Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) is the primary regulatory authority in Nigeria responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use of health products, 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 derives additional powers from the Food and Drugs Act. The general approval process involves product registration, which requires submission of a dossier for technical review, laboratory analysis, facility inspection, and final approval before a product can be legally marketed in Nigeria. Registration certificates are typically valid for five years and must be renewed before expiry.

Applicants seeking product registration in Nigeria must appoint a local responsible person or Nigerian-based legal entity to serve as the local representative, as NAFDAC does not accept applications directly from foreign manufacturers without a local agent. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, and NAFDAC increasingly aligns its technical guidelines with WHO prequalification standards and the African Medicines Regulatory Harmonization (AMRH) initiative under the African Union Development Agency (AUDA-NEPAD). In recent years, NAFDAC has introduced notable reforms including a risk-based registration pathway that allows expedited review for WHO-prequalified products, generic medicines, and products previously approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, and Health Canada. The agency has also digitized portions of its submission and tracking process through the NAFDAC Product Registration Portal, improving transparency and reducing administrative bottlenecks.

Public procurement of health products in Nigeria operates through a multi-tiered structure involving federal and state government entities. At the federal level, the Federal Ministry of Health and Social Welfare (FMOHSW) sets national health policy and coordinates procurement through affiliated agencies such as the National Primary Health Care Development Agency (NPHCDA), the National Health Insurance Authority (NHIA), and government-owned hospitals and medical centers. Large-scale federal procurement is subject to the Public Procurement Act of 2007, which is administered by the Bureau of Public Procurement (BPP). This act mandates open competitive tendering for contracts above defined thresholds, with international competitive bidding required for high-value procurements. 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, requirements, and pricing across subnational jurisdictions. This federal-state split means that suppliers must often engage both federal and state procurement channels to achieve meaningful market penetration.

The private sector constitutes a substantial portion of health product demand in Nigeria, given the significant out-of-pocket expenditure that characterizes the Nigerian health financing landscape. Private hospitals, pharmacy chains, and wholesale distributors represent key commercial channels, with major wholesale hubs concentrated in Lagos (Idumota and Apongbon markets), Kano, and Onitsha. Donor-funded procurement channels also play a critical role, particularly in areas such as HIV/AIDS, malaria, tuberculosis, and reproductive health. Key donors and implementing partners active in Nigeria include the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through USAID, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gavi the Vaccine Alliance, UNICEF, and the World Bank. These donors typically procure through international tender processes or pre-approved supplier lists, often requiring WHO prequalification or SRA approval as a baseline eligibility criterion. Nigeria has also pursued local manufacturing preference policies under the Federal Government's National Action Plan for the Domestication and Local Manufacture of Essential Medicines and Health Products, which provides incentives such as import duty waivers for raw materials and preferential procurement margins for locally manufactured goods, aiming to strengthen domestic pharmaceutical and device manufacturing capacity in alignment with the Africa Medicines Manufacturing Plan.