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The National Agency for Food and Drug Administration and Control (NAFDAC) is a statutory Regulatory authority under the Federal Ministry of Health in Nigeria. Established by Decree No. 15 of 1993 (amended by Decree 19 of 1999, now cited as NAFDAC Act Cap N1 LFN 2004), NAFDAC’s mandate is to safeguard public health by regulating and controlling a comprehensive range of products and industry practices. It is the central authority for ensuring that only safe, effective, and quality products circulate in Nigeria, and for protecting public health from fake or substandard goods.

Mandate and Legal Foundation 

  • NAFDAC’s legal framework is set by the NAFDAC Act Cap N1, Laws of the Federation of Nigeria 2004.
  • The agency’s core mandate is to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of:

Key Functions 

NAFDAC’s main responsibilities include:

  • Registration/Authorization of all regulated products to ensure only safe, effective, and quality products are marketed and used.
  • Inspection of manufacturing, import, storage, distribution, and retail sites for compliance with quality standards such as Good Manufacturing Practice (GMP).
  • Import and export control by inspecting products at ports of entry and exit.
  • Pharmacovigilance and post-marketing surveillance to monitor safety and quality in the market.
  • Clinical trials oversight for new medicines and vaccines (authorization and monitoring of trials).
  • Market Regulation – regulation of advertisement and promotion of medical products.
  • Combating counterfeit and substandard products—active enforcement and surveillance to protect the public from fake or forged drugs and foods.
  • Product recall management for unsafe or defective products.
  • Enable Regulatory harmonization and collaborate with local and international agencies to align Regulatory standards.
  • Regularly updates its guidelines and implements best international practices.

Institutional Structure 

  • NAFDAC is led by a Director General, reporting to a Governing Council made up of government appointees and heads of related Regulatory bodies.
  • The agency maintains multiple directorates and departments, including Drug Evaluation & Research, Ports Inspectorate, Laboratory Services, and Enforcement.

Quality and Global Recognition 

  • NAFDAC operates an e-registration system (NAPAMS) for regulated products.
  • Recognized by the World Health Organization (WHO) as a Maturity Level 3 (ML3) National Regulatory Authority. This status confirms that NAFDAC has advanced, robust systems for effectiveness, quality, and safety oversight for medicines and vaccines (one of the highest ratings for national medicine Regulatory authorities in Africa).

Stakeholders and Customer Service 

  • Primary stakeholders include manufacturers, importers, exporters, distributors, healthcare professionals, marketers, wholesalers, retailers, Public Health Councils, NGOs, Agencies, Programs, Patients and consumers of regulated products.
  • NAFDAC prioritizes transparent, customer-oriented services, consistent with its SERVICOM Charter, ensuring accountability and responsiveness.

Public Interaction and Complaint Management 

  • NAFDAC offers clear complaint channels, publicizes its standards, and regularly consults with stakeholders.
  • Contact information:
    • Website: https://nafdac.gov.ng/
    • Customer Lines: 07001NAFDAC (07001623322) for enquiries, 08001NAFDAC (08001623322) for complaints
  • All grievances/complaints are acknowledged within 2 days and are meant to be resolved, with a response provided within 2 weeks.

Impact 

  • NAFDAC’s work has been instrumental in removing counterfeit drugs/foods from the market and ensuring that Nigerians have access to quality, safe, and effective regulated products.
  • The agency actively collaborates nationally and internationally on Regulatory harmonization and continual improvement.

Summary 

  • NAFDAC is Nigeria’s leading Regulatory authority ensuring the safety, quality, and effectiveness of foods, medicines, medical devices, cosmetics, chemicals, and packaged water.
  • Established in law, its scope covers from registration, inspection, and market monitoring to enforcement and combating counterfeiting.
  • Holds World Health Organization recognition (ML3) for advanced Regulatory capability, and operates a structured, customer-focused service mandate.
  • NAFDAC plays a critical public health protection role, working continually to improve standards and market safety in Nigeria.

Conclusion:

NAFDAC plays a pivotal role in safeguarding public health in Nigeria by enforcing strict Regulatory standards across the product lifecycle—from registration to post-market surveillance.

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