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Nigeria’s pharmaceutical Regulatory landscape is governed by the National Agency for Food and Drug Administration and Control (NAFDAC), the national authority ensuring public health protection through the regulation and control of pharmaceutical products. The NAFDAC product registration process is a mandatory step for both locally manufactured and imported drugs before entering the Nigerian market.
To ensure safety, efficacy, and quality, applicants must comply with the structured Regulatory framework NAFDAC has established. Below is the detailed, step-by-step process for drug registration.
NAFDAC Product Registration: Step-by-Step Procedure
1. Dossier Submission & Clearance
- Prepare a Common Technical Document (CTD) dossier containing administrative, quality, non-clinical, and clinical data.
- Submit one application / dossier per product to NAFDAC for registration via the NAPAMS portal Nigeria (NAFDAC Automated Product Administration and Monitoring (https://registration.nafdac.gov.ng/)
- The submission package to NAFDAC must include the product dossier (CTD), Application letter addressed to Director – General NAFDAC and notarized / legalized declarations and certificates as described in the NAFDAC Registration requirements. (https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/DR_And_R_Guidelines/Guidelines-for-Registration-of-Imported-Drug-Products-in-Nigeria-Human-and-Veterinary-Drugs.pdf)
- Obtain the Dossier Screening Clearance Letter, mandatory for both imported and locally manufactured drugs.
2. Administrative Document Submission
Prepare and upload essential administrative documents on the NAFDAC Automated Product Administration and Monitoring System (NAPAMS) portal, including:
- Application letter
- Evidence of business incorporation (Corporate Affairs Commission certificate)
- Notarized Declaration
- Power of Attorney / Contract Manufacturing Agreement
- Trademark registration evidence
- Certificate of Pharmaceutical Product (COPP-WHO Format)
- Manufacturing License/Certificate of Free Sale
- Current Good Manufacturing Practice (cGMP) of the manufacturing facility.
- Information on the manufacturers and local agent
3. Application & Processing Fee Payment
- Pay the relevant registration timeline and fees NAFDAC specifies through the NAPAMS portal. For imported drugs, apply and pay for an Import Permit for sample submission.
- Refer to https://www.nafdac.gov.ng/wp-content/uploads/Publications/Others/Press_Release_PDF/NAFDAC-2019-Tariff_Final_Combined.pdf for complete details on the fees payment as described by NAFDAC.
4. Document Vetting
NAFDAC reviews administrative and technical documents for compliance within 10 working days.
5. Import Permit (for Imported Products)
Upon satisfactory vetting, NAFDAC issues an official Import Permit authorizing sample importation for laboratory testing.
6. Product Sample Submission
Submit product samples to NAFDAC with Certificates of Analysis (CoAs) and proof of laboratory testing fee payment.
7. Laboratory Analysis & Vetting
Samples undergo safety, efficacy, and quality tests in recognized laboratories as part of the NAFDAC drug evaluation and approval process.
8. Good Manufacturing Practice (GMP) Inspection
- NAFDAC conducts a current Good Manufacturing Practice (cGMP) inspection of the manufacturing site.
- Inspections may be local or international, depending on the manufacturing location.
- Compliance with cGMP standards is mandatory for approval.
- For more Information on the Inspection of manufacturing facility, visit the Drug Evaluation and Research (DER) Directorate section of the Agency’s website.
9. Evaluation of Results
- To ensure satisfactory Dossier review, GMP standards of the production facility and laboratory analysis of product (where applicable), the Food and Drug Registration Committee (FDRC) NAFDAC, performs a technical and administrative evaluation and conducts approval meetings for the presented dossier data, laboratory test results, and GMP inspection outcomes.
- NAFDAC also holds the right to inquire from the applicant / manufacturer(s) on any queries during the evaluation, failure to respond promptly to queries or enquiries raised by NAFDAC on the application (within 90 working days) will automatically lead to the closure of the Application.
10. Notice of Registration & NAFDAC Registration Number (NRN)
Upon approval, NAFDAC issues a Notice of Registration and assigns a unique NAFDAC number to the product.
11. Approval Meeting
- The Registration and Evaluation Committee reviews the dossier, supporting documents, and results before granting final approval.
- For products approved at the meeting, an electronic Certificate of Product Registration or Listing is issued to the applicant.
12. Certificate of Registration
- After successful committee approval, NAFDAC issues the Certificate of Registration, valid for five (5) years.
- The registered product must comply with labeling, post-market surveillance, and renewal requirements.
Conclusion
The NAFDAC product registration process ensures that only safe and high-quality drugs are available in Nigeria. Understanding the NAFDAC registration steps—from dossier preparation to GMP inspection and final approval—ensures smooth compliance and faster approvals.
With its in-depth expertise in Regulatory compliance and local market understanding, Freyr Solutions supports companies in managing submissions, coordinating inspections, and navigating the NAFDAC product registration system efficiently facilitating a seamless pathway to market access in Nigeria.
