Indonesia

Pharmacovigilance in Indonesia is regulated by BPOM under BPOM Regulation No. 4 of 2026. The MAH/PV operator must designate a pharmacovigilance responsible person and deputy domiciled in Indonesia and maintain the national pharmacovigilance-system documentation required by BPOM, including the Ringkasan Sistem Farmakovigilans (Pharmacovigilance System Summary). Serious reportable cases are submitted within 15 calendar days and non-serious reportable cases within 90 calendar days, subject to the categories and procedures of the 2026 rule. Periodic safety reporting, risk-management, signal activities and regulatory supervision/inspection apply according to product status and BPOM requirements. The BPOM source remains the regulatory authority for Indonesia. Where the cited public sources do not expressly define pharmacovigilance system file, ICSR reporting route and timelines and risk-management plan, 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): How to Prepare and Comply with a Pharmacovigilance Inspection.