South Korea's MFDS to Increase New Drug Approval Fees to Expedite Review Process
Key Insights
The Ministry of Food and Drug Safety (search) (MFDS (search)) in South Korea will raise new drug approval fees from 8.83 million won to 410 million won starting January 1 next year.
MFDS (search) aims to shorten the review period for new drugs by ensuring GMP due diligence is conducted within 90 days of receiving applications.
The increased revenue will fund the expansion of review personnel by over 100 and enhance their training and infrastructure.
The South Korean Ministry of Food and Drug Safety (search) (MFDS (search)) has announced a significant increase in new drug approval fees, set to take effect on January 1 of the coming year. This decision, made after consultations with fiscal authorities, aims to expedite the drug review process and enhance the predictability of approval timelines for pharmaceutical companies.
The new fee structure will raise the cost of licensing a new drug from 8.83 million won ($6,300) to 410 million won. While the pharmaceutical industry has expressed concerns about the steep increase, the MFDS (search) maintains that the change is necessary to improve its review capabilities and infrastructure.
Streamlining the Approval Process
According to MFDS (search) officials, the increased fees will enable the ministry to conduct Good Manufacturing Practice (GMP) surveys within 90 days of application receipt and GCP surveys within 60 days of the first supplement. This expedited due diligence is expected to shorten the overall review period for new drugs.
"We will improve the consultation process to increase face-to-face contact," said Kim Young-joo, director of the General Approval Division. "We will increase the predictability of (approval) for complainants and shorten the review period for new drugs by ensuring that GMP (Good Manufacturing Practice) due diligence is conducted within 90 days of receiving applications."
Investing in Review Capacity
The additional revenue generated from the fee increase is earmarked for expanding the MFDS (search)'s review personnel by more than 100. The ministry also plans to invest in training programs to enhance the expertise of its reviewers.
"If we estimate the number of new drug license applications to be 26-30 per year, about 10 billion won will be secured (from the fee increase). Accordingly, we plan to expand the number of review personnel by more than 100," said Director Kim Choon-rae of the Drug Policy Division.
Addressing Industry Concerns
While acknowledging the industry's concerns, the MFDS (search) has indicated a willingness to review specific issues, such as potentially exempting new drugs with multiple contents besides main ingredients from additional fees and excluding new drugs for rare diseases from the approval fee. The ministry has stated that the increase will shorten the review period by 120 days, helping drug developers better understand the implications and benefits.
"We collected opinions from the pharmaceutical industry until last week," said Director Kim Choon-rae. "We have finalized the timing and process of the new drug approval fee increase, but we will adjust the details gradually."