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National Agency for Food and Drug Administration and Control
National Agency for Food and Drug Administration and Control
National Agency for Food and Drug Administration and Control
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The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale, and use of food, drugs, cosmetics, medical devices, chemicals, and packaged water.[1][2]

Key Information

The agency is headed by Mojisola Adeyeye, who was appointed in 2017 by the President of the Federal Republic of Nigeria as the director-general. She completed her five-year term on 2 November 2022 and was reappointed for a second term on 1 December 2022.[3][4]

Formation

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The organisation was established to counter illicit and counterfeit products in Nigeria in 1993 under the country's health and safety law. Adulterated and counterfeit drugs are a problem in Nigeria. In one 1989 incident, over 150 children died as a result of paracetamol syrup containing diethylene glycol. The problem of fake drugs was so severe that neighbouring countries such as Ghana and Sierra Leone officially banned the sale of drugs, foods, and beverage products made in Nigeria.[citation needed]

Such problems led to the establishment of NAFDAC, with the goal of eliminating counterfeit pharmaceuticals, foods, and beverages products that are not manufactured in Nigeria and ensuring that available medications are safe and effective.

The formation of NAFDAC was inspired by a 1988 World Health Assembly resolution requesting countries' help in combating the global health threat posed by counterfeit pharmaceuticals.[5]

In December 1992, NAFDAC's first governing council was formed. The council was chaired by Tanimu Saulawa. In January 1993, supporting legislation was approved as Legislative Decree No. 15 of 1993. On 1 January 1994, NAFDAC was officially established as a parastatal of the federal ministry of health.[6]

NAFDAC replaced an earlier federal ministry of health body, the Directorate of Food and Drug Administration and Control, which had been deemed ineffective, partially because of a lack of laws concerning fake drugs.[citation needed]

Administration

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Chairman and council

The NAFDAC governing council is chaired by a chairman appointed by the president on the recommendation of the minister of health. The council members include:[7]

Three people from the general public are also represented on the council.

NAFDAC is divided into 20 directorates and several units, including:[8]

  • The legal unit, charged with offering legal advice on "law arising from employee-employer relationships and is the custodian of legal documents and all agreements relating to the agency."
  • The public relations unit, headed by the director-general's office. Its main function is to inform, sensitize, enlighten, and create awareness concerning the role of the agency. The agency is divided into eight directorates.
  • Internal audit that provides a means of measuring the effectiveness of the system of internal control and accounting and carries out special investigations.

Functions

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NAFDAC has various basic functions.[8] According to the requirements of its enabling decree, the agency was authorised to:

  • Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale, and use of drugs, cosmetics, medical devices, packaged water, and chemicals
  • Conduct appropriate tests and ensure compliance with standard specifications designated and approved by the council for the effective control of the quality of food, drugs, cosmetics, medical devices, packaged water, and chemicals.
  • Undertake appropriate investigation into the production premises and raw materials for food, drugs, cosmetics, medical devices, bottled water, and chemicals, and establish a relevant quality assurance system, including certification of the production sites and of the regulated products.
  • Undertake inspection of imported foods, drugs, cosmetics, medical devices, bottled water, and chemicals and establish a relevant quality assurance system, including certification of the production sites and of the regulated products.
  • Compile standard specifications, regulations, and guidelines for the production, importation, exportation, sale, and distribution of food, drugs, cosmetics, medical devices, bottled water, and chemicals.
  • Undertake the registration of food, drugs, medical devices, bottled water, and chemicals.
  • Control the exportation and issue quality certification of food, drugs, medical devices, bottled water, and chemicals intended for export.
  • Establish and maintain relevant laboratories or other institutions in strategic areas of Nigeria as may be necessary for the performance of its functions.

NAFDAC envisions that by making these functions known, its actions will be apparent "in all sectors that deal with food, cosmetics, medical devices, bottled water, and chemicals to the extent of instilling the extra need for caution and compulsion to respect and obey existing regulations both for healthy living and knowledge of certain sanctions or default. Despite the establishment of NAFDAC, the sale and use of fake drugs did not end. [check quotation syntax]

New amendments since 2001

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Dissatisfied with progress in combating fake drugs, President Olusegun Obasanjo's administration dissolved the management of NAFDAC in August 2000. In April 2001, a new management, with Dora Akunyili as director-general, was inaugurated.[9] The team reorganised the agency, which has been successful in the recent past due to three new federal policies:

  • The outright ban on the importation of drugs and other regulated products through land borders.
  • The designation of Calabar and Apapa seaports, Murtala Muhammed, and Mallam Aminu Kano International Airports as exclusive ports of entry for the importation of drugs and pharmaceutical raw materials.
  • Release of shipping and cargo manifests by the Nigerian Ports Authority, shipping lines, and airlines to NAFDAC inspectors.[9] For several years, Nigeria was drowned in an ocean of fake drugs. Then Dora Akunyili approached her job with zeal in order to rid the Nigerian drug market of fake drugs and contaminated water sold as "pure water."[10]

Controversies

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The activities of NAFDAC have been the subject of considerable scrutiny in recent years. The agency has drawn fire for being susceptible to overt government interference, subject to bribery, internal feuding, and constant rumours and allegations abound concerning the misappropriation of funds. In one high-profile (and typical) case, the former NAFDAC director of finance and accounts, Andrew Ademola Mogbojuri, alleged mass fraud in 2015 against the agency's director-general, Paul Orhii.[11] The agency claimed sour grapes were behind the allegation and labelled Mogbojuri's claim "misleading and cheap blackmail."

