ARCSA operates Ecuador's national pharmacovigilance framework through the Centro Nacional de Farmacovigilancia (CNFV).
Core official resources
- ARCSA — national regulatory authority and pharmacovigilance material.
- Industry adverse-event reporting instruction — detailed official instructions for holders of sanitary registrations and pharmaceutical establishments.
Important national distinction
ARCSA's current published instruction directs holders of sanitary registrations to submit suspected medicine adverse events through eReporting Industria, using manual entry or E2B upload as applicable. Yellow-card or other alternative channels are retained only for exceptional justified circumstances under the instruction.