The Korean Ministry of Food and Drug Safety (MFDS) plans to continue strengthening its support for innovative medical products, including new drugs, advanced biopharmaceuticals, and medical devices. The effort is meant to expedite the development and market release of innovative healthcare solutions.
At a recent conference, the National Institute of Food and Drug Safety Evaluation (NIFDS) a division of the MFDS, introduced the GILJABI (Guiding Insight to Lead the Journey toward Advanced and Breakthrough Innovative Products) system. This program offers early-stage guidance to researchers and innovative companies through the regulatory process. From June 2025, twenty innovative products will be selected to receive strong government support starting from the early development stage to final product approval.
Another program in Korea for fast-tracking innovation is the GIFT program, which was initiated in 2021 to expedite innovative drug approvals. The MFDS has been trying to increase transparency through publicly accessible information regarding drugs under the GIFT program, such as the mechanisms of action, clinical data, and potential side effects. In addition, a new forum called the HOPE Forum will be initiated this year for public consultations by industry stakeholders with patients on rare disease treatments.
Furthermore, the government is facilitating collaboration among different agencies to ensure faster patient access to treatments. The GIFT program is now integrated with the health insurance evaluation system, which enables real-time data sharing and streamlined reimbursement decisions. Thanks to this initiative, the neuroblastoma drug Qarziba (dinutuximab beta) was able to secure insurance coverage within six months of approval. The reimbursement process generally takes over one year in Korea.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.