Orhii was also the subject of a sweeping fraud allegation by NAFDAC whistleblowers earlier in 2015. A petition was sent to Nigerian President Muhammadu Buhari, alleging frivolous contract awards and supplies, manipulated publicity efforts, donations, and international air travel racketeering.[12]

Some of the world's largest brewers have been caught up in NAFDAC scandals as well. From a 2013 report alleging bribery conducted by Guinness and Heineken:

Two multinational beer companies (Guinness and Heineken) have decided to do it the illegal way, which insiders alleged is to bribe officials of National Agency for Food and Drugs Administration Control (NAFDAC) to deny the manufacturers of local herbal gin accreditation, knowing that Nigerians who had been patronizing them will desist once they are not accredited by the agency. The bribes amount to millions of Naira.[13]Guinness was back in the NAFDAC glare in 2016. Having been fined about ₦1 billion in November 2015[14] for allegedly re-validating and using expired raw materials without prior approval, the multinational brewer responded with a lawsuit, which was quietly dropped in March 2016.[15]

Stakeholders

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NAFDAC ensures it maintains very close contact with a number of national and international organisations whose activities relate to its functions. Such organisations include the following.[16]

  • Consumer Protection Council of Nigeria (CPC)[17]
  • Standards Organisation of Nigeria (SON)[18]
  • National Drug Law Enforcement Agency (NDLEA)[19]
  • National Institute for Pharmaceutical Research and Development (NIPRD)[20]
  • Pharmacists Council of Nigeria (PCN)[21]
  • Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN)
  • Consumer Association of Nigeria
  • Institute of Public Analysts of Nigeria (IPAN)[22]
  • Pharmaceutical Society of Nigeria (PSN)
  • Association of Food, Beverage, and Tobacco Employees of Nigeria (AFBTE)
  • National Association of Government-Approved Freight Forwarders (NAGAFF)
  • Association of Nigeria Custom Licensed Agents (ANCLA)
  • Patent and Proprietary Medicine Dealers Association (PPMDA)
  • National Union of Road Transport Workers (NURTW)
  • National Association of Road Transport Owners (NARTO)

In order to keep in touch with the international scene for information, training, cooperation assistance, aid, and financing of specific projects, especially in these days of global and national austerity, the agency maintains close relationships with a number of international agencies, some of which include:

See also

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References

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Revisions and contributorsEdit on WikipediaRead on Wikipedia

National Agency for Food and Drug Administration and Control

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The National Agency for Food and Drug Administration and Control (NAFDAC) is a parastatal of Nigeria's Federal Ministry of Health, established by Decree No. 15 of 1993 (as amended by Decree No. 19 of 1999 and codified in the NAFDAC Act Cap N1 LFN 2004), with operations commencing in October 1992. Its core mandate encompasses regulating and controlling the importation, exportation, manufacture, advertisement, distribution, sale, and use of , drugs, , medical devices, , chemicals, and detergents to ensure their , , and through registration, , testing, and . NAFDAC gained prominence under the leadership of Professor , who served as Director-General from 2001 to 2008 and spearheaded aggressive campaigns against pharmaceuticals, which previously comprised up to 80% of drugs in circulation in Nigeria.68634-0/fulltext) These efforts included raiding illicit production sites, prosecuting offenders, strengthening import controls, and public destruction of seized fakes, resulting in a substantial decline in substandard and falsified medicines to approximately 10-20%.68634-0/fulltext) The agency's transformation during this period established it as a model for regulatory enforcement in developing economies, despite facing violent opposition from entrenched criminal networks. In recent years, NAFDAC has attained and retained Maturity Level 3 (ML3) status for medicines and vaccines regulation—the highest functional level short of full reliance—becoming the first African national regulatory to achieve this in 2022. This certification underscores its stable, effective systems for product evaluation, inspection, and market surveillance. Defining characteristics include ongoing operations to destroy billions of naira worth of goods annually and collaborations with international bodies, though enforcement actions such as market raids have occasionally drawn criticism for economic disruptions amid persistent challenges like porous borders and limited resources.

History

Establishment

The National Agency for Food and Drug Administration and Control (NAFDAC) was officially established in October 1992 as a specialized regulatory body under the Federal Ministry of Health, amid rising concerns over substandard, falsified, and products flooding the Nigerian market, which posed severe risks. This creation addressed the inadequacies of prior fragmented oversight, where drugs alone were estimated to comprise up to 80% of pharmaceuticals in circulation by the early , leading to widespread illness and deaths from ineffective or toxic substances. NAFDAC's formal legal foundation came via Decree No. 15 of 1993, promulgated by Nigeria's Federal Military Government, which transformed it into an autonomous parastatal with expanded powers to regulate the importation, exportation, manufacture, advertisement, distribution, sale, and use of , drugs, , devices, , chemicals, and detergents. The decree mandated the agency to enforce quality standards, conduct inspections and laboratory testing, issue certifications, and collaborate with to curb violations, while promoting industrial development through compliance guidelines. It also established a , chaired by a presidential appointee and comprising representatives from , industry, , and legal sectors, to oversee ; a Director-General, appointed for a five-year term (renewable once), served as chief executive responsible for day-to-day operations. The agency's directorates—covering administration, , registration, , laboratories, and narcotics—were outlined to support these functions, replacing weaker ministry directorates with a dedicated structure equipped for proactive surveillance and enforcement. This establishment marked a shift toward centralized, evidence-based grounded in scientific evaluation, though initial implementation faced resource constraints typical of Nigeria's post-oil boom economic challenges.

