Nepal

Pharmacovigilance in Nepal is coordinated by the Department of Drug Administration (DDA) under the औषधि ऐन, २०३५ – amended २०८२. The DDA's Pharmacovigilance programme coordinates adverse-drug-reaction monitoring through national and regional centres, and the published regulatory divisions and responsibilities assign pharmacovigilance and inspection functions within the authority. The reviewed official material does not publish a comprehensive MAH-specific GVP framework establishing a Nepal-resident QPPV, PSMF, universal numerical MAH ICSR deadlines, fixed PSUR/PBRER frequencies, blanket RMP obligations or a dedicated routine GVP-inspection interval. Those requirements should not be imported from another jurisdiction. MAHs should maintain effective post-marketing safety monitoring, report through the applicable DDA channels and confirm current product-specific reporting, signal-management, risk-minimisation, recall and inspection obligations directly with the DDA. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection; Effective Signal Management in Pharmacovigilance.