The Global Innovative Product Fast-Track Review Support System (GIFT), launched by Korea’s Ministry of Food and Drug Safety, is significantly enhancing treatment accessibility for patients with severe and rare diseases. Since its introduction in August 2022, as part of the Regulatory Reform 1.0 initiative, the system has expedited the approval process for new drugs by 25 percent, reducing the average review period to 90 days. This initiative has been particularly impactful for rare and intractable diseases, with 55 items designated as GIFT targets and 39 receiving approval. The majority of these approvals are for rare diseases like myasthenia gravis and severe conditions such as pediatric neuroblastoma. The GIFT system has doubled its designations and approvals from 2022 to 2023, with some reviews completed in as few as 70 days. It has also facilitated faster insurance listings through a pilot project with the Ministry of Health and Welfare. Despite its success, the system faces challenges, including a shortage of specialized personnel and the need for better-prepared applications from pharmaceutical companies. To address these, the MFDS plans to strengthen its review workforce and encourage systematic submissions. Additionally, the ministry is launching the “HOPE Forum” to engage patient groups and the pharmaceutical industry in sharing information and fostering drug development.
How is Korea’s GIFT system accelerating treatment approvals for rare diseases?
