Kiribati

Medicines oversight in Kiribati is carried out by the Ministry of Health and Medical Services (MHMS). The available Pacific Community (SPC) pharmaceutical regulatory profile describes the national medicines framework and Medicines and Therapeutics Committee under the Medicines Act 2016. It does not identify a country-specific MAH requirement for an EU-style QPPV or PSMF/PSSF, fixed serious/non-serious ICSR timelines, a universal PSUR/PBRER schedule, a universal RMP/signal-management obligation, or a specific routine MAH pharmacovigilance-inspection programme. Product- and registration-specific safety obligations therefore depend on MHMS requirements. The SPC profile is a regional supporting source rather than a Kiribati national authority publication. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.