Pharmaceutical Registration in Korea Still Slow

In late 2022, the Korean Pharma Association did an evaluation of over 200 drugs that were approved in Korea between 2011 – 2022. Western countries and Japan have been able to reduce the review times for new drug approvals, but during this 10-year period, the review time in Korea increased by about 25%. In addition, new drugs in Korea trailed approvals in the West by 1.5 years. Thus, Korean patients in need of new therapies have had to wait.

Given this lag, Korea initiated the Global Innovative Products on Fast Track program (GIFT) in late 2022. Under the GIFT program, Korea hopes to expedite drugs in high need that are very innovative similar to the FDA’s “Breakthrough” program. The GIFT program will aid both foreign and domestic drug companies to expedite drug approval in Korea. Korea has the 4th largest drug market in Asia, and given the wealth of the people and government efforts to provide better products at more reasonable rates, drug companies should still be interested in the Korean market.

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.