Ecuador

Pharmacovigilance activities in Ecuador are regulated by the National Agency for Regulation, Control and Health Surveillance (ARCSA) through the National Pharmacovigilance Centre (CNFV). Under the current national pharmacovigilance framework, marketing authorisation Holders (MAHs) must establish and maintain an effective pharmacovigilance system and formally designate a qualified Responsible Person for Pharmacovigilance (RFV), resident in Ecuador, together with a deputy where applicable. MAHs must maintain an up-to-date Pharmacovigilance System Master File (AMSF/AMFV), submit serious adverse-event reports within 15 days and non-serious reports within 30 days through the applicable electronic reporting system, and maintain traceable safety records. MAHs are also responsible for periodic safety reports (IPS/PBRER), benefit-risk and signal evaluation, Risk Management Plans (PMR/PGR) when required by ARCSA, risk-minimisation measures, scientific-literature surveillance, quality-system activities and periodic pharmacovigilance audits. The Sistema Nacional de Farmacovigilancia provides the national reporting framework. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.