Bangladesh

Pharmacovigilance in Bangladesh is regulated by the Directorate General of Drug Administration (DGDA) under the Good Pharmacovigilance Practices (GVP) Guideline for MAHs in Bangladesh (Version 01, effective September 2023). MAHs must establish an appropriate pharmacovigilance system and designate a Qualified Person for Pharmacovigilance (QPPV) based in Bangladesh and contactable by DGDA, with backup personnel available in the QPPV's absence. Serious adverse events for registered products must be reported to the DGDA ADRM Cell immediately and no later than 15 calendar days, and non-serious adverse events within 30 calendar days; these timelines also apply to follow-up information. All MAHs are required to prepare and maintain a Pharmacovigilance System Master File (PSMF), although submission to DGDA is required for MAHs involved in GVP inspections and when requested. The guideline also covers PSURs, RMPs, signal management, risk minimisation, quality systems, training, and pharmacovigilance inspections. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.