As mentioned in our earlier newsletter, Korea has implemented a new drug approval system to expedite drug approvals, which began on January 1, 2025. To do so, the MFDS has increased its fees by 50x to hire more staff, etc. However, the industry has complained that these significantly higher fees are unacceptable. The new drug approval system will offer four main benefits – 1. A dedicated MFDS review team will focus on each product, 2. The number of times a drug company can consult and review information with the MFDS has been expanded from a maximum of three times to ten times, 3. Results of all interactions with drug companies, and the MFDS will now have meeting notes in writing, and 4. GMP evaluations for new drug manufacturing sites will be conducted within 90 days of getting the approval application.
Korean GMP regulations have also been revised to expedite drug registrations. The number of documents that drug companies need to submit for KGMP will be synthesized and reduced from 11 types to 4. For GMP certification, production sites in the past needed to have an on-site audit every 3 years, but now for drug factories with no big changes, the GMP license can be extended 2 more years via written correspondence with MFDS, without an on-site audit.
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.