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2 min read
Introduction
Understanding the approval pathway for any pharmaceutical product in Nigeria is essential for companies aiming to ensure smooth market entry and long-term Regulatory compliance. The National Agency for Food and Drug Administration and Control (NAFDAC) is the central authority responsible for drug registration, enforcing Regulatory requirements, upholding quality standards, and monitoring product safety.
Below are 11 key questions with detailed answers to help you navigate Nigeria’s drug registration and approval process effectively.
1. Who regulates the drug approval process in Nigeria?
National Agency for Food and Drug Administration and Control (NAFDAC) regulates all processes related to pharmaceutical product approval, including application review, manufacturing oversight, GMP inspections, and post-marketing surveillance to ensure national Regulatory compliance.
2. What documents are required to register a drug product in Nigeria?
Applicants must submit a complete technical dossier that meets NAFDAC’s Regulatory requirements. Mandatory documents include administrative data, GMP certificates, Certificates of Analysis, batch manufacturing records, labeling samples, and product samples for analysis.
Duly filled Application Form, proof of business registration, CoAs for the product, Evidence of payment of prescribed fees, Power of Attorney (for imported products), issued by the product manufacturer and notarized in the country of origin, Manufacturer’s Product License, Good Manufacturing Practice (GMP) certificate issued by the competent health/certifying authority of the product’s country of origin, Samples of the drug product and labels/packaging materials, Product dossier in CTD format, Evidence of marketing approval from other Regulatory agencies, Batch Manufacturing Records, etc.
3. How long does the drug registration process typically take?
Timelines vary: straightforward generic pharmaceutical product registrations can take 6–12 months, while novel or incomplete applications may take over a year. Pre-inspection, laboratory testing, queries, and corrections can affect the timeline.
4. Is pre-registration inspection mandatory for manufacturing facilities?
Yes. NAFDAC conducts pre-registration GMP inspections for both local and foreign facilities to verify that all Regulatory requirements for quality and safety are met.
5. Can foreign drugs be registered in Nigeria?
Yes, foreign pharmaceutical products can be registered, but the manufacturer must appoint a Nigerian agent responsible for all submissions, Regulatory communication, and post-approval Regulatory compliance.
6. What is the NAPAMS portal?
NAPAMS (NAFDAC Product Administration and Monitoring System) is the online platform for submitting, monitoring, and managing product registration applications, including uploads, tracking, and Regulatory communication.
7. What is the Collaborative Registration Procedure (CRP)?
The CRP accelerates registration for certain medicines approved or prequalified by the WHO, enabling faster access using existing robust assessments.
8. Are clinical trials required for drug registration in Nigeria?
Clinical trials are needed for new drug molecules and may be required for imported products. Most generics only require bioequivalence studies, unless otherwise determined by NAFDAC.
9. What about labeling requirements?
Labels must be in English, legible, and contain the product name, composition, usage instructions, batch number, expiry date, manufacturing date, manufacturer details, and the NAFDAC registration number.
10. How can a holder renew a drug’s registration certificate?
Registration is typically valid for five years. Renewal requires updated dossiers, proof of ongoing GMP compliance, sales data, and a review of current labeling.
11. Can NAFDAC reject or revoke a drug approval?
Yes. Approvals may be denied, suspended, or revoked for safety concerns, Regulatory breaches, misrepresentation, or report of adverse effects.
Conclusion: Simplifying Regulatory Compliance with Freyr
Achieving approval for a pharmaceutical product in Nigeria requires accuracy, strategic planning, and strict adherence to NAFDAC’s Regulatory requirements. Every stage—from dossier compilation to lifecycle management—demands robust Regulatory compliance and expert navigation.
Freyr Solutions supports global pharmaceutical companies with end-to-end Regulatory services, including dossier preparation, GMP support, NAFDAC submission management, labeling compliance, and post-approval assistance—ensuring faster and more efficient entry into the Nigerian market. Contact us to streamline your Regulatory pathway.
