Nigeria

Pharmacovigilance in Nigeria is regulated by the National Agency for Food and Drug Administration and Control (NAFDAC) through its Pharmacovigilance (PV) Directorate and published pharmacovigilance regulatory guidance. The Good Pharmacovigilance Practice Guidelines require the MAH to operate a pharmacovigilance system and maintain a PSMF. The Guidelines for Qualified Person for Pharmacovigilance require a QPPV who resides and operates in Nigeria, with backup arrangements. Serious post-marketing ICSRs are due within 15 calendar days and non-serious cases within 90 days. For new drug molecules, PSUR/PBRERs are submitted at least six-monthly for two years, annually for the next three years and every five years thereafter. MAHs must manage safety signals and maintain or update RMPs where applicable. The Pharmacovigilance Inspection Guidelines for Nigeria Regulated Drugs provide for inspection of the MAH's system, organisation, procedures, documentation and regulatory compliance. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.