Brunei

Pharmacovigilance in Brunei Darussalam is administered by the Ministry of Health, Department of Pharmaceutical Services, through the National Adverse Drug Reaction Monitoring Centre (NADRMC). The official Brunei Darussalam Pharmacovigilance Guidelines require licensed manufacturers, wholesalers, importers and Product Licence Holders to have written ADR procedures and appoint personnel responsible for pharmacovigilance/product safety as the Ministry's safety contact, with current contact details provided to NADRMC. For registered products, fatal or life-threatening spontaneous ADRs occurring in Brunei should be reported as soon as possible or within 24 hours, but no later than 7 calendar days; other serious and non-serious spontaneous ADRs are also due no later than 7 calendar days, with complete/follow-up information within 8 additional calendar days. Foreign ADRs are not routinely submitted, except for an emerging safety issue or on request; relevant foreign regulatory safety actions must be notified within 7 calendar days. The guideline does not establish an EU-style QPPV or PSMF requirement. Where the cited public sources do not expressly define ICSR reporting route and timelines, 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.