pathway for essential medicines and emergency-use products, as well as a separate pathway for in vitro diagnostics and medical devices under its Medical Devices and Diagnostics directorate.

Applicants are required to appoint a local registered agent or company incorporated in Nigeria to act as the in-country representative for the product registration. Dossiers are generally expected to follow the Common Technical Document (CTD) format, and NAFDAC increasingly aligns its requirements with the African Union's African Medicines Regulatory Harmonisation (AMRH) initiative and the African Medicines Agency (AMA) framework. Key submission requirements include a valid Certificate of Pharmaceutical Product (CPP) from the country of manufacture, Good Manufacturing Practice (GMP) certification, labelling compliance with Nigerian standards, and post-market surveillance commitments. Notable recent reforms include the NAFDAC e-Registration portal, which digitises submission and tracking of applications, the adoption of collaborative registration procedures with stringent regulatory authorities (SRAs) to reduce review timelines, and the launch of the Medical Devices and Diagnostics regulations providing a more structured framework for non-pharmaceutical health products.

Public procurement of health products in Nigeria is structured across federal and state levels. At the federal level, the Federal Ministry of Health and Social Welfare (FMOHSW) oversees health policy and coordinates national procurement programmes, while the Bureau of Public Procurement (BPP) enforces compliance with the Public Procurement Act 2007, which governs all federal government purchasing activities. Key federal procurement entities include the National Primary Health Care Development Agency (NPHCDA) for vaccines and primary care commodities, the National Agency for the Control of AIDS (NACA), and the National Malaria Elimination Programme (NMEP). Each of Nigeria's 36 states and the Federal Capital Territory (FCT) maintains its own State Ministry of Health and procurement processes, leading to significant variation in timelines, tender requirements, and budget availability at the subnational level. Public tenders are typically issued through open competitive bidding, and suppliers must be registered with the BPP or relevant state procurement authority. Local content policies, while more formally developed in sectors such as oil and gas, are increasingly reflected in health procurement guidelines that give preference to locally manufactured or assembled products.

The private sector constitutes a substantial share of health product distribution in Nigeria, with a large network of private hospitals, pharmacy chains, patent medicine vendors, and distributors operating independently of public procurement channels. Entry into the private market typically occurs through agreements with national distributors or direct engagement with hospital procurement committees. Nigeria also receives significant donor and development partner funding that shapes procurement outside of government budgets. Major channels include UNICEF supply division procurement for essential medicines and diagnostics, the Global Fund to Fight AIDS, Tuberculosis and Malaria (which finances a large volume of health commodity procurement through principal recipients such as NACA and the Society for Family Health), USAID and its implementing partners (including the USAID Global Health Supply Chain programme), and Gavi, the Vaccine Alliance for immunisation commodities channelled through NPHCDA. Products procured through these donor mechanisms are often subject to pre-qualification by the World Health Organization (WHO) or equivalent SRA approval, in addition to NAFDAC registration. Manufacturers seeking to participate in donor-funded tenders should ensure WHO prequalification or SRA approval status is in place alongside valid NAFDAC registration.