Major Reforms and Amendments

The National Agency for Food and Drug Administration and Control (NAFDAC) underwent its primary legislative amendment through Decree No. 19 of 1999, which revised the foundational Decree No. 15 of 1993 to enhance the agency's autonomy, expand its regulatory powers over , drugs, , and related products, and strengthen penalties for violations such as the production and distribution of items. This amendment, codified as the NAFDAC Act (Cap. N1, Laws of the , 2004), shifted NAFDAC from a directorate within the Federal Ministry of Health to a parastatal with greater operational independence, enabling more effective enforcement against substandard and falsified products. A transformative operational occurred under Director-General (2001–2008), who initiated a comprehensive restructuring to combat rampant , where substandard drugs constituted approximately 70% of the market in 2001. Key changes included banning unregulated drug imports via land borders to centralize inspections at seaports and airports, retraining competent staff while dismissing over 100 corrupt officials, and launching nationwide raids that destroyed billions of naira worth of fake products and led to hundreds of prosecutions. These measures, supported by public awareness campaigns and stakeholder workshops, reduced counterfeit prevalence to about 16.7% by 2006, aligning closer to standards. Subsequent reforms have focused on post-market surveillance and international harmonization, including 2019 regulations mandating control over active pharmaceutical ingredients for both imported and locally manufactured drugs to prevent substandard formulations at the source. In 2025, NAFDAC advocated for further amendments to the Act to impose or death penalties for severe offenses, amid ongoing challenges with falsified medicines contributing to risks. These efforts reflect persistent adaptation to global threats, though implementation has faced resistance from entrenched interests in informal markets.

Recent Developments

In August 2025, NAFDAC retained its (WHO) Maturity Level 3 (ML3) status for the regulation of medicines and , marking the closure of all critical recommendations from prior assessments and affirming the agency's stable, well-functioning regulatory capable of assuring the quality, safety, and efficacy of pharmaceutical products. This milestone builds on NAFDAC's prior advancements in and post-market surveillance, enabling it to conduct joint assessments with global partners. In July 2025, NAFDAC hosted the African ML3 National Regulatory Agencies Meeting in , convening heads from seven other WHO ML3 agencies to discuss harmonization of standards, , and collaborative enforcement against substandard and falsified medical products across the continent. The event, led by Director-General Prof. , emphasized data sharing and joint inspections to address cross-border threats, reflecting NAFDAC's growing role in regional regulatory leadership. NAFDAC established a dedicated Directorate for Vaccines, Biologics, and Medical Devices in to enhance oversight and support local production capabilities, including intensified plans for post-COVID-19 through strengthened institutional frameworks and partnerships with Nigerian firms. This restructuring aligns with broader efforts to reduce import dependency and bolster domestic biopharmaceutical infrastructure. In September 2025, NAFDAC launched the implementation of its Strategy and Roadmap for regulating trans-fatty acids (TFAs) in foods, aiming to limit industrially produced TFAs to below 2% of total fat content by 2025, in line with WHO recommendations to mitigate cardiovascular risks. The initiative includes monitoring compliance, reformulation incentives for industry, and public awareness campaigns. Enforcement actions intensified in 2024, with NAFDAC withdrawing 40 pharmaceutical products, cancelling registration for 4 others, and banning various consumables due to safety concerns, substandard quality, or falsification risks; this included destruction of over 491,000 seized and adulterated items worth millions of naira. Public alerts issued in 2024-2025 targeted specific fakes, such as Postinor-2 in August 2025 and falsified Oheal / in May 2024, underscoring ongoing post-market surveillance. In early 2026, NAFDAC issued further alerts on counterfeit and falsified drugs, including Public Alert No. 010/2026 (February 22) on WHO's notice of concern for products from Meril Diagnostics Pvt Ltd deemed falsified in Nigeria; No. 07/2026 (February 13) for counterfeit Dostinex (0.5 mg) tablets in batches GG3470 (exp. June 2027), LG8659 (exp. January 2026), and GG2440 (exp. April 2026); No. 05/2026 (February 6) for counterfeit Dermazin (1% Silver Sulphadiazine) Cream in fake batch MV5093; No. 01/2026 for falsified TAVANIC 500 mg Tablets; and No. 03/2026 for unauthorized and unregistered Risperdal 2 mg Tablets. NAFDAC advises the public to purchase medicines only from authorized suppliers, verify authenticity, avoid unregistered products, and report suspicions via 0800-1-NAFDAC or [email protected]. Updated (GMP) guidelines for pharmaceutical products took effect on November 26, 2024, incorporating risk-based approaches, enhanced documentation, and alignment with international standards to improve product quality and . Concurrently, the agency's 2024-2027 Strategic Plan outlined priorities for , , and risk-based regulation to sustain protections amid economic pressures.

