Papua New Guinea

Pharmacovigilance in Papua New Guinea is administered by the National Department of Health through its Pharmaceutical Services. The Department describes Medicines and Therapeutics Committees in hospitals as entry points for pharmacovigilance activities, including monitoring suspected adverse drug reactions and providing reports for onward transmission to the Uppsala Monitoring Centre. This framework places practical emphasis on facility-based detection, reporting, medicine-use review, and coordination with the national pharmaceutical programme. Publicly available national material does not clearly establish a comprehensive set of industry obligations requiring every marketing authorisation Holder (MAH) to appoint a resident QPPV, maintain a local PSMF, or follow separately defined national ICSR and periodic-safety-report timelines. Importers, suppliers, and authorisation holders should therefore confirm product-specific conditions with Pharmaceutical Services, maintain documented global safety processes and a reachable local contact, and ensure that serious or unexpected adverse reactions, product-quality defects, medication errors, recalls, and other urgent safety information are escalated promptly through the appropriate national or hospital channel. Where the cited public sources do not expressly define periodic safety reporting, risk-management plan, signal management and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.