NAFDAC Guidelines for Post Marketing Surveillance in Nigeria
Guideline · Trade
Guidelines establish a framework for monitoring the safety and quality of NAFDAC-registered products after market release. They target regulated entities, inspection teams, and industry stakeholders. This helps detect and address safety issues promptly.
NAFDAC Guidelines for Post Marketing Surveillance in Nigeria
What Is This Policy?
Guidelines establishing the framework for monitoring the safety, quality, and effectiveness of NAFDAC-registered products after they have been approved and placed on the market.
Who Does It Target?
Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders
What Does It Aim to Achieve?
Detect and respond to safety issues, quality defects, and adverse reactions that may emerge only after widespread use of registered products.
Key Features
Adverse Event Reporting: Requirements for healthcare professionals and manufacturers to report adverse events Quality Monitoring: Market sampling and laboratory testing of registered products Risk Assessment: Evaluation of post-market safety signals and quality defects Regulatory Action: NAFDAC authority to restrict, suspend, or withdraw products based on post-market findings Pharmacovigilance: Manufacturer obligations to maintain pharmacovigilance systems
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply with these guidelines. Report adverse events through NAFDAC's pharmacovigilance channels Manufacturers maintain post-market surveillance systems NAFDAC conducts routine market monitoring
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), which empowers NAFDAC to make regulations, issue guidelines, and enforce standards. Operates alongside the Food and Drugs Act Cap F32 LFN 2004, the Standards Organisation of Nigeria Act 2015, and the Codex Alimentarius Commission standards adopted by Nigeria. Draws on WHO guidelines on post-market surveillance of medicines, the ICH E2 pharmacovigilance guidelines, and the Consumer Protection Council Act 2004 on defective product recalls.