Organizational Structure

Leadership and Governing Council

The Governing Council serves as the highest policy-making body of the National Agency for Food and Drug Administration and Control (NAFDAC), responsible for providing strategic direction, approving policies, and overseeing the agency's operations as outlined in the NAFDAC Act of 1993 (as amended). It comprises a chairman appointed by the President on the recommendation of the Minister of Health; the of the Federal Ministry of or a representative; the Director-General of the National Institute for Pharmaceutical Research and Development or a representative; the Director-General of the Standards Organisation of Nigeria or a representative; the Chairman of the or a representative; the Chairman of the Pharmacists Council of Nigeria or a representative; one representative each from the Pharmaceutical Group and the Food and Beverages Group of the Manufacturers Association of Nigeria; three members representing appointed by the Minister; and the Director-General of NAFDAC ex officio. Appointments for members other than the chairman are made by the Minister on recommendations from the relevant bodies, with terms of four years renewable once for non-ex-officio members. The Director-General functions as the , managing daily administration, implementing Council policies, and executing regulatory mandates, while also participating in Council deliberations. The position requires expertise in , , or related fields and is appointed by the President on the Minister's recommendation for a five-year term, renewable once. As of October 2025, the Governing Council is chaired by Dr. Mansur Kabir. Key members include Alh. Tukur S. Fada Tambuwal and Dr. Mufutau Bolaji Yahaya (both appointed by the Federal Government of Nigeria), alongside statutory representatives such as the Director-General of NAFDAC, Prof. Mojisola Christianah Adeyeye, who has led the agency since her appointment on November 11, 2017. The Council meets periodically to deliberate on regulatory frameworks, resource allocation, and alignment with national health priorities.

Directorates and Divisions

The National Agency for Food and Drug Administration and Control (NAFDAC) operates through a network of directorates, each led by a director and subdivided into specialized divisions to manage regulatory, administrative, , and activities. As detailed in the agency's 2024 organogram, over 20 directorates exist, coordinated under five coordinating directors overseeing thematic clusters such as evaluation, and agricultural oversight, market control and trade, and zonal operations. This structure supports NAFDAC's mandate to regulate , s, , medical devices, and related products across , importation, distribution, and post-market . Technical and regulatory directorates form the core of operations, handling product evaluation, registration, and safety assessments. For instance, the Drug Evaluation and Research (DE&R) Directorate includes divisions for clinical trials, vaccines and biologics, cosmetics and medical devices, herbal medicines and nutraceuticals, and pharmaceutical compliance oversight. Similarly, the Food Registration and Regulatory Affairs (FR&R) Directorate comprises divisions for food registration, made-in-Nigeria foods, food advert control, imported foods and feeds, and packaged water. Other key directorates address specialized risks and compliance:
  • Narcotics and Controlled Substances (NCS) Directorate: Divisions cover narcotics and psychotropic substances, controlled chemicals, inspection and monitoring, and drug demand reduction.
  • Pharmacovigilance (PV) Directorate: Includes operations, advocacy and collaborations, and the food and drug information center.
  • Food Safety and Applied Nutrition (FSAN) Directorate: Divisions handle bakery and baked products, packaged , storage and quick-service restaurants, and standards, and evaluation, storage, and quality.
  • Investigation and Enforcement (I&E) Directorate: Focuses on pharmaceuticals, products, and drinks, cosmetics, and chemicals and medical devices.
  • Chemical Evaluation and Research (CER) Directorate: Oversees chemical imports control, monitoring and , agro-chemicals control, and chemical research and review.
Laboratory services directorates provide analytical support, such as the Laboratory Services (Food) Directorate with facilities in locations including Oshodi Central, Agulu, , and for chemical and biological testing. The Vaccines, Biologicals, and Medical Devices Laboratory Services (VBM-LS) Directorate includes divisions for medical devices and sundries, vaccines and biologics, and . Administrative directorates ensure operational efficiency, including the Human Resources Management (HRM) Directorate with divisions for administration and personnel development, staff welfare and , and general services; the and Accounts (F&A) Directorate covering and expenditure , exports, budgeting, and financial administration; and the Information and Communication Technology (ICT) Directorate managing IT maintenance, , and user support. Legal Services (LeSD) handles regulatory inspection and litigation. Zonal directorates, such as North West, North East, and others, extend regulatory reach across Nigeria's regions, coordinating local enforcement and .

Zonal and Enforcement Offices

NAFDAC operates six zonal offices aligned with Nigeria's geopolitical zones to coordinate the oversight of state offices and enforce regulations on micro, small, and medium-sized enterprises at the zonal level. These offices facilitate localized , compliance monitoring, and rapid response to regulatory violations, supplementing the agency's central directorates. The zones and their covered states are as follows:
  • North Central Zonal Office: Benue, Kogi, Kwara, Nasarawa, , Plateau (with coordination extending to the Territory).
  • North East Zonal Office: Adamawa, Bauchi, Borno, Gombe, Taraba, Yobe.
  • North West Zonal Office: Jigawa, , Kano, Katsina, Kebbi, Sokoto, Zamfara.
  • South East Zonal Office: Abia, Anambra, Ebonyi, Enugu, Imo.
  • South South Zonal Office: Akwa Ibom, Bayelsa, Cross River, Delta, , Rivers.
  • South West Zonal Office: Ekiti, , , Ondo, Osun, Oyo.
Enforcement activities are primarily managed by the Investigation and Enforcement Directorate (IED), which ensures nationwide compliance through surveillance, raids, investigations, and destruction of substandard or falsified products. The IED headquarters is located at 10-15 Mobil Road, , , with outstation offices in (), (), and the Federal Capital Territory, , to support regional operations. It coordinates enforcement efforts across all directorates, zonal offices, and state offices, incorporating attached mobile police units and investigative police officers for executing arrests and seizures. Within , the IED maintains five divisional offices led by deputy directors, specializing in pharmaceuticals, chemicals and medical devices, , , and water and drinks, to address sector-specific violations. Supporting units include and miscellaneous offenses, legal advisory, , systems, and accounts, and administration and , enabling comprehensive handling of cases from gathering to prosecution. The directorate also engages in international collaborations, such as Operation Pangea targeting online sales.

