Ghana

Pharmacovigilance activities in Ghana are regulated by the Food and Drugs Authority (FDA Ghana) under the Public Health Act, 2012 (Act 851) and national pharmacovigilance guidelines. MAHs must establish and maintain a pharmacovigilance system and permanently appoint a QPPV who is resident in Ghana, together with appropriate back-up arrangements. The pharmacovigilance system, including the PSMF, is subject to FDA GVP inspection. Serious adverse reactions received by the MAH or Local Representative must be reported to the FDA within 7 calendar days. MAHs are also subject to local and international literature monitoring, PSUR/PBRER requirements, risk-management and RMP requirements where applicable, signal management, safety variations, post-authorisation safety activities, internal audits and routine or targeted GVP inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.