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 the Food and Drug Act, with additional guidance provided through product-specific regulations and guidelines. The general approval process requires applicants to submit a registration dossier for review, after which NAFDAC conducts technical evaluation, facility inspections (for manufacturers), and product testing before granting a Certificate of Registration. Products must be registered before they can be legally marketed or distributed in Nigeria, and registration is typically valid for five years, subject to renewal.

Key submission requirements include the appointment of a local responsible person or Nigerian registered company as the in-country representative for foreign manufacturers, who assumes regulatory responsibility for the product. NAFDAC accepts dossiers compiled in accordance with the Common Technical Document (CTD) format and has progressively aligned its requirements with standards promoted by the African Medicines Regulatory Harmonisation (AMRH) initiative and the African Union Development Agency (AUDA-NEPAD). Recent reforms under NAFDAC's Pharma Vision 2020 and subsequent modernisation programmes have introduced an e-submission platform, expedited review pathways for essential medicines and emergency use authorisations, and reliance mechanisms that allow NAFDAC to leverage approvals from stringent reference regulatory authorities (SRAs) such as the US FDA, EMA, and WHO Prequalification to accelerate local review timelines. NAFDAC has also introduced a Post-Market Surveillance programme and risk-based regulatory frameworks particularly relevant to medical devices and in vitro diagnostics.

Public procurement of health products in Nigeria is structured across federal and state levels, governed primarily by the Public Procurement Act 2007, which established the Bureau of Public Procurement (BPP) as the oversight body for federal procurement. At the federal level, the Federal Ministry of Health and Social Welfare (FMOHSW) coordinates health commodity procurement, often working through specialised agencies such as the National Primary Health Care Development Agency (NPHCDA) for vaccines and primary care commodities, the National Malaria Elimination Programme (NMEP), and the Nigeria Centre for Disease Control and Prevention (NCDC) for disease-specific supplies. State Ministries of Health manage procurement independently within their jurisdictions, leading to significant variation in processes, timelines, and supplier requirements across Nigeria's 36 states and the Federal Capital Territory. Procurement is generally conducted through open competitive tendering, with contracts awarded based on technical compliance and price, and suppliers are typically required to demonstrate NAFDAC registration of their products prior to bid evaluation.

The private sector represents a substantial share of health product consumption in Nigeria, channelled through a network of pharmaceutical distributors, retail pharmacies, patent medicine vendors, and private hospitals, particularly in urban centres. Major donor-funded programmes play a critical role in supplementing public procurement, with organisations such as USAID (through its implementing partners including the Global Health Supply Chain Programme), the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF, and Gavi, the Vaccine Alliance financing and procuring significant volumes of health commodities for government programmes. These donors often procure through international competitive tenders or pre-qualified supplier lists, requiring WHO Prequalification or SRA approval alongside NAFDAC registration. Nigeria has enacted local content and local manufacturing preference policies, notably through the Nigerian government's push to develop domestic pharmaceutical manufacturing under initiatives such as the Pharmaceutical Manufacturing Plan for Africa (PMPA), and the Federal Government's Executive Order No. 5 (2018), which directs preference for locally manufactured goods in public procurement, creating incentives for manufacturers with in-country production or packaging operations.