National Quality Assurance Policy for Medicines and Other Health Products
Policy · Health
A Policy strengthens systems for assuring the quality, safety, and efficacy of medicines and health products in Nigeria. It targets pharmaceutical manufacturers, importers, and regulatory personnel to enforce standards. This protects public health by ensuring only safe products are used.
National Quality Assurance Policy for Medicines and Other Health Products
What Is This Policy?
A policy framework that strengthens the systems for assuring the quality, safety, and efficacy of medicines, vaccines, diagnostics, medical devices, and other health products throughout their lifecycle in Nigeria.
Who Does It Target?
Pharmaceutical manufacturers and importers Quality control laboratories NAFDAC regulatory personnel Healthcare providers and procurement agencies
What Does It Aim to Achieve?
Protect public health by ensuring that only quality-assured medicines and health products are manufactured, imported, distributed, and used in Nigeria.
Key Features
Regulatory Strengthening: Enhanced capacity for NAFDAC to conduct registration, inspection, and post-market surveillance Quality Control Laboratories: Upgrading and accreditation of national and zonal drug quality testing laboratories Good Manufacturing Practice: Enforcement of GMP compliance for local pharmaceutical manufacturers Pharmacovigilance: Expanded systems for detecting and responding to adverse drug reactions and quality defects Anti-Counterfeiting: Technologies and enforcement measures to combat counterfeit and substandard health products
Current Status
Rollout Stage: Active with progressive strengthening Coverage: All health product manufacturers, importers, and distribution channels Lead Agency: NAFDAC Partners: WHO, USP, Global Fund, development partners
How to Access
The policy is operationalized through NAFDAC regulatory activities. Manufacturers and importers comply with NAFDAC registration and GMP requirements Healthcare facilities procure only NAFDAC-registered products Report suspected substandard or counterfeit products to NAFDAC
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC Headquarters, Abuja
Legal Framework
Operates under the National Agency for Food and Drug Administration and Control Act 1993, the Food and Drugs Act Cap F32 LFN 2004, the National Health Act 2014, and the Pharmacists Council of Nigeria Act. Draws on WHO guidelines on quality assurance of pharmaceuticals, the ICH Q10 Pharmaceutical Quality System, and the WHO Prequalification Programme standards.