Korea MFDS Expands GIFT Review to Include Patient Experience Data

On the 28th, the Ministry of Food and Drug Safety (MFDS) under Director‑General Oh Yu‑kyung announced a revision to the guidance for priority‑review designation applications. The amendment allows patient experience data—such as self‑reported symptoms, quality‑of‑life measures, treatment preferences, patient and caregiver interviews, patient‑generated videos, and written comments—to be used as reference material in the evaluation of Global Innovation Products Fast‑Track (GIFT) designation for rare and severe disease therapies. This change aims to capture real‑world patient perspectives that are difficult to reflect through clinical trial metrics alone, enhancing the assessment process for innovative treatments.