Nauru

Medicines and pharmacy oversight in Nauru is administered through the Department of Health and Medical Services. Nauru substantially updated its health and pharmaceutical framework in 2025: the Nauru Trade Portal, a government-supported regulatory and trade information platform, lists the Pharmacy Act 2025, while Nauru’s RONLAW legal database provides access to the country’s current legislation. The Health and Medical Services Act 2025 is also confirmed in the current WHO country profile for Nauru, reflecting the country’s recent strengthening of national health governance. However, the publicly accessible Nauruan regulatory material reviewed does not establish a detailed Good Pharmacovigilance Practice framework for marketing authorisation Holders comparable with those available in larger jurisdictions. In particular, no publicly published national requirements could be identified establishing a local QPPV, PSMF, defined MAH ICSR reporting timelines, routine PSUR/PBRER frequencies, a standardized RMP requirement, or pharmacovigilance-inspection frequency. These requirements should therefore not be inferred from Australian, EU or other foreign pharmacovigilance rules. For medicines supplied in Nauru, applicable post-market safety reporting and any product-specific pharmacovigilance obligations should be confirmed directly with the competent Nauruan health authorities. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.