Regulatory Functions

Scope of Oversight

The National Agency for Food and Drug Administration and Control (NAFDAC) exercises regulatory authority over the importation, exportation, manufacture, advertisement, distribution, sale, and use of food, drugs, , medical devices, packaged water, chemicals, and related processed products in , as stipulated in its enabling legislation. This mandate, derived from the NAFDAC Act (Cap. N1, Laws of the , 2004), aims to safeguard by enforcing standards for safety, quality, and efficacy, including the removal of harmful substances from regulated items. Oversight excludes raw agricultural products prior to processing but encompasses all stages of handling for items entering the consumer market. NAFDAC's purview specifically targets pharmaceuticals (including human drugs and biologics), where it evaluates and therapeutic claims; foods and , focusing on risks and nutritional labeling—for instance, under the NAFDAC Bread Regulations 2025, approved preservatives include calcium or sodium propionate (maximum 0.3% of wheat flour), sorbic acid (maximum 0.1%), acetic or lactic acid (maximum 0.04%), vinegar acid (5-6%), and anti-staling agents (maximum 0.4%), with calcium propionate being the most commonly used in the Nigerian bread industry for preventing mold and extending shelf life; and for safety against adulterants; and devices ranging from diagnostics to , ensuring functionality and sterility. Chemicals under are those integral to or packaging of the aforementioned products, such as excipients or preservatives. The agency also supervises clinical trials for drugs and biologics conducted in , requiring protocol approval and site inspections to verify compliance with international standards. This comprehensive framework applies nationwide, with provisions for border controls to prevent illicit entry of unregulated goods.

Product Registration and Evaluation

The product registration process at NAFDAC mandates that all regulated products—encompassing pharmaceuticals, food, cosmetics, medical devices, and chemicals—undergo evaluation for safety, quality, and efficacy before importation, local manufacture, distribution, advertisement, or sale in Nigeria. Applicants initiate the process by creating an account on NAFDAC's online portal and submitting a completed application form, along with a detailed product dossier that includes formulation specifications, manufacturing process descriptions, stability studies, analytical methods, and labeling details. For drugs, the dossier must demonstrate compliance with international standards such as those from the World Health Organization (WHO) for prequalification where applicable, including bioequivalence data for generics and clinical trial evidence for new entities. Evaluation is conducted primarily by the Drug Evaluation and Research (DER) Directorate for pharmaceuticals, involving administrative screening of the dossier for completeness, followed by testing of submitted samples to verify identity, purity, potency, and absence of contaminants or adulterants. Facility inspections assess adherence to Good Manufacturing Practices (GMP), evaluating aspects such as production controls, systems, personnel training, and environmental controls to mitigate risks. For food products, evaluation emphasizes nutritional content, microbial safety, and additive limits per standards, while cosmetics undergo checks for microbial limits, , and prohibited ingredients like mercury. Medical devices and diagnostics are classified by risk level (low, moderate, high), with higher-risk items requiring clinical performance data and conformity assessments. The timeline for evaluation targets 90 working days for food and cosmetics from dossier acceptance, extending to 240 working days for drugs due to the complexity of therapeutic claims and requirements. Imported products necessitate additional , including certificates of free sale, from the manufacturing country, and import permits, with evaluations cross-verifying against foreign regulatory approvals to ensure equivalence. Micro, small, and medium enterprises (MSMEs) benefit from a streamlined pathway, requiring fewer dossier elements and on-site vetting of samples, but still subject to the same core safety and quality benchmarks. Successful registration yields a unique NAFDAC number, valid for five years and renewable, which must appear on labels alongside batch numbers, /expiry dates, and dosage instructions to enable . Rejections occur if evaluations reveal non-compliance, such as substandard or unsubstantiated claims, prompting applicants to address deficiencies or appeal via administrative review. This framework aligns with NAFDAC's mandate under the National Agency for Food and Drug Administration and Control Act of 1993 (as amended), prioritizing over promotional assertions to safeguard .

