South Korea

Pharmacovigilance in the Republic of Korea is regulated by the Ministry of Food and Drug Safety (MFDS) with national adverse-event data managed through the Korea Institute of Drug Safety and Risk Management. Korea uses the statutory Korean role of Safety Management Officer, rather than the EU title QPPV. The current Regulation on Safety of Pharmaceuticals requires marketing-authorisation holders and importers, subject to specified exceptions, to appoint at least one appropriately qualified Safety Management Officer and comply with post-marketing safety-management duties. The official Standards for Post-Marketing Safety Management require written procedures, trained personnel, documented collection and evaluation of safety information, risk-management activities and periodic self-inspection. Serious adverse drug reactions must generally be reported within 15 days of awareness through the accepted Korean reporting system. Korea does not simply apply the EU PSMF/QPPV model; the required local safety-management documentation, periodic safety reporting, re-examination or risk-management commitments depend on the product and its approval conditions. Companies should therefore confirm the current Korean-language MFDS requirements and electronic reporting route for each product. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.