Drug reviews in Korea take a lot longer than in other advanced global markets. The current MFDS review time is about 420 days, and the new plan is to reduce this to 295 days. To do this, the MFDS is going to dramatically increase its fees to fund additional staff and resources. Drug registration fees will be increased from 8.8 million won (US $6,500) to 410 million won (USD $306,000) a 50x increase. Despite this large increase, the KFDS claims that their new fees will be in line with other ICH member countries. To alleviate this burden on smaller drug and biotech companies with innovative new drugs, their registration fees will only be 50% of the new MFDS fees, and subsequent approvals by the same company will only be 10% of the fees outlined above.
As mentioned above, the new program looks to add more qualified reviewers. Currently, doctors, pharmacists, and people with at least 3 years of post-doctoral experience only make up about 30% of the MFDS review staff. Going forward, this percentage of “qualified” reviewers will increase to 70%. In addition, once a new drug registration has been sent in, a committed team of 10-15 accomplished specialists will be put together to focus on that specific drug. Also, Korean drug factory inspections, for new drug approvals, will be reduced to 90 days. Finally, the new plan will also reduce the average approval times of new medical devices from 300 days to 235 days. Quicker reviews will get new healthcare products to Korean patients faster.
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.