NAFDAC Drugs and Related Products Registration Regulation
Regulation · Health
Regulations manage the registration of drugs and related health products in Nigeria, specifying application requirements and evaluation processes. They target pharmaceutical manufacturers, importers, and regulatory professionals. This ensures only safe and effective products enter the market.
NAFDAC Drugs and Related Products Registration Regulation
What Is This Policy?
The principal regulation governing the registration of all medicines, medical devices, and related health products with NAFDAC, specifying the application requirements, evaluation criteria, and approval process.
Who Does It Target?
Pharmaceutical manufacturers seeking to register products in Nigeria Importers of medicines and medical devices Regulatory affairs professionals NAFDAC Drug Evaluation and Registration Directorate
What Does It Aim to Achieve?
Ensure that only safe, effective, and quality medicines and health products are available in Nigeria through a rigorous evaluation and registration process.
Key Features
Application Dossier: Required documentation including product quality, safety, and efficacy data Facility Inspection: GMP inspection of manufacturing facilities as a prerequisite for registration Evaluation Process: Scientific assessment of product dossiers by NAFDAC evaluation teams Registration Certificate: Issuance of a NAFDAC registration number valid for a defined period Renewal: Re-registration requirements and renewal procedures
Current Status
Rollout Stage: Active Coverage: All medicines, medical devices, and related products Lead Agency: NAFDAC, Drug Evaluation and Registration Directorate
How to Access
Manufacturers and importers apply through the NAFDAC online portal. Prepare a complete product dossier per NAFDAC requirements Submit through the NAFDAC online registration platform Undergo facility inspection and product evaluation Receive registration certificate upon approval
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.