Bhutan

Pharmacovigilance in Bhutan is regulated by the Bhutan Food and Drug Authority (BFDA). The official Pharmacovigilance Guide for Adverse Drug Reaction Monitoring and Causality Assessment identifies the national pharmacovigilance centre and states that MAHs are primarily responsible for the safety of their products, are obligated to report serious adverse drug reactions received for their products to the authority, and should include non-serious ADRs in Periodic Safety Update Reports (PSURs). BFDA subsequently reported revision of its Guideline for Pharmacovigilance of Human Allopathic Medicines, including medication-error provisions. The current public official materials do not establish an EU-style QPPV or PSMF requirement, so those requirements are not established without a specific current BFDA provision. Where the cited public sources do not expressly define ICSR reporting route and timelines, 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.