Regulatory Updates
Sep 9, 2026•1 min read
Korea MFDS Expands GIFT Review to Include Patient Experience Data
The Korean MFDS revised its GIFT fast‑track guidelines, permitting patient‑reported symptoms, quality‑of‑life data, preferences, interviews, videos and written opinions as reference material for priority review of rare disease drugs.
Regulatory Updates
Sep 9, 2026•1 min read
MFDS revises GIFT review guidelines to include patient experience for rare disease drugs
South Korea's MFDS updated its GIFT fast‑track review criteria on March 28, adding patient real‑world experience to priority assessment for innovative rare‑disease therapies.