Inspection, Enforcement, and Post-Market Surveillance

NAFDAC's inspection activities encompass routine and risk-based assessments of manufacturing facilities, distribution centers, and markets to verify compliance with Good Manufacturing Practices (GMP) and other regulatory standards. These inspections include pre-registration site visits, Good Distribution Practice (GDP) evaluations, and unannounced checks to detect deviations in production, storage, and handling of regulated products such as drugs, foods, and cosmetics. The agency's Inspector's Guide to GMP Inspection outlines protocols for onsite evaluations, emphasizing documentation review, facility audits, and sampling for laboratory analysis. In 2023, NAFDAC intensified risk-based foreign pharmaceutical inspections under its strategic plan to prioritize high-risk manufacturers. Enforcement measures involve investigating consumer complaints, conducting raids on illicit markets, seizing substandard or falsified products, and pursuing legal actions through prosecutions in federal courts. The Investigation and coordinates these efforts, including destruction of confiscated goods; for instance, in 2023, NAFDAC destroyed 135 truckloads of fake, , expired, and seized products. Recent operations, such as the to 2025 raid on open drug markets, removed unregistered, expired, and banned pharmaceuticals, while a 2025 drive in Onitsha's Head Bridge market targeted medical products. NAFDAC participates in international initiatives like Operation PANGEA against online illicit pharmacies and OPSON for seizures, with notable actions yielding ₦100 million in and beverages in 2017. Prosecutions have resulted in convictions, such as those in and courts for distributing fake drugs and cosmetics. Post-market surveillance (PMS) is managed by a dedicated directorate responsible for ongoing monitoring of regulated products' quality, , and efficacy after approval, including to track adverse drug reactions (ADRs) via a national database. Divisions handle specific categories: drugs and medical devices for efficacy assessments and complaint responses; foods for wholesomeness checks and Rapid Alert System for Food and Feed (RASFF) coordination; for ; and GDP for integrity to prevent falsified products through track-and-trace systems. PMS activities, such as surveys and laboratory testing of high-risk items from 2021 to 2023, revealed a 5.8% in quality assessments for selected medical products. Guidelines mandate collaboration with authorization holders for plans, recalls of defective products, and annual PMS reporting for registration renewals, ensuring continuous regulatory action against emerging risks.

Achievements and Public Health Impact

Reduction of Counterfeit and Substandard Products

NAFDAC has implemented post-marketing programs, including risk-based surveys and analyses, to detect and remove substandard and falsified medical products from circulation. These efforts have contributed to a documented decline in prevalence, from over 41% of medicines being or substandard prior to 2001 to approximately 10% by 2011, as measured through NAFDAC-conducted studies and international assessments. Independent analyses corroborate this trend, noting a drop from 67% in 2001 to around 5-10% in subsequent years, though recent estimates place it at 15-17% amid ongoing challenges. Enforcement actions, such as raids on open drug markets and seizures of unregistered products, form a core component of reduction strategies. In 2025 alone, NAFDAC destroyed , expired, and substandard drugs valued at over ₦15 billion in , following coordinated operations that targeted illicit distribution networks. Additional seizures included ₦20.5 billion worth of fake pharmaceuticals handed over by customs in in July 2025, highlighting inter-agency collaboration with entities like the and police. Between 2020 and 2025, such operations led to the sealing of 1,125 stores, 62 factories, and 108 warehouses, disrupting supply chains for falsified goods. Technological interventions have enhanced detection capabilities, including the deployment of TruScan handheld devices for on-site verification of product authenticity during field inspections. Complementary tools like mobile authentication services have empowered consumers and regulators to verify NAFDAC registration numbers, reducing the circulation of unapproved items in informal markets. Public awareness campaigns, town hall meetings, and media outreach further support these measures by educating stakeholders on identification and reporting. NAFDAC's strategic plan targets a of no more than 5% for substandard and falsified medicines by the end of , building on sustained and international alignments such as WHO guidelines. While progress is evident in reduced treatment failures and fewer reported incidents from contaminated products, persistent underscores the need for expanded laboratory capacity and enforcement resources.

Capacity Building and International Alignment

NAFDAC has prioritized staff training and development as a core component of its strategy, including targeted programs on international standards such as the International Council for Harmonization (ICH) E6(R3) guidelines, with a workshop held from April 7 to 9, 2025, to enhance oversight. The agency's 2024-2027 Strategic Plan explicitly outlines building staff and stakeholder capacities through specialized training initiatives to improve regulatory efficiency. This includes training supported by the Global Fund, which equipped 76 staff members across 36 states plus the Federal Capital Territory in monitoring adverse effects of treatments for AIDS, , and by November 2023. Additional efforts encompass zonal workshops for institutional drug safety officers and capacity building for contract research organizations (CROs), reviewers, and sponsors under ICH M13A guidelines. In alignment with global benchmarks, NAFDAC has pursued regulatory harmonization through adoption of ICH guidelines and collaboration with international bodies, including the United States Pharmacopeia (USP) Promoting Quality Medicines Plus (PQM+) program, which sponsored retreats toward World Health Organization (WHO) prequalification of laboratories. The agency coordinates foreign Good Manufacturing Practice (GMP) inspections and staff specialization programs via its Planning, Research, and Statistics Directorate to meet international quality standards. NAFDAC achieved and maintained WHO Maturity Level 3 (ML3) status, signifying a stable, well-functioning medicines regulatory system capable of reliance by other agencies, with confirmation from WHO in August 2025. To foster continental regulatory reliance, NAFDAC hosted the inaugural meeting of Africa's eight WHO-ML3 national regulatory agencies in in July 2025, following a February 2025 Memorandum of Understanding (MoU) among these bodies to enhance collaboration and access to quality medicines. This builds on earlier partnerships, such as with the U.S. (FDA) for food and drug safety checks initiated in 2013, and an MoU with the (WFP) in 2025 to bolster food safety efficiency. These initiatives reflect NAFDAC's integration into global and frameworks, including WHO-listed authority status for vaccine regulation.

