South Korea Pharmacovigilance Resources

South Korea's medicine-safety system is led by the Ministry of Food and Drug Safety (MFDS), with adverse-event collection and safety-information infrastructure supported by the Korea Institute of Drug Safety & Risk Management.

Core official resources

• MFDS — national regulator for medicines and the primary source for safety regulations, notices and guidance.
• MFDS medicines-safety reporting policy material — official policy material addressing medicines-safety information reporting and adverse-event reporting considerations.
• Drug Safety Information Portal — medicines safety and adverse-event information portal operated through the national drug-safety infrastructure.

Practical use

Search MFDS by the Korean terms for pharmacovigilance (약물감시), adverse events (이상사례) and risk management plan (위해성 관리 계획). Product-specific RMP obligations and post-marketing surveillance requirements should be checked against the current MFDS approval conditions and notices.