Cuba

Pharmacovigilance activities in Cuba are overseen by the Ministry of Public Health (MINSAP) and the Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED). Under the Buenas Prácticas de Farmacovigilancia para la industria farmacéutica, holders of sanitary registration must maintain a documented pharmacovigilance system and designate a qualified Responsable de Farmacovigilancia (RFV) as the contact with CECMED. Serious adverse reactions received by the registration holder must be communicated immediately, preferably within 24 hours and no later than 72 hours after awareness. The framework also covers periodic safety reports (IPS), risk-management plans when appropriate, post-authorisation safety activities, literature and signal evaluation, quality assurance and periodic internal audits, and CECMED pharmacovigilance inspections. Current CECMED signal-management requirements additionally provide a national process for pharmacovigilance signal management. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.