What is the NAFDAC Reliance Pathway and How Can Overseas Pharma Companies Use It?

The NAFDAC Reliance Pathway is an accelerated Regulatory route designed to help eligible pharmaceutical companies bring approved products to the Nigerian market more efficiently. By leveraging assessments, inspections, and approvals already conducted by recognized Stringent Regulatory Authorities (SRAs) and WHO Listed Authorities (WLAs), NAFDAC reduces duplication of Regulatory efforts while maintaining high standards for quality, safety, and efficacy. For overseas manufacturers seeking faster market access in Nigeria, understanding this pathway can provide a significant advantage.

Definition and Purpose

• The Reliance Pathway allows NAFDAC to recognize and give significant weight to prior assessments, GMP/GDP/GCP inspections, and decisions made by WHO Listed Authorities (WLA), ICH Observers, or other trusted reference authorities.
• The goal is to enable timely access to safe, effective, and quality-assured medicines, vaccines, and in-vitro diagnostics in Nigeria, reducing duplication of Regulatory work and speeding up market entry for eligible products.

NAFDAC recognizes the following as trusted reference authorities:

• World Health Organization (WHO) Listed Authorities (WLAs)
• Stringent Regulatory Authorities (SRAs)
• International Council for Harmonisation (ICH) Observers
• Veterinary International Conference on Harmonization (VICH) members
• Some regional and national authorities (as specified by NAFDAC)

Scope & Eligible Products

The reliance pathway is specifically applicable to:

• Drugs, vaccines, and in-vitro diagnostics
• Products that have already been registered/authorized by a stringent Regulatory authority (SRA)/WHO Listed Authority or equivalent authority for at least 6 months
• Products must be identical or sufficiently similar in quality, safety, and efficacy to those approved by the original SRA

How Does the Reliance Pathway Benefit Overseas Companies?

One of the key advantages of the reliance procedure is its ability to streamline Nigeria Drug Registration for eligible products. Instead of undergoing a full independent review from the beginning, applicants can leverage existing approvals and assessment reports from trusted Regulatory authorities, potentially reducing review timelines while still meeting NAFDAC's Regulatory expectations.

How Overseas Pharma Companies Can Use the Reliance Pathway?

1. Appoint a Local Representative

Overseas manufacturers must appoint a corporate entity in Nigeria (local representative) authorized to act on their behalf. The representative must provide legal documentation (e.g., Power of Attorney) confirming appointment.

2. Submit an Expression of Interest

• Companies must submit a formal written request (expression of interest) on company letterhead to the Director-General (NAFDAC), specifically stating intent to use the reliance pathway.
• The request is addressed to the Director, Drug Registration Regulatory Affairs (DRR) Directorate — submission may also be via email.

3. Submit Dossier and Documentation

• Provide the manufacturing site assessment/inspection reports like GMP certificates, and supporting documentation from the reference regulatory authority.
• Submit a full Common Technical Document (CTD) format dossier (unless otherwise instructed).
• Attach assessment and inspection reports, Marketing Authorization from the SRA/WHO Listed Authority, GMP certificates, and post-marketing surveillance data if available.

4. Verification and Abridged Review

• Through its NAFDAC Regulatory Reliance framework, the agency will verify the product's SRA registration (minimum 6 months registration with originating SRA).
• Product characteristics and local information must be aligned with that of the SRA authorization.
• NAFDAC performs an abridged assessment, focusing on quality, safety, and efficacy data, and may rely on SRA reports for decision making.

5. Final Decision & Market Authorization

• If all criteria are met, NAFDAC grants Pharmaceutical Market Authorization Nigeria, significantly reducing Regulatory timelines compared to full independent assessment.

Specific Regulatory/Documentary Requirements

Key Points for Overseas Pharma

• The pathway is not open to products on the NAFDAC Ceiling List, Import Prohibition List, or banned formulations.
• NAFDAC retains sovereignty in final decisions, even when relying on foreign reports.
• Applicants must strictly comply with all documentary and process requirements or risk delays/denial.

Summary

• The NAFDAC Reliance Pathway enables accelerated review for overseas pharma products already approved by recognized stringent authorities (SRA, WHO, etc.).
• Overseas companies must appoint a Nigerian corporate representative and formally apply for the pathway through an expression of interest.
• Submission of a full CTD dossier and relevant foreign regulatory documentation (assessment reports, GMP, etc.) is required.
• NAFDAC will verify the product’s SRA registration, perform an abridged assessment, and may require additional local data.
• If approved, registration timelines are shortened, but all NAFDAC procedural, legal, and documentary requirements must be met exactly.

The reliance process requires a close match between the Nigerian and reference market dossiers and ongoing compliance with local regulations. NAFDAC reserves independent decision-making authority despite using reliance for efficiency.

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