Laos

Pharmacovigilance in Lao PDR is overseen by the Ministry of Health, Food and Drug Department (FDD). The amended Law on Medicines and Medical Products (2025) requires relevant entities to maintain adverse-reaction surveillance and reporting arrangements. The accessible law does not establish a universal EU-style QPPV title or residency rule, an EU PSMF requirement, a universal 15/90-day MAH ICSR timetable, or a fixed PSUR/PBRER schedule. FDD lists a pharmacovigilance guideline on its Lao-language guidance pages; detailed MAH-specific requirements should be checked against the current FDD guideline and product-specific instructions before use. Risk-management and regulatory-oversight obligations follow the applicable national requirements. Where the cited public sources do not expressly define 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.