Measurable Health and Economic Outcomes

NAFDAC's regulatory interventions have contributed to a substantial decline in the circulation of and substandard medicines, which previously posed severe risks to public health. In 2002, the estimated that approximately 70% of medicines available in were fake or substandard, correlating with elevated incidences of treatment failures, adverse reactions, and fatalities from ineffective or toxic products. Under intensified starting in 2001, NAFDAC reported an 80% reduction in drugs by 2005, achieved through raids, prosecutions, and public awareness campaigns that dismantled open drug markets and improved supply chain controls. More recent NAFDAC assessments indicate that substandard and falsified medicines now constitute 10-15% of the market, a figure lower than earlier WHO surveys but contested by some stakeholders who cite persistent open markets and sampling limitations as underestimating the true prevalence. This decline has been linked to fewer documented cases of mass poisoning and drug-related morbidity, though comprehensive longitudinal studies quantifying reductions in mortality—such as from treatment failures or resistance exacerbated by substandards—remain limited, with no direct attribution to NAFDAC in peer-reviewed epidemiological data. NAFDAC's system, established in alignment with WHO standards, has facilitated reporting of adverse drug reactions, enabling targeted recalls and contributing to safer product use, as evidenced by its retention of WHO Maturity Level 3 status in 2025 for medicines and vaccines regulation—the first sustained achievement by an African national regulatory authority. Economically, NAFDAC's port inspections and enforcement have generated direct fiscal recoveries, including over 700 million naira in evaded duties and fines in 2018 alone, with ongoing efforts preventing revenue losses from unregulated imports. By curbing proliferation, which fuels a parallel market estimated in the trillions of naira annually, NAFDAC has supported legitimate pharmaceutical growth, including local incentives that reduce import dependency and medicine costs—strategies emphasized by the agency's as key to long-term affordability. These measures enhance investor confidence and export potential, as reflected in NAFDAC's WHO-aligned maturity, though quantifiable GDP contributions or cost savings from averted health expenditures lack independent econometric validation in available sources.

Criticisms and Challenges

Corruption Allegations and Internal Issues

The National Agency for Food and Drug Administration and Control (NAFDAC) has faced multiple allegations of financial impropriety, including the unaccounted-for disappearance of approximately ₦500 million in agency funds prior to the tenure of Director-General Prof. , who assumed office in 2017 and publicly disclosed inheriting this shortfall alongside a ₦3.2 billion debt. group HEDA Resource Centre demanded an (EFCC) probe into these missing funds in August 2024, citing potential looting and urging recovery and prosecution. Earlier, the Independent Corrupt Practices Commission (ICPC) investigated NAFDAC for illegally expending over ₦14 billion of its generated revenue between 2006 and 2010, in violation of federal guidelines requiring remittance of such funds to government coffers. Staff-level corruption has also surfaced, notably in a 2025 case involving Mr. Ikoro Mang Ifendua, a NAFDAC employee accused of impersonating agency officials to foreign companies across multiple countries using forged NAFDAC documents, fake letterheads, certificates, and bogus revenue receipts to extract funds under . NAFDAC's internal investigation confirmed the fraud's legitimacy-mimicking tactics, leading to the agency's public disavowal and collaboration with international partners. Enforcement operations have drawn extortion claims, such as during the February 2025 closure of parts of Main Market, where a rights group alleged NAFDAC officials solicited bribes from traders to expedite reopenings or overlook violations, prompting calls for an internal probe. In June 2025, Nigeria's initiated an inquiry into NAFDAC's imposition of ₦700,000 fines on drug traders, amid accusations of systematic involving over 1,200 deployed security personnel. Internal governance challenges include long-standing recruitment irregularities; in July 2025, the on grilled NAFDAC for over two decades of skewed hiring practices that disregarded federal character principles, favoring certain regions and potentially enabling or . These issues have compounded perceptions of institutional vulnerabilities, though NAFDAC has implemented policies and digital reforms to curb sharp practices like in product registration.

Enforcement Limitations and Resource Constraints

NAFDAC's enforcement capabilities are severely constrained by chronic understaffing, with the agency employing approximately 2,000 personnel as of January 2025, compared to the estimated 10,000 needed to oversee regulatory functions for Nigeria's population exceeding 200 million. This deficit limits the frequency and scope of inspections, , and raids on illicit markets, allowing substandard and falsified products to persist despite registration of over 58,000 items. Director-General Prof. has stated that personnel shortages directly threaten core operations, including compliance monitoring and response to counterfeit threats, while inadequate funding restricts investments in skilled hires, laboratory upgrades, and equipment for advanced testing. NAFDAC's 2024-2027 Strategic Plan explicitly identifies insufficient staff strength and funding as primary barriers to effective enforcement, exacerbating challenges like porous borders and resistance from informal sector operators. These constraints result in fragmented oversight, with enforcement concentrated in urban areas while rural and border regions remain under-monitored, contributing to uneven compliance and ongoing circulation of unsafe goods. Limited resources also hinder sustained post-raid follow-ups and inter-agency coordination, as noted in assessments of regulatory gaps in combating food and drug adulteration.

