Yemen

Pharmacovigilance in Yemen is coordinated by the National Pharmacovigilance and Drug Safety Centre within the Supreme Board of Drugs and Medical Appliances. The National Pharmacovigilance Centre monitors medicines, evaluates safety information and supports regulatory action. Healthcare professionals, patients and pharmaceutical stakeholders can use the SBDMA adverse-reaction reporting form, which captures the patient, suspect product, reaction, concomitant therapy and reporter. The reviewed public sources do not set out a comprehensive MAH framework requiring a local QPPV, PSMF, fixed MAH ICSR deadlines, routine PSUR/PBRERs, a universal RMP, formal signal procedures or routine GVP inspections. The MAH should confirm these items, and any product-specific safety conditions, directly with the competent authority. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.