The National Agency for Food and Drug Administration and Control (NAFDAC) is a semi-autonomous agency under the Nigerian Ministry of Health. Like other NMRAs, the functions performed by the NMRA includes marketing authorization, inspection, licensing, import control, pharmacovigilance, clinical trials control, medicines advertising and promotion.
NAFDAC is involved in harmonization and collaboration initiatives such as the WADRAN (West African Drug Regulatory Authority Network.

NAFDAC has an e-registration platform, where applicants can submit medicine registration applications, named NAPAMS (NAFDAC Automated Product Administration and Monitoring System). The first step of the e-registration process involves logging-in or creating an account if the applicant does not have one. To create an account the applicant has to provide her company details and contact information, her personal information including her name and desired password, and other documentation required of applicants such as the Pharmacist's License to Practice, Receipt of Payment for Renewal and the Current Premises License. After creating an account, the applicant can now complete application, make the necessary payments and wait for feedback on the application.

As part of the registration process, applicants are supposed to provide NAFDAC with the relevant information and description of the facility for inspection where it relates to registration and importation of NAFDAC regulated products. Facility inspections and sampling are estimated to take about 20 days for drug registration. NAFDAC has also approved pre-shipment inspection and testing agents for issuance of Clean Reports of Inspection And Analysis (CRIA) in India and China. NAFDAC does not honor any other Agent apart from those accredited by NAFDAC. Lists of inspected local and foreign manufacturing facilities, and clinical trials sites. NAFDAC’s Port Inspection Directorate is in charge of, among other things, inspecting regulated products at ports of entry before their release.

The NMRA issues licenses to importers, wholesalers and distributors. NAFDAC has an online portal where certificate and permit holders can digitize their already existing licenses. This can be accessed on Nigeria’s single window for Trade: https://trade.gov.ng/nafdac.

NAFDAC’s Port Inspection Directorate ensures that NAFDAC regulated products imported into or exported out of Nigeria meet requisite standards of safety and right quality. The functions of the directorate include:
•      To regulate and control the importation of drug, food, medical devices, cosmetics, detergents, drinks and bottled water.
•      Screening of import documents before the issuance of pre-release stamps.
•      To undertake the inspection of imported food, drugs, medical devices, cosmetics, Chemicals, detergents, drinks and bottled water at ports of entry before release.
•      To control the exportation of regulated products and issue quality certification for such regulated products
•      Users can access the import and export prohibition lists for pharmaceuticals, certificate and permits lists, and apply for or view e-licenses on the Trade Portal.

The Pharmacovigilance/Post-Market Surveillance Directorate is one of the technical directorates under NAFDAC. The Directorate is responsible for pharmacovigilance inspections, creating awareness about pharmacovigilance among health professionals, MA holders and the general public, and maintaining the national ADR reporting database. NAFDAC has an ADR e-reporting form that can be accessed by health professionals, patients, or the general public. The form requests information such as the reporter’s personal information, the patient’s personal details, previous illnesses of the patient, the medicines the patient took prior to using the reported medicine, and the adverse reactions the patient was experiencing.

Samples of medicines are collected during the registration process to ensure the requisite standards of NAFDAC. Pharmaceuticals imported from India and China must be inspected and tested by NAFDAC agents in the countries. When the results prove satisfactory, the agents issue a Clean Report of Inspection and Analysis (CRIA).

There are legal provisions that permit clinical trials to be conducted in Nigeria. Importing, procuring and manufacturing drugs, cosmetics or medical devices are not allowed without a valid clinical trial approval from NAFDAC. All conducted clinical trials are also supposed to comply with the Good Clinical Practices (GCP) and the NAFDAC’s requirements. The two regulatory bodies that govern clinical trials in Nigeria are NAFDAC and the National Health Research Ethics Committee (NHREC).
NAFDAC inspects the sites where clinical trials are conducted, ensures that the well-being of the participants is protected, and credible information is taken. The Agency also views protocols and authorizes the clinical trial to be performed in the country. However, ethical opinion must be obtained before NAFDAC issues final authorization for the conduct of the trial subject to satisfactory review. The NHREC gives accreditation to the Independent Ethics Committee (IEC) and or Institutional Review Board (IRB) that give ethical opinion on study protocols depending on the number of trial sites involved.

NAFDAC allows users to apply for product registration and register details of current NAFDAC approved products on the NAPAMS portal. There is also the e-license application that allows NAFDAC clients to digitize their already issued certificates and permits.