Economic and Industry Burdens

The registration process for products under NAFDAC oversight imposes significant financial and operational costs on businesses, particularly small and medium-sized enterprises (SMEs) in the , , and sectors. Fees for product registration have historically doubled in some cases, such as the increase from ₦73,500 to ₦147,000 per product, alongside hikes in pack design changes to ₦84,000, which SMEs have described as stifling due to their limited capital reserves. Additional charges include 5% VAT on processing fees and international inspection costs of approximately ₦10,500 for foreign facilities, compounding the economic strain on importers and local manufacturers seeking . Delays in NAFDAC approvals further exacerbate these burdens by prolonging time-to-market, often due to requirements for physical inspections of overseas production sites and extensive reviews, which the Nigerian government has acknowledged hinder clearances. The process can exceed 60 working days even without applicant-induced holds, with non-compliance risking application cancellation, thereby increasing opportunity costs for businesses in a competitive market where rapid entry is critical. Regulatory policy shifts, such as enhanced and quality controls, have imposed expenses on local pharmaceutical firms, limiting their and contributing to higher prices amid dependencies. Enforcement actions, including facility raids and market closures, add direct financial liabilities, as targeted businesses must cover associated expenses like police deployment and , a practice criticized for shifting regulatory costs onto private entities. Crackdowns on illicit drug markets, while generating substantial fines—such as ₦2.5 billion from operations in , , and Aba in 2025—have forced structural relocations and compliance upgrades, imposing unjustified burdens on compliant operators affected by proximity to non-compliant ones. These measures, though aimed at curbing substandard products, strain industry resources, particularly for SMEs lacking the power of larger firms, and have been linked to broader complaints of multiple overlapping taxes that erode profitability.

Founding Legislation

The National Agency for Food and Drug Administration and Control (NAFDAC) was established under Decree No. 15 of 1993, promulgated by the Federal Military Government of on July 1, 1993. This legislation created NAFDAC as a parastatal agency under the Federal Ministry of Health, tasked with regulating and controlling the importation, exportation, manufacture, advertisement, distribution, sale, and use of food, drugs, , medical devices, and related products to ensure and safety. The decree empowered the agency to conduct inspections, enforce standards, and prohibit substandard or falsified goods, addressing prior fragmented regulatory efforts by the Directorate of Food and Drug Administration and Control. Decree No. 15 of 1993 outlined NAFDAC's governance structure, including a Governing Council appointed by the President and a Director-General as chief executive, with provisions for advisory committees on technical matters. It became operational on January 1, 1994, replacing ad hoc ministerial divisions and centralizing authority to combat widespread counterfeit pharmaceuticals and adulterated foods prevalent in Nigeria during the early 1990s. The founding decree was amended by Decree No. 19 of 1999, which refined operational powers, enhanced penalties for violations (such as fines up to ₦500,000 or for up to five years), and expanded scope to include and chemicals used in households or industry. These amendments addressed implementation gaps identified in the initial framework, strengthening enforcement amid rising threats from unregulated imports. In 2004, the legislation was domesticated as the National Agency for Food and Drug Administration and Control Act, Cap. N1, Laws of the (LFN) 2004, incorporating the 1993 and 1999 provisions into statutory law post-military rule, while retaining core functions without substantive changes to founding mandates. This codification ensured continuity under civilian governance, with the agency maintaining autonomy in regulatory decisions subject to ministerial oversight.

Evolving Regulations and Guidelines

NAFDAC has periodically revised its regulations and guidelines to incorporate international standards and address local challenges such as products and vulnerabilities. Early reforms in the focused on streamlining registration processes, reducing approval times from years to months through centralized evaluations and risk-based assessments, which improved access to essential medicines while enhancing quality controls. These changes were driven by of widespread substandard drugs, prompting stricter pre-market testing and post-market surveillance protocols. In alignment with global harmonization efforts, NAFDAC adopted elements of WHO and ICH guidelines, evident in updates to Good Manufacturing Practices (GMP) for pharmaceuticals, which were revised in 2024 to emphasize and quality systems for active pharmaceutical ingredients (APIs). Similarly, (GCP) guidelines were updated in 2025 based on ICH E6 (R3), mandating ethical standards, , and sponsor responsibilities for clinical trials conducted in to ensure trial reliability and participant safety. Recent regulatory evolutions include the 2025 Foods and Related Products Registration Regulations, which require mandatory registration, labeling transparency, and post-registration variation notifications to mitigate adulteration risks in the food sector. Food hygiene regulations updated in 2025 incorporate Hazard Analysis and Critical Control Points (HACCP) principles, covering water quality, pest control, and raw material sourcing to reduce contamination incidents verifiable through compliance inspections. For medical devices, 2025 regulations and 2024 GMP guidelines establish conformity assessments, including in-vitro diagnostics, aligning with ISO standards to address device failures observed in post-market data. NAFDAC's 2024-2027 Strategic Plan outlines ongoing reviews of regulations to strengthen enforcement, including amendments for digital traceability and , responding to data showing persistent gaps in rural compliance. These evolutions reflect causal links between updated guidelines and measurable declines in reported adverse events, though implementation challenges persist due to resource limitations.

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  122. https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/NAFDAC-Food-Hygiene-Regulations-2025.pdf
  123. https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2025/NAFDAC-Medical-Devices-including-In-vitro-Diagnostics-and-Related-Products-Regulations-2025.pdf
  124. https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/DER_Guidelines/Medical_Devices_2025/NAFDAC-Good-Manufacturing-Practice-GMP-for-Medical-Devices-IVDs-and-Related-Products-Guidelines-2024.pdf
  125. https://www.linkedin.com/posts/strenandblan_strenandblanpartners-commerciallawfirm-activity-7239599396407984129-5Ezt
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