Korea Introduces a New Accelerated Drug Approval System

Korea’s Ministry of Food and Drug Safety (MFDS) recently announced a new program titled –  Global Innovative Products on Fast Track (GIFT) which is similar to the US FDA’s breakthrough therapy designation system. The GIFT program is in addition to the already implemented 2020 Korean Fast Track Approval system. Under the Korean Fast Track system over the last 2 years, over 20 drugs have received fast track approvals including orphan, cancer, and COVID drugs. Approvals for fast-track drugs normally take less than 90 days (half the normal review time) with COVID vaccine approvals taking about 30 days. The GIFT program is geared towards further accelerating the review timeframes, especially for groundbreaking products. Products that show strong clinical development will be favored. Creative time-saving regulatory measures will be further implemented.