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Using Foreign and International Clinical Data

MFDS generally accepts well-conducted foreign clinical data when:

  • Study population comparable to Korean patients
  • Same intended use as applied for in Korea
  • Conducted per GCP principles (ICH E6 or ISO 14155)
  • Published in peer-reviewed journals or from major regulatory submissions (FDA, CE, TGA)

When MFDS may require a Korean trial​

  • Safety concerns requiring Korean-specific investigation
  • First-in-class with limited global experience
  • Patient population or treatment pathways differ significantly in Korea

Bridging studies​

A smaller Korean bridging study may satisfy MFDS instead of a full trial where the key finding to verify is performance in Korean patients.