Korea’s Ministry of Food and Drug Safety (MFDS) plans to make its approval system the world’s fastest by sharply reducing review timelines for drugs, biosimilars, and medical devices under its 2026 administrative plan. Biosimilar reviews will be shortened from up to 420 days to 240 days – supported by expanded parallel reviews, enhanced pre-application consultations, and dedicated review teams. The MFDS will also deploy AI-based review tools to streamline data assessment and documentation. Additional measures include a more relaxed requirement for medical device changes (only changes that may affect safety and efficacy need to be approved by the MFDS). In addition, the plan calls for regulatory support for AI and digital-based medical technologies to speed market entry and boost global competitiveness.
In addition, the MFDS plans to institutionalize humanitarian access to high-cost orphan drugs in 2026, building on the expansion of the rare disease treatment access achieved in 2025. The Ministry stated that it strengthened supply stability last year by mandating essential medicine supply, extending advance notice of shortages to 180 days, and importing 45 emergency unapproved drugs and medical devices for patients with rare and intractable diseases. Under its 2026 agenda, the MFDS will expand direct government supply of urgently needed treatments and formalize a humanitarian support program enabling pharmaceutical companies to provide high-cost orphan drugs free of charge before insurance coverage begins – while also reducing administrative burdens for these patients.
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.