Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) is the primary regulatory authority responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use 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 relevant subsidiary regulations, including the Medical Devices and Diagnostics Regulations. The general approval process involves product registration through the NAFDAC e-Submission portal, dossier review, facility inspection (local or foreign), laboratory analysis where applicable, and final approval leading to issuance of a NAFDAC Registration Number (NRN). Different regulatory pathways exist depending on product category and risk classification, with expedited review routes available for products addressing public health emergencies or those already approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or Health Canada.

All applicants seeking product registration in Nigeria must appoint a locally registered entity or an accredited local representative to submit and manage the application, as NAFDAC does not accept direct foreign applications. Dossiers are generally expected to follow the Common Technical Document (CTD) or ACTD format for pharmaceuticals, while medical devices and diagnostics follow risk-based classification frameworks aligned with the Global Harmonization Task Force (GHTF) and African Union guidance. NAFDAC has undertaken several notable reforms in recent years, including the rollout of its electronic submission and tracking system, participation in the African Medicines Regulatory Harmonization (AMRH) initiative, and adoption of a Collaborative Registration Procedure (CRP) with the African Union Development Agency (AUDA-NEPAD), which allows for recognition of approvals from reference SRAs to shorten review timelines. Post-market surveillance obligations, including adverse event reporting and renewal of registration every five years, apply to all registered products.

Public procurement of health products in Nigeria operates within a layered federal structure governed by the Public Procurement Act of 2007, which established the Bureau of Public Procurement (BPP) as the oversight authority for federal procurement processes. At the federal level, the Federal Ministry of Health and Social Welfare (FMOHSW) coordinates health commodity procurement, often working through agencies such as the National Primary Health Care Development Agency (NPHCDA), the National Health Insurance Authority (NHIA), and the Pharmacy Council of Nigeria. Tenders for large-scale public sector health product procurement are typically published through the BPP portal and relevant ministry channels, with open competitive bidding required above certain thresholds. Nigeria operates a dual federal and state governance structure, meaning each of the 36 states and the Federal Capital Territory (FCT) maintains its own Ministry of Health and procurement mechanisms, leading to significant variation in processes, timelines, and requirements across subnational jurisdictions. Local government authorities (LGAs) also play a role in primary healthcare supply chains, though procurement at this level is often centrally coordinated through state or federal agencies.

The private sector represents a substantial and growing channel for health product distribution in Nigeria, encompassing hospital groups, retail pharmacy chains, patent medicine vendors, and private diagnostic laboratories, all served by a network of registered importers and distributors. Donor-funded procurement constitutes a critical parallel channel, with organizations such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID (through mechanisms such as PEPFAR and PMI), Gavi the Vaccine Alliance, and the World Bank financing significant volumes of health commodities, often procured internationally through UN agencies or pre-qualified suppliers and delivered in-country through implementing partners. Nigeria has progressively implemented local manufacturing preference policies, including the National Drug Policy and various Executive Orders encouraging local content in public procurement, with the federal government offering incentives to domestic manufacturers. The Pharmaceutical Sector Governance Initiative and ongoing efforts under the Nigeria Health Sector Renewal Investment Initiative (NHSRII) further signal commitment to strengthening local production capacity and reducing import dependency for essential health products.