NAFDAC Good Pharmacovigilance Practice Guidelines 2016
Guideline · Health
Policy date: 2016-01-01
Guidelines define standards for pharmacovigilance activities in Nigeria, including the detection, assessment, reporting, and management of adverse events for medicinal products. These guidelines target regulated entities, NAFDAC teams, and industry stakeholders. They aim to strengthen post-market safety monitoring and protect patients from adverse drug reactions.
NAFDAC Good Pharmacovigilance Practice Guidelines 2016
What Is This Policy?
Guidelines defining the standards for pharmacovigilance activities in Nigeria, including adverse event detection, assessment, reporting, and risk management for all medicinal products.
Who Does It Target?
Marketing authorisation holders and pharmaceutical manufacturers with products on the Nigerian market; healthcare professionals including doctors, pharmacists, and nurses required to report adverse events; NAFDAC's pharmacovigilance division; hospitals and health facilities; patients and their caregivers
NAFDAC teams Industry stakeholders
What Does It Aim to Achieve?
Strengthen post-market medicine safety monitoring to protect patients from adverse drug reactions and quality defects.
Key Features
Adverse Event Reporting: Requirements for healthcare professionals, patients, and manufacturers to report adverse events Manufacturer Obligations: Pharmacovigilance systems, periodic safety update reports, and signal detection Risk Management: Risk minimization measures and risk-benefit evaluation NAFDAC Pharmacovigilance Centre: National coordination of pharmacovigilance data and regulatory action
Current Status
Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply. Establish pharmacovigilance systems per guidelines Report adverse events through NAFDAC channels Submit periodic safety reports as required
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
The NAFDAC Good Pharmacovigilance Practice Guidelines are issued under the NAFDAC Act and operate alongside the National Health Act 2014, the Pharmacy Council of Nigeria Act, and the Medical and Dental Practitioners Act. International alignment is with the ICH E2 series of guidelines on pharmacovigilance, the WHO Guidelines on Safety Monitoring of Medicinal Products, and the African Medicines Regulatory Harmonization (AMRH) pharmacovigilance framework.