Honduras

Pharmacovigilance activities in Honduras are regulated by the Agencia de Regulación Sanitaria (ARSA) through the Centro Nacional de Farmacovigilancia (CNFV), created under Acuerdo No. 0534-ARSA-2024. The CNFV coordinates pharmacovigilance activities for pharmaceutical products throughout Honduras and is responsible for receiving and evaluating suspected adverse reactions and other safety problems, signal detection, benefit–risk evaluation, and the assessment and maintenance of records relating to Periodic Safety Reports and Risk Management Plans. Manufacturers, distributors, importers, exporters, marketers, dispensers and users of pharmaceutical products are required to notify the CNFV of product-safety problems. ARSA also provides for Informes Periódicos de Seguridad (IPS) and Planes de Gestión de Riesgo (PGR), with periodicity determined by ARSA. Based on the currently published national requirements, a specific EU-style QPPV or PSMF requirement could not be confirmed as a mandatory Honduran requirement. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.