NAFDAC Guidelines for Registration of Drug Products Made in Nigeria
Guideline · Health
Guidelines establish requirements for registering drug products manufactured in Nigeria, including application dossiers and GMP inspections. They target local pharmaceutical companies and NAFDAC compliance teams. This ensures only safe and effective medicines reach consumers.
NAFDAC Guidelines for Registration of Drug Products Made in Nigeria
What Is This Policy?
Guidelines for registering pharmaceuticals manufactured in Nigeria, covering the full application dossier, bioequivalence requirements, GMP inspection, and post-registration obligations.
Who Does It Target?
Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders
What Does It Aim to Achieve?
Ensure only safe, effective, and quality-assured medicines from Nigerian manufacturers reach the market.
Key Features
Full Dossier: Quality, safety, and efficacy data per CTD format Bioequivalence: Studies required for generic products to demonstrate equivalence to reference products GMP Compliance: Current GMP certification from NAFDAC required Post-Registration: Obligations for pharmacovigilance, variation reporting, and renewal
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply with these guidelines. Prepare complete product dossier Obtain GMP certification for facility Submit registration application
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the Food and Drugs Act Cap F32 LFN 2004, the Pharmacists Council of Nigeria Act, the ICH Good Manufacturing Practice guidelines, WHO prequalification standards, and the Falsified Medicines guidelines adopted